3Spine Gains IDE Approval for Clinical Trial

3Spine's MOTUS device replaces the function of the disc and facet joints through a posterior approach.

Study: Injectable Gel May Reduce Chronic Low Back Pain

The image-guided procedure from ReGelTec could potentially offer a treatment for degenerative disc disease.

Lipogems To Launch Study to Treat Knee Osteoarthritis

Lipogems will conduct an IDE study for treatment of knee osteoarthritis compared to corticosteroids for a period of 12 months.

Study Compares Premia Spine’s TOPS to TLIF

Results suggest that TOPS Spinal Arthroplasty is cost-effective compared with TLIF. Further, TOPS becomes the dominant strategy when data is examined at 2+ years.

Study Results: Bioretec Bioresorbable Elastic Activa IM-Nail

The bioresorbable elastic intramedullary nail Activa IM makes implant removal operations redundant.

Kuros MagnetOs: First Trial Results

Kuros Biosciences announces favorable preliminary results for MagnetOs as standalone alternative to autograft in its first randomized controlled trial.

Study Results: In Favor of Fully Personalized Knee Replacements

The study supports Conformis' assertion that knee replacements that are fully personalized may be best to limit post-op pain and optimize satisfaction.

Study Results: XPERIENCE Reduces Bacteria, Biofilms

The no-rinse solution demonstrated persistent efficacy against both planktonic bacteria and bacterial biofilms in total hip replacement.

First In-Human Use of ReVivo Medical Cervical Fusion Devices

Study participants will receive ReVivo's next-gen cervical plate and interbody cages used in anterior cervical discectomy and fusion.

Study: Stryker InSpace in Rotator Cuff Tears

The study compared the InSpace balloon with partial repair to treat full-thickness massive irreparable tears.

Study Results: Bioretec ActivaPin in Pediatric Fracture

Bioretec's ActivaPin bioresorbable implant demonstrated excellent clinical outcomes in the treatment of pediatric wrist fractures.

100 U.S. Patients Treated in Clinical Trial of Baguera C Spinal Disc

The BAGUERA C cervical disc implant is designed to maintain the natural behavior of a functional spinal unit.

Two-year Study Results: NuVasive Simplify Cervical Disc

Peer-reviewed results from the two-level multicenter FDA Investigational Device Exemption study reiterate disc's superiority to ACDF.

Study: No Revisions, Low Complications with Vantage Total Ankle

The two-year minimum clinical outcome study reported positive results for Exactech's Vantage Ankle Fixed Bearing System.

Cline Completes Initial Testing of Cartilage Repair Product

StemCART is a preclinical Advanced Therapy Medical Product intended for the treatment of cartilage damage in patients worldwide.

Study Launch: 2-year Follow-up of Episealer Talus Patients

Episealer Talus is Episurf Medical's CE-Marked joint implant intended for treatment of osteochondral ankle lesions.

First Case in aap Implantate Study of Silver Coating Technology

aap's antibacterial silver coating technology is reportedly effective against the antibiotic-resistant MRSA bacterium.

OssDsign Enrolls First Patient in U.S. PROPEL Registry

The multicenter, prospective spinal fusion registry will evaluate the use and outcome of Catalyst bone graft in real-world clinical practice.

Study Compares Cementless to Standard Knee Replacement Outcomes

Researchers found no difference in length of hospital stay, complications, readmission within 90 days or rates of revision surgery at two years.

Study Results: Creative Medical StemSpine Procedure

StemSpine is a patented procedure that uses a patient's own bone marrow aspirate for the treatment of chronic lower back pain.

Study: Bilateral Knee Patients Prefer Conformis’ Fully Personalized Solution

The study included only patients with a fully personalized Conformis implant in one knee after previously receiving a competitive off-the-shelf implant in their other knee.

Enrollment Complete in Cerapedics’ Bone Graft Study

The ASPIRE study is intended to evaluate use of P-15L Bone Graft in TLIF in 290 patients with degenerative disc disease.

Mobility Improvement in Vertos Medical Study

The mild procedure supports a minimally invasive outpatient treatment for lumbar spinal stenosis that requires no anesthesia.

Prospective Episealer Talus Study 50% Recruited

Episealer Talus is Episurf Medical's CE-Marked implant technology, intended for the treatment of osteochondral ankle lesions.

Orthox Gains Funds for Knee Cartilage Clinical Trial

FibroFix technology is a tissue scaffold based on fibroin, a tissue regenerative protein extracted from silk fibers.

Ortho Regenerative Technologies Partners on Rotator Cuff Repair Trial

Ortho has provided the company with a right of first offer to distribute ORTHO-R in alongside its own proprietary PRP System.

Study: Synergy Biomedical BioSphere Bone Graft Technology

Results address bone formation properties of a clinically accepted bone graft material, bioactive glass, and its optimization.

IDE Study Update: FX Solutions Reversed Stemless Shoulder

FX Solutions completed U.S. enrollment in the Investigational Device Exemption study of the Easytech Stemless Reverse Shoulder.

Hip Innovation Study of Reverse Hip Replacement

The company will initiate a pivotal clinical study to further evaluate the Reverse Hip Replacement System for use in primary total hip replacement.

OssDsign to Collect Data on Catalyst Bone Graft

OssDsign will launch a U.S. clinical registry to collect real-world data on Catalyst in spinal fusion applications.

aap Launches 1st Human Clinical Study for Antibacterial Coating

The technology addresses the reduction of surgical site infections with antimicrobial silver coating of trauma devices.

Biomedical Bondings’ Coating Shows Biological Safety Properties

DendroPrime coating prevents soft-tissue ingrowth to implants inserted close to tendons and joints, improving mobility after hand surgery.

Study Results: Inspan Interspinous Lumbar Fixation

Unlike extension block designs, the Inspan device fixates the spine to allow immediate stability, distraction, decompression and fusion.

Study Results: Premia Spine TOPS Arthroplasty System

TOPS was developed to provide mobility and stability after decompression in cases of lumbar spinal stenosis and degenerative spondylolisthesis.

Study Results: Centinel Spine’s STALIF Integrated Interbody

Studies indicate that patients receiving STALIF C-Ti implants showed significant improvements in outcome scores with minimal overall complication.

ReVivo Medical Raises $2 Million for FDA Sanctioned Clinical Trial

The 50-patient study will support an application for clearance of anterior cervical plates and interbody cages for commercial use.

Clinical Study: Treace Medical Mini3D Lapiplasty

The first patient was treated in the Mini3D Lapiplasty clinical study, which will evaluate outcomes using Lapiplasty Mini-Incision.

Study Results: Conformis iTotal CR Knee

Review of 540 procedures revealed 98.5% implant survivorship and 89.0% patient satisfaction for the patient-specific iTotal CR device.

Clinical Trial: Medtronic Pediatric Spinal Tether

The trial will evaluate the Braive growth modulation system to treat progressive Adolescent Idiopathic Scoliosis.

Study Results: Pixee Medical Knee+ and Vuzix Smart Glasses

The clinical pilot study confirms the accuracy and effectiveness of Knee+ using Vuzix m400 Smart Glasses for total knee arthroplasty

Miach Orthopaedics Initiates Postmarket Study for BEAR Implant

BEAR is the first medical technology to clinically demonstrate that it enables healing of a patient's torn anterior cruciate ligament.

Study Update: OssDsign Synthetic Bone Graft

The first patient has been treated in a study to investigate OssDsign Catalyst in patients undergoing spinal fusion.

Product Update: Episealer Products in Sweden and Spain

The first Talus case is scheduled in Spain, while 5-7 year follow-up of Episealer Knee results are available from Sweden.

Study Results: PainTEQ LinQ in SI Joint Dysfunction

Results show that posterior SI joint fusion with LinQ has the potential to rescue patients with inadequate relief from previous therapies.

AAOS Reports Trends, Outcomes from Joint Registries

Clinical data reports from the American Joint Replacement and Shoulder & Elbow Registry reports offer actionable information on patient care.

Study: Centinel Spine prodisc L Effectiveness

The study expands the evidence of the prodisc L disc replacement with results up to 21 years across a large patient cohort.

Lazurite Partners to Study ArthroFree Wireless Surgical Camera

ArthroFree is expected to be the world's first FDA-cleared fully wireless, minimally invasive modular camera system for the operating room.

Study Results: Bone Therapeutics’ Viscosupplement for Knee OA

The Phase III study with JTA-004 viscosupplement did not meet the primary and consequently the key secondary endpoints.

Study Results: Cerapedics’ i-FACTOR vs. Local Autologous Bone in ACDF

Published data show that i-FACTOR is not only cost-effective compared to autograft in ACDF, but is the dominant economic strategy.

Next Science Begins Trial for XPERIENCE No Rinse Antimicrobial Solution

The randomized, controlled, double-blinded study will evaluate the effects of XPERIENCE solution in decreasing surgical site infections.

Study Results: CartiHeal Agili-C vs. Microfracture and Debridement

The study was conducted to test superiority of Agili-C over microfracture and debridement to treat knee joint surface lesions.

Study Update: Orthofix Medical M6-C Artificial Cervical Disc

The study will evaluate patients treated for cervical degenerative disc disease at two contiguous levels with the M6-C disc vs. ACDF.

Carlsmed Partners to Study aprevo Spinal Device

The International Spine Study Group Foundation will help collect data on surgical treatment with the personalized interbody device.

Study Results: Aesculap Implant Systems’ activL Artificial Disc

Patient outcomes at seven years post-op compare the activL Artificial Disc with the ProDisc-L to treat single-level lumbar degenerative disc disease.

European Study with 5-year Follow-up of Episealer Talus Patients

Episealer Talus is Episurf Medical's CE Marked joint implant for treatment of osteochondral ankle lesions.

Study Results: REGENETEN Bioinductive Implant in Rotator Cuff Tear

Investigators compared the REGENETEN Implant alone vs. with traditional surgical repair to treat partial-thickness rotator cuff tears.

Episurf Medical Updates: U.S./European Markets, Talus Study

Among its updates, Episurf is preparing for commercial U.S. launch of the Episealer Patellofemoral System during 2022.

Active Implants NUsurface Meniscus Study Results

The NUsurface Implant is the first artificial meniscus to be marketed in Europe and is currently under review by FDA.

Histogen Initiates Knee Cartilage Regeneration Trial

Histogen's human extracellular matri is intended for regenerating hyaline cartilage for the treatment of articular cartilage defects.

European Study for 5-Year Follow-up on Episealer Knee Patients

The study is a continuation of the European multicenter study, from which 2 years' follow-up results were released in 2020.

Study Results: Relievant Medsystems’ INTRACEPT in Back Pain

Study Results validate the superiority of basivertebral nerve ablation vs. standard of care.

Study Results: Spinal Elements Luna XD Multi-Expandable Interbody

Retrospective analysis of 69 consecutive patients over a 2-year period demonstrated statistically significant improvement in leg/back pain, disability index, etc.

Elute Authorized for Clinical Trial of Antibiotic Eluting Bone Void Filler

Elute received authorization from FDA to use its EP Granules with Tobramycin in a pivotal clinical trial.

Histogen Development and Pipeline Update

The company plans to focus its regenerative medicine platform on orthopedic product candidates to repair the knee and spinal disc.

