Clinical trials: Rotator Cuff Tears
Rotator Cuff Tear
Prospective Study for Safety and Efficacy of InSpace™ in Rotator Cuff Tear Subjects
Title: One-arm, international, multi-center with competitive recruitment, prospective study to assess the safety and efficacy of OrthoSpace's InSpace™ in rotator cuff tear subjects scheduled for surgery of the rotator cuff - A…
- Trial name
- NCT00916994
- Testing
- SpaceGuard Balloon
- Where
- Israel
- Volunteers
- 58 people
- Sponsor
- OrthoSpace Ltd.
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.
Rotator Cuff Injuries
Phase 1/2 Clinical Study of TPX-115 in Patients With Partial-Thickness Rotator Cuff Tear
Rotator cuff tear is one of the most common shoulder diseases and conservative treatment is commonly used for tears involving ≤50% of tendon thickness.
- Trial name
- NCT04470167
- Testing
- TPX-115
- Where
- 2 sites in South Korea
- Volunteers
- 49 people
- Sponsor
- Tego Science, Inc.
Rotator Cuff Tear, Rotator Cuff Tendinitis
Autologous Adult Adipose-Derived Regenerative Cell Injection Into Chronic Partial-Thickness Rotator Cuff Tears
The purpose of this investigation is to evaluate the safety and superior effectiveness in functional improvement in patients with partial-thickness rotator cuff tears (PTRCTs) after the administration of a single injection of…
- Trial name
- NCT03752827
- Testing
- Adipose Derived Regenerative Cells, Corticosteroid
- Where
- 14 sites in United States
- Volunteers
- 168 people, healthy volunteers welcome
- Sponsor
- InGeneron, Inc.
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 Tear, Rotator Cuff Injury
Rotator Cuff Tendon Repair With FiberLocker System Patch Augmentation
The overall objective of this clinical investigation is to assess the safety and efficacy of full-thickness arthroscopic rotator cuff repairs augmented with the FiberLocker System for the subjects.
- Conditions
- Rotator Cuff Tear, Rotator Cuff Injury, Rotator Cuff Rupture
- Trial name
- FIBERLOCK (NCT07005063)
- Testing
- FiberLocker® System (encompassing SpeedPatch® PET and FiberLocker Instrument® SN)
- Where
- Switzerland
- Volunteers
- 50 people
- Sponsor
- ZuriMED Technologies AG
Osteoarthritis of Shoulder
HUPS: Hyalgan Use in Painful Shoulder
Three-arm, parallel, double-blind, masked observer, randomized, PB-Saline controlled clinical trial. In order to avoid problems in the interpretation of the final results due to disparate enrollment from various centers, the…
- Trial name
- NCT00377624
- Testing
- sodium hyaluronate
- Where
- United States
- Volunteers
- 602 people
- Sponsor
- Sanofi
Rotator Cuff Tear
InSpace™ System Implantation in a Procedure Under Local Anesthesia
The study objective is to assess the feasibility, efficacy and safety of the InSpace™ Device implantation in a surgical procedure under local anesthesia using arthroscopic and/or fluoroscopic visualization of the affected…
- Trial name
- NCT02208453
- Testing
- InSpace Implantation
- Where
- Italy
- Volunteers
- 45 people
- Sponsor
- OrthoSpace Ltd.
Primary Osteoarthritis, Secondary Osteoarthritis
SMR Stemless Shoulder Arthroplasty Clinical Study
Shoulder arthroplasty is a reliable procedure for the treatment of severe shoulder joint diseases to relieve pain and restore shoulder function.
- Conditions
- Primary Osteoarthritis, Secondary Osteoarthritis, Post-traumatic; Arthrosis, Rheumatoid Arthritis
- Trial name
- NCT02679352
- Testing
- SMR Stemless
- Where
- 4 sites in Germany, Netherlands and 1 more
- Volunteers
- 78 people
- Sponsor
- Limacorporate S.p.a
Primary Osteoarthritis, Secondary Osteoarthritis
Clinical and Radiological Outcomes of Medacta Shoulder System (BE)
This is a post-market surveillance study on Medacta Shoulder System
- Conditions
- Primary Osteoarthritis, Secondary Osteoarthritis, Rotator Cuff Tear Arthropathy, Rheumatoid Arthritis Shoulder
- Trial name
- NCT05002335
- Testing
- Medacta Shoulder System
- Where
- 3 sites in Belgium
- Volunteers
- 200 people
- Sponsor
- Medacta International SA
Osteoarthritis of the Shoulder, Avascular Necrosis
Database Retrieval for the Comprehensive Shoulder
This study is a retrieval of database information regarding survivorship of the Comprehensive Shoulder System family of products.
