Clinical trials: Rotator Cuff
Rotator Cuff Tear, Fatty Atrophy
Efficacy of an Amniotic Fluid Derived Allograft, (FlōGraft®) in Rotator Cuff Repairs: A Prospective Study
Rotator Cuff (RC) repair will be augmented with the injection of a human amniotic fluid derived allograft at the repair interface junction.
- Trial name
- NCT03379324
- Testing
- Superiority of augmented repairs, Fat degeneration of supraspinatus muscle
- Where
- United States
- Volunteers
- 260 people, healthy volunteers welcome
- Sponsor
- Applied Biologics, LLC
Tendinopathy
Study of Efficacy and Safety of AIN457/Secukinumab in Patients With Rotator Cuff Tendinopathy
The purpose of this study was to investigate the efficacy and safety of secukinumab subcutaneously (s.c.) compared to placebo in adult patients with moderate to severe rotator cuff tendinopathy and failure to conventional therapy.
- Trial name
- UnchAIN (NCT05569174)
- Testing
- Secukinumab
- Where
- 19 sites in Germany
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Tendinopathy
Study of Efficacy, Safety and Tolerability of AIN457 in Patients With Active Overuse Tendinopathy
This was a randomized, double-blind, placebo-controlled, multi-center, Phase II study of s.c. secukinumab 300 mg in 98 randomized patients with overuse rotator-cuff tendinopathy without systemic inflammatory disease.
- Trial name
- NCT03344640
- Testing
- secukinumab
- Where
- 12 sites in United States, Czechia and 3 more
- Volunteers
- 96 people
- Sponsor
- Novartis Pharmaceuticals
Osteoarthritis, Rheumatoid Arthritis
Outcomes Study of the Trabecular Metal (TM) Reverse Shoulder System
The objectives of this study are to obtain survival and outcome data on the Trabecular Metal Reverse Shoulder System when used in primary or revision reverse total shoulder arthroplasty.
- Conditions
- Osteoarthritis, Rheumatoid Arthritis, Post-traumatic Arthritis, Ununited Humeral Head Fracture
- Trial name
- NCT01480440
- Testing
- Trabecular Metal Reverse Shoulder System
- Where
- 5 sites in United States, United Kingdom
- Volunteers
- 200 people
- Sponsor
- Zimmer Biomet
Postoperative Pain
Safety and Efficacy of Tapentadol Immediate Release (IR) and Oxycodone IR for Treatment of Acute Post-op Pain Following Elective Arthroscopic (Surgery Using a Thin Flexible Scope) Shoulder Surgery
The purpose of this study is to evaluate how tapentadol immediate release (IR) and oxycodone IR treat moderate to severe post-operative pain after elective arthroscopic shoulder surgery.
- Trial name
- NCT00814580
- Testing
- Tapentadol IR, Oxycodone IR
- Volunteers
- 382 people
- Sponsor
- Ortho-McNeil Janssen Scientific Affairs, LLC
Glenohumeral Osteoarthritis, Proximal Humerus Fracture
Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of Tıpmed™ Shoulder Prosthesis System
This study is designed as a prospective, multicenter, observational post-market clinical follow-up (PMCF) study to evaluate the safety and effectiveness of the Tipmed™ Shoulder Prosthesis System at 12 months postoperatively.
- Conditions
- Glenohumeral Osteoarthritis, Proximal Humerus Fracture, Rotator Cuff Arthropathy, Rheumatoid Arthritis
- Trial name
- NCT07678034
- Testing
- Tipmed™ Reverse Shoulder Prosthesis System, Tipmed™ Shoulder Prosthesis System (Hemiarthroplasty Configuration)
- Where
- 4 sites in Turkey (Türkiye)
- Volunteers
- 54 people
- Sponsor
- TIPMED Medical Device Manufacturing Ltd. Co.
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
Full Thickness Rotator Cuff Tear
Pilot Study of Augment Rotator Cuff for Surgical Treatment of Full Thickness Rotator Cuff Tears
Study Purpose: To evaluate the safety and performance of Augment Rotator Cuff as a primary surgical treatment for full thickness rotator cuff tears.
- Trial name
- NCT01256242
- Testing
- Augment Rotator Cuff, Standard Suture Repair
- Where
- 4 sites in Canada
- Volunteers
- 31 people
- Sponsor
- BioMimetic Therapeutics
Rotator Cuff Repair of the Shoulder
Safety and Tolerability of 4975 in Patients Undergoing Arthroscopic Surgery to Repair the Rotator Cuff of the Shoulder
The purpose of this study is to evaluate the safety, tolerability and explore the efficacy of a single intraoperative injection of 4975 in patients undergoing arthroscopic surgery for rotator cuff repair of the shoulder
- Trial name
- NCT00672568
- Testing
- 4975 - Highly purified capsaicin
- Where
- 4 sites in South Korea
- Volunteers
- 24 people
- Sponsor
- Anesiva, Inc.
Rotator Cuff Tear Surgical Repair
H-Wave® Device Stimulation for Post-operative Rotator Cuff Repair Surgery
The goal of this intent-to-treat study is to evaluate the efficacy of H-Wave Device Stimulation following rotator cuff repair surgery.