Ortho Regenerative Technologies Receives Clinical Hold Letter From FDA

FDA requested data related to an application to begin a Phase I/II clinical trial for ORTHO-R as an adjunct to surgery in rotator cuff tear repair.

Study Results: Bioventus Placental Tissue Biologic Candidate

The biologic candidate demonstrated significant reduction of pain and cartilage degeneration in a rat osteoarthritis model.

Interim Study Results: Treace ALIGN3D Clinical Study

ALIGN3D is evaluating the Lapiplasty 3D Bunion Correction System to treat Hallux Valgus.

Study Results: Biologica Technologies’ ProteiOS in Foot and Ankle Arthrodesis

Study results show fusion rates that are higher than or comparable to those in other published studies of any other bone graft material.

MedShape and CurveBeam Initiate Joint Prospective Clinical Study

The research will evaluate the efficacy of a sustained dynamic compression device using longitudinal weight-bearing CT.

Puregraft Fat Used to Treat Knee Osteoarthritis

Studies indicate that Puregraft fat grafting significantly improved function and symptom relief at 3 and 6 months in patients with knee OA.

Aurora Spine Launching Study of SiLO SI Fusion System

The company received Institutional Review Board approval for the new multicenter study of SiLO in the U.S.

Favorable Study Results for Total Hip Navigation with Smith+Nephew Implants

Studies suggest that technology like RI.HIP NAVIGATION reduces the risk of revision and increases patient satisfaction when used with Smith+Nephew implants.

DiscGenics Study Updates: Injectable Discogenic Cell Therapy

The company has completed enrollment in its Japanese safety study of allogeneic, injectable discogenic cell therapy for lumbar disc degeneration.

LimaCorporate Announces First Surgery with SMR Stemless Reverse Shoulder in IDE Study

The randomized, multi-center comparative trial is evaluating the SMR Stemless Reverse Shoulder System vs. the SMR Reverse Shoulder.

Ortho RTI Submits Application for Rotator Cuff Repair

Initiation of a Phase I/II clinical trial of ORTHO-R in rotator cuff tear repair is anticipated within 2Q21.

Study: Conformis iTotal Knee More Cost-Effective than Off the Shelf Implants

Retrospective review demonstrates that Conformis' iTotal implants enable expedited surgical time and reduce length of hospital stay.

FDA Clinical Hold Removed for Histogen Trial in Knee Regeneration

Histogen can proceed with a Phase I/II clinical trial examining human extracellular matrix plus microfracture to regenerate hyaline cartilage.

First Patients Enrolled in Bioventus MOTYS Trial for Knee OA

The trial is examining MOTYS placental tissue particulate in the treatment of osteoarthritis of the knee.

Creative Medical Begins Recruitment of StemSpine Clinical Sites

StemSpine is the company's regenerative stem cell procedure for the treatment of degenerative disc disease.

ZygoFix Completes $2 Million Round and Launches Clinical Study

Funds will support further clinical studies, enhancements to the zLOCK miniature screwless implant and regulatory clearance.

TissueTech to Commence Study on Facet Joint Osteoarthritis Pain

The study is investigating Cryopreserved Amniotic Membrane and Cryopreserved Umbilical Cord for pain relief and functional improvement.

First U.S. Patient Treated with Spineart’s BAGUERA C Cervical Disc

This is the first surgery in the two-level U.S. Investigational Device Exemption trial of the BAGUERA C Cervical Disc Prosthesis.

Empirical Spine Begins PMA Submission for Limiflex Band

The LimiFlex Paraspinous Tension Band is an investigational device designed as an alternative to spinal fusion.

First Implant of AlloSource AlloWrap Membrane in Clinical Study

First patients are enrolled in AlloSource's study of the amniotic membrane for 2-level anterior cervical discectomy and fusion.

ReVivo Medical Moves on Clinical Trial for Spinal Products

The 50-patient study will support an application for clearance of anterior cervical plates and interbody cages for commercial use.

Signature Cord Prime Phase 1 Study for Knee OA

FDA approved an IND Application to study Signature Cord Prime in patients with symptomatic osteoarthritis of the knee.

Study Results: BandGrip Skin Closure Device

BandGrip is reportedly more than five times faster in closing orthopedic incisions compared to traditional sutures.

Study Results for X-Bolt Sliding Hip Screw

The WHITE4 study compared the company's flagship X-Bolt XHS device vs. the gold standard Sliding Hip Screw treatment.

Synergy Disc Enrolls First Patient in Clinical Trial

The multicenter study will examine efficacy of the Synergy Disc vs. anterior cervical discectomy and fusion in patients with degenerative disc disease.

FDA Clinical Hold for Histogen Trial in Knee Regeneration

FDA verbally notified the company of additional questions in the application for the planned Phase I/II trial of HST-003 combined with microfracture.

Bone Therapeutics Kicks Off ALLOB Tibial Fracture Study

ALLOB will be applied by a single injection up to 4 days post-reduction surgery in patients with fresh tibial fractures at risk for delayed or non-union.

Study Validates NuVasive X360 Approach

The single position circumferential fusion was found to improve operative efficiency and reduce complications vs. traditional circumferential fusion.

Study Update: Bone Therapeutics’ Phase III Knee Trial

The company has completed recruitment and treated all patients in its Phase III study with the viscosupplement, JTA-004, in patients with knee osteoarthritis.

Study Results: OrthoGrid Systems’ Technology for Total Hip

Adjustable grid systems demonstrated an efficient method for consistent cup positioning and restoration of hip symmetry.

Aurora Spine Plans Study of ZIP Interspinous Fixation

In 1Q21, Aurora will begin a multicenter study of its ZIP Interspinous Fixation device for the treatment of degenerative disc disease.

Histogen Files Investigational New Drug Application for HST-003

The human extracellular matrix is slated to enter a Phase 1/2 Trial for knee cartilage regeneration in 1Q21.

Registry Data Backs Smith+Nephew’s POLAR3 Total Hip

Components of the POLAR3 Total Hip Solution reportedly excelled at ten and fifteen year benchmarks in global registries.

Study Results: Episealer Implant Survival Rate

Postmarket surveillance data for the Episealer Knee show a cumulative survival rate of >96% over 7 years.

Analysis: ViviGen Cellular Bone Matrix Lowers Hospital Costs vs. rhBMP-2

Analysis of more than 16,000 lumbar fusion procedures showed similar clinical outcomes with average hospital fees up to $50,000 lower using ViviGen.

LimaCorporate to Launch Study of SMR Stemless Reverse Shoulder

FDA has approved the Investigational Device Exemption to start the clinical trial of the SMR Stemless Reverse Shoulder System.

Bioventus Can Proceed to Clinical Trial of Knee OA Treatment

MOTYS placental tissue particulate will be evaluated for safety and efficacy to treat osteoarthritis of the knee.

AlloSource Completes ProChondrix Study Milestone

First patients completed 12-month follow-up in its prospective, multi-center study of ProChondrix CR to repair knee articular cartilage defects.

Smith+Nephew 2-Year NOVOSTITCH Study

NOVOSTITCH Meniscal Repair Systems achieved 82.6% success rate for difficult to repair horizontal cleavage tears at two year follow-up.

Study Results: Integrity Implants’ FlareHawk Multiplanar Expandable Cage

Results show that FlareHawk delivers favorable fusion and patient outcomes demonstrating conformity to endplate anatomy, with no observed device subsidence.

Anika Growth Driven by Arthrosurface and Parcus Acquisitions

While the company's orthobiologics business remains impacted by COVID, gains from joint preservation and restoration products offset the losses.

Member-Only Content

SUBSCRIBE Login

Preliminary Results from Zimmer Biomet mymobility Study

Early results of the mymobility remote care management platform on Apple Watch and iPhone demonstrate significant reductions in in-person physical therapy.

Simplify Medical Completes PMA Submission for 2-Level Simplify Disc IDE Study

Simplify Disc is designed for MRI compatibility, physiologic motion and anatomical height-matching to improve patient outcomes and expand treatment options.

Study Results: DiFusion ZFUZE Biomaterial Beats Titanium

Multiple studies indicate that ZFUZE biomaterial does not illicit a long-term foreign body response compared to titanium and PEEK.

ALLOB Shows 90% Fusion Rate at 2 Years in Phase IIa Study

90% of patients show bone fusion as well as strong clinical improvements in function and pain at 24 months follow-up with a good product safety profile.

Tyber Medical Launches Study for Titanium Integrated Interbody

The PEEK devices offer titanium integration for solid bone formation between the interbody device and surrounding tissues following spinal fusion.

Spineart Conducts Ti-LIFE Animal Study

Ti-LIFE Technology is an enhanced algorithm for additive manufacturing of titanium cages resulting in structures with a bone-like matrix.

Spineology Duo Postmarket Study Completes Enrollment

The Duo spinal system has demonstrated reduced operative times, shorter hospital stays and improved clinical outcomes vs. traditional lateral surgery.

MiMedx Concludes Enrollment for Phase III Plantar Fasciitis Trial

The research is investigating amniotic tissue as a potential treatment for chronic musculoskeletal pain and function disorders.

Panther Orthopedics Mid-Term Clinical Outcomes with the PUMA System

The FDA-cleared superelastic syndesmosis device features a spring-like design for initial and continuous compression without the need to over-tension.

Episurf Medical Episealer Knee Study Updates

Episurf marked the first surgery in the IDE study in Europe, and positive study results with up to 7 year follow-up in patients receiving an Episealer Knee.

Study Results: Exactech Equinoxe Shoulder Among Lowest Published Fracture Rates

The extensive study addressed rare and challenging types of scapula fractures after reverse total shoulder replacement surgery.

Kuros Biosciences Treats First Patient in Spinal Fusion Trial with Fibrin-PTH

This U.S. Phase II trial intends to demonstrate safety and efficacy of Fibrin-PTH in patients undergoing a single-level TLIF procedure.

Ortho Regenerative Technologies Closes $2.5 Million Private Placement

The company raises the funds through a non-brokered private placement. The proceeds will fund initiatives like securing FDA approval for clinical trials.

MicroPort Skywalker Joint Replacement Surgical Robot Completes First-in-Man Case in Human Trial

The Skywalker Joint Replacement Robot developed by MicroPort OrthoBot recently completed a robotic-assisted total knee arthroplasty.

PainTEQ Begins Novel Biomechanical Study on SI Joint Fusion

Data captured from the study will advance research in the treatment of sacroiliac joint dysfunction using a novel therapeutic device.

90% Patient Satisfaction Reported in Peer-Reviewed Clinical Study of Conformis iTotal PS Knee Replacements

Clinical research found that patients who received Conformis patient-specific iTotal PS knees were 90% satisfied at 18 to 28 months post-surgery.

Spineart Gains IDE Approval for BAGUERA C Trial

The single-level trial will compare the BAGUERA C Cervical Disc Prothesis to another FDA approved arthroplasty device at up to 30 U.S. sites.

Study Results: Neo Medical Pedicle Screws Reduce O.R. Time and Costs

Studies indicate that the controlled fixation platform significantly decreased expenses for processing and rates of contaminated instruments.

MedShape Awarded Grant to Develop MTP Joint Replacement

Impressio and MedShape were awarded a $250,000 grant for research and development of a new surgical treatment for hallux rigidus.

Empirical Spine Completes Enrollment in LimiFlex Trial

The U.S. IDE trial is studying use of LimiFlex with decompression for patients suffering from degenerative spondylolisthesis with lumbar spinal stenosis.

