Clinical trials: Full Rotator Cuff Tear
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.
Full-thickness 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
- NCT02208440
- Testing
- Best Repair of torn Rotator Cuff, InSpace™ system
- Where
- United Kingdom
- Volunteers
- 14 people
- Sponsor
- OrthoSpace Ltd.
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
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 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
Rotator Cuff, Arthroscopic Surgery
Arthroscopic Surgical Outcome Study In Subjects With Rotator Cuff Tears
This is an observational study that involves subjects with full-thickness rotator cuff tears treated by means of arthroscopy surgical repair, also known as arthroscopic surgery.
- Trial name
- NCT00739947
- Testing
- Observational study of the surgical outcome
- Where
- 37 sites in United States
- Volunteers
- 162 people
- Sponsor
- Pfizer
Rotator Cuff Tear
A Safety Study Of BMP-655/ACS As An Adjuvant Therapy For Treatment Of Rotator Cuff Tears
Subjects undergoing an open surgical repair for their torn Rotator Cuff (RC) will be consented, screened, and enrolled in the study if they meet all eligibility criteria.
- Trial name
- NCT01122498
- Testing
- BMP-655/ACS+Standard of care or Standard of care
- Where
- 9 sites in Japan
- Volunteers
- 23 people
- Sponsor
- Pfizer
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.
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.
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 Tear
Study Evaluating Safety Of BMP-655/ACS As An Adjuvant Therapy For Rotator Cuff Repair
Study to assess the safety of 3 differing concentrations of BMP-655/ACS in subjects with full thickness Rotator Cuff Tears (RCTs).
- Trial name
- NCT00936559
- Testing
- BMP-655/ACS or Standard of Care
- Where
- 4 sites in Germany, Netherlands
- Volunteers
- 13 people
- Sponsor
- Pfizer
Full- Thickness Massive RCT (MRCT) of at Least 5 cm in Diameter Including Fatty Infiltration Grade III or IV
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
- NCT01890733
- Testing
- Best Repair of torn Rotator Cuff, InSpace™ system
- Where
- Italy
- Volunteers
- 5 people
- Sponsor
- OrthoSpace Ltd.
Partial Thickness Supraspinatus Tendon Tear, Full Thickness Supraspinatus Tendon Tear
Post-Market Evaluation of the Rotation Medical Rotator Cuff System
The purpose of this study is to evaluate bioinduction of new tissue and tendon healing after implantation of the Rotation Medical Bioinductive Implant used as either a standalone device or adjunct to surgical repair in the…
- Trial name
- NCT02200939
- Testing
- Bioinductive implant, Surgical repair
- Where
- 15 sites in United States
- Volunteers
- 148 people
- Sponsor
- Smith & Nephew, Inc.
Rotator Cuff Tears
BioBrace® Implant for Arthroscopic Repair of Full Thickness Rotator Cuff Tears
This study aims to evaluate the safety and effectiveness of arthroscopic rotator cuff repair augmented with the BioBrace® Implant vs.
- Trial name
- REinForce (NCT05997381)
- Testing
- Arthroscopic rotator cuff repair with BioBrace® Implant augmentation., Arthroscopic rotator cuff repair
- Where
- United States
- Volunteers
- 268 people, healthy volunteers welcome
- Sponsor
- CONMED Corporation
Rotator Cuff Tears, Full-thickness Rotator Cuff Tears
Rotator Cuff Healing Using a Nanofiber Scaffold in Patients Greater Than 55 Years
Randomized controlled trial of patients over the age of 55 treated with and without a nanofiber scaffold during rotator cuff repair.
- Trial name
- NCT04325789
- Testing
- nanofiber scaffold
- Where
- 4 sites in United States
- Volunteers
- 91 people
- Sponsor
- Atreon Orthopedics
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
Rotator Cuff Tear
Rotation Medical Bioinductive Implant Database Registry
The purpose of this clinical registry is to prospectively collect and compare preoperative and postoperative patient-reported data using validated shoulder-specific and health-related quality of life (QoL) instruments during…
- Trial name
- REBUILD (NCT02784600)
- Testing
- Bioinductive implant
- Where
- 19 sites in United States
- Volunteers
- 483 people
- Sponsor
- Smith & Nephew, Inc.
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.
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 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.