Clinical trials: Rotator Cuff Injury
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
Osteo Arthritis Shoulders, Avascular Necrosis of the Head of Humerus
Easytech Reversed Shoulder System Clinical Study
The purpose of the study is to collect data to demonstrate the safety and effectiveness of the Easytech Reversed Shoulder System for the treatment of patients who require a reverse total shoulder arthroplasty.
- Conditions
- Osteo Arthritis Shoulders, Avascular Necrosis of the Head of Humerus, Rotator Cuff Tear
- Trial name
- NCT03806842
- Testing
- Easytech group
- Where
- 6 sites in United States
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- FX Shoulder Solutions
Rotator Cuff Syndrome of Shoulder and Allied Disorders, Osteoarthritis Shoulder
FX Shoulder Solutions Retrospective / Prospective Clinical Study
Subjects implanted with the shoulder replacement medical devices manufactured by FX Shoulder Solutions and distributed by FX Shoulder Solutions.
- Conditions
- Rotator Cuff Syndrome of Shoulder and Allied Disorders, Osteoarthritis Shoulder, Fracture, Shoulder
- Trial name
- NCT06077942
- Testing
- FX Artificial Shoulder Prosthesis
- Where
- 2 sites in United States
- Volunteers
- 600 people
- Sponsor
- FX Shoulder Solutions
Rotator Cuff Injuries, Shoulder Pain
Anaverse™ Glenoid System and Its Instrumentation
The objectives of this study are to confirm safety, performance and clinical benefits of the Anaverse™ Glenoid System and its instrumentation by analysis of standard scoring systems, radiographs and adverse event records.
- Conditions
- Rotator Cuff Injuries, Shoulder Pain, Arthropathy, Arthroplasty Complications
- Trial name
- NCT05215600
- Testing
- Anaverse Shoulder System
- Where
- Switzerland
- Volunteers
- 20 people
- Sponsor
- Zimmer Biomet
Rotator Cuff Tear, Acromial Spur
Study Comparing Patient Function and Satisfaction With Arthroscopic Subacromial Decompression Before and After Repair of Complete Rotator Cuff Tears
The investigators aim to establish whether completing a subacromial decompression before or after repair of a complete rotator cuff tear has any clinical significance.
- Trial name
- NCT01430598
- Testing
- Rotator Cuff Repair and Subacromial Decompression, Questionnaire
- Where
- 2 sites in United States
- Volunteers
- 100 people
- Sponsor
- Ascension Health
Rotator Cuff Tear
Digital Biofeedback System Versus Conventional Rehabilitation After Rotator Cuff Repair
This study was designed to compare the clinical outcomes of a mixed home-based rehabilitation program after arthroscopic rotator cuff repair, incorporating face-to-face sessions as well as sessions performed with a novel digital…
- Trial name
- NCT03648047
- Testing
- Digital kinematic biofeedback device, Conventional rehabilitation, Additional face-to-face rehabilitation sessions
- Where
- Portugal
- Volunteers
- 50 people
- Sponsor
- Sword Health, SA
Rotator Cuff Tear, Rotator Cuff Tears
Post-Market Clinical Follow-up (PMCF) Study of the Pitch-Patch for the Augmentation or Reinforcement of the Rotator Cuff
This is a clinical investigation study. It will verify the long-term safety and performance of the Pitch-Patch when implanted to reinforce partially repairable rotator cuff tears and used as described by the manufacturer's…
- Conditions
- Rotator Cuff Tear, Rotator Cuff Tears, Rotator Cuff Tears of the Shoulder, Rotator Cuff Injuries
- Trial name
- NCT05906004
- Testing
- Pitch-Patch
- Where
- United Kingdom
- Volunteers
- 37 people
- Sponsor
- Xiros Ltd
Rotator Cuff Tear
InSpace™ System Over Rotator Cuff Repair in Comparison to Repair Alone.
This is a post-marketing study to further assess the safety and effectiveness of the InSpace™ in the study population in comparison to surgical RCT repair.
- Trial name
- NCT02210910
- Testing
- InSpace™ system over repair, Best Repair of torn Rotator Cuff
- Where
- Israel
- Volunteers
- 39 people
- Sponsor
- OrthoSpace Ltd.
Rotator Cuff Tear, Labral Tear
Phase 3 Study of the Efficacy and Safety of MR Arthrography Using the NEMO-103 Injection in Patients With Known or Suspected Shoulder Joint Diseases
The goal of this Phase 3 clinical trial is to evaluate whether MR arthrography enhanced with NEMO-103 injection (NEMO-103 Inj.) provides superior diagnostic imaging quality compared to unenhanced MRI in patients with known or…
- Conditions
- Rotator Cuff Tear, Labral Tear, Rotator Cuff Tendinosis, Rotator Cuff Tendonitis
- Trial name
- NCT07057037
- Testing
- NEMO-103 Injection
- Where
- 8 sites in South Korea
- Volunteers
- 85 people
- Sponsor
- Inventera Inc.