Life Spine Initiates PROLIFT Lateral Expandable Outcomes Study

This is one of eight active studies underway to research the safety and efficacy of Life Spine's products.

Providence Medical Enrolls in FUSE IDE Study

FUSE is designed to demonstrate superiority of Circumferential Cervical Fusion vs. traditional ACDF in patients at high risk for nonunion or revisions.

BONESUPPORT Completes Trial Enrollment

Enrollment of the FORTIFY study on CERAMENT G has been completed, with 198 subjects enrolled. BONESUPPORT expects to submit a PMA application in late 2021.

Relievant 5-Year Study Data for Intracept Procedure

Relievant announces publication of 5-year data demonstrating long term clinical benefits of the Intracept procedure in chronic low back pain patients.

Study Results: Smith+Nephew’s OXINIUM on XLPE for Total Hips

Study results indicate that procedures using OXINIUM on XLPE had the lowest risk of revision of all bearing combinations for any reason beyond 10 years.

Orteq Shares 5-Year Study Data for Actifit Meniscal Scaffold

The synthetic biodegradable polymer is designed to preserve the knee joint and promote new tissue growth in damaged areas of an irreparable meniscus.

Cerapedics Announces Results from Clinical Trial of i-FACTOR in Lumbar Fusion

Results show that elderly patients undergoing non-instrumented fusion achieve statistically significantly higher fusion rates with i-FACTOR vs. allograft.

Bone Therapeutics Treats First Patients in Phase III Knee Osteoarthritis Study

The JTA-004 Phase III study is approved in five of seven territories. These are the first patients treated after resumption of clinical activities.

Histogen Publishes Preclinical Data on Spinal Disc Repair

The company's cell conditioned media has been shown to stimulate stem cells in vivo, possibly leading to the repair of the intravertebral disc matrix.

Bone Therapeutics Secures EUR 11.0 Million Financing

Funds will support studies of ALLOB allogeneic cell therapy to treat difficult tibial fractures and JTA-004 protein to treat for osteoarthritic knee pain.

FDA Grants Carmell Therapeutics Expedited Review for Bone Healing Accelerant

Carmell will begin enrolling in a pivotal clinical program for Plasma-based Bioactive Material used in long-bone fractures as an adjunctive treatment.

aap Gains Approval for Study of Silver Coating Technology

aap's antibacterial silver coating technology has applications in trauma devices and other areas inside and outside of orthopedics.

BONESUPPORT Announces CERAMENT Preclinical Long-term Study Results

New preclinical data confirms that local delivery of a bisphosphonate in combination with CERAMENT can regenerate cancellous bone.

InGeneron Cell Therapy in Rotator Cuff Repair – Study Results

InGeneron announces favorable study results using regenerative autologous adipose-derived cells that are prepared with the Transpose® RT System for treatment of partial-thickness rotator cuff tears.

Episealer Knee Preliminary Study Results

Preliminary results from a study of Episurf Medical's Episealer® Knee implant show good patient satisfaction and good knee function.

Bone Therapeutics Gains Approval for Studies of OA Knee Pain Therapies

Bone Therapeutics received regulatory approvals for next studies of both of its lead therapeutic candidates to treat osteoarthritic knee pain.

Episurf Medical Reports Episealer Knee Study Results

Results from a clinical study of Episurf Medical's Episealer® Knee show good implant safety and significantly improved patient-reported outcome scores.

Ortho Regenerative Technologies Results from Rotator Cuff Tear Repair Study

Ortho Regenerative Technologies confirmed the safety profile of ORTHO-R biopolymer as well as statistical significance over standard-of-care following completion of a pivotal preclinical study in rotator cuff tear repair.

Arthrosurface OVO with Inlay Glenoid Total Shoulder Study Update

Study results indicate that use of Arthrosurface's OVO® with Inlay Glenoid Shoulder Arthroplasty System to treat glenohumeral OA yielded improved clinical outcomes, no reoperations or radiographic loosening and a high rate of return to activity.

NuVasive Attrax Putty Study Results

Study results support the use of NuVasive's Attrax® Putty as a standalone bone graft substitute for autograft in instrumented thoracolumbar posterolateral lumbar fusion.

RTI Surgical SImmetry System Interim Study Results

RTI Surgical's SImmetry® sacroiliac fusion system yielded evidence of fusion in 98% of treated joints, per interim study results.

INSPAN Reports Study Results from Inspan Interspinous Fixation Device

INSPAN announced successful results from a long-term follow-up clinical study of outpatient L4-L5 lumbar interspinous fixation for degenerative spinal stenosis using the Inspan® ScrewLES™ Fusion interspinous fixation device.

Tenon Medical’s Catamaran SI Fixation Study Results

Studies indicate that Tenon Medical's Catamaran™ Sacroiliac Joint Fixation System demonstrated an over 85% reduction in SIJ pain at six weeks, with radiographic evidence of solid continuous bridging bone across the treated joint at six months.

Episurf Medical EU Clinical Trial Updates for Episealer

Episurf Medical's Episealer® knee implant system continues to deliver excellent results in multiple ongoing clinical trials.

Study Results: RTI Surgical’s TETRAfuse 3D PEKK Technology

Studies show that RTI Surgical's TETRAfuse® PEKK implants demonstrated bone ingrowth, no radiographic interference, no fibrotic tissue membrane formation, a significant increase in bony apposition over time and a significantly higher push-out strength vs. standard PEEK.

CartiHeal Announces Positive Interim Results of Agili-C IDE Study

CartiHeal announced that per the results of an interim analysis of the IDE study of Agili-C™ in the treatment of cartilage lesions, trial enrollment will stop at 250 subjects.

Vertos Medical Completes Trial Enrollment for mild LSS Procedure

Vertos Medical completed enrollment of 150 patients in the MOTION study of the mild® Procedure used in the treatment of lumbar spinal stenosis.

Empirical Spine Completes Portion of Enrollment for LimiFlex Clinical Trial

Empirical Spine completed enrollment in the investigational arm of its U.S. IDE trial of the LimiFlex Paraspinous Tension Band with decompression to treat degenerative spondylolisthesis with lumbar spinal stenosis.

SpineOvations Launches Clinical Study of DiscSeal for Disc Augmentation

SpineOvations began a clinical study of DiscSeal percutaneous injection for the treatment of low back pain.

Personalized Stem Cells Clinical Trial Update

Personalized Stem Cells treated the first patients in an FDA-approved clinical trial for stem cell treatment of knee osteoarthritis.

Spineology U.S. Fusion Trial 24-Month Outcomes Data

Two-year outcomes from Spineology's SCOUT trial of the OptiMesh® device revealed substantial improvements in low back pain and function scores at 6, 12 and 24 months.

Arthrosurface OVO with Inlay Glenoid Total Shoulder Study Update

Results of a study of Arthrosurface's OVO® with Inlay Glenoid Shoulder Arthroplasty System demonstrated excellent clinical benefits, including pain relief and increased range of motion in patients with glenohumeral arthritis.

ADAM Project to Launch Clinical Trials of 3D-Printed Synthetic Bone

ADAM, a 3D bone printing project, plans to complete pre-clinical trials within the month and commence first human trials by the end of 2019.

Personalized Stem Cells Enrolls in Clinical Trial for Treatment of OA with Stem Cells

Personalized Stem Cells enrolled the first patients in an FDA-approved clinical trial for treatment of knee osteoarthritis with stem cells.

Cellular Biomedicine’s ReJoin for Knee OA Accepted for Trial in China

Cellular Biomedicine's drug application for ReJoin® therapy for knee osteoarthritis was accepted for a Phase II clinical trial in China.

DiscGenics IDCT Study Update

Preclinical study results demonstrated that intradiscal injection of Discogenic Cells, the active ingredient in DiscGenics' IDCT allogeneic cell therapy, may be a viable treatment for degenerative disc disease.

Medtronic Initiates Clinical Trial for Infuse Bone Graft in TLIF

Medtronic commenced site recruitment in a prospective, randomized pivotal clinical trial on the use of Infuse Bone Graft in TLIF.

SI-BONE 5-Year iFuse Study Results

SI-BONE reports that 5-year follow-up from studies of the iFuse implant for SI joint fusion showed excellent durability of clinical responses and positive radiographic outcomes.

4WEB Medical Completes Cell Differentiation and Gene Expression Study

4WEB Medical completed Phase I in vitro testing to demonstrate that surface roughness on its 3D-printed truss implants stimulates a superior osteogenic response vs. smooth titanium and PEEK.

Stryker Announces SAKOS Pivotal Trial Results for SpineJack

Results from the SAKOS pivotal trial of Stryker's SpineJack® implantable fracture reduction system successfully demonstrated non-inferiority to balloon kyphoplasty (BKP), with an excellent risk/benefit profile for up to 12 months.

Benvenue Medical Releases MIS TLIF Clinical Data on Luna Device

Clinical studies of Benvenue Medical's Luna interbody fusion device in minimally invasive Transforaminal Lumbar Interbody Fusion (TLIF) showed improved patient outcomes and decreased back and leg pain at 12 months post-op.

Study Results: Benvenue Medical, DiscGenics, Stryker

Benvenue Medical, DiscGenics and Stryker shared study results for spinal technologies.

DiscGenics’ U.S. Clinical Study of Cell Therapy for Disc Degeneration Passes Halfway Mark

The first 30 patients received treatment in DiscGenics' first-in-human U.S. clinical study of IDCT injectable disc cell therapy for mild to moderate degenerative disc disease.

X-BOLT Hip Fixation Shows 0.8% Reoperation Rate in Study

Preliminary study results indicate that X-BOLT Orthopaedics' X-BOLT device for hip fracture repair demonstrated a cut-out rate of 0.8% in a population of 476 patients, and performed as well as a hip sliding screw in measures such as quality of life, mortality, revision, etc.

Wright Medical Completes Enrollment in U.K. INFINITY Ankle Study

Wright Medical completed enrollment of 500 patients in its U.K.-based postmarket INFINITY Total Ankle follow-up study.

Cellular Biomedicine Launching AlloJoin Knee OA Phase II Clinical Trial

Cellular Biomedicine launched a Phase II clinical trial for AlloJoin® allogenic mesenchymal progenitor cell therapy in the treatment of knee osteoarthritis.

CoNextions Medical Completes Enrollment in Trial of Tendon Repair Device

CoNextions Medical completed enrollment in the clinical trial of the CoNextions TR tendon-to-tendon repair device.

Kuros to Begin Fibrin-PTH Clinical Trial in Spinal Fusion

Kuros Biosciences gained FDA approval for its IND application to initiate a Phase IIA clinical trial evaluating Fibrin-PTH orthobiologic in single-level TLIF to treat degenerative disc disease, with autograft as comparator.

Aesculap activL Lumbar Disc: 5-Year Study Results

At five-year follow-up, Aesculap Implant Systems' activL® lumbar disc was found to more effectively preserve range of motion vs. first-generation lumbar total disc replacement devices to treat degenerative disc disease.

Kinamed CarboJet Bone Preparation System Study Results

Studies demonstrate that use of Kinamed's CarboJet® CO2 Bone Preparation System yields increased bone cement penetration in total knee arthroplasty, even without a tourniquet.

