Trial/Study

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.

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.

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

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

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.

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

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

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

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 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.

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.

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.

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

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.

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

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

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

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.

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.

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

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 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.

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

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.

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

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

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

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.

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.

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

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

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

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' InSet Glenoid demonstrated long-term efficacy and safety in total shoulder replacement to reconstruct deficient, arthritic glenoid 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 Concepts announced additional positive clinical data supporting the Lapiplasty® 3D Bunion Correction procedure.

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

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

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.

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.

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

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

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

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

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 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.

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' 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 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. 

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

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. 

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

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. 

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

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

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

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

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.

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

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

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' 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 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 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.

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

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

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

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

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

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

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

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

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

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

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.

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

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 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.

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

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

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

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.

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.

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 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 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.

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

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

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

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. 

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.

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

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.

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

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

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

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

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

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

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.

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.

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

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

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

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.

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 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.

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

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.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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.

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

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.

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

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

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

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.

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

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

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

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

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

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

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.

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. 

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 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.

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

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.

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

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. 

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

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.

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

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

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.

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.

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

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.

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

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

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. 

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.

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.

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

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.

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.

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.

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.

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.

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. 

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

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

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.

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.

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 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 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.

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 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%.

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.

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 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.

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.

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

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.

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

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

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

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

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

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

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.

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

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 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 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.

Study results suggest that AMNIOX Medical's CLARIX®  FLO and CLARIX® CORD 1K regenerative therapies improved outcomes in plantar fasciitis treatment and tarsal coalition repair.

Interim results from a U.S. 300+ patient multi-center prospective study of ConforMIS' iTotal CR total knee indicate that 92% of patients were satisfied with their procedures at one year. 

Preclinical data on adipose-derived mesenchymal stem cells in a rat model, using technology similar to AlloSource's AlloStem® Cellular Bone Allograft process, showed bone formation within a critical-sized defect in all study subjects.

Study results indicate that patients treated with Spineart's BAGUERA® C cervical disc in 1- or 2-level arthroplasty exhibited good mobility at treated and adjacent levels, disc height restoration and evidence of adjacent level preservation.

Microbion enrolled the first patient in its U.S. Phase IIA study of MBN-101 candidate for treatment of orthopaedic implant-related infections.

Pre-clinical study results demonstrated that BONESUPPORT's CERAMENT™, loaded with rhBMP-2 + zoledronic acid in very low doses, was able to quantitatively/qualitatively generate a high amount of mineralized bone volume.

Active Implants announced the first meniscus replacement in the SUN (Safety Using NUsurface®) clinical trial for patients with persistent knee pain following medial meniscus surgery.

Results from a 421-patient study revealed a 97.75% survival rate at 5 years for Medacta's AMIStem hip implant. AMIStem has been implanted >100,000 times, to date.

Bone Therapeutics is planning a Phase II trial with ALLOB® allogeneic bone cell therapy for the treatment of severe osteoporosis. 

Bone Therapeutics announced positive efficacy results for the 2nd patient cohort in its Phase I/IIA trial of ALLOB® allogeneic bone cell therapy product for the treatment of delayed-union fractures.

Study results suggest that Moximed's Atlas™ knee provided rapid, clinically-effective pain relief for patients with early knee OA in the pre-arthroplasty disease stage.

Bone Therapeutics completed recruitment for its ALLOB® allogeneic cell therapy Phase IIA spinal fusion study. The company will extend the trial to assess early onset of bone formation and fusion.

Seven-year follow-up data demonstrated favorable clinical outcomes and patient satisfaction for Medtronic's 2-level Prestige LP™ cervical disc vs. 2-level ACDF.

Since limited launch in 2015, MedShape's FastForward™ Bunion Correction System has been used in >100 hallux valgus correction procedures. 

Results from a 2-year study of SI-BONE's iFuse implant for sacroiliac (SI) joint fusion show that improvements in SI joint pain, disability and quality of life at 6 and 12 months were maintained to 2 years.

Zyga Technology enrolled the 1st 4 patients in an expanded EVoluSIon Clinical Study evaluating long-term fusion and pain reduction in patients receiving SImmetry® Sacroiliac Joint Fusion.

Study results demonstrated that patients implanted with ConforMIS' iTotal® CR customized total knee exhibited more natural knee kinematics vs. those receiving an "off-the-shelf" total knee.

Results from 5-year clinical study comparing cervical total disc replacement (LDR's Mobi-C) with anterior discectomy and fusion to treat 2-level degenerative disc disease indicated overall success rates of 61% and 31% for cTDR and ACDF, respectively.

Initial 12-month efficacy results from a Phase IIA trial demonstrate positive effects on pain and osteoporosis blood markers from a single administration of Bone Therapeutics' PREOB® autologous osteoblastic cell therapy.

Results from a 6-month study observing BioElectronics' ActiPatch® musculoskeletal pain therapy device indicated an average 61% reduction in pain for >90% of participants, a decrease in doctor visits, etc. 

Implanet commenced a prospective, multicenter clinical study to document outcomes with the JAZZ Band™ implant in adult degenerative and deformity indications.

Study results suggest that use of pulsed electromagnetic field therapy, such as Orthofix's Physio-Stim®, may reduce cellular inflammation and degredation in intervertebral disc cells.

Preliminary study results indicate that the Vital 5 ReLeaf Catheter improved pain scores and reduced post-op narcotic use following orthopaedic and spinal surgeries, and may support a transition to outpatient procedures.

Study findings demonstrate a statistically significant reduction in bacteria on implant surfaces processed with Tyber Medical's BioTy™ Modified Surface Treatment.

United Orthopedic Corporation commenced patient enrollment in a U.S. follow-up study of the U-Motion II+ Acetabular System and UTF Reduced Stem in primary total hip arthroplasty.

Bone Therapeutics has treated 12 patients in the ALLOB® Phase IIA spinal fusion trial, and reports no safety concerns.

Study results suggest that a permanent bond may form between cartilage and the hydroxyapatite coating of Episurf's Episealer® device, suggesting that implantation may stop or significantly slow the progression to OA.

Regentis Biomaterials closed a US $15MM Series D investment round. Funds will primarily support a pivotal U.S. clinical trial of GelrinC®, a cell-free implant for the treatment of articular knee cartilage injuries.

Studies concluded that, for patients with 2-level degenerative disc disease, cervical total disc replacement appears to be highly cost-effective vs. ACDF, and supports greater quality of life at less cost. 

CollPlant announced positive final clinical trial results for Vergenix™STR, intended for the treatment of tendinopathy.

Histogenics has completed >50% of the required enrollment in its ongoing NeoCart® Phase III clinical trial in the treatment of knee cartilage defects.

Active Implants initiated SUN (Safety Using NUsurface®), a 2nd clinical trial evaluating the investigational meniscus implant.

Study results from 5-year follow-up demonstrate the long-term, sustained therapeutic effect of Paradigm Spine's coflex® Interlaminar Stabilization® vs. fusion in the treatment of lumbar spinal stenosis.

Bone Therapeutics commenced a Phase IIA study for the treatment of multiple delayed-union fractures with ALLOB® allogeneic bone cell therapy product. 

Vexim initiated a new clinical study in France to compare 1-year and 2-year follow-up of SpineJack® vs. bracing in 100 acute traumatic vertebral compression fracture patients.

CartiHeal completed a US $15MM financing round. Funds will support ongoing manufacturing scale-up, EU product commercialization in 2017 and clinical studies in new therapeutic areas for Agili-C™ cartilage regeneration technology.