Clinical trials: Rotator Cuff Tear
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.
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 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
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
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.
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
Rotator Cuff Tears of the Shoulder
SINEFIX-2022 Comparative 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
- NCT06818448
- Testing
- Rotator cuff repair with the SINEFIX, Rotator cuff repair with comparator device
- Where
- 2 sites in Germany
- Volunteers
- 60 people
- Sponsor
- BAAT Medical Products B.V.
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 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
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 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