Clinical trials: Rotator Cuff Tear Repair
Rotator Cuff Tear Surgical Repair
H-Wave® Device Stimulation for Post-operative Rotator Cuff Repair Surgery
The goal of this intent-to-treat study is to evaluate the efficacy of H-Wave Device Stimulation following rotator cuff repair surgery.
- Trial name
- NCT07501949
- Testing
- Routine post-surgical care plus H-Wave® Device Stimulation (HWDS), Routine post-surgical care
- Where
- 4 sites in United States
- Volunteers
- 80 people
- Sponsor
- Electronic Waveform Lab
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.
Rotator Cuff Tear
Pilot Study of the Use of ULTRABRAID PLUS SUTURE in the Repair of Tears of the Rotator Cuff
The primary objective of this study is to obtain safety data on the use of the ULTRABRAID PLUS SUTURE, and to assess the preliminary effectiveness of the use of the ULTRABRAID PLUS SUTURE in comparison to the ULTRABRAID SUTURE in…
- Trial name
- NCT01767740
- Testing
- ULTRABRAID PLUS SUTURE, ULTRABRAID SUTURE
- Where
- 4 sites in Canada
- Volunteers
- 82 people
- Sponsor
- Smith & Nephew, Inc.
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 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 Tear
Outcomes in Rotator Cuff Repair Using Graft Reinforcement
The purpose of this study is to evaluate patient shoulder functional outcomes following rotator cuff repairs reinforced with a surgical mesh.
- Trial name
- NCT01025037
- Testing
- Conexa Reconstructive Tissue Matrix
- Where
- 6 sites in United States
- Volunteers
- 61 people
- Sponsor
- Stryker Trauma and Extremities
Rotator Cuff Tear
Utilization of AMSC to Enhance Rotator Cuff Repair - Safety and Efficacy
Subjects received perioperative hAMSC treatment in order to accelerate the healing of the surgically repaired rotator cuff and increase the mechanical properties of the tendon, according to inclusion and exclusion criteria (see…
- Trial name
- AMSC-RC-001 (NCT03838666)
- Testing
- Suspension of human autologous MSC 3P
- Volunteers
- 9 people
- Sponsor
- Bioinova, s.r.o.
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.
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, Rotator Cuff Injury
Rotator Cuff Tendon Repair With FiberLocker System Patch Augmentation
The overall objective of this clinical investigation is to assess the safety and efficacy of full-thickness arthroscopic rotator cuff repairs augmented with the FiberLocker System for the subjects.
- Conditions
- Rotator Cuff Tear, Rotator Cuff Injury, Rotator Cuff Rupture
- Trial name
- FIBERLOCK (NCT07005063)
- Testing
- FiberLocker® System (encompassing SpeedPatch® PET and FiberLocker Instrument® SN)
- Where
- Switzerland
- Volunteers
- 50 people
- Sponsor
- ZuriMED Technologies AG
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
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
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
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
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 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 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.
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
Labral Tear, Glenoid, Acetabular Labrum Tear
Safety and Performance of MICRORAPTOR™ Suture Anchors in Shoulder and Hip
This is a prospective, multi-center, PMCF study to evaluate the safety and performance of the MICRORAPTOR REGENESORB suture anchors, MICRORAPTOR Knotless REGENESORB suture anchors, and MICRORAPTOR Knotless PEEK suture anchors…
- Conditions
- Labral Tear, Glenoid, Acetabular Labrum Tear, Bankart Lesions, Anterior Shoulder Instability
- Trial name
- NCT03985839
- Testing
- MICRORAPTOR™ REGENESORB™ Suture Anchor, MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor, MICRORAPTOR™ Knotless PEEK Suture Anchor
- Where
- 12 sites in United States
- Volunteers
- 298 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