Clinical trials: Rotator Cuff Tear
Osteoarthritis Shoulder, Rotator Cuff Syndrome of Shoulder and Allied Disorders
FX Shoulder Prospective Clinical Study
Prospective Multi-Center Registry on study subjects with implanted devices marketed and legally commercialized in the USA by FX Shoulder Solutions.
- Conditions
- Osteoarthritis Shoulder, Rotator Cuff Syndrome of Shoulder and Allied Disorders, Fracture, Shoulder
- Trial name
- NCT06078865
- Testing
- FX Artificial Shoulder Prosthesis
- Where
- 4 sites in United States
- Volunteers
- 600 people
- Sponsor
- FX Shoulder Solutions
Rotator Cuff Tear
Rotation Medical Bioinductive Implant Database Registry
The purpose of this clinical registry is to prospectively collect and compare preoperative and postoperative patient-reported data using validated shoulder-specific and health-related quality of life (QoL) instruments during…
- Trial name
- REBUILD (NCT02784600)
- Testing
- Bioinductive implant
- Where
- 19 sites in United States
- Volunteers
- 483 people
- Sponsor
- Smith & Nephew, Inc.
Rotator Cuff Tear Arthropathy
Subscapularis Repair in Reverse Shoulder Arthroplasty
This study will evaluate the subscapularis repair versus non-repair during a reverse shoulder arthroplasty (RSA).
- Trial name
- Subscap (NCT05438914)
- Testing
- Repair of the subscapularis
- Where
- 6 sites in United States
- Volunteers
- 134 people
- Sponsor
- Arthrex, Inc.
Rotator Cuff Tears of the Shoulder
Integrity Implant System Post Market Clinical Follow-Up Study
The study design is a prospective, multi-center, single-arm, non-randomized post market clinical follow-up study to confirm the performance, safety and clinical benefit of the Integrity Implant System when used for rotator cuff…
- Trial name
- NCT06741527
- Testing
- Integrity Implant System
- Where
- 9 sites in United States
- Volunteers
- 150 people
- Sponsor
- Anika Therapeutics, Inc.
Rotator Cuff Tear
InSpace™ System in Comparison to Best Repair of Massive Rotator Cuff Tear
This is a post-marketing study to further assess the safety and effectiveness of the InSpace™ device implantation in comparison to surgical repair of full thickness Massive Rotator Cuff Tear .
- Trial name
- NCT02211183
- Testing
- Best Repair of torn Rotator Cuff, InSpace™ system
- Where
- Spain
- Volunteers
- 4 people
- Sponsor
- OrthoSpace Ltd.
Full-thickness Rotator Cuff Tear
InSpace™ System in Comparison to Best Repair of Massive Rotator Cuff Tear.
This is a post-marketing study to further assess the safety and effectiveness of the InSpace™ device implantation in comparison to surgical repair of full thickness Massive Rotator Cuff Tear .
- Trial name
- NCT02208440
- Testing
- Best Repair of torn Rotator Cuff, InSpace™ system
- Where
- United Kingdom
- Volunteers
- 14 people
- Sponsor
- OrthoSpace Ltd.
Full- Thickness Massive RCT (MRCT) of at Least 5 cm in Diameter Including Fatty Infiltration Grade III or IV
InSpace™ System in Comparison to Best Repair of Massive Rotator Cuff Tear.
This is a post-marketing study to further assess the safety and effectiveness of the InSpace™ device implantation in comparison to surgical repair of full thickness Massive Rotator Cuff Tear .
- Trial name
- NCT01890733
- Testing
- Best Repair of torn Rotator Cuff, InSpace™ system
- Where
- Italy
- Volunteers
- 5 people
- Sponsor
- OrthoSpace Ltd.
Rotator Cuff Injuries
A Phase I/III Clinical Study of TPX-114 for the Treatment of Full-Thickness Rotator Cuff Tear
Rotator cuff tear is one of the most common shoulder diseases and retears occur frequently after arthroscopic repair. Therefore, there is a growing need of new therapy to improve structural outcome.
- Trial name
- NCT03668028
- Testing
- TPX-114, Arthroscopic surgery
- Where
- 2 sites in South Korea
- Volunteers
- 93 people
- Sponsor
- Tego Science, Inc.
Partial Thickness Supraspinatus Tendon Tear, Full Thickness Supraspinatus Tendon Tear
Post-Market Evaluation of the Rotation Medical Rotator Cuff System
The purpose of this study is to evaluate bioinduction of new tissue and tendon healing after implantation of the Rotation Medical Bioinductive Implant used as either a standalone device or adjunct to surgical repair in the…
- Trial name
- NCT02200939
- Testing
- Bioinductive implant, Surgical repair
- Where
- 15 sites in United States
- Volunteers
- 148 people
- Sponsor
- Smith & Nephew, Inc.
Osteoarthritis Shoulder, Fracture
Multi Centre Study on TESS V2 Shoulder System
This study is a Post Market Clinical Follow-up study to fulfill the post market surveillance requirements. The data collected from this study will serve the purpose of confirming safety and performance of the TESS Shoulder System.
