Clinical trials: Rotator Cuff Tears of the Shoulder
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.
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.
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, 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
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.
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
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 Tears, Rotator Cuff Injuries
PMCF Study on the Safety, Performance and Clinical Benefits Data of the Quattro X Broadband
The study is a multicenter, retrospective and prospective, non-randomized, noncontrolled, and consecutive series post-market study.
- Trial name
- NCT05690776
- Where
- 2 sites in France
- Volunteers
- 106 people
- Sponsor
- Zimmer Biomet
Primary Osteoarthritis, Secondary Osteoarthritis
SMR Stemless Shoulder Arthroplasty Clinical Study
Shoulder arthroplasty is a reliable procedure for the treatment of severe shoulder joint diseases to relieve pain and restore shoulder function.
- Conditions
- Primary Osteoarthritis, Secondary Osteoarthritis, Post-traumatic; Arthrosis, Rheumatoid Arthritis
- Trial name
- NCT02679352
- Testing
- SMR Stemless
- Where
- 4 sites in Germany, Netherlands and 1 more
- Volunteers
- 78 people
- Sponsor
- Limacorporate S.p.a
Rotator Cuff Tear
InSpace™ System in Comparison to Best Repair of Massive Rotator Cuff Tear
This is a post-marketing study to further assess the safety and effectiveness of the InSpace™ device implantation in comparison to surgical repair of full thickness Massive Rotator Cuff Tear .
- Trial name
- NCT02211183
- Testing
- Best Repair of torn Rotator Cuff, InSpace™ system
- Where
- Spain
- Volunteers
- 4 people
- Sponsor
- OrthoSpace Ltd.
Osteo Arthritis Shoulders, Avascular Necrosis of the Head of Humerus
Easytech Reversed Shoulder System Clinical Study
The purpose of the study is to collect data to demonstrate the safety and effectiveness of the Easytech Reversed Shoulder System for the treatment of patients who require a reverse total shoulder arthroplasty.
- Conditions
- Osteo Arthritis Shoulders, Avascular Necrosis of the Head of Humerus, Rotator Cuff Tear
- Trial name
- NCT03806842
- Testing
- Easytech group
- Where
- 6 sites in United States
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- FX Shoulder Solutions
Rotator Cuff Tears
Clinical Trial on the Effect of the Flexible Suturing System With Anchors (FSSA) in Full-thickness Rotator Cuff Tendon Tears
The purpose of this research study is to evaluate tendon healing when using the Flexible Suturing System with Anchors (FSSA) to surgically repair full-thickness rotator cuff tendon tears.
- Trial name
- NCT06868108
- Testing
- Flexible Suturing System with Anchors (FSSA)
- Where
- 3 sites in United States
- Volunteers
- 100 people
- Sponsor
- Integrity Orthopaedics, Inc.
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 Tears
InSpace Accelerated Rehabilitation Study
This is a prospective, parallel group, open-label, multi- center, randomized study to assess two accelerated rehabilitation programs for use with the InSpace device in the treatment of full thickness Massive, Irreparable Rotator…
- Trial name
- iAccelerate (NCT05329584)
- Testing
- InSpace Subacromial Tissue Spacer
- Where
- 11 sites in United States
- Volunteers
- 160 people, healthy volunteers welcome
- Sponsor
- Stryker Endoscopy
Rotator Cuff Tear
Effectiveness of the Ivivi Torino II, Pulsed Radio Frequency Device, on Narcotic Use, Pain and Quality of Life Following Shoulder Arthroscopic Rotator Cuff Repair.
To determine the effectiveness of non-thermal PRF delivered with the Ivivi Torino II on narcotic use, pain, and health-related quality of life following shoulder arthroscopic rotator cuff surgery comparing: Active treatment…
- Trial name
- NCT01507818
- Testing
- Ivivi Torino II
- Where
- 3 sites in United States
- Volunteers
- 37 people
- Sponsor
- Amp Orthopedics, Inc.
Cuff Tear Arthropathy, Osteoarthritis With Cuff Deficiency
Long-term Clinical Effectiveness of the Delta Xtend Reverse Total Shoulder
This post-marketing study is designed to collect data relating to the use of the Delta Xtend™ Total Shoulder Replacement System in shoulder with rotator cuff deficiencies.
- Conditions
- Cuff Tear Arthropathy, Osteoarthritis With Cuff Deficiency, Rheumatoid Arthritis, Post Traumatic Injury to Shoulder
- Trial name
- NCT00737087
- Testing
- Delta Xtend Reverse Total Shoulder
- Where
- 5 sites in Belgium, France and 1 more
- Volunteers
- 144 people
- Sponsor
- DePuy International
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
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
Anterior Cruciate Ligament Injury, Rotator Cuff Tear
MDR EZ Pass and Precision Flexible Reamer
The objective of this study is to confirm the safety and performance on the EZPass Suture Passer Instrumentation and the Precision Flexible Reamer Instrumentation.
- Trial name
- NCT03914703
- Testing
- EZ Pass Suture Passer
- Where
- United States
- Volunteers
- 73 people
- Sponsor
- Zimmer Biomet