Rotator Cuff Tear
Pilot Study of the Use of ULTRABRAID PLUS SUTURE in the Repair of Tears of the Rotator Cuff
The primary objective of this study is to obtain safety data on the use of the ULTRABRAID PLUS SUTURE, and to assess the preliminary effectiveness of the use of the ULTRABRAID PLUS SUTURE in comparison to the ULTRABRAID SUTURE in…
- Trial name
- NCT01767740
- Testing
- ULTRABRAID PLUS SUTURE, ULTRABRAID SUTURE
- Where
- 4 sites in Canada
- Volunteers
- 82 people
- Sponsor
- Smith & Nephew, Inc.
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
Rotator Cuff, Arthroscopic Surgery
Arthroscopic Surgical Outcome Study In Subjects With Rotator Cuff Tears
This is an observational study that involves subjects with full-thickness rotator cuff tears treated by means of arthroscopy surgical repair, also known as arthroscopic surgery.
- Trial name
- NCT00739947
- Testing
- Observational study of the surgical outcome
- Where
- 37 sites in United States
- Volunteers
- 162 people
- Sponsor
- Pfizer
Arthroscopic Surgical Treatment of High-grade (>50%) Partialthickness
Treatment of Partial-Thickness Rotator Cuff Tears
The goal of this clinical trial is to demonstrate that REGENETEN is superior to standard repair techniques when surgically treating high-grade (>50%) partial-thickness tears.
- Trial name
- REGEN PUB 2018 (NCT03734536)
- Testing
- REGENETEN™ Bioinductive Implant, Arthroscopic repair of the high-grade (>50%) partial-thickness
- Where
- 10 sites in United States
- Volunteers
- 168 people
- Sponsor
- Smith & Nephew, 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
Rotator Cuff Injuries
Evaluation Of Outcomes Following Rotator Cuff Repair Using the REGENETEN Bioinductive Implant
This prospective, single-arm, multicenter registry is being conducted to collect real world post-market data from patients who are undergoing rotator cuff repair using the REGENETEN◊ Bioinductive Implant System.
- Trial name
- RePaRe (NCT06857084)
- Testing
- Arthroscopic rotator cuff repair with REGENETEN Bioinductive Implant augmentation
- Where
- 22 sites in Australia, Germany and 2 more
- Volunteers
- 400 people
- Sponsor
- Smith & Nephew, Inc.
Rotator Cuff Tear
Utilization of AMSC to Enhance Rotator Cuff Repair - Safety and Efficacy
Subjects received perioperative hAMSC treatment in order to accelerate the healing of the surgically repaired rotator cuff and increase the mechanical properties of the tendon, according to inclusion and exclusion criteria (see…
- Trial name
- AMSC-RC-001 (NCT03838666)
- Testing
- Suspension of human autologous MSC 3P
- Volunteers
- 9 people
- Sponsor
- Bioinova, s.r.o.
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
InSpace Accelerated Rehabilitation Study
This is a prospective, parallel group, open-label, multi- center, randomized study to assess two accelerated rehabilitation programs for use with the InSpace device in the treatment of full thickness Massive, Irreparable Rotator…
- Trial name
- iAccelerate (NCT05329584)
- Testing
- InSpace Subacromial Tissue Spacer
- Where
- 11 sites in United States
- Volunteers
- 160 people, healthy volunteers welcome
- Sponsor
- Stryker Endoscopy
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
Labral Tear, Glenoid, Acetabular Labrum Tear
Safety and Performance of MICRORAPTOR™ Suture Anchors in Shoulder and Hip
This is a prospective, multi-center, PMCF study to evaluate the safety and performance of the MICRORAPTOR REGENESORB suture anchors, MICRORAPTOR Knotless REGENESORB suture anchors, and MICRORAPTOR Knotless PEEK suture anchors…
- Conditions
- Labral Tear, Glenoid, Acetabular Labrum Tear, Bankart Lesions, Anterior Shoulder Instability
- Trial name
- NCT03985839
- Testing
- MICRORAPTOR™ REGENESORB™ Suture Anchor, MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor, MICRORAPTOR™ Knotless PEEK Suture Anchor
- Where
- 12 sites in United States
- Volunteers
- 298 people
- Sponsor
- Smith & Nephew, Inc.