- Trial name
- NCT07501949
- Testing
- Routine post-surgical care plus H-Wave® Device Stimulation (HWDS), Routine post-surgical care
- Where
- 4 sites in United States
- Volunteers
- 80 people
- Sponsor
- Electronic Waveform Lab
Bankart Lesion, Acetabular Labrum Tear
S&P of Q-Fix™ All-Suture Anchor System
Post-market clinical follow-up needed to address existing clinical data and gaps on the existing Q-Fix™ device and meet existing MDD/MEDDEV requirements
- Conditions
- Bankart Lesion, Acetabular Labrum Tear, SLAP Lesion, Acromioclavicular Sprain
- Trial name
- NCT03594071
- Testing
- The Q-Fix™ All-Suture Anchor
- Where
- 5 sites in United States
- Volunteers
- 294 people, healthy volunteers welcome
- Sponsor
- Smith & Nephew, Inc.
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
Shoulder Injury, Shoulder Sprain
Use of Human Dehydrated Umbilical Cord Allograft in Supraspinatus Tendon Repair
To determine the effectiveness of human dehydrated umbilical cord allograft in standard open rotator cuff repair as assessed by the American Shoulder and Elbow Surgeons (ASES) score 12 months post-op.
- Conditions
- Shoulder Injury, Shoulder Sprain, Supraspinatus Tear
- Trial name
- NCT03084068
- Testing
- Human dehydrated umbilical cord allograft
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- MiMedx Group, Inc.
Rotator Cuff Tears of the Shoulder, Labrum Injury
Lok™ Suture Anchors Safety & Performance Trial
The aim of this study is to evaluate the performance and safety of Move-Up's lok™ system (lok™ suture anchors range and associated instrumentation).
- Trial name
- NCT07448584
- Testing
- Rotator cuff lesions repair combined to a long head of biceps pathology, PASTA lesion, Shoulder instability repair
- Where
- France
- Volunteers
- 216 people
- Sponsor
- Move Up SAS
Rotator Cuff Injuries
Performance and Safety of the FIXIT® Anchor in Arthroscopic Rotator Cuff Repair
Verification of the performance and safety of the first row resorbable threaded anchor FIXIT® in arthroscopic rotator cuff repair Non-interventional, prospective, non-comparative, multi-center study as part of the post-marketing…
- Trial name
- FIXIT®2018 (NCT05720286)
- Testing
- Arthroscopic rotator cuff repair
- Where
- 2 sites in France
- Volunteers
- 30 people
- Sponsor
- Science and biomaterials
Arthropathy of Shoulder Region, Grossly Deficient Rotator Cuff
Post-Market Study of Comprehensive Reverse Augmented Glenoid and Mini Humeral Tray in Total Shoulder Arthroplasty
This study is a multicenter, prospective, non-randomized, non-controlled, dual cohort post market surveillance study. The primary objective of this study is to confirm the safety and performance of the Comprehensive Reverse…
- Conditions
- Arthropathy of Shoulder Region, Grossly Deficient Rotator Cuff, Osteoarthritis of the Shoulder, Rheumatoid Arthritis Without Humeral Metaphyseal Defects
- Trial name
- NCT03726554
- Testing
- Comprehensive Reverse Porous Augmented Glenoid, Comprehensive Mini Humeral Tray
- Where
- 6 sites in United States
- Volunteers
- 99 people
- Sponsor
- Zimmer Biomet
Rotator Cuff Tear
BioWick SureLock Clinical Outcomes Study
The purpose of this study is to collect postmarket data in subjects who receive surgical treatment of a full-thickness rotator cuff tear (of at least 1.5 cm) with the BioWick™ SureLock™ implant.
- Trial name
- NCT03199391
- Testing
- BioWick SureLock Implant
- Where
- 7 sites in United States
- Volunteers
- 71 people
- Sponsor
- Zimmer Biomet
Rotator Cuff Tear
Rotator Cuff Repair (RCR) With and Without OrthoADAPT Augmentation
Prospective, randomized, multi-center, controlled study for patients undergoing open rotator cuff repair. Patients are stratified based on tear size to one of three groups.
- Trial name
- NCT00957255
- Testing
- OrthoADAPT, Standard of care
- Where
- United States
- Sponsor
- Baxter Healthcare Corporation
Rotator Cuff Tear
Outcomes in Rotator Cuff Repair Using Graft Reinforcement
The purpose of this study is to evaluate patient shoulder functional outcomes following rotator cuff repairs reinforced with a surgical mesh.
- Trial name
- NCT01025037
- Testing
- Conexa Reconstructive Tissue Matrix
- Where
- 6 sites in United States
- Volunteers
- 61 people
- Sponsor
- Stryker Trauma and Extremities
Osteoarthritis Shoulder, Rheumatoid Arthritis
TESS V3 Modular Total Shoulder System PMCF
This is a multicenter, retrospective and prospective, non-controlled post market surveillance study. The objectives of this study are to confirm safety, performance and clinical benefits of the T.E.S.S.® Version 3 Anatomic and…
- Conditions
- Osteoarthritis Shoulder, Rheumatoid Arthritis, Rheumatoid Arthritis Shoulder, Avascular Necrosis
- Trial name
- NCT05002959
- Testing
- Anatomic TESS V3, Reverse TESS V3
- Where
- 2 sites in France
- Volunteers
- 67 people
- Sponsor
- Zimmer Biomet