Bio2 Technologies Enrolls First Vitrium Patient in Cervical Spine Fusion Trial

Bio2 Technologies enrolled the first patient in the Investigational Device Exemption trial of the Vitrium cervical interbody device.

Personalized Stem Cells Gains Approval for Trial of Stem Cell OA Treatment

Personalized Stem Cells received FDA approval for an Investigational New Drug application for use of a person's own stem cells to treat osteoarthritis.

Miach Orthopaedics BEAR Implant ACL Repair Study

Miach Orthopaedics announced study results showing that torn anterior cruciate ligaments (ACLs) treated with the Bridge-Enhanced® ACL Repair (BEAR®) implant were similar to the native ACL at one year.

MedShape’s DynaNail Demonstrates Favorable Outcomes in Challenging Fusions

Studies indicate that MedShape's DynaNail® TTC Fusion System demonstrated successful arthrodesis in patients at high risk for nonunion.

Centinel Spine Announces prodisc C Clinical Trials

Centinel Spine received Investigational Device Exemption approval to initiate a two-level clinical trial with prodisc® C Vivo and prodisc C SK anterior cervical total discs.

ExactechGPS Study Results: Knee and Shoulder Replacement

Study results indicate that use of Exactech's ExactechGPS® computer-assisted technology yielded an improved surgical experience in knee and shoulder joint reconstruction.

Smith & Nephew NOVOSTITCH Study Results

Study results indicate that Smith & Nephew's NOVOSTITCH knee meniscal repair technology delivered a 0% re-operation rate and 100% meniscal healing at 6 months.

Episurf Medical Commencing Enrollment in Episealer Knee IDE Clinical Study

Episurf Medical is set to begin patient enrollment in the U.S. IDE clinical study of the EPIC-Knee Episealer® Knee.

CartiHeal Enrolls 200th Patient in Agili-C Study

CartiHeal, developer of the Agili-C implant to treat cartilage and osteochondral defects, enrolled the 200th patient in the Agili-C IDE pivotal clinical study.

CyMedica Launches Clinical Trial of e-vive Plus Wearables Data

CyMedica Orthopedics launched a clinical trial to examine the e-vive app-driven muscle strengthening device and its effects on knee OA symptoms.

CartiHeal’s Agili-C Implant In-vitro Study Results

CartiHeal announced a study demonstrating that the Agili-C implant may enhance osteogenic differentiation of human bone marrow-derived mesenchymal stem cells.

THINK Surgical Completes Enrollment for Study of Active Robot for TKR

THINK Surgical completed enrollment for a U.S. investigational clinical study of the TSolution One® active robot for use in total knee procedures.

Globus Medical ExcelsiusGPS Shows 99% Screw Placement Success

Globus Medical's ExcelsiusGPS® robotic navigation system demonstrated a 99% success rate in pedicle screw placement in the first 100 cases at a single center.

Smith & Nephew OXINIUM Technology: $296MM in Potential U.S. Health System Savings

Data collected using the Comprehensive Care for Joint Replacement model suggests that if Smith & Nephew's OXINIUM bearing surface was used in all U.S. primary hip procedures in 2020, it could yield ~$296MM in savings to the nation's health system.

Treace Medical: Lapiplasty 3D Bunion Correction Multicenter Study Results

Results from a retrospective, multicenter study with Treace Medical's Lapiplasty® 3D Bunion Correction procedure revealed a 96.8% maintenance of 3-plane correction at 13.5-month follow-up with an early weight-bearing protocol.

InGeneron Launches Study for Rotator Cuff Tendinopathy Therapy

First patients have been enrolled in InGeneron's pivotal study for cell therapy to treat rotator cuff tendinopathy.

Innovasis HA PEEK Data Registry Reaches Milestone of 150 Enrollees

Innovasis' HA PEEK Data Registry achieved significant enrollment of 150 patients since its 2018 launch.

Centinel Spine Reports New prodisc C Study Results

Centinel Spine announced results from a single-center study that suggest strong support of the safety of the prodisc® C cervical artificial disc.

NuVasive Cohere Porous PEEK Comparative Study Results

NuVasive's Cohere® Porous PEEK interbody demonstrated clear benefits in promoting improved early outcomes in ACDF procedures when compared to both structural allograft and smooth PEEK.

Shoulder Innovations Announces Long Term Data for Inset Glenoid

Shoulder Innovations' InSet Glenoid demonstrated long-term efficacy and safety in total shoulder replacement to reconstruct deficient, arthritic glenoid bone.

BONESUPPORT: Study Affirms Cerament Remodels into Human Bone

Retrospective review of 163 patients at one-year follow-up revealed clinical evidence of BONESUPPORT's CERAMENT® bone void filler remodeling into bone in humans.

Treace Medical: Lapiplasty 3D Bunion Correction Study Results

Treace Medical Concepts announced additional positive clinical data supporting the Lapiplasty® 3D Bunion Correction procedure.

Orthofix M6-C Artificial Cervical Disc Study: Full 2-Year Data

Full 2-year outcomes from a U.S. IDE study of Orthofix Medical's M6-C artificial cervical disc demonstrated that disc replacement with the device is not inferior to treatment with ACDF.

FzioMed Enrolls 50th Patient in Oxiplex Study

FzioMed reached a milestone of 1/3 patient enrollment in a clinical study of Oxiplex® gel for reduction of pain following partial discectomy.

Bone Biologics Receives Approval for Trial of NB1 Growth Factor in Australia

Bone Biologics received regulatory approval in Australia for a multicenter pilot clinical trial to evaluate NELL-1/DBX® in the treatment of degenerative disc disease.

AlloSource Enrolls in ProChondrix CR Study

AlloSource enrolled the first patient in a study to evaluate the effectiveness of ProChondrix CR® fresh cryopreserved osteochondral allograft, when used on cartilage defects in the knee.

RTI Surgical Enrolls 1st Patient in FORTE Clinical Study of Fortilink Interbody

RTI Surgical enrolled the first patient in FORTE, a clinical evaluation of the Fortilink® interbody fusion device in the treatment of degenerative disc disease. Enrollment is slated for completion in 1Q20.

Smith & Nephew POLAR3 Total Hip: Results from National Joint Registry

Smith & Nephew's POLAR3 total hip system demonstrated excellent survivorship and significantly higher patient satisfaction vs. other cementless stems in National Joint Registry in the U.K.

CyMedica Orthopedics: e-vive Clinical Trial Results

CyMedica Orthopedics' e-vive app-driven muscle strengthening device demonstrated statistically significant and positive results in a clinical trial evaluating the recovery of total knee replacement patients.

OrthoSensor Shares New VERASENSE Clinical Highlights

New clinical data suggest that use of OrthoSensor's VERASENSE sensor-assisted technology for total knee replacement helps address tissue balance and improve patient outcomes.

Stryker Mako Total Knee: Clinical Studies Demonstrate Early Functional Recovery

Clinical studies demonstrated that Stryker's Mako Total Knee was associated with less pain and need for opiates, shorter hospital stays, improved flexion and soft tissue protection vs. manual techniques.

SI-BONE reports 4Q18 revenue of $15.6MM, +13% vs. 4Q17

SI-BONE reports 4Q18 revenue of USD $15.6MM, +13% vs. 4Q17, with 2018 full year revenue of $55.4MM, +15.4% vs. 2017.

Member-Only Content

SUBSCRIBE Login

Miach Orthopaedics 2-Year Study Results on ACL Repair

Results from a feasability study indicate that use of the Bridge-Enhanced® ACL Repair (BEAR®) procedure from Miach Orthopaedics resulted in similar clinical, functional and patient-reported outcomes as autograft ACL reconstruction at 24 months.

CartiHeal Study Enrolls 150th Patient

CartiHeal announced treatment of the 150th patient in the IDE clinical study of Agili-C for knee cartilage repair.

Aesculap Biologics Announces NOVOCART 3D Trial Enrollment Milestone

Aesculap Biologics achieved 50% enrollment in its Phase III clinical trial of NOVOCART® 3D, an autologous chondrocyte transplantation system to treat articular cartilage defects in the knee.

Ortho RTi Confirms Timeline to Initiate Human Clinical Program in Rotator Cuff Repair

Ortho Regenerative Technologies announced that following a formal meeting with FDA, an IND can be submitted in parallel with completion of a pivotal study on Ortho-R biopolymer for rotator cuff repair.

Seikagaku and Ono Announce Positive Study Results

Seikagaku and Ono Pharmaceutical obtained positive topline results from a Phase III confirmatory study of an HA/NSAID formulation in the treatment of knee OA.

Ortho RTi Commences Pivotal Study in Rotator Cuff Repair

Ortho Regenerative Technologies initiated a 6-month pivotal animal study on Ortho-R biopolymer for rotator cuff repair.

FH Orthopedics: LP-ESP Disc Replacement Study Update

Study results indicate that FH Orthopedics' LP-ESP® Lumbar Prosthesis demonstrated excellent midterm follow-up results in total disc replacement at five years.

Aesculap Implant Systems PlasmaporeXP Surface Enhancement Study

Studies of Aesculap Implant Systems' Plasmapore®XP Surface Enhancement indicate that early bone-forming activity was upregulated in osteoblast-like cells that attached to the PlasmaporeXP.

X-Bolt Orthopaedics: 1,000 Patients Reach One Year in Hip Fracture Trial

X-Bolt Orthopaedics announced that the 1,000th patient has reached one-year follow-up in WHITE4, a randomized controlled trial comparing the X-BOLT® expanding bolt device vs. a sliding hip screw in hip fracture treatment.

Flower Orthopedics: FlowerCube Study Results

Study results indicate that use of Flower Orthopedics' FlowerCube implant and instrument system in first metatarsal phalangeal joint fusion at an ASC resulted in a 33% decrease in intraoperative time and $1,300 savings in reimbursement costs, while providing equivalent clinical outcomes.

DiscGenics’ IDCT Passes Initial Safety Review in Phase I/II Trial

DiscGenics' injectable disc cell therapy passed an initial planned safety review of its Phase I/II trial for the treatment of mild to moderate degenerative disc disease.

Histogenics to Explore Strategic Alternatives for NeoCart Cartilage Treatment

Histogenics plans to evaluate the range of potential strategic alternatives for its NeoCart® cell therapy following FDA's indication that an additional clinical trial would be required before acceptance of a Biologics License Application submission.

Study Results: InSpace Balloon vs. Superior Capsular Reconstruction

Results from cadaveric study of OrthoSpace's InSpace balloon spacer vs. superior capsular reconstruction in the treatment of rotator cuff tears found that InSpace effectively restored the humeral head to a nearly normal position.

Kinamed CarboJet Study: Tourniquetless TKR May Decrease Pain, Opiod Use

Kinamed, developer of the CarboJet® CO2 bone prep system, announced a clinical study examining its use in traditional tourniquet vs. tourniquetless TKR.

Safe Orthopaedics Study: Cost Savings with Single-use Instruments

Study results revealed an average 50% cost-per-patient savings with use of Safe Orthopaedics' instruments vs. reusable ones in the treatment of spinal fractures.

aap Implantate Reports Positive LOQTEQ Study Results

In biomechanical study, aap Implantate's LOQTEQ® anatomical fracture plating system displayed better explantation properties than those of the market leader.

