Clinical trials: Rotator Cuff Repairs
Rotator Cuff
Safety of Treatment of Shoulder Repair
This study evaluates the safety of the HEALICOIL Knotless Suture Anchors in patients requiring a repair of the rotator cuff tendon repair
- Trial name
- HEALICOIL_KNTL (NCT04552119)
- Testing
- HEALICOIL Knotless PEEK, HEALICOIL Knotless REGENESORB
- Where
- 5 sites in United States
- Volunteers
- 138 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 Arthropathy
Subscapularis Repair in Reverse Shoulder Arthroplasty
This study will evaluate the subscapularis repair versus non-repair during a reverse shoulder arthroplasty (RSA).
- Trial name
- Subscap (NCT05438914)
- Testing
- Repair of the subscapularis
- Where
- 6 sites in United States
- Volunteers
- 134 people
- Sponsor
- Arthrex, Inc.
Rotator Cuff Tear
Use of Graft Jacket for Rotator Cuff Repair
This study is to evaluate the safety and effectiveness of GraftJacket, a human tissue product used in fixing large and massive reparable rotator cuff tears.GraftJacket allograft (Wright Medical Technology, Inc., Arlington, TN) is…
- Trial name
- NCT00456781
- Testing
- Augmentation, Rotator Cuff Repair without augmentation
- Where
- 7 sites in United States, Canada
- Volunteers
- 79 people, healthy volunteers welcome
- Sponsor
- Stryker Trauma and Extremities
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
Pain
Efficacy, Safety, and Pharmacokinetics of Brachial Plexus Block With EXPAREL in Shoulder Surgery
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study in 155 adult subjects undergoing primary unilateral total shoulder arthroplasty or rotator cuff repair with general anesthesia
- Trial name
- NCT02713230
- Testing
- bupivacaine liposome injectable suspension
- Where
- 20 sites in United States, Belgium and 1 more
- Volunteers
- 156 people
- Sponsor
- Pacira Pharmaceuticals, Inc
Rotator Cuff Repairs
PMCF Study on the Safety, Performance and Clinical Benefits Data of the ComposiTCP
The study is a multicenter, retrospective and prospective, non-randomized, noncontrolled, and consecutive series post-market study.
- Trial name
- NCT07080450
- Where
- France
- Volunteers
- 43 people
- Sponsor
- Zimmer Biomet
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 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
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
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.
Postoperative Pain
Safety and Efficacy of Tapentadol Immediate Release (IR) and Oxycodone IR for Treatment of Acute Post-op Pain Following Elective Arthroscopic (Surgery Using a Thin Flexible Scope) Shoulder Surgery
The purpose of this study is to evaluate how tapentadol immediate release (IR) and oxycodone IR treat moderate to severe post-operative pain after elective arthroscopic shoulder surgery.
- Trial name
- NCT00814580
- Testing
- Tapentadol IR, Oxycodone IR
- Volunteers
- 382 people
- Sponsor
- Ortho-McNeil Janssen Scientific Affairs, LLC
Rotator Cuff Tear, Rotator Cuff Tears
Post-Market Clinical Follow-up (PMCF) Study of the Pitch-Patch for the Augmentation or Reinforcement of the Rotator Cuff
This is a clinical investigation study. It will verify the long-term safety and performance of the Pitch-Patch when implanted to reinforce partially repairable rotator cuff tears and used as described by the manufacturer's…
- Conditions
- Rotator Cuff Tear, Rotator Cuff Tears, Rotator Cuff Tears of the Shoulder, Rotator Cuff Injuries
- Trial name
- NCT05906004
- Testing
- Pitch-Patch
- Where
- United Kingdom
- Volunteers
- 37 people
- Sponsor
- Xiros Ltd
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
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.
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
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 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.
Bankart Lesion, Acetabular Labrum Tear
S&P of Q-Fix™ All-Suture Anchor System
Post-market clinical follow-up needed to address existing clinical data and gaps on the existing Q-Fix™ device and meet existing MDD/MEDDEV requirements
- Conditions
- Bankart Lesion, Acetabular Labrum Tear, SLAP Lesion, Acromioclavicular Sprain
- Trial name
- NCT03594071
- Testing
- The Q-Fix™ All-Suture Anchor
- Where
- 5 sites in United States
- Volunteers
- 294 people, healthy volunteers welcome
- Sponsor
- Smith & Nephew, Inc.
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.