Clinical trials: Rotator Cuff Repairs
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 Injury
Interscalene Brachial Plexus Block Combined With Suprascapular Nerve Block
The investigators compared the results of sono-guided interscalene brachial plexus block (ISB) combined with arthroscopy-guided suprascapular nerve block (SSNB) with those of ISB alone within the first 48 h after arthroscopic…
- Trial name
- NCT02424630
- Testing
- Ultrasound-guided ISB, Arthroscopy-guided SSNB, Ropivacaine
- Volunteers
- 52 people
- Sponsor
- Chuncheon Sacred Heart Hospital
Full-thickness Rotator Cuff Tear
Efficacy of Continuous Infusion Ropivacaine Interscalene Blocks
Arthroscopic rotator cuff repair is a common and painful procedure routinely performed on an outpatient basis. Postoperative pain control regimens can include narcotic pain medicine, non-steroidal anti-inflammatory medications…
- Trial name
- NCT02462382
- Testing
- Arthroscopic Rotator Cuff Repair, Ropivacaine, Saline
- Where
- United States
- Volunteers
- 51 people
- Sponsor
- Orlando Health, Inc.
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
Nonopioid Analgesia After Rotator Cuff Repair
This is a randomized, single blinded, standard of care controlled clinical trial. This project aims to compare postoperative pain control in patients in two treatment arms of rotator cuff repair: a treatment group given a…
- Trial name
- NCT03818919
- Testing
- Celecoxib, Ketorolac, Gabapentin
- Where
- United States
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Henry Ford Health System
Postoperative Pain, Adverse Effects
Continuous Interscalene Block Results in Superior Recovery Throughout the First Postoperative Week
The investigators undertook this prospective, randomized trial to compare the recovery profile throughout the first postoperative week in patients receiving continuous (CISB) interscalene brachial plexus block, single injection…
- Trial name
- NCT01881776
- Testing
- ISB
- Where
- United States
- Volunteers
- 71 people, healthy volunteers welcome
- Sponsor
- St. Luke's-Roosevelt Hospital Center
Full Thickness Rotator Cuff Tear
Mesenchymal Stem Cell Augmentation in Patients Undergoing Arthroscopic Rotator Cuff Repair
The primary objective of this study is to compare the clinical outcomes of arthroscopic rotator cuff repair with and without augmentation of mesenchymal stem cells (MSCs).
- Trial name
- NCT02484950
- Testing
- Mesenchymal stem cell augmentation in rotator cuff repair, Standard arthroscopic rotator cuff repair
- Where
- United States
- Volunteers
- 62 people
- Sponsor
- Rush University Medical Center
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
Types of Fixation in Arthroscopic Rotator Cuff Repair
The study will identify if there is a difference of quality of life after surgery between two techniques used in surgery. The two different techniques are either the Single Row Fixation or the Double Row Fixation.
- Trial name
- NCT00508183
- Testing
- single row, double row fixation
- Where
- Canada
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Ottawa Hospital Research Institute
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 Tear Arthropathy
Effect of Ibuprofen on Postoperative Opiate Medication Use and Shoulder Functional Outcomes
This will be a randomized controlled trial to determine if postoperative ibuprofen after arthroscopic rotator cuff repair impacts postoperative opiate medication use, Visual Analog Scale (VAS) pain scores, shoulder range of…
- Trial name
- NCT02588027
- Testing
- Ibuprofen
- Where
- United States
- Volunteers
- 110 people
- Sponsor
- University of California, San Francisco
Arthroscopic Surgical Treatment of High-grade (>50%) Partialthickness
Treatment of Partial-Thickness Rotator Cuff Tears
The goal of this clinical trial is to demonstrate that REGENETEN is superior to standard repair techniques when surgically treating high-grade (>50%) partial-thickness tears.
- Trial name
- REGEN PUB 2018 (NCT03734536)
- Testing
- REGENETEN™ Bioinductive Implant, Arthroscopic repair of the high-grade (>50%) partial-thickness
- Where
- 10 sites in United States
- Volunteers
- 168 people
- Sponsor
- Smith & Nephew, Inc.
Rotator Cuff Repair, Anterior Cruciate Ligament Reconstruction
Ultrasound-Guided Percutaneous Peripheral Nerve Stimulation: A Department of Defense Funded Multicenter Pilot Study
Postoperative pain is usually treated with opioids that have undesirable and sometimes dangerous side effects (e.g., vomiting and respiratory depression)-and yet over 80% of patients still experience inadequate pain relief.
- Conditions
- Rotator Cuff Repair, Anterior Cruciate Ligament Reconstruction, Ankle Arthrodesis or Arthroplasty, Hallux Valgus Correction
- Trial name
- NCT03481725
- Testing
- ACTIVE peripheral nerve stimulation with a percutaneously inserted lead and wearable stimulator (SPR Therapeutics, Cleveland, Ohio)
- Where
- 6 sites in United States
- Volunteers
- 65 people
- Sponsor
- University of California, San Diego
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
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 Repair, Ankle Arthroplasty or Arthrodesis
Ultrasound-Guided Percutaneous Peripheral Nerve Stimulation: A Department of Defense Funded Pragmatic Clinical Trial
Postoperative pain is usually treated with opioids that have undesirable and sometimes dangerous side effects (e.g., vomiting and respiratory depression)-and yet over 80% of patients still experience inadequate pain relief.
- Conditions
- Rotator Cuff Repair, Ankle Arthroplasty or Arthrodesis, Hallux Valgus (Bunion) Resection
- Trial name
- NCT04713098
- Testing
- Peripheral Nerve Stimulation
- Where
- 6 sites in United States
- Volunteers
- 250 people
- Sponsor
- University of California, San Diego
Shoulder Pain
Rotator Cuff Pathway
Rotator cuff surgery is mostly performed on an outpatient basis, and many patients still experience moderate to severe pain after surgery, despite the use of regional anesthesia and opioids.
- Trial name
- NCT03717753
- Testing
- Pathway
- Where
- United States
- Volunteers
- 140 people
- Sponsor
- Hospital for Special Surgery, New York
Rotator Cuff Syndrome
Prospective Randomized Comparative Study of Outcome of Subscapularis Tear
The purpose of this study was to report actual percentage of subscapularis tear in concomitant with supraspinatus tendon tear (with or without infraspinatus tear) and investigate the amount of contribution of subscapularis repair…
- Trial name
- NCT01996904
- Testing
- arthroscopic repair, arthroscopic debridement
- Where
- South Korea
- Volunteers
- 191 people
- Sponsor
- CM Chungmu Hospital
Rotator Cuff Tear
Post-Op Rotator Cuff Pain Study With Subacromial Bupivacaine Infusion
Subacromial pain catheters have been used with uncertain efficacy for many years after rotator cuff repair to aid in postoperative pain control.
- Trial name
- NCT01126593
- Testing
- 0.5% bupivacaine, Normal Saline
- Where
- United States
- Volunteers
- 96 people
- Sponsor
- Orlando Health, Inc.