Clinical trials: Rotator Cuff Tears
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, Rotator Cuff Tendinitis
Effectiveness of Corticosteroid vs. Ketorolac Shoulder Injections: A Prospective Double-Blinded Randomized Trial
The purpose of this study is to compare the functional outcomes of patients with shoulder pathology treated with either ketorolac or corticosteroid injections, in a randomized double-blinded study.
- Trial name
- NCT04115644
- Testing
- Ketorolac, Kenalog
- Where
- 2 sites in United States
- Volunteers
- 82 people, healthy volunteers welcome
- Sponsor
- Michael Khazzam
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.
Osteoarthritis Shoulder, Fracture
Multi Centre Study on TESS V2 Shoulder System
This study is a Post Market Clinical Follow-up study to fulfill the post market surveillance requirements. The data collected from this study will serve the purpose of confirming safety and performance of the TESS Shoulder System.
- Conditions
- Osteoarthritis Shoulder, Fracture, Rheumatoid Arthritis, Avascular Necrosis
- Trial name
- NCT03431857
- Testing
- TESS V2
- Where
- 2 sites in Belgium, France
- Volunteers
- 106 people
- Sponsor
- Zimmer Biomet
Rotator Cuff Injury
Suture Anchor Comparison in Rotator Cuff Repairs
Patients will be randomized to receive HEALICOIL™ REGENESORB (the study anchor) or TWINFIX Ultra HA, a similar comparative product, for use in the repair of their shoulder injury.
- Trial name
- NCT02350647
- Testing
- Suture Anchor HEALOCOIL, Suture anchor Twinfix Ultra HA
- Where
- United States
- Volunteers
- 64 people
- Sponsor
- The Hawkins Foundation
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
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.
Anterior Cruciate Ligament Injury, Rotator Cuff Tear
MDR EZ Pass and Precision Flexible Reamer
The objective of this study is to confirm the safety and performance on the EZPass Suture Passer Instrumentation and the Precision Flexible Reamer Instrumentation.
- Trial name
- NCT03914703
- Testing
- EZ Pass Suture Passer
- Where
- United States
- Volunteers
- 73 people
- Sponsor
- Zimmer Biomet
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
Osteoarthritis, Rotator Cuff Tear Arthropathy
Prediction of Development of Scapular Notching Following Reverse Total Shoulder Arthroplasty
The hypothesis is that computer simulated bony impingement of the bone surrounding the spherical glenoid implant (the glenosphere) along the scapular neck on three-dimensional (3-D) computed tomography (CT) imaging analysis is…
- Conditions
- Osteoarthritis, Rotator Cuff Tear Arthropathy, Reverse Total Shoulder Arthroplasty, Scapular Notching
- Trial name
- NCT02052466
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Eric Ricchetti
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.
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.
Rotator Cuff Tears, Hemorrhage, Surgical
Effect of Intravenous Tranexamic Acid on Visual Clarity During Shoulder Arthroscopy in the Beach Chair Position
Shoulder arthroscopy offers numerous advantages and has led to a continuous increase in procedural complexity. Adequate intraoperative visual clarity is essential for successful performance of the procedure and is primarily…
- Conditions
- Rotator Cuff Tears, Hemorrhage, Surgical, Shoulder Injuries
- Trial name
- NCT05397652
- Testing
- Tranexamic Acid Injectable Product
- Where
- Croatia
- Volunteers
- 121 people, healthy volunteers welcome
- Sponsor
- Nikola Matejcic
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 Tear
The Effect of EXPAREL® on Postsurgical Pain, and the Use of Narcotics
Patients undergoing shoulder rotator cuff surgery in an outpatient setting are the focus of this study. The purpose of this study is to determine if the product EXPAREL® can be used as a safe alternative in shoulder surgery to…
- Trial name
- NCT03290196
- Testing
- EXPAREL 1.3 % in 20 ML Injection
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Andrews Research & Education Foundation
Rotator Cuff Tear
Rotator Cuff Repair Using Standard Double Row Technique With Platelet Rich Fibrin Membrane vs. Standard Double Row Technique
This study is a single-blind, randomized study evaluating the 6 month and 2 year outcomes of patients treated with arthroscopic rotator cuff repair using one of two techniques.
- Trial name
- RCRPRFM (NCT02256891)
- Testing
- PRFM, Double Row
- Where
- United States
- Volunteers
- 97 people, healthy volunteers welcome
- Sponsor
- HealthPartners Institute
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.
Cuff-tear Arthropathy
Anatomical Shoulder™ Inverse/Reverse Study
The purpose of this study is to obtain outcomes data on the Anatomical Shoulder™ Inverse/Reverse System by analysis of standard scoring systems and radiographs.
- Trial name
- NCT02466321
- Testing
- Inverse/Reverse Shoulder Arthroplasty
- Where
- 5 sites in Belgium, Germany and 2 more
- Volunteers
- 154 people
- Sponsor
- Zimmer, GmbH
Rotator Cuff Tear, Shoulder Impingement Syndrome
Arthroscopic Rotator Cuff Repair of Full Thickness Tears With and Without Arthroscopic Acromioplasty
Surgical repair of full thickness tears of the rotator cuff is a controversial issue, with several procedures currently being used to treat the tear.
- Trial name
- NCT00290888
- Testing
- Acromioplasty
- Where
- Canada
- Volunteers
- 86 people
- Sponsor
- Panam Clinic
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