- Conditions
- Osteoarthritis of the Shoulder, Avascular Necrosis, Rheumatoid Arthritis, Prior Failed Revision
- Trial name
- NCT03409718
- Testing
- Biomet Comprehensive Shoulder System
- Where
- United States
- Volunteers
- 160 people
- Sponsor
- Zimmer Biomet
Bankart Lesions, SLAP Lesion
PMCF Study on the Safety, Performance and Clinical Benefits Data of the ToggleLoc™ 2.9mm and JuggerLoc™ in the Shoulder
The study is a multicenter, retrospective, non-randomized, non-controlled and consecutive series post-market study. The purpose of this study is to collect data confirming safety, performance and clinical benefits of the…
- Conditions
- Bankart Lesions, SLAP Lesion, Acromioclavicular; Dislocation, Capsular Shift/Capsulolabral Reconstruction
- Trial name
- NCT05584553
- Testing
- ToggleLoc 2.9 mm soft tissue device, JuggerLoc soft tissue device
- Where
- 3 sites in United States, Spain
- Volunteers
- 214 people
- Sponsor
- Zimmer Biomet
Rotator Cuff Tears, Rotator Cuff Injuries
PMCF Study on the Safety, Performance and Clinical Benefits Data of the Quattro X Broadband
The study is a multicenter, retrospective and prospective, non-randomized, noncontrolled, and consecutive series post-market study.
- Trial name
- NCT05690776
- Where
- 2 sites in France
- Volunteers
- 106 people
- Sponsor
- Zimmer Biomet
Rotator Cuff Tear
A Safety Study Of BMP-655/ACS As An Adjuvant Therapy For Treatment Of Rotator Cuff Tears
Subjects undergoing an open surgical repair for their torn Rotator Cuff (RC) will be consented, screened, and enrolled in the study if they meet all eligibility criteria.
- Trial name
- NCT01122498
- Testing
- BMP-655/ACS+Standard of care or Standard of care
- Where
- 9 sites in Japan
- Volunteers
- 23 people
- Sponsor
- Pfizer
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
Study Evaluating Safety Of BMP-655/ACS As An Adjuvant Therapy For Rotator Cuff Repair
Study to assess the safety of 3 differing concentrations of BMP-655/ACS in subjects with full thickness Rotator Cuff Tears (RCTs).
- Trial name
- NCT00936559
- Testing
- BMP-655/ACS or Standard of Care
- Where
- 4 sites in Germany, Netherlands
- Volunteers
- 13 people
- Sponsor
- Pfizer
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.
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.
Rheumatoid Arthritis, Osteoarthritis Shoulder
Tornier HRS (Humeral Reconstruction System) Study (REVIVE)
This is an international, single arm, multicenter, prospective follow-up, non-significant risk, Post-Market Clinical Follow-up (PMCF) study.
- Conditions
- Rheumatoid Arthritis, Osteoarthritis Shoulder, Fractures Humerus, Avascular Necrosis
- Trial name
- REVIVE (NCT05500066)
- Testing
- Tornier HRS (HUMERAL RECONSTRUCTION SYSTEM) shoulder system
- Where
- 4 sites in United States
- Volunteers
- 110 people
- Sponsor
- Stryker Trauma and Extremities
Osteo Arthritis Shoulders, Osteonecrosis
Exactech Shoulder Post Market Clinical Follow-up Study
The objective of this study is to collect and evaluate long-term clinical and radiographic outcomes data in order to better understand the safety and performance of the shoulder arthroplasty over time.
- Conditions
- Osteo Arthritis Shoulders, Osteonecrosis, Rotator Cuff Tears, Rotator Cuff Tear Arthropathy
- Trial name
- NCT05603728
- Where
- 40 sites in United States, Canada and 4 more
- Volunteers
- 20,000 people
- Sponsor
- Exactech