Clinical trials: Rotator Cuff Rupture
Full Thickness Rotator Cuff Tear
BioFiber Scaffold Post-Market Observational Study
The aim of this study is to collect and report data from a consecutive series of patients implanted with these products as part of a post-market surveillance plan for CE Mark approval in the European Union.
- Trial name
- NCT01849458
- Testing
- BioFiber
- Where
- 3 sites in United States, France
- Volunteers
- 50 people
- Sponsor
- Stryker Trauma and Extremities
Rotator Cuff Tears, Rotator Cuff Injuries
Tapestry Rotator Cuff Repair PMCF
The study design is a prospective, multi-center, single-arm, non-randomized, and noncontrolled post market clinical follow-up study involving orthopedic surgeons skilled in arthroscopic rotator cuff repair as determined by the…
- Trial name
- NCT06287853
- Testing
- Tapestry Biointegrative Implant
- Where
- 3 sites in United States
- Volunteers
- 170 people
- Sponsor
- Zimmer Biomet
Osteoarthritis Shoulder, Fracture
Multi Centre Study on TESS V2 Shoulder System
This study is a Post Market Clinical Follow-up study to fulfill the post market surveillance requirements. The data collected from this study will serve the purpose of confirming safety and performance of the TESS Shoulder System.
- Conditions
- Osteoarthritis Shoulder, Fracture, Rheumatoid Arthritis, Avascular Necrosis
- Trial name
- NCT03431857
- Testing
- TESS V2
- Where
- 2 sites in Belgium, France
- Volunteers
- 106 people
- Sponsor
- Zimmer Biomet
Full-thickness Rotator Cuff Tear
Dermal Allograft Augmentation of Large and Massive Rotator Cuff Tears
The purpose of this study is to compare postoperative healing of large and massive rotator cuff tears with preoperative MRI confirmed fatty infiltration stage II and higher repaired with or without dermal allograft augmentation…
- Trial name
- NCT05981833
- Testing
- Repair with DAA (dermal allograft augmentation)
- Where
- 4 sites in United States
- Volunteers
- 120 people
- Sponsor
- Arthrex, Inc.
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.
Shoulder Injury, Shoulder Sprain
Use of Human Dehydrated Umbilical Cord Allograft in Supraspinatus Tendon Repair
To determine the effectiveness of human dehydrated umbilical cord allograft in standard open rotator cuff repair as assessed by the American Shoulder and Elbow Surgeons (ASES) score 12 months post-op.
- Conditions
- Shoulder Injury, Shoulder Sprain, Supraspinatus Tear
- Trial name
- NCT03084068
- Testing
- Human dehydrated umbilical cord allograft
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- MiMedx Group, Inc.
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 Injuries
REGENETEN™ Bioinductive Implant System in Full-thickness Tears
The study is designed to assess the safety and efficacy of Arthroscopic rotator cuff repair (ARCR) augmented with REGENETEN in subjects requiring full-thickness rotator cuff tear repair or revision repair versus Arthroscopic…
- Trial name
- REGENETEN (NCT04450342)
- Testing
- Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation, Arthroscopic rotator cuff repair, Arthroscopic rotator cuff repair for revision surgery
- Where
- 30 sites in United States, Australia and 6 more
- Volunteers
- 119 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
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
Rotator Cuff Injuries
Phase 1/2 Clinical Study of TPX-115 in Patients With 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
- NCT04470167
- Testing
- TPX-115
- Where
- 2 sites in South Korea
- Volunteers
- 49 people
- Sponsor
- Tego Science, Inc.
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.
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, 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, 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 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.
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
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 Tear
Rotator Cuff Repair (RCR) With and Without OrthoADAPT Augmentation
Prospective, randomized, multi-center, controlled study for patients undergoing open rotator cuff repair. Patients are stratified based on tear size to one of three groups.
- Trial name
- NCT00957255
- Testing
- OrthoADAPT, Standard of care
- Where
- United States
- Sponsor
- Baxter Healthcare Corporation
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.