Clinical trials: Rotator Cuff Injuries
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
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
Humeral Fracture, Proximal, Glenohumeral Osteoarthritis
RETRO-PROSPECTIVE POSTMARKET CLINICAL STUDY FOR FX SHOULDER SOLUTIONS SHOULDER SYSTEMS
This study takes place in the framework of the PostMarket Clinical Follow-up plan of the Shoulder Systems commercialized by FX SHOULDER SOLUTIONS. The included cases will be followed for 10 years after index surgery.
- Conditions
- Humeral Fracture, Proximal, Glenohumeral Osteoarthritis, Avascular Necrosis of the Head of Humerus, Rotator Cuff Tear
- Trial name
- NCT07558590
- Testing
- Shoulder arthroplasty
- Where
- 22 sites in France, Monaco
- Volunteers
- 1,004 people
- Sponsor
- FX Solutions
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 Tendinopathy
Clinical Benefits and Safety of Tropho Tend in the Management of Painful Rotator Cuff Tendinopathy
This is a prospective, open label, controlled, exploratory clinical investigation aimed to evaluate the clinical benefit and safety of Tropho Tend in the conservative management of painful Rotator Cuff Tendinopathy (RCT).
- Trial name
- NCT06809543
- Testing
- Polynucleotides (Tropho Tend), Rehabilitation physiotherapy
- Where
- Italy
- Volunteers
- 60 people
- Sponsor
- Mastelli S.r.l
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
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
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
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 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
Use of the REGENETEN™ Bioinductive Implant System in High Grade Partial-thickness Tears
The purpose of the study is to assess whether the REGENETEN™ Bioinductive Implant allows patients to get back to their everyday activities quicker than if the tendon is repaired by the standard repair technique 'Completion and…
- Trial name
- IMPACT (NCT05444465)
- Testing
- Isolated Bioinductive Repair, Completion and Repair
- Where
- 20 sites in United States, Australia and 4 more
- Volunteers
- 234 people
- Sponsor
- Smith & Nephew, 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
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.
Shoulder Arthritis, Shoulder Osteoarthritis
S-11 SMR TT Hybrid Glenoid and Cementless Finned Short Stem
Post-market, prospective, non randomized, open label, multicentre, clinical study analysing outcomes of shoulder arthroplasty with SMR TT Hybrid Glenoid with or without SMR Cementless Finned Short Stem
- Conditions
- Shoulder Arthritis, Shoulder Osteoarthritis, Arthrosis, Osteoarthritis
- Trial name
- NCT05314387
- Testing
- SMR TT Hybrid Glenoid without Cementless Finned Short Stem, SMR TT Hybrid Glenoid with Cementless Finned Short Stem
- Volunteers
- 100 people
- Sponsor
- Limacorporate S.p.a
Rotator Cuff Tears (RCTs)
SINEFIX-2022 Pilot 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
- NCT05721560
- Testing
- Rotator cuff repair with the SINEFIX
- Where
- Germany
- Volunteers
- 9 people
- Sponsor
- BAAT Medical Products B.V.
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
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
Rotator Cuff Tears, Full-thickness Rotator Cuff Tears
Rotator Cuff Healing Using a Nanofiber Scaffold in Patients Greater Than 55 Years
Randomized controlled trial of patients over the age of 55 treated with and without a nanofiber scaffold during rotator cuff repair.
- Trial name
- NCT04325789
- Testing
- nanofiber scaffold
- Where
- 4 sites in United States
- Volunteers
- 91 people
- Sponsor
- Atreon Orthopedics
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 Injuries
Demineralized Bone Matrix Rotator Cuff Study
Patients undergoing rotator cuff repair surgery will experience improved tendon healing with the use of demineralized bone matrix augmentation.
- Trial name
- NCT04686396
- Testing
- Demineralized bone matrix
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Arthrex, Inc.