- Conditions
- Osteoarthritis Shoulder, Fracture, Rheumatoid Arthritis, Avascular Necrosis
- Trial name
- NCT03431857
- Testing
- TESS V2
- Where
- 2 sites in Belgium, France
- Volunteers
- 106 people
- Sponsor
- Zimmer Biomet
Rotator Cuff Injuries
REGENETEN™ Bioinductive Implant System in Full-thickness Tears
The study is designed to assess the safety and efficacy of Arthroscopic rotator cuff repair (ARCR) augmented with REGENETEN in subjects requiring full-thickness rotator cuff tear repair or revision repair versus Arthroscopic…
- Trial name
- REGENETEN (NCT04450342)
- Testing
- Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation, Arthroscopic rotator cuff repair, Arthroscopic rotator cuff repair for revision surgery
- Where
- 30 sites in United States, Australia and 6 more
- Volunteers
- 119 people
- Sponsor
- Smith & Nephew, Inc.
Full Thickness Rotator Cuff Tear
BioFiber Scaffold Post-Market Observational Study
The aim of this study is to collect and report data from a consecutive series of patients implanted with these products as part of a post-market surveillance plan for CE Mark approval in the European Union.
- Trial name
- NCT01849458
- Testing
- BioFiber
- Where
- 3 sites in United States, France
- Volunteers
- 50 people
- Sponsor
- Stryker Trauma and Extremities
Rotator Cuff Tear, Rotator Cuff Tears
FiberLocker® System Augmentation of Rotator Cuff Repairs
The purpose of this study is to prospectively evaluate healing, functional clinical outcomes, and safety of arthroscopic rotator cuff repairs augmented with the FiberLocker® System (encompassing the SpeedPatch® PET and the…
- Conditions
- Rotator Cuff Tear, Rotator Cuff Tears, Rotator Cuff Tears of the Shoulder
- Trial name
- NCT06918041
- Testing
- FiberLocker® System (encompassing FiberLocker® Instrument & SpeedPatch® PET)
- Where
- 4 sites in United States
- Volunteers
- 60 people
- Sponsor
- ZuriMED Technologies Inc.
Massive Rotator Cuff Tears, Massive Rotator Cuff Tear
Voll Non-Degradable Shoulder Spacer FIH Study
The Voll Non-Degradable Shoulder Spacer First-in-Human study aims to evaluate the initial safety, effectiveness, and clinical outcomes of a non-degradable shoulder spacer in over 50 years old patients with symptomatic massive…
- Trial name
- NCT07745647
- Testing
- Voll Non-Degradable Shoulder Spacer
- Where
- Israel
- Volunteers
- 10 people
- Sponsor
- Voll Medical Technologies Ltd.
Arm Injuries
Pilot Study to Evaluate the Restore Orthobiologic Implant in Rotator Cuff Tear Repair
Primary Endpoints: Comparative evaluation of any differences between the two groups in change from baseline to the 3-month time point in terms of: Functional recovery (patient-based) - using the Oxford Shoulder Score.
- Trial name
- NCT00208338
- Testing
- RESTORE SIS Patch, Rotator cuff repair
- Where
- 2 sites in Belgium, United Kingdom
- Volunteers
- 33 people
- Sponsor
- DePuy International
Rotator Cuff Tears of the Shoulder
SINEFIX-2022 Comparative Phase
Shoulder pain is one of the most commonly reported musculoskeletal complaints, which negatively affects upper limb use, night rest, daily life activities, work, sports performance and autonomy.
- Trial name
- NCT06818448
- Testing
- Rotator cuff repair with the SINEFIX, Rotator cuff repair with comparator device
- Where
- 2 sites in Germany
- Volunteers
- 60 people
- Sponsor
- BAAT Medical Products B.V.
Rotator Cuff Tear Arthropathy, Osteoporosis
COMPREHENSIVE® REVERSE SHOULDER Mini BasePlate
Evaluate Survivorship for the Biomet® Comprehensive® Reverse Shoulder Mini Baseplate.
- Conditions
- Rotator Cuff Tear Arthropathy, Osteoporosis, Osteomalacia, Joint; Destruction, Sacroiliac
- Trial name
- NCT02084693
- Testing
- COMPREHENSIVE
- Where
- 5 sites in South Korea
- Volunteers
- 100 people
- Sponsor
- Zimmer Biomet
Rotator Cuff Tear
Regenexx™ SD Versus Exercise Therapy for Rotator Cuff Tears
The primary objective of this study is to compare the improvement in subject-reported clinical outcomes, for Regenexx SD treatment vs.
- Trial name
- NCT01788683
- Testing
- Regenexx SD, Exercise Therapy
- Where
- United States
- Volunteers
- 51 people
- Sponsor
- Regenexx, LLC
Full-thickness Rotator Cuff Tear
PEMF as Adjunctive Treatment Following Surgical Repair of Full Thickness Rotator Cuff Tears
The primary objective of this study is to prospectively determine, at 12 months post-surgical repair of full thickness rotator cuff tears, the safety and efficacy of treating full thickness rotator cuff repairs with pulsed…
- Trial name
- RCStim (NCT03339492)
- Testing
- RCStim Model 1114
- Where
- 23 sites in United States
- Volunteers
- 377 people
- Sponsor
- Orthofix Inc.
Rotator Cuff Tear
Use of Graft Jacket for Rotator Cuff Repair
This study is to evaluate the safety and effectiveness of GraftJacket, a human tissue product used in fixing large and massive reparable rotator cuff tears.GraftJacket allograft (Wright Medical Technology, Inc., Arlington, TN) is…
- Trial name
- NCT00456781
- Testing
- Augmentation, Rotator Cuff Repair without augmentation
- Where
- 7 sites in United States, Canada
- Volunteers
- 79 people, healthy volunteers welcome
- Sponsor
- Stryker Trauma and Extremities