Clinical Trials
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Large Joint
Myoscience Completes Enrollment in the Campbell Clinic Study
Trial compares the effect of cryoanalgesia using the iovera° system to the standard of care for managing pain after TKA.Myoscience Inc. 12.18.18
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SetPoint Medical Completes Enrollment in Study Evaluating Bioelectronic Arthritis Treatment
Proprietary device delivers doses of electricity to activate systemic anti-inflammatory response.SetPoint Medical 12.13.18
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Spine/Neurology
Successful First-in-Human for ZygoFix's Spinal Facet Joint Fixation System
The zLOCK implant is designed as a miniature facet fusion cage to stabilize the segment.PR Newswire 12.10.18
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Extremities
FX Shoulder USA Begins Clinical Study on Stemless Reversed Total Shoulder
Over 800 Easytech Stemless Reversed prostheses have already been successfully implanted in France.PR Newswire 12.06.18
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Data Monitoring Committees: Making DMCs Work for Your Study
The use of independent data monitoring committees is becoming increasingly prevalent in the U.S. medtech industry. The FDA outlines these groups and their operation in a 12-year-old guidance due to expire at the end of this year. However, the composi…Margeaux Rogers, Senior Associate, Regulatory Affairs, Musculoskeletal Clinical Regulatory Advisers LLC 11.30.18
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Spine/Neurology
Simplify Medical Completes Enrollment in U.S. IDE Pivotal Trial of Simplify Disc
Disc is designed for biomechanical motion, anatomical height-matching, and MRI compatibility.Globe Newswire 11.15.18
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Spine/Neurology
SpinalCyte Announces Positive 12-Month Pain Data From Trial for Degenerative Disc Disease
CybroCell is the first off-the-shelf allogeneic HDF product for treatment of degenerative disc disease.Business Wire 10.26.18
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Biologics | Large Joint
Regentis Biomaterials Expands SAGE Clinical Trial of GelrinC for Knee Pain
The study compares GelrinC to microfracture, the current standard of care treatment for damaged knee cartilage.Business Wire 10.24.18
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Large Joint
Two New Studies Demonstrate INTERTAN Intertrochanteric Antegrade Nail Improves Patient Outcomes
Product also lowers healthcare costs when treating hip fractures, data show.Smith & Nephew plc 10.23.18
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Large Joint
Zimmer Biomet, Apple Collaborate on Clinical Study
Effort leverages Apple Watch and mymobility app to detail the patient experience and improve the joint replacement journey.PR Newswire 10.15.18
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Spine/Neurology
NASS News: Spineology Presents 12-Month Data for SCOUT Trial
The fusion implant used in the SCOUT Study was Spineology’s porous graft containment mesh.Business Wire 10.02.18
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3-D Printing/Additive Mfg. | Materials | Spine/Neurology
First Ever Clinical Trial Evaluates 3D-Printed Titanium vs. PEEK
Trial will evaluate the clinical and radiographic outcomes of the Nexxt Matrixx System following lumbar interbody fusion.Business Wire 09.28.18
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Spine/Neurology
NuVasive Enrolls First Patients in Study Evaluating Advanced Spinal Implants Used in XLIF Procedures
The study will evaluate and compare the clinical and radiographic outcomes.NuVasive Inc. 09.27.18
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Large Joint
Ethicon's Skin Closure System Leads to Higher Patient, Surgeon Satisfaction After TKR
Study finds combination topical skin adhesive and self-adhering mesh preferred over skin staples for wound closure.Johnson & Johnson 09.26.18
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Getting Started on the Right Foot: Initiating Orthopedic Clinical Trials
Initiating an orthopedic clinical trial (OCT) is an exciting milestone for companies as years of pre-clinical testing and conversations with the U.S. Food and Drug Administration (FDA) finally come to fruition. Focusing on specific elements of the st…Bhavana Shivakumar , Clinical Research Associate, Musculoskeletal Clinical Regulatory Advisers LLC 09.19.18
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Augmedics Begins First-in-Human Trial of xvision-spine Surgical Navigation System
Study will evaluate the safety, performance, accuracy, and usability of XVS during spine fusion procedures.Videos Augmedics 08.10.18
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Spine/Neurology
Newly Published Data Demonstrate Bone In-Growth Potential of Stryker’s 3D-Printed Tritanium Cage
Results showed that Stryker’s Tritanium cages achieved statistically significant increases in bone in-growth.Stryker Corp. 08.02.18
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Biologics
Cerapedics Enrolls First Patients in IDE Clinical Trial of P-15L Bone Graft for TLIF Surgery
Proprietary synthetic small peptide technology is being evaluated in U.S. patients with degenerative disk disease.Cerapedics 07.30.18
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Large Joint
JOURNEY II BCS Knee System Demonstrates Improved Patient Outcomes, Lower Healthcare Costs
Reduced cost is equivalent to approximately 10 percent in savings to the overall procedure price.PR Newswire 07.26.18
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Extremities
Cartiva Presents Clinical Data on Treating Big Toe Arthritis With Synthetic Cartilage Implant
Data confirms long-term durability of pain and functional improvements at mean follow up of 5.8 years.Cartiva Inc. 07.18.18
