Clinical trials: Cuff
Rotator Cuff Tears
BioBrace® Implant for Arthroscopic Repair of Full Thickness Rotator Cuff Tears
This study aims to evaluate the safety and effectiveness of arthroscopic rotator cuff repair augmented with the BioBrace® Implant vs.
- Trial name
- REinForce (NCT05997381)
- Testing
- Arthroscopic rotator cuff repair with BioBrace® Implant augmentation., Arthroscopic rotator cuff repair
- Where
- United States
- Volunteers
- 268 people, healthy volunteers welcome
- Sponsor
- CONMED Corporation
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 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.
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
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 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
Osteoarthritis Shoulder, Avascular Necrosis
Perform Humeral System Study
This study is an international, single arm, multicenter, prospective, non-significant risk, Post-Market Clinical Follow-up study, which is designed to collect safety and performance data at baseline, surgery, immediate post-op…
- Conditions
- Osteoarthritis Shoulder, Avascular Necrosis, Post-traumatic Arthrosis of Other Joints, Shoulder Region, Rotator Cuff Tear Arthropathy
- Trial name
- PHS (NCT05067543)
- Testing
- Tornier Perform Humeral - Stem
- Where
- 11 sites in United States, Canada and 3 more
- Volunteers
- 300 people
- Sponsor
- Stryker Trauma and Extremities
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
Rotator Cuff Tears, Rheumatoid Arthritis Shoulder
Shoulder iD™ Primary Reversed Glenoid Outcomes Clinical Study
The goal of the Shoulder iD™ Primary Reversed Glenoid Outcomes Clinical Study is to collect safety and performance data on the commercially available Shoulder iD™ Primary Reversed Glenoid device.
- Conditions
- Rotator Cuff Tears, Rheumatoid Arthritis Shoulder, Osteoarthritis Shoulder, Avascular Necrosis of the Head of Humerus
- Trial name
- SiD (NCT05868148)
- Testing
- Shoulder iD™ Primary Reversed Glenoid
- Where
- 5 sites in United States
- Volunteers
- 200 people
- Sponsor
- Stryker Trauma and Extremities
Shoulder Pain, Shoulder Impingement Syndrome
Performance and Safety of LightForce® Therapy Lasers on Shoulder Soft Tissue Inflammation Pain Reduction
DJO UK Ltd (ENOVIS) is conducting this study to assess the effectiveness of LightForce® Therapy Lasers on pain reduction in shoulder soft tissue inflammation.
- Conditions
- Shoulder Pain, Shoulder Impingement Syndrome, Rotator Cuff Tendinitis
- Trial name
- SHINE (NCT06759935)
- Testing
- Laser therapy, physiotherapy/exercise protocol
- Where
- 10 sites in France, Italy and 1 more
- Volunteers
- 104 people
- Sponsor
- DJO UK Ltd
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.
Massive Rotator Cuff Tear
Voll Degradable Shoulder Spacer FIH Study
The Voll Degradable Shoulder Spacer First-in-Human study aims to evaluate the initial safety, effectiveness, and clinical outcomes of a degradable shoulder spacer in over 50 years old patients with symptomatic massive rotator…
- Trial name
- NCT07208448
- Testing
- Voll Degradable Shoulder Spacer
- Where
- 4 sites in Israel, Italy
- Volunteers
- 20 people
- Sponsor
- Voll Medical Technologies Ltd.
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.
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
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, 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.
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.
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.
Partial Thickness Rotator Cuff Tears
Efficacy and Safety Study of TPX-115 on Partial-thickness Rotator Cuff Tear
The goal of this study is to evaluate the efficacy and safety of allogeneic dermal fibroblasts (TPX-115) compared to placebo in patients with Partial-Thickness Rotator Cuff Tear(PTRCT).
- Trial name
- NCT07219654
- Testing
- TPX-115, Cryopreserving hyaluronic acid medium, Saline
- Where
- 3 sites in United States
- Volunteers
- 60 people
- Sponsor
- Tego Science, Inc.
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