Clinical trials: Rotator Cuff
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.
Rotator Cuff Injuries, Shoulder Pain
ASHCOM Shoulder System and Its Related Instruments
The objectives of this study are to confirm safety, performance and clinical benefits of the ASHCOM Shoulder System and its related instruments by analysis of standard scoring systems, radiographs and adverse event records.
- Conditions
- Rotator Cuff Injuries, Shoulder Pain, Arthropathy; Traumatic, Arthroplasty Complications
- Trial name
- NCT04258605
- Testing
- ASHCOM Shoulder System
- Where
- Italy
- Volunteers
- 24 people
- Sponsor
- Zimmer Biomet
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 Tendinopathy
Study of Efficacy and Safety of Secukinumab in Participants With Moderate-severe Rotator Cuff Tendinopathy
The purpose of the present study was to assess the efficacy of secukinumab 300 mg s.c. (subcutaneous) compared to placebo, each in combination with standard of care, in improving signs, symptoms and physical function in…
- Trial name
- NCT05722522
- Testing
- Secukinumab
- Where
- 15 sites in United States, Argentina and 5 more
- Volunteers
- 33 people
- Sponsor
- Novartis Pharmaceuticals
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 Arthropathy, Failed Total Shoulder
Reverse Shoulder Prosthesis Study
The objective of this clinical study is to evaluate the safety and efficacy of the Encore Reverse Shoulder Prosthesis (RSP). The clinical results of the RSP will be compared to clinical results published in literature for rotator…
- Conditions
- Rotator Cuff Arthropathy, Failed Total Shoulder, Failed Hemi-arthroplasty
- Trial name
- RSP (NCT00764504)
- Testing
- Reverse Shoulder Prosthesis
- Where
- 25 sites in United States
- Volunteers
- 516 people
- Sponsor
- Encore Medical, L.P.
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 Tendinopathy
Study of Efficacy and Safety of Secukinumab in Participants With Moderate-severe Rotator Cuff Tendinopathy
The purpose of the present study was to assess the efficacy of secukinumab 300 mg s.c. (subcutaneous) compared to placebo, each in combination with standard of care, in improving signs, symptoms and physical function in…
- Trial name
- NCT05758415
- Testing
- Secukinumab
- Where
- 24 sites in United States, China and 4 more
- Volunteers
- 60 people
- Sponsor
- Novartis Pharmaceuticals
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
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
Rotator Cuff Syndrome, Shoulder Bursitis
TRARO (Traumeel® S in Rotator Cuff Syndrome)-Study
To evaluate functional, clinical, and subjective parameters in patients with rotator cuff syndrome and bursitis treated with Traumeel® S injections versus corticosteroid injections and versus placebo.
- Trial name
- TRARO (NCT01702233)
- Testing
- Traumeel S inj, Fortecortin/Dexamethasone 8 mg/2 ml inj, Saline inj
- Where
- Belgium
- Volunteers
- 175 people
- Sponsor
- Biologische Heilmittel Heel GmbH
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
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 Deficiency, Glenohumeral Arthritis
Retrospective Encore Reverse Shoulder Prosthesis Study
The purpose of this study is to evaluate the survivorship and efficacy of the Encore Reverse Shoulder Prosthesis in a group of no more than 50 subjects for whom data collection has already begun.
- Trial name
- NCT00765037
- Testing
- Encore Reverse Shoulder Prosthesis
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- Encore Medical, L.P.
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 Tears, Rotator Cuff Injuries
PMCF Study on the Safety, Performance and Clinical Benefits Data of the Quattro X Broadband
The study is a multicenter, retrospective and prospective, non-randomized, noncontrolled, and consecutive series post-market study.
- Trial name
- NCT05690776
- Where
- 2 sites in France
- Volunteers
- 106 people
- Sponsor
- Zimmer Biomet
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
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.
Procedural Sedation
A Safety Study of AQUAVAN® (Fospropofol Disodium) Injection for Sedation During Minor Surgical Procedures.
Very often patients receive medications before a diagnostic, therapeutic, or surgical procedure to help them relax, keep them calm, and to relieve them from pain. This is called procedural sedation.
- Trial name
- NCT00327392
- Testing
- AQUAVAN® (fospropofol disodium) Injection
- Where
- 15 sites in United States
- Volunteers
- 123 people
- Sponsor
- Eisai Inc.
Rotator Cuff Tendinitis, Syndrome Rotator Cuff
Performance and Safety Evaluation of MD-Shoulder Collagen Medical Device in the Treatment of Rotator Cuff Syndrome
Rotator Cuff Syndrome is a commonly encountered musculoskeletal disorder in clinical practice, with an incidence ranging from 0.3% to 5.5%, and an annual prevalence of 0.5% to 7.4%.
- Conditions
- Rotator Cuff Tendinitis, Syndrome Rotator Cuff, Tendinopathy, Tendinoses, Rotator Cuff
- Trial name
- ROPIRAMED (NCT05489484)
- Testing
- MD-Shoulder Collagen Medical Device
- Where
- Italy
- Volunteers
- 24 people
- Sponsor
- Guna S.p.a