Clinical Trials
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Spine/Neurology
Life Spine Announces Initiation of SIMPACT Sacroiliac Joint Fixation Outcomes Study
SIMPACT is a cannulated and fenestrated screw, intended for sacroiliac joint fusion.Business Wire 02.15.19
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Spine/Neurology
Study Shows Safety, Efficacy of Radiological Outcomes for Oblique Lateral Lumbar Interbody Fusion
Trial conducted by Inspired Spine.PR Newswire 02.14.19
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Design | Research & Development
Trial Master File: Paper or Electronic?
The Trial Master File (TMF) is the central location for all clinical trial documents. From the start of a clinical trial through its conclusion, the TMF contains and secures a variety of information such as signature pages, study logs, ethics committ…Anuradha Nagulapati, Clinical Research Associate, Musculoskeletal Clinical Regulatory Advisers 02.13.19
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Large Joint
CartiHeal Enrolls Patients in Study of its Agili-C Cartilage Repair Implant
The product is designed to help patients with knee-cartilage defects to regenerate their own healthy cartilage.PR Newswire 02.06.19
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Extremities
Ortho RTi Announces More Prestigious Scientific Validation
The study used MRI and histopathology to compare the results of Ortho-R versus standard of care in a non-clinical rotator cuff injury model in sheep.PR Newswire 02.05.19
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Large Joint | Trauma/Sports
Largest Ever Trial in Hip Fracture Fixation Completes One-Year Follow-Up
The X-BOLT revolutionary hip fracture device was also granted FDA 510(k) clearance.PR Newswire 01.23.19
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Spine/Neurology
New Data Reinforces Benefits of Abbott's BurstDR Spinal Cord Stimulation for Chronic Pain
Microdosing BurstDR stimulation at lowest effective energy allows patients to manage their pain without the burden of recharging their devices.Abbott Laboratories 01.21.19
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Large Joint
Kolon TissueGene Doses First Patient in U.S. Phase III Clinical Trial for Knee Osteoarthritis
Invossa study will enroll close to 1,020 patients in approximately 60 clinical sites across the United States.Kolon TissueGene Inc. 01.16.19
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Spine/Neurology
SpinalCyte Announces Sustained 12-Month MRI Outcomes After CybroCell Injection
Data shows significant improvement in clinically relevant endpoints.Business Wire 01.08.19
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Large Joint
First-Ever Surgery Tests Device to Prevent Knee Replacements
Shock-absorbing device designed to relieve pain and slow progression of osteoarthritis.The Ohio State University Wexner Medical Center 01.04.19
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Spine/Neurology
Life Spine Initiates PROLIFT Expandable Interbody Clinical Study
Product allows for in-situ disc height restoration.Business Wire 01.02.19
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Extremities
Treace Medical Enrolls First Patient in ALIGN3D Post-Market Clinical Study
Trial aims to validate long-term maintenance of three-dimensional correction following early return to weight-bearing.Business Wire 12.28.18
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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
