Clinical trials: Rotator Cuff Tear
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
Shoulder Pain, Shoulder Injuries
MDR SureLock All-Suture Anchor
To report the outcomes of a series of patients with recurrent anterior and/or posterior shoulder instability who underwent surgical repair of the affected labrum using the SureLock all-suture anchor.
- Conditions
- Shoulder Pain, Shoulder Injuries, Shoulder Disease, Shoulder Pain Chronic
- Trial name
- NCT04093700
- Testing
- SureLock All-Suture Anchor
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Zimmer Biomet
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.
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.
Rotator Cuff Tears
Safety and Efficacy of Adult Adipose-Derived Stem Cell Injection Into Partial Thickness Rotator Cuff Tears
Extension Study of Protocol RC-001- Safety and Efficacy of Adult Adipose-Derived Stem Cell Injection into Partial Thickness Rotator Cuff Tears.
- Trial name
- NCT04077190
- Testing
- Adipose-derived stem cells, cortisone injection
- Where
- 2 sites in United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- InGeneron, 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
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 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.
Bankart Lesions, SLAP Lesion
PMCF Study on the Safety, Performance and Clinical Benefits Data of the ToggleLoc™ 2.9mm and JuggerLoc™ in the Shoulder
The study is a multicenter, retrospective, non-randomized, non-controlled and consecutive series post-market study. The purpose of this study is to collect data confirming safety, performance and clinical benefits of the…
- Conditions
- Bankart Lesions, SLAP Lesion, Acromioclavicular; Dislocation, Capsular Shift/Capsulolabral Reconstruction
- Trial name
- NCT05584553
- Testing
- ToggleLoc 2.9 mm soft tissue device, JuggerLoc soft tissue device
- Where
- 3 sites in United States, Spain
- Volunteers
- 214 people
- Sponsor
- Zimmer Biomet
Rotator Cuff Tear, Acromial Spur
Study Comparing Patient Function and Satisfaction With Arthroscopic Subacromial Decompression Before and After Repair of Complete Rotator Cuff Tears
The investigators aim to establish whether completing a subacromial decompression before or after repair of a complete rotator cuff tear has any clinical significance.
- Trial name
- NCT01430598
- Testing
- Rotator Cuff Repair and Subacromial Decompression, Questionnaire
- Where
- 2 sites in United States
- Volunteers
- 100 people
- Sponsor
- Ascension Health
Osteoarthritis Shoulder, Rotator Cuff Syndrome of Shoulder and Allied Disorders
FX Shoulder Prospective Clinical Study
Prospective Multi-Center Registry on study subjects with implanted devices marketed and legally commercialized in the USA by FX Shoulder Solutions.
- Conditions
- Osteoarthritis Shoulder, Rotator Cuff Syndrome of Shoulder and Allied Disorders, Fracture, Shoulder
- Trial name
- NCT06078865
- Testing
- FX Artificial Shoulder Prosthesis
- Where
- 4 sites in United States
- Volunteers
- 600 people
- Sponsor
- FX Shoulder Solutions
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
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
Primary Osteoarthritis, Secondary Osteoarthritis
Clinical and Radiological Outcomes of Medacta Shoulder System
This is a post-marketing surveillance on Medacta Shoulder System
- Conditions
- Primary Osteoarthritis, Secondary Osteoarthritis, Rotator Cuff Tear Arthropathy, Rheumatoid Arthritis Shoulder
- Trial name
- NCT03547947
- Testing
- Medacta Shoulder System
- Where
- 6 sites in France, Germany and 1 more
- Volunteers
- 200 people
- Sponsor
- Medacta International SA
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 Arthropathy, Osteoporosis
COMPREHENSIVE® REVERSE SHOULDER Mini BasePlate
Evaluate Survivorship for the Biomet® Comprehensive® Reverse Shoulder Mini Baseplate.
- Conditions
- Rotator Cuff Tear Arthropathy, Osteoporosis, Osteomalacia, Joint; Destruction, Sacroiliac
- Trial name
- NCT02084693
- Testing
- COMPREHENSIVE
- Where
- 5 sites in South Korea
- Volunteers
- 100 people
- Sponsor
- Zimmer Biomet
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
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.
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 - Partial Thickness
Safety and Efficacy Adipose-Derived Stem Cell Injection Partial Thickness Rotator Cuff Tears
This is a prospective, randomized, multi-site, safety and efficacy study in subjects with rotator cuff injuries. Patients will fall into two categories: treatment group (12 subjects) and non-treatment or control group (six…
- Trial name
- NCT02918136
- Testing
- Adipose derived regenerative cells, Cortisone Injectable
- Where
- 2 sites in United States
- Volunteers
- 18 people
- Sponsor
- InGeneron, Inc.