Clinical trials: Rupture of the Rotator Cuff
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
Rotator Cuff Tears
Safety and Efficacy of Rotator Cuff Function Restoration Balloon in Irreparable Rotator Cuff Tear
This study is a prospective, multicenter, randomized, controlled clinical study aiming to evaluate the safety and efficacy of the rotator cuff function restoration balloon in patients with irreparable rotator cuff tear compared…
- Trial name
- NCT04538001
- Testing
- Balloon implantation, Rotator cuff repair
- Volunteers
- 112 people
- Sponsor
- Shanghai MicroPort Medical (Group) Co., 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
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
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 Syndrome
A Pivotal Study to Assess the InSpace™ Device for Treatment of Full Thickness Massive Rotator Cuff Tears
A pivotal study to assess the safety and effectiveness of the InSpace™ device implantation in comparison to surgical partial repair of full thickness Massive Rotator Cuff Tear (MRCT).
- Trial name
- NCT02493660
- Testing
- InSpace sub-acromial tissue spacer system, Partial repair of rotator cuff
- Where
- 21 sites in United States, Canada
- Volunteers
- 184 people
- Sponsor
- OrthoSpace Ltd.
Rotator Cuff Tear
Prospective Study for Safety and Efficacy of InSpace™ in Rotator Cuff Tear Subjects
Title: One-arm, international, multi-center with competitive recruitment, prospective study to assess the safety and efficacy of OrthoSpace's InSpace™ in rotator cuff tear subjects scheduled for surgery of the rotator cuff - A…
- Trial name
- NCT00916994
- Testing
- SpaceGuard Balloon
- Where
- Israel
- Volunteers
- 58 people
- Sponsor
- OrthoSpace Ltd.
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
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 Injuries
A Phase I/III Clinical Study of TPX-114 for the Treatment of Full-Thickness Rotator Cuff Tear
Rotator cuff tear is one of the most common shoulder diseases and retears occur frequently after arthroscopic repair. Therefore, there is a growing need of new therapy to improve structural outcome.
- Trial name
- NCT03668028
- Testing
- TPX-114, Arthroscopic surgery
- Where
- 2 sites in South Korea
- Volunteers
- 93 people
- Sponsor
- Tego Science, Inc.
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
- 80 people
- Sponsor
- Integrity Orthopaedics, 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.
Arm Injuries
Pilot Study to Evaluate the Restore Orthobiologic Implant in Rotator Cuff Tear Repair
Primary Endpoints: Comparative evaluation of any differences between the two groups in change from baseline to the 3-month time point in terms of: Functional recovery (patient-based) - using the Oxford Shoulder Score.
- Trial name
- NCT00208338
- Testing
- RESTORE SIS Patch, Rotator cuff repair
- Where
- 2 sites in Belgium, United Kingdom
- Volunteers
- 33 people
- Sponsor
- DePuy International
Orthopedic Disorder, Arthritis Shoulder
Blueprint® Mixed Reality Pilot Study
A pilot Single-Arm, Multicenter, Prospective, Post-Market 6 months Follow-Up Clinical Investigation to Evaluate the Safety and Effectiveness of the Blueprint Mixed Reality HOLOBLUEPRINT™ (HOLOBLUEPRINT™).
- Conditions
- Orthopedic Disorder, Arthritis Shoulder, Arthritis, Degenerative, Cuff Tear Arthropathy
- Trial name
- BLUEMR (NCT06080412)
- Where
- 4 sites in France
- Volunteers
- 44 people
- Sponsor
- Stryker Trauma and Extremities
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
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.
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
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.
Rotator Cuff Tear, Fatty Atrophy
Efficacy of an Amniotic Fluid Derived Allograft, (FlōGraft®) in Rotator Cuff Repairs: A Prospective Study
Rotator Cuff (RC) repair will be augmented with the injection of a human amniotic fluid derived allograft at the repair interface junction.
- Trial name
- NCT03379324
- Testing
- Superiority of augmented repairs, Fat degeneration of supraspinatus muscle
- Where
- United States
- Volunteers
- 260 people, healthy volunteers welcome
- Sponsor
- Applied Biologics, LLC
Full-thickness Rotator Cuff Tear
PEMF as Adjunctive Treatment Following Surgical Repair of Full Thickness Rotator Cuff Tears
The primary objective of this study is to prospectively determine, at 12 months post-surgical repair of full thickness rotator cuff tears, the safety and efficacy of treating full thickness rotator cuff repairs with pulsed…
- Trial name
- RCStim (NCT03339492)
- Testing
- RCStim Model 1114
- Where
- 23 sites in United States
- Volunteers
- 377 people
- Sponsor
- Orthofix Inc.