Trial/Study

Study Validates NuVasive X360 Approach

Study Validates NuVasive X360 Approach
The single position circumferential fusion was found to improve operative efficiency and reduce complications vs. traditional circumferential fusion.

Spineart Conducts Ti-LIFE Animal Study

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.

Providence Medical Enrolls in FUSE IDE Study

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.

INSPAN Reports Study Results from Inspan Interspinous Fixation Device

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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. 

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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. 

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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. 

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.

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.

Preclinical Study Validates Science Behind AlloSource AlloStem Cellular Bone Allograft

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.

Two-year Clinical Results for Spineart’s Baguera C Cervical Disc

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.

Study Results Show Benefits of SI Joint Fusion after Two Years

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.

Independent Peer-Reviewed 5-Year Follow-Up: 2-Level Cervical Disc Replacement vs. ACDF

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.

Results from 6-month ActiPatch Product Observation Study

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. 

Study of PEMF in Disc Degeneration

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.

Five-Year Results of Mobi-C Cost Utility Analysis

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. 

CartiHeal Raises $15 Million

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.