Clinical trials: Rotator Cuff, open to volunteers
Primary Osteoarthritis, Secondary Osteoarthritis
Clinical and Radiological Outcomes of Medacta Shoulder System FR
This is a post-marketing surveillance on Medacta Shoulder System
- Conditions
- Primary Osteoarthritis, Secondary Osteoarthritis, Rotator Cuff Tear Arthropathy, Rheumatoid Arthritis Shoulder
- Trial name
- NCT05926622
- Where
- France
- Volunteers
- 200 people
- Sponsor
- Medacta International SA
Rotator Cuff Repairs
PMCF Study on the Safety, Performance and Clinical Benefits Data of the ComposiTCP
The study is a multicenter, retrospective and prospective, non-randomized, noncontrolled, and consecutive series post-market study.
- Trial name
- NCT07080450
- Where
- France
- Volunteers
- 43 people
- Sponsor
- Zimmer Biomet
Arthropathy of Shoulder Region, Grossly Deficient Rotator Cuff
Comprehensive Reverse Shoulder Data Collection
This study is a multicenter, prospective, non-randomized, non-controlled clinical outcome study. The primary objective of this study is to evaluate improvement of pain score at one year for the Biomet Comprehensive Reverse…
- Conditions
- Arthropathy of Shoulder Region, Grossly Deficient Rotator Cuff, Osteoarthritis of the Shoulder, Rheumatoid Arthritis Without Humeral Metaphyseal Defects
- Trial name
- NCT03404778
- Testing
- Biomet Comprehensive Reverse Shoulder
- Where
- 4 sites in United States
- Volunteers
- 175 people
- Sponsor
- Zimmer Biomet
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.
Rheumatoid Arthritis, Osteoarthritis Shoulder
Tornier HRS (Humeral Reconstruction System) Study (REVIVE)
This is an international, single arm, multicenter, prospective follow-up, non-significant risk, Post-Market Clinical Follow-up (PMCF) study.
- Conditions
- Rheumatoid Arthritis, Osteoarthritis Shoulder, Fractures Humerus, Avascular Necrosis
- Trial name
- REVIVE (NCT05500066)
- Testing
- Tornier HRS (HUMERAL RECONSTRUCTION SYSTEM) shoulder system
- Where
- 4 sites in United States
- Volunteers
- 110 people
- Sponsor
- Stryker Trauma and Extremities
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
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.
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 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.
Arthroplasty, Replacement
SMR Stemless Reverse vs SMR Reverse Shoulder System
The SMR Stemless Reverse is intended for total, primary shoulder joint replacement by reducing pain and restoring shoulder articular mobility function.
- Trial name
- NCT04697004
- Testing
- Investigational Arm: SMR Stemless Reverse, Control Arm: SMR Reverse Shoulder System
- Where
- 13 sites in United States
- Volunteers
- 200 people
- Sponsor
- Limacorporate S.p.a
Low Back Pain, Radicular Syndrome
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
This pilot randomized controlled trial aims to compare the clinical effectiveness of advanced high-intensity physical therapy modalities with conventional physical therapy in patients suffering from musculoskeletal disorders.
- Conditions
- Low Back Pain, Radicular Syndrome, Sacroiliac Joint Dysfunction, Shoulder Impingement Syndrome
- Trial name
- NCT07903142
- Testing
- Repetitive Peripheral Magnetic Stimulation (rPMS), High-Intensity Laser Therapy (HIL), Extracorporeal Shockwave Therapy (ESWT)
- Where
- Czechia
- Volunteers
- 60 people
- Sponsor
- BTL Industries Ltd.
Partial Thickness Rotator Cuff Tear
A Phase 2b/3 Study of TPX-115 on 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
- NCT06414005
- Testing
- TPX-115
- Where
- 2 sites in South Korea
- Volunteers
- 166 people
- Sponsor
- Tego Science, Inc.
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.
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.
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.
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 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
Severe Arthropathy With a Grossly Deficient Rotator Cuff
The Influence of Repairing the Sub-scapularis on Outcomes After Reverse Arthroplasty
The study is a prospective, multi-center, randomized blinded study to determine how repairing the subscapularis vs. not repairing the subscapularis when subjects are implanted with the AltiVate Reverse® Shoulder System for…
- Trial name
- NCT03711175
- Testing
- Subscapularis repair, Shoulder implant
- Where
- 4 sites in United States
- Volunteers
- 200 people
- Sponsor
- Encore Medical, L.P.
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
Osteoarthritis Shoulder, Rotator Cuff Tears
DenCT Shoulder Bone Quality Evaluation
The objective of the study is to evaluate the preoperative bone quality assessment based on CT to later establish a scale for the decision of stemless shoulder arthroplasty.
- Trial name
- NCT06032416
- Testing
- Preoperative CT Scan
- Where
- Japan
- Volunteers
- 200 people
- Sponsor
- Zimmer Biomet