Vertiflex Study: 85% Reduction in Opiod Use after Treatment with Superion

Results from a randomized, controlled trial of Vertiflex's Superion® Indirect Decompression System showed an 85% decrease in the proportion of patients using opioids, 5 years after treatment for lumbar spinal stenosis.

Smith & Nephew: Positive Study Results for JOURNEY II BACS Knee

New clinical evidence represents positive mid-term survivorship results on 2,059 patients with Smith & Nephew's JOURNEY II BCS knee.

BONESUPPORT Announces Positive top-line data from the CERTiFy CERAMENT Study

BONESUPPORT announced that the CERTiFy study of CERAMENT bone void filler met its primary endpoint of non-inferiority to autologous iliac bone graft in the treatment of tibia plateau fractures.

CartiHeal Enrolls First Agili-C Patient on East Coast

CartiHeal announced successful enrollment of the first patient in the Agili-C IDE pivotal study on the East Coast.

Treace Medical Kicks Off Postmarket Study of Bunion Correction

Treace Medical Concepts enrolled the first patient in the ALIGN3D postmarket study of Lapiplasty® 3D Bunion Correction.

Bio2 Gains Approval to Study Vitrium in Interbody Fusion

Bio2 Technologies received FDA approval to enroll subjects in an IDE clinical study of Vitrium bioactive glass as a cervical interbody fusion device.

CartiHeal: Positive Study Results for Agili-C Implant

CartiHeal announced a study demonstrating that its Agili-C implant promotes the regenerative capacity of articular cartilage defects in a human cadaveric ex-vivo model.

Bone Therapeutics to End Phase III PREOB Study

The Data and Safety Monitoring Board recommended discontinuation of the Phase III hip osteonecrosis study of Bone Therapeutics' PREOB viscosupplement, following interim analysis of results.

CartiHeal Reaches 100th Surgery in Agili-C IDE Study

CartiHeal has successfully enrolled and treated the 100th patient in the pivotal IDE study of the Agili-C implant.

Study Results: DJO EMPOWR 3D Knee Reduces Patient Dissatisfaction

Results from a clinical study of DJO's EMPOWR 3D Knee indicate that the technology reduces patient dissatisfaction while improving function and activity levels.

Regentis Biomaterials Expands SAGE Trial of GelrinC

Regentis Biomaterials expanded the SAGE clinical trial of GelrinC to 11 U.S. sites. The investigational device is in evaluation to regrow knee cartilage.

Smith & Nephew: Positive Study Result for INTERTAN Intertrochanteric Antegrade Nail

Smith & Nephew reported study results that show its INTERTAN intertrochanteric antegrade nail significantly reduced the risk of implant-related failures in hip fracture patients.

Bone Therapeutics Reports Results of Viscosupplement Study

Bone Therapeutics' first efficacy study of the JTA-004 viscosupplement to treat knee OA showed that a single injection delivered higher pain reduction vs. a reference product.

Zimmer Biomet Launches Study of mymobility Apple Watch App

Zimmer Biomet launched a clinical study of mymobility, an Apple Watch app to support connection between hip and knee replacement patients and their surgical care teams.

Vertos Medical Enrolls in New MOTION Study of MILD Procedure

Vertos Medical enrolled the first patient into MOTION, a new multicenter two-year U.S. study of the mild® outpatient procedure for minimally invasive treatment of lumbar spinal stenosis.

Kuros Biosciences: First Procedure in MagnetOS Spinal Fusion Trial

The first patient has been treated in a multicenter study comparing Kuros Bioscience's MagnetOs bone graft substitute vs. autologous bone in spinal fusion.

Ethicon’s Skin Closure in Knee Replacement Study

Total knee replacement patients and surgeons reported greater satisfaction with Ethicon's DERMABOND PRINEO Skin Closure System for surgical incisions vs. traditional skin staples.

NuVasive Enrolls Patients in Advanced Materials Science in XLIF Study

NuVasive commenced patient enrollment in a prospective, multicenter U.S. study evaluating advanced spinal implants used in XLIF® procedures.

Nexxt Spine Clinical Trial Evaluating 3D Printed Ti vs. PEEK

Nexxt Spine commenced a clinical trial evaluating Nexxt Matrixx® 3D-printed lumbar interbody fusion devices vs. PEEK cages.

Bone Therapeutics’ ALLOB Achieves Primary Endpoint in Delayed-Union Fracture Study

Bone Therapeutics reported all patients met the primary endpoint in the U.S. Phase I/IIA study of ALLOB® allogeneic bone-cell therapy in the treatment of delayed-union fractures.

Vertos Medical: Positive Study Results for mild Procedure

Vertos Medical announced that data from a two-year study demonstrates long-term safety and efficacy of mild® lumbar decompression procedure.

Histogenics’ Top-Line Results From Phase 3 Trial of NeoCart

Histogenics' Phase III clinical trial of NeoCart® tissue engineered implant did not meet the primary endpoint of a statistically significant improvement in pain and function vs. microfracture in a dual threshold responder analysis at one year.

CartiHeal Performs First Belgian Case in Agili-C Study

CartiHeal announced successful enrollment of the first Belgian patient in the Agili-C IDE pivotal study.

First U.S. Patients Receive Agili-C Implants

CartiHeal announced successful enrollment of the first two U.S. patients in the Agili-C IDE pivotal study.

Augmedics’ First-in-Human Trial of xvision-spine Underway

Augmedics commenced a first-in-human clinical trial of xvision-spine augmented-reality surgical navigation.

Episurf Hears FDA Feedback on IDE for Episealer Knee

Episurf Medical is entering its next phase on its IDE application to initiate a U.S. clinical study of the Episealer® knee implant.

Cerapedics Enrolls Patients in IDE Study of P-15L Bone Graft in TLIF

Cerapedics enrolled the first patients in an IDE clinical trial evaluating P-15L Bone Graft vs. autograft in TLIF.

ReVivo Medical Efficacy Study Results

Results from an efficacy study of ReVivo Medical's spinal fusion technology demonstrated that loadsharing through elastic micro-motion accelerates bone formation and interbody fusion.

CoNextions Launches Clinical Trial for Tendon Repair

CoNextions enrolled the first two patients in a clinical trial comparing the CoNextions TR system to suture repair to treat Zone 2 tendon lacerations.

Cartiva Synthetic Cartilage Implant Long-Term Clinical Data

Five-year follow-up results demonstrate that Cartiva's Synthetic Cartilage Implant provided long-term durability in pain and functional improvements in the treatment of great toe arthritis.

Final Patient Treated in Active Implants’ NUsurface Trials

Active Implants announced treatment of the final patient in two clinical trials evaluating the NUsurface® Meniscus Implant.

Anika Therapeutics Announces Top-Line Results from CINGAL Trial in Knee OA

In the Phase III 16-02 clinical trial of Anika Therapeutics' CINGAL, statistically significant results in pain reduction were not demonstrated at the primary endpoint of 26 weeks.

Study Validates NuVasive’s Porous PEEK Cohere

Study results indicate that NuVasive's porous PEEK technology, used in the Cohere® cervical interbody fusion device, presents a clinically viable option to improve osseointegration and fusion.

Arthrosurface Trial Results with PF Wave Implant

Five-year midterm clinical study results reconfirmed joint preservation in patellofemoral surgery using Arthrosurface's PF Wave implant.

Kuros Biosciences Begins Trial of MagnetOs in Spinal Fusion

Kuros Biosciences commenced a multicenter study comparing MagnetOs bone graft substitute vs. autologous bone in spinal fusion.

Wenzel Spine Announces Case Study of VariLift-LX System

Wenzel Spine announced publication of a case series detailing endoscopic transforaminal decompression and fusion with the VariLift-LX system.

Cerapedics Study Results: i-FACTOR Bone Graft in Lumbar Posterolateral Spine

Study results indicate that Cerapedics' i-FACTOR Peptide Enhanced Bone Graft demonstrated a 50% fusion rate in lumbar posterolateral spine surgery patients vs. 20% fusion rate with allograft.

Globus Medical Announces Positive LLIF Study Results

In a study comparing expandable and static LLIF devices, at 2-year follow-up, researchers observed no implant subsidence in patients treated with expandable devices, with 16% subsidence in levels treated with static spacers.

DePuy Synthes ATTUNE Knee Linked to Improved Quality of Life, Shorter LOS

Study results indicate that DePuy Synthes' ATTUNE knee may be associated with positive impacts on patient function and shorter lengths of hospital stays.

X-Bolt Orthopaedics Completes Hip Fracture Trial Enrollment

X-Bolt Orthopaedics completed recruitment of 1,140 patients for WHITE4, a randomized control trial comparing the X-Bolt expanding bolt device vs. a sliding hip screw in hip fracture treatment.

Biologica Technologies Presents Update on ProteiOS Growth Factor

Biologica Technologies is debuting initial clinical data from spinal applications using ProteiOS® growth factor. The product, which entered limited U.S. launch in 4Q17, is now available nationwide.

DiscGenics Treats First Patient in IDCT Trial

The first patient has been treated in DiscGenics' Phase I/II U.S. clinical trial of IDCT injection to treat degenerative disc disease.

Fidia Presents HYMOVIS Viscosupplement Study Data

Studies indicate that Fidia's HYMOVIS® viscosupplement enhanced cartilage volume and thickness in patients suffering from symptomatic knee OA.

Augmedics Cadaver Study Results with xvision-spine Navigation

Study results indicate that Augmedics' xvision-spine augmented-reality surgical navigation system was used to place 120 pedicle screws with 96.7% placement accuracy.

Spineology U.S. Fusion Trial Interim 12-Month Outcomes Data

Initial outcomes from the SCOUT trial of Spineology's OptiMesh® device revealed statistically significant improvements in low back pain and function scores at 6 and 12 months.

activL Lumbar Disc Study Results: Adjacent-Level Degeneration

Newly-published results from a 5-year study of Aesculap Implant Systems' activL® lumbar disc indicate that, in select patients, lumbar TDR is more effective than fusion at slowing the adjacent segment degenerative cascade.

NuVasive Porous PEEK Material Impaction Study Results

Studies demonstrated advantages of NuVasive's Porous PEEK interbody fusion devices vs. titanium-coated PEEK in impaction durability.

RTI’s Simmetry Reduces SI Joint Range of Motion

Study results demonstrate that RTI Surgical's Simmetry® Sacroiliac Joint Fusion system provided effective joint fixation, markedly reducing range of motion in the SI joint.

Vericel’s MACI Shows Sustained Benefit at Five Years

Study results demonstrated that improvements in pain and function from use of Vericel's MACI vs. microfracture in the treatment of knee cartilage defects were sustained for five years following surgery.

Cerapedics Launching IDE Study of P-15L Bone Graft in TLIF

Cerapedics received FDA approval for an IDE clinical trial of P-15L Peptide Enhanced Bone Graft vs. autograft in TLIF to treat degenerative disc disease.

Benvenue Medical Luna Interbody Fusion Study Results

Retrospective analysis of Benvenue Medical's Luna® 3D Multi-Expandable Interbody Fusion system indicate that minimally invasive TLIF placement of the device was safe and effective.

Lima Corporate Awarded New ODEP Ratings for SMR Reverse Shoulder

Lima Corporate received two new ODEP ratings for the SMR Shoulder System, and announced a 2H18 U.S. launch of the SMR TT Hybrid Glenoid.

