Clinical trials: Cuff
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
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 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 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
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 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.
Abdominal Aortic Aneurysm
Suprarenal Proximal Cuff Study for Treatment of Abdominal Aortic Aneurysm
The use of a suprarenal extension device during the index AAA procedure to accommodate the patient's anatomy and to prevent or repair leakage.
- Trial name
- NCT00739401
- Testing
- Suprarenal Proximal Cuff Extension
- Where
- 8 sites in United States
- Volunteers
- 44 people
- Sponsor
- Endologix
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
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
Tendinopathy
Study of Efficacy and Safety of AIN457/Secukinumab in Patients With Rotator Cuff Tendinopathy
The purpose of this study was to investigate the efficacy and safety of secukinumab subcutaneously (s.c.) compared to placebo in adult patients with moderate to severe rotator cuff tendinopathy and failure to conventional therapy.
- Trial name
- UnchAIN (NCT05569174)
- Testing
- Secukinumab
- Where
- 19 sites in Germany
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
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 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
Rotator Cuff Injuries, Shoulder Pain
Anaverse™ Glenoid System and Its Instrumentation
The objectives of this study are to confirm safety, performance and clinical benefits of the Anaverse™ Glenoid System and its instrumentation by analysis of standard scoring systems, radiographs and adverse event records.
- Conditions
- Rotator Cuff Injuries, Shoulder Pain, Arthropathy, Arthroplasty Complications
- Trial name
- NCT05215600
- Testing
- Anaverse Shoulder System
- Where
- Switzerland
- Volunteers
- 20 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
- NCT05722522
- Testing
- Secukinumab
- Where
- 15 sites in United States, Argentina and 5 more
- Volunteers
- 33 people
- Sponsor
- Novartis Pharmaceuticals
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
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 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
Abdominal Aortic Aneurysm
34mm Cuff Study for Endovascular Repair of Abdominal Aortic Aneurysms
Study of anatomical fixation with a 34mm proximal extension
- Trial name
- NCT00706394
- Testing
- Endologix Powerlink 34 mm stent graft cuff
- Where
- 10 sites in United States
- Volunteers
- 19 people
- Sponsor
- Endologix
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.