Orthofix Cervical-Stim Device Shown to Improve Fusion Rates

Studies show that use of pulsed electromagnetic field treatment after ACDF significantly increased the fusion rate vs. control at 6 and 12 months, for participants at risk for pseudoarthrosis.

Biomatlante’s MBCP Matrix Selected for Fracture Study

Biomatlante's MBCP+ synthetic bone graft matrix has been selected for comparison to autograft in a 5-year trial in the treatment of long bone nonunions.

Bone Therapeutics Completes Enrollment for ALLOB Spinal Fusion Study

Bone Therapeutics finished recruitment of 32 patients in the U.S. Phase IIA study of ALLOB® allogeneic bone-cell therapy in lumbar spinal fusion.

Orthofix to Study PEMF in Rotator Cuff Repair

Orthofix commenced enrollment in a clinical trial of the RCStim pulsed electromagnetic field device as an adjunct to surgical repair of rotator cuff tears.

Spineology Completes Enrollment in Trial of OptiMesh Spinal Fusion Implant

Spineology completed enrollment in the Spineology Clinical Outcomes Trial, investigating use of the OptiMesh® implant in instrumented lumbar interbody fusion.

Bioventus Invests in CartiHeal Study

CartiHeal gained an investment of $2.5MM from Bioventus to support the IDE trial of the Agili-C cartilage regeneration implant.

Ceterix Completes Enrollment in NovoStitch Trial

Ceterix Orthopaedics completed enrollment in STITCH, a prospective, non-randomized, multi-center investigation of all-suture-based repair of horizontal meniscal tears.

Patient Satisfaction from MicroPort Evolution Knee

Study results suggest that patients who underwent medial-pivot TKA with MicroPort Orthopaedics' Evolution® system scored significantly better on the Forgotten Joint Score vs. posterior-stabilized knee recipients.

Anterior Approach THA 90-Day Outcomes Data

The anterior approach to total hip arthroplasty may provide a significant increase in hip function and reduction in pain and narcotics use through the first 90 days post-op vs. a posterior approach.

Paradigm Spine Announces 2-Year coflex Study Results

Two-year study results indicate that decompression plus use of Paradigm Spine's coflex® Interlaminar Stabilization® device may enhance the procedure's durability and sustainability vs. decompression alone.

Smith & Nephew’s eCAP Shows 97% Decrease in Readmission Rates

Smith & Nephew observed a 97.3% decrease in hospital readmissions following total joint arthroplasties conducted under its eCAP/Episode of Care Assurance Program.

X-Bolt Orthopaedics Reaches Patient Enrollment Milestone

The WHITE Four randomized control trial, comparing the X-Bolt expanding bolt device to a sliding hip screw, has surpassed enrollment of 1,000 patients.

MiMedx Enrolls Patients in AmnioFix Phase III Trial

MiMedx commenced enrollment in a Phase III Investigational New Drug clinical trial of AmnioFix® Injectable in the treatment of Achilles Tendonitis.

Spineology Duo LIF Postmarket Study Update

First study cases are complete in Spineology's postmarket investigation of the Duo Lumbar Interbody Fusion system.

ConforMIS iTotal CR in Mechanical Alignment: Independent Study Results

Study results suggest that use of ConforMI's iTotal CR Knee plus patient-specific instrumentation yields more consistent mechanical alignment than use of patient-specific cutting guides and off-the-shelf implants.

Zyga Reports Initial Results in SImmetry SI Fusion Study

Initial outcomes from Zyga's EVSI study indicate a significant reduction in low back pain and opioid use in patients receiving the SImmetry® SI Joint Fusion implant.

Zimmer Biomet Reports Positive Study Results with nSTRIDE APS in Knee OA

Zimmer Biomet announced positive results in a pilot study demonstrating safety and promising efficacy from use of the nSTRIDE® Autologous Protein Solution Kit to treat knee OA.

Bone Biologics Study: Preclinical Data for Spine Fusion Demonstrates Osteopromotive Properties

Preclinical study results indicate that Bone Biologics' rhNELL-1 growth factor effectively promoted bone formation in a spine model.

Globus Medical SECURE-C Disc vs. ACDF: 7-Year Follow-up

Results of seven-year clinical trial follow-up indicate superiority of Globus Medical's SECURE-C® cervical disc vs. ACDF in the treatment of cervical disc disease.

Rotation Medical Bioinductive Implant Study Update

Study results indicate that Rotation Medical's Bioinductive Implant may consistently heal rotator cuff tears, increase tendon thickness and prevent tear progression.

Regentis Biomaterials Launches Phase III Pivotal Trial of GelrinC

Regentis Biomaterials commenced first surgeries in its Phase III pivotal clinical trial of GelrinC in the treatment of focal knee cartilage defects.

Wright Medical INFINITY Postmarket Studies Update

Wright Medical announced the first patient implantation in a multi-center, 10-year U.S. follow-up study of the INFINITY™ Total Ankle.

Study Indicates Reduced Subsidence with 4WEB’s Lateral Spine Truss

Studies indicate that 4WEB Medical's Lateral Spine Truss demonstrated a better resistance to subsidence vs. an annular interbody implant.

Anika Fully Enrolls Second Phase III CINGAL Trial

Anika Therapeutics completed enrollment in its second pivotal Phase III trial evaluating CINGAL® HA/corticosteroid viscosupplement for the treatment of knee osteoarthritis symptoms.

Studies Indicate 5-Fold Reduction in Surgical Complications with Mazor Core Technology

Interim study results demonstrated that surgeries performed with Mazor Robotics' Renaissance Guidance System yielded a 5-fold reduction in surgical complications and a 7-fold reduction in revisions vs. freehand-based, minimally invasive lumbar fusion.

FzioMed Receives FDA Approval Oxiplex Study

FzioMed received FDA approval to conduct a small confirmatory study of Oxiplex® synthetic viscoelastic gel, examining its use following lumbar surgery.

Spineology Initiates Postmarket Study of Duo Lumbar Interbody Fusion System

Spineology launched a postmarket study to assess patient outcomes with the Duo™ Lumbar Interbody Fusion system.

Study: JNJ’s CareAdvantage Reduces Costs, Improves OR Efficiency

Studies indicate that the CareAdvantage Perioperative Efficiency approach yielded improvements for hip and knee procedures that led to an estimated annual cost savings of >$262,000.

CartiHeal Initiates Agili-C Implant IDE Multinational Pivotal Study

CartiHeal enrolled and treated 16 patients in its IDE study of Agili-C™ implants in the treatment of joint surface lesions.

Integra Enrollment in Cadence Total Ankle Postmarket Study

Integra LifeSciences implanted the first Cadence® Total Ankle as part of a non-randomized, prospective, multi-center postmarket study.

Bone Therapeutics ALLOB Phase I/IIA Delayed-Union Fracture Trial Update

Bone Therapeutics reports positive interim efficacy results and early conclusion of the Phase I/IIA study of ALLOB® allogeneic bone cell therapy in the treatment of delayed-union fractures.

Interim Results in ALLOB Phase IIA Spinal Fusion Study

Interim results in a Phase IIA trial with Bone Therapeutics' ALLOB® show evidence of successful spinal fusion and statistically significant improvements at 12 months.

Ten-Year Results with Arthrosurface HemiCAP Toe

Ten-year follow-up data indicate excellent outcomes from use of the Arthrosurface HemiCAP resurfacing implant in the treatment of hallux rigidus.

Cerapedics 2-Year Follow-Up Data on i-FACTOR Bone Graft in the Cervical Spine

Follow-up data from an IDE clinical trial of Cerapedics' i-FACTOR™ bone graft indicated statistical superiority to autograft in ACDF.

MiMedx Can Launch Phase 3 IND Trial for Achilles Tendonitis

MiMedx received permission to proceed with an Investigational New Drug Phase III clinical trial of AmnioFix® Injectable in the treatment of Achilles Tendonitis.

Orthocell Recruits First Patient for Ortho-ATI Shoulder Tendon Study

Orthocell announced recruitment of the first patient in a clinical trial investigating Ortho-ATI® to treat rotator cuff tendinopathy.

Medtronic Launches Study of INFUSE in PLF and TLIF

Medtronic launched a long-term global clinical study to collect prospective data on INFUSE® bone graft in posterolateral and transforaminal lumbar interbody fusion.

Study Results: Anika’s HYALOFAST in Knee Cartilage Lesions

Studies indicate that Anika Therapeutics' HYALOFAST® scaffold + autologous adult MSCs present a viable option to treat knee cartilage lesions, regardless of patient age.

MiMedx Files for Achilles Tendonitis IND Phase III Clinical Trial

MiMedx filed to initiate an Investigational New Drug Phase III clinical study comparing AmnioFix® Injectable to saline placebo in the treatment of Achilles Tendonitis.

MiMedx Plantar Fasciitis Clinical Trial Underway

MiMedx commenced a Phase III study to evaluate AmnioFix Injectable allograft vs. placebo in the treatment of Plantar Fasciitis.

Premia Spine Launches IDE Study of TOPS Spinal Arthroplasty Device

Premia Spine launched its U.S. pivotal Investigational Device Exemption study of the TOPS™ posterior arthroplasty device vs. traditional lumbar fusion.

Smith & Nephew, Imperial College to Study Meniscus Function

Smith & Nephew signed a 3-year partnership with Imperial College London to study meniscus function and develop techniques to treat knee injuries caused by sports.

Study Results: Inspired Spine’s OLLIF Procedure for Adult Scoliosis

Research indicates that Inspired Spine's OLLIF procedure yielded substantial pain relief and minimal post-op complications in the trestment of adult degenerative scoliosis.

Study Results: Providence Medical’s CAVUX and DTRAX Fusion Technologies

Studies indicate that Providence Medical Technology's tissue-sparing cervical fusion devices, CAVUX® Cervical and DTRAX® Expandable cages, yielded improvements in pain, with radiographic confirmation of fusion.

Clinical Trial of Stem Cells to Treat Massive Knee Cartilage Injury

A 6-year, randomized clinical trial is underway to evaluate use of a patient's own stem cells to regenerate knee cartilage.

Study Results Indicate Rotator Cuff Function and Pain Improve with Use of InSpace

Study results indicated 37 patients demonstrated improved rotator cuff function and pain after undergoing InSpace™ procedure.

Histogenics Completes Enrollment for NeoCart Phase III Clinical Trial

Histogenics completes enrollment of 245 patients in its NeoCart Phase III clinical trial.

ConforMIS Retrospective Study: Customized vs. Off the Shelf Total Knees

Retrospective study results indicate lower adverse events, more rapid discharge, lower follow-up care costs, etc. with custom knee implants vs. standard, off the shelf devices.

Clinical Trial for New Indication of DJO Bone Growth Stimulators

DJO Global announced a clinical trial for a fresh fracture indication with the CMF OL1000™ Bone Growth Stimulator.

Bone Therapeutics Completes Recruitment in PREOB Phase III Trial

Bone Therapeutics completed patient recruitment for interim analysis in its Phase III trial of PREOB® for the treatment of hip osteonecrosis.

New ATTUNE Knee Implant Survivorship Data from DePuy Synthes

Independent analysis of 10,605 ATTUNE® Knee procedures showed a cumulative revision rate of 1.3% at 4 years vs. a 1.9% cumulative revision rate for the overall class of total knee replacement.

Anika Enrolls First Patient in Supplemental Phase III CINGAL Trial

Anika Therapeutics enrolled the first patient in a supplemental Phase III trial evaluating CINGAL® viscosupplement for the treatment of knee OA symptoms.

United Orthopedic Enrolls First Patient in U2 Knee Study

United Orthopedic enrolled its first patient in a study of the U2 Knee™, evaluating the system's use in primary total knee arthroplasty.

CINGAL Phase III Data Demonstrates Efficacy and Safety to Treat Knee OA Pain

Phase III study results demonstrated that Anika Therapeutics' CINGAL® provided superior immediate and short term OA pain relief after injection vs. hyaluronic acid alone, and superior relief at 26 weeks vs. saline.

BONESUPPORT Enrolls First Patient in FORTIFY Trial With CERAMENT G

BONESUPPORT enrolled the first patient in the pivotal IDE trial of CERAMENT G in the surgical repair of open diaphyseal tibial fractures.

Rotation Medical BioInductive Implant REBUILD Study Results

Interim study results indicate that patients receiving Rotation Medical's Bioinductive Implant to treat rotator cuff disease reported statistically significant improvement at six months.

Life Spine Announces Approval of Spine Outcomes Study

Life Spine announces the approval of a study to help determine optimal outcomes for Open vs. Minimally Invasive Posterior Lumbar Spine Surgery.

Carmell Therapeutics to Launch Phase III Study of Bone Healing Accelerant

Carmell Therapeutics will launch a Phase III clinical study for Bone Healing Accelerant, its first Plasma-based Bioactive Material product/indication, designed to treat fractures.

Aesculap Implant Systems Presents Long-term activL Study Data

Studies indicate that, at 5 years, the activ-L® Artificial Disc from Aesculap Implant Systems had a protective effect on the progression of degenerative disc disease at adjacent levels in 91.2% of patients.

Inspired Spine Presents OLLIF Procedure Study Results

Results from a 124-patient study indicate that Inspired Spine's OLLIF procedure was completed at ~2x the speed of an open TLIF, and reduced blood loss by >80% vs. TLIF.

Premia Spine Secures FDA Approval for IDE Study of TOPS

Premia Spine secured FDA approval for a pivotal IDE study of TOPS™, a posterior arthroplasty device for the treatment of spondylolisthesis and spinal stenosis. The study seeks to establish the superiority of TOPS vs. traditional lumbar spinal fusion.

Patient Enrollment Complete in Thumb OA Study of Cartiva SCI

Cartiva completed enrollment and treatment of all 50 patients in a multi-center study evaluating the Synthetic Cartilage Implant for thumb base OA.

SI-BONE 6-year Clinical Results of iFuse Implant System

Six-year study results on the treatment of SI joint disorders indicated that treatment with conservative management or radiofrequency denervation led to worsened outcomes, while iFuse Implant patients demonstrated superior improvements.

BioPoly RS Partial Resurfacing Knee: 2-Year Clinical Results of Patient Outcomes

Two-year clinical results from a study of BioPoly's RS Partial Resurfacing Knee indicate statistically significant and clinically meaningful improvement in knee pain and function.

Zyga EVoluSIon Study Enrolls 100th Patient

Zyga Technology enrolled the 100th patient in the EVoluSIon trial investigating long-term results and pain reduction following the SImmetry® Sacroiliac Joint Fusion procedure.

24-month CT Fusion and Clinical Results for SImmetry SI Joint Fusion

Results from a study of Zyga Technology's SImmetry® Sacroiliac Joint Fusion indicate radiographically-evident fusion as early as 12 months, and increased fusion rates at 24 months.

Clinical Trial Update: Simplify Medical’s Cervical Disc

The first patient has been treated in a pivotal clinical trial of Simplify Medical's Simplify® cervical disc, investigating use in two adjacent levels to treat degenerative disc disease.

Study Results: ConforMIS iTotal PS Total Knee

Study results suggest that ConforMIS' iTotal® PS yields knee motion patterns that more closely resemble those of a normal knee than those achieved with a traditional off-the-shelf implant.

Burst Biologics Spinal Fusion Study

Burst Biologics received IRB approval for a U.S. prospective clinical study of BioBurst cellular allograft in spinal fusion.

Study Results: RepliCel’s RCT-01 Tendon Repair Clinical Trial

Six-month results from Phase I/II study indicate that RepliCel's RCT-01 fibroblasts demonstrated product safety and clinical potential for tendon regeneration and healing.

One-Year Study Results: Percutaneous Application of the IlluminOss System

Study results indicate that percutaneous intramedullary fixation provided by IlluminOss Medical's light curable monomer system can provide stabilization of fractures without open surgery.

Additive Orthopaedics Launches Clinical Study of 3D Printed Bone Segments

Additive Orthopaedics commenced a multi-center clinical study to measure bone in-growth into 3D-printed bone segments.

Study Results: Mesoblast’s Cell Therapy in Degenerative Disc Disease

Studies suggest that a single injection of Mesenchymal Precursor Cells resulted in meaningful improvements in chronic low back pain and function that were durable for at least 3 years.

Study Results: Rotation Medical Bioinductive Implant in Rotator Cuff Tears

Study results indicate that Rotation Medical's collagen-based Bioinductive Implant induced new tissue formation in all study participants with large and massive rotator cuff tears.

Study Results: ATTUNE Knee Clinical and Economic Data

Study results demonstrate the clinical and economic value of DePuy Synthes' ATTUNE® knee in a healthcare environment experiencing cost constraint and growing procedure volumes.

Collaborative Clinical Study of TracPatch Wearable Device

Consensus Orthopedics and the University of Miami Health launched a collaborative clinical study to evaluate the recovery effectiveness of acute care total knee arthroplasty in patients using the TracPatch wearable device.

5-Year Clinical Data on Cartiva Synthetic Cartilage Implant

Five-year results from a clinical trial of the Cartiva Synthetic Cartilage Implant in the treatment of great toe arthritis demonstrated pain relief and functional outcomes equivalent to first MTP arthrodesis at two years post-op.

Recruitment Status for ALLOB Delayed-Union Study

Bone Therapeutics completed recruitment of 16 patients in the Phase I/IIA delayed-union fracture study of ALLOB® allogeneic cell therapy product.

Positive Interim Data from Trial for BonyPid Antibiotic Eluting Bone Substitute

Interim results from study of BonyPid®-1000 bone substitute in the treatment of open tibial fractures indicate that the product met performance and safety endpoints in first patients at 6 months.

Study Results: Vitrium Bioactive Glass in Ovine Spinal Fusion

Results from ovine study of Bio2 Technologies' Vitrium bioactive glass demonstrated the device's capability to support interbody fusion.

Bioactive Glass Shown Effective Towards Antibiotic-resistant Bacteria

Studies of BonAlive® indicate that the naturally-antibacterial bioactive glass yields excellent results in the treatment of osteomyelitis, without the use of local antibiotics.

Study Results: Use of CT Imaging in Post-op Assessment of Spine Surgery

Studies found that prevalence of CT imaging following complex spine surgery grew more than 2-fold from 6 months to 5 years, with patients averaging 2 scans during the period.

Study Results: 98.8% Implant Survivorship of MicroPort Orthopedics Medial Pivot Knee

Results of evaluation of MicroPort Orthopedics' Medial Pivot Knee demonstrated 95.0% satisfaction and 98.8% survivorship at 17 years, with patients reporting high stability and comfort during regular activity.

Study Results: Independent Femoral Head Wear Testing

Independent study results indicate that mean wear associated with Amedica's MC2® silicon nitride femoral heads was ~15% lower than a BIOLOX®delta sample after five million cycles.

SpineJack FDA Trial Completes Patient Enrollment

Vexim completed enrollment in its FDA clinical trial comparing SpineJack® to balloon kyphoplasty on 152 patients with osteoporotic vertebral compression fractures.

AxioMed Completes 2-Year Follow-up for Freedom Lumbar Disc

AxioMed has completed collection and analysis of 2-year follow-up data in its U.S. IDE clinical study of the Freedom® viscoelastic lumbar disc.

FDA Approves Expanded 26-week Efficacy Claim for Gel-One to Knee OA Pain

Zimmer Biomet announced FDA approval of an expanded 26-week efficacy claim for single-injection Gel-One® Cross-linked Hyaluronate viscosupplement for the treatment of knee pain associated with osteoarthritis.

Study Results: iFuse vs. SI Joint Fixation with Screws

Retrospective study results on patients undergoing sacroiliac joint fusion vs. fixation showed a 5.7% revision rate in fusion patients receiving SI-BONE's iFuse™ vs. a 30.8% revision rate for those undergoing screw fixation.

Retrospective Study: Spinal Elements’ Magnum+ ALIF Device With Ti-Bond Coating

Patients in a retrospective study of Spinal Elements' Magnum+® ALIF device with Ti-Bond® coating demonstrated a 96% success rate, with subjects achieving solid arthrodesis at an average of 7.3 ± 2.3 months.

Histogenics’ NeoCart Phase I/Phase II Clinical Trial Data

Results from Phase I and Phase II study indicate that Histogenics' NeoCart® tissue-engineered implant is a safe, effective treatment for articular cartilage lesions through 5-year follow-up.

Positive Long-Term Follow-Up Data for InSpace System

Long-term follow-up study results indicate that patients with massive rotator cuff tears that were treated with the OrthoSpace InSpace™ system showed improvements in function and pain at 6 weeks, with effects maintained for up to 5 years.

Australian Joint Registry Data for DePuy’s ATTUNE Knee

Implant survivorship data from the 2016 Australian Orthopaedic Association National Joint Replacement Registry confirm positive early results for DePuy Synthes' ATTUNE® Knee.

Study Results: InSpace in the Treatment of Massive Rotator Cuff Tears

Initial study results indicate that patients undergoing the InSpace™ procedure to treat massive rotator cuff tears experienced durable improvements in shoulder function and reductions in shoulder pain at one year.

SpinalCyte’s IRB Approval for Phase I Clinical Trial

SpinalCyte received IRB approval to commence Phase I clinical trials with its CybroCell dermal fibroblast cell product in the treatment of degenerative disc disease.

Study Results: OrthoTrophix TPX-100 in Knee OA

OrthoTrophix announced results of the first proof of principle study of TPX-100 in bilateral knee osteoarthritis, showing improvements at 6 and 12 months in key knee-related outcome measures.

U.K. National Joint Registry Analysis of Zimmer Biomet Trabecular Metal Cups

Zimmer Biomet announced positive outcomes associated with use of Trabecular Metal™ Cups in >9,500 revision hip arthroplasty cases, as reported in data from the National Joint Registry for England, Wales, Northern Ireland and the Isle of Man.

12-month Clinical and Radiographic Results with SImmetry Sacroiliac Joint Fusion

Results from a study of Zyga Technology's SImmetry® Sacroiliac Joint Fusion procedure indicate that, at 12 months, fusion was reported in 88% of patients and back pain decreased by 46%.

Study Results: Biomatlante’s MBCP+ Synthetic Bone Graft and MSCs

Study results demonstrated a high rate of clinical success from a combination of Biomatlante's MBCP+™ synthetic bone graft plus mesenchymal stem cells, particularly in the treatment of long bone non-union fractures.

Three-Month Interim Safety Data from Phase I Clinical Trial of AlloJoin

Three-month safety data from a Phase I clinical trial in China for Cellular Biomedicine's AlloJoin™ off-the-shelf allogeneic stem cell therapy in the treatment of knee osteoarthritis demonstrated a safety and tolerability profile of AlloJoin in the three doses tested, with adverse events similar to that of earlier autologous trials. The trial is slated for completion in 3Q17.

JAZZ Band Clinical Results in Hypokyphotic Idiopathic Scoliosis Patients

Study results indicate that Implanet's JAZZ sublaminar bands offered a safe, efficient alternative to traditional techniques at up to 34 months in the treatment of complex hypokyphotic thoracic scoliosis.

Study Results: EXOGEN Ultrasound Bone Healing System

Study results indicate that the latest-generation design of Bioventus' EXOGEN® Ultrasound Bone Healing System improves patient compliance by 10%, with overall compliance at a minimum of 76%.

Study Results: Generic Orthopaedic Implants Clinically Equivalent, Provide High Value

Independent study results indicate comparable clinical outcomes with the use of generic vs. conventional orthopaedic trauma implants, with savings averaging US $1,197 per case. Generic implants were provided by The Orthopaedic Implant Company.

New UK Joint Registry Data for DePuy Synthes ATTUNE Knee

DePuy Synthes announced new clinical evidence indicating positive performance of the ATTUNE® Knee, indicating a favorable comparison to the class of cemented total knee systems.

Medovex Announces Successful Largest Living Tissue Population Test to Date

Medovex conducted a successful live tissue test of the DenerveX™ system under the most stringent standards required by FDA and other regulatory agencies. The device is intended to treat pain associated with facet joint syndrome.

Pre-clinical Study Results: Stryker’s 3D-printed Tritanium PL Interbody Cage

Results from a pre-clinical interbody fusion study of Stryker Spine's 3D-printed Tritanium PL Interbody Cage demonstrated statistically superior range of motion, bone in-growth and greater average construct stiffness vs. PEEK and titanium plasma-sprayed PEEK cages.

Positive Comparative Data from 7-Year Follow-Up Study of Mobi-C

Seven-year outcomes study data demonstrated statistical superiority of Zimmer Biomet's Mobi-C® Cervical Disc vs. 2-level ACDF in overall success.

Study Results: AMNIOX CLARIX Regenerative Matrix as Adjunct to Lumbar Discectomy

Results from a study of AMNIOX Medical's proprietary cryopreserved Amniotic Membrane as an adjunct to lumbar discectomy indicate improved outcomes in disability scores at 6 weeks and 2 years.

Early Outcomes with Porous PEEK COHERE Fusion Device

Vertera Spine announced initial successful outcomes using the COHERE® Cervical Interbody Fusion device.

Randomized Study Results: Safe Orthopaedics

Randomized study results indicate that Safe Orthopaedics' single-use spine surgical instruments yielded an 80% decrease in pre- and post-operative times.

12-month Fusion and Clinical Results with SImmetry Sacroiliac Joint Fusion

Results from a study of Zyga Technology's SImmetry® Sacroiliac Joint Fusion with decortication procedure indicated fusion in 74% of patients, at 12 months.

Positive Efficacy Data from ALLOB Phase IIA Spinal Fusion Trial

Bone Therapeutics reported positive efficacy data from its Phase IIA trial of ALLOB® in spinal fusion.

Study Results: Rotation Medical Bioinductive Implant in Growth of New Tendinous Tissue

Study results support the biocompatibility of Rotation Medical's collagen-based bioinductive implant and its ability to promote new connective tissue with the appearance of tendon.

Regentis Receives IDE Approval for Pivotal GelrinC Clinical Trial

Regentis Biomaterials received FDA Investigational Device Exemption approval to initiate a pivotal Phase III clinical study of its GelrinC procedure to treat focal knee cartilage defects.

Study Results from Inspired Spine’s MIS Direct Thoracic Interbody Fusion Procedure

Study results indicate that the minimally invasive direct thoracic interbody fusion or MIS-DTIF approach, offered by Inspired Spine, was shown to alleviate back pain in patients with degenerative disc disease or herniation.

OSTEOGROW Research Update

OSTEOGROW, an EU-funded collaborative research project, is investigating a new bone regeneration therapy based on autologous blood + BMP-6 for use in applications requiring partial bone replacement, without the need for secondary interventions.

Orthofix Enrolls First Patient in Knee OA Study

Orthofix enrolled the first patient in a study evaluating use of Physio-Stim pulsed electromagnetic field technology to treat knee osteoarthritis.

Study Results from Rotation Medical’s Bioinductive Implant in Partial Thickness Rotator Cuff Tears

Studies indicate that Rotation Medical's collagen-based bioinductive implant induced new tissue formation in all 13 patients with partial thickness rotator cuff tears.

2-Year Results from SI-BONE iFuse INSITE Trial

Two-year results from a randomized, controlled trial in the management of sacroiliac joint dysfunction revealed that SI-BONE's iFuse yielded more rapid improvements in pain, disability and quality of life vs. non-surgical treatment.

Clinical Study Results: ConforMIS iTotal CR Customized Knees

Study results indicate that total knee patients receiving ConforMIS' iTotal® CR outperformed recipients of off-the-shelf implants in terms of length of stay, discharge within 24 hours, discharge to home vs. a SNF, etc.

BONESUPPORT Receives FDA Approval to Initiate IDE Clinical Study

BONESUPPORT received FDA approval to launch an Investigational Device Exemption study of CERAMENT G bone graft substitute in the treament of open diaphyseal tibial fractures.

Study Results: Trinity Evolution Allograft in Anterior Cervical Discectomy & Fusion

Data from a 12-month study of 1-level ACDF patients treated with Trinity Evolution® + a PEEK interbody spacer demonstrated fusion rates of 78.6% at 6 months and 93.5% at one year.

Pluristem to Conduct Phase III Trial of PLX-PAD Following Hip Fracture Surgery

Pluristem Therapeutics intends to conduct a U.S./EU Phase III trial assessing use of PLX-PAD (PLacental eXpanded) cells to support recovery following surgery for femoral neck fracture.

Pre-clinical Study Results: Multipotent Adult Progenitor Cells on an Allograft Scaffold

Pre-clinical studies suggest that multipotent adult progenitor cells (MAPCs), such as the technology used in RTI Surgical's map3® Cellular Allogeneic Bone Grafts, exhibited a more robust angiogenic protein release profile vs. mesenchymal stem cells in vitro.

Trial/Study

3Spine Gains IDE Approval for Clinical Trial

Study: Injectable Gel May Reduce Chronic Low Back Pain

Lipogems To Launch Study to Treat Knee Osteoarthritis

Study Compares Premia Spine’s TOPS to TLIF

Study Results: Bioretec Bioresorbable Elastic Activa IM-Nail

Kuros MagnetOs: First Trial Results

Study Results: In Favor of Fully Personalized Knee Replacements

Study Results: XPERIENCE Reduces Bacteria, Biofilms

First In-Human Use of ReVivo Medical Cervical Fusion Devices

Study: Stryker InSpace in Rotator Cuff Tears

Study Results: Bioretec ActivaPin in Pediatric Fracture

100 U.S. Patients Treated in Clinical Trial of Baguera C ...

Two-year Study Results: NuVasive Simplify Cervical Disc

Study: No Revisions, Low Complications with Vantage Total Ankle

Cline Completes Initial Testing of Cartilage Repair Product

Study Launch: 2-year Follow-up of Episealer Talus Patients

First Case in aap Implantate Study of Silver Coating Technology

OssDsign Enrolls First Patient in U.S. PROPEL Registry

Study Compares Cementless to Standard Knee Replacement Outcomes

Study Results: Creative Medical StemSpine Procedure

Study: Bilateral Knee Patients Prefer Conformis’ Fully Personalized Solution

Enrollment Complete in Cerapedics’ Bone Graft Study

Mobility Improvement in Vertos Medical Study

Prospective Episealer Talus Study 50% Recruited

Orthox Gains Funds for Knee Cartilage Clinical Trial

Ortho Regenerative Technologies Partners on Rotator Cuff Repair Trial

Study: Synergy Biomedical BioSphere Bone Graft Technology

IDE Study Update: FX Solutions Reversed Stemless Shoulder

Hip Innovation Study of Reverse Hip Replacement

OssDsign to Collect Data on Catalyst Bone Graft

aap Launches 1st Human Clinical Study for Antibacterial Coating

Biomedical Bondings’ Coating Shows Biological Safety Properties

Study Results: Inspan Interspinous Lumbar Fixation

Study Results: Premia Spine TOPS Arthroplasty System

Study Results: Centinel Spine’s STALIF Integrated Interbody

ReVivo Medical Raises $2 Million for FDA Sanctioned Clinical Trial

Clinical Study: Treace Medical Mini3D Lapiplasty

Study Results: Conformis iTotal CR Knee

Clinical Trial: Medtronic Pediatric Spinal Tether

Study Results: Pixee Medical Knee+ and Vuzix Smart Glasses

Miach Orthopaedics Initiates Postmarket Study for BEAR Implant

Study Update: OssDsign Synthetic Bone Graft

Product Update: Episealer Products in Sweden and Spain

Study Results: PainTEQ LinQ in SI Joint Dysfunction

AAOS Reports Trends, Outcomes from Joint Registries

Study: Centinel Spine prodisc L Effectiveness

Lazurite Partners to Study ArthroFree Wireless Surgical Camera

Study Results: Bone Therapeutics’ Viscosupplement for Knee OA

Study Results: Cerapedics’ i-FACTOR vs. Local Autologous Bone in ACDF

Next Science Begins Trial for XPERIENCE No Rinse Antimicrobial Solution

Study Results: CartiHeal Agili-C vs. Microfracture and Debridement

Study Update: Orthofix Medical M6-C Artificial Cervical Disc

Carlsmed Partners to Study aprevo Spinal Device

Study Results: Aesculap Implant Systems’ activL Artificial Disc

European Study with 5-year Follow-up of Episealer Talus Patients

Study Results: REGENETEN Bioinductive Implant in Rotator Cuff Tear

Episurf Medical Updates: U.S./European Markets, Talus Study

Active Implants NUsurface Meniscus Study Results

Histogen Initiates Knee Cartilage Regeneration Trial

European Study for 5-Year Follow-up on Episealer Knee Patients

Study Results: Relievant Medsystems’ INTRACEPT in Back Pain

Study Results: Spinal Elements Luna XD Multi-Expandable Interbody

Elute Authorized for Clinical Trial of Antibiotic Eluting Bone Void ...

Histogen Development and Pipeline Update

Ortho Regenerative Technologies Receives Clinical Hold Letter From FDA

Study Results: Bioventus Placental Tissue Biologic Candidate

Interim Study Results: Treace ALIGN3D Clinical Study

Study Results: Biologica Technologies’ ProteiOS in Foot and Ankle Arthrodesis

MedShape and CurveBeam Initiate Joint Prospective Clinical Study

Puregraft Fat Used to Treat Knee Osteoarthritis

Aurora Spine Launching Study of SiLO SI Fusion System

Favorable Study Results for Total Hip Navigation with Smith+Nephew Implants

DiscGenics Study Updates: Injectable Discogenic Cell Therapy

LimaCorporate Announces First Surgery with SMR Stemless Reverse Shoulder in ...

Ortho RTI Submits Application for Rotator Cuff Repair