Clinical trials: Rotator Cuff Rupture
Rotator Cuff Tear - Partial Thickness
Safety and Efficacy Adipose-Derived Stem Cell Injection Partial Thickness Rotator Cuff Tears
This is a prospective, randomized, multi-site, safety and efficacy study in subjects with rotator cuff injuries. Patients will fall into two categories: treatment group (12 subjects) and non-treatment or control group (six…
- Trial name
- NCT02918136
- Testing
- Adipose derived regenerative cells, Cortisone Injectable
- Where
- 2 sites in United States
- Volunteers
- 18 people
- Sponsor
- InGeneron, Inc.
Rotator Cuff Tears of the Shoulder
Integrity Implant System Post Market Clinical Follow-Up Study
The study design is a prospective, multi-center, single-arm, non-randomized post market clinical follow-up study to confirm the performance, safety and clinical benefit of the Integrity Implant System when used for rotator cuff…
- Trial name
- NCT06741527
- Testing
- Integrity Implant System
- Where
- 9 sites in United States
- Volunteers
- 150 people
- Sponsor
- Anika Therapeutics, 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, Fatty Atrophy
Efficacy of an Amniotic Fluid Derived Allograft, (FlōGraft®) in Rotator Cuff Repairs: A Prospective Study
Rotator Cuff (RC) repair will be augmented with the injection of a human amniotic fluid derived allograft at the repair interface junction.
- Trial name
- NCT03379324
- Testing
- Superiority of augmented repairs, Fat degeneration of supraspinatus muscle
- Where
- United States
- Volunteers
- 260 people, healthy volunteers welcome
- Sponsor
- Applied Biologics, LLC
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 Tears
Clinical Trial on the Effect of the Flexible Suturing System With Anchors (FSSA) in Full-thickness Rotator Cuff Tendon Tears
The purpose of this research study is to evaluate tendon healing when using the Flexible Suturing System with Anchors (FSSA) to surgically repair full-thickness rotator cuff tendon tears.
- Trial name
- NCT06868108
- Testing
- Flexible Suturing System with Anchors (FSSA)
- Where
- 3 sites in United States
- Volunteers
- 100 people
- Sponsor
- Integrity Orthopaedics, Inc.
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
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.
Rotator Cuff Tear
Pilot Study of the Use of ULTRABRAID PLUS SUTURE in the Repair of Tears of the Rotator Cuff
The primary objective of this study is to obtain safety data on the use of the ULTRABRAID PLUS SUTURE, and to assess the preliminary effectiveness of the use of the ULTRABRAID PLUS SUTURE in comparison to the ULTRABRAID SUTURE in…
- Trial name
- NCT01767740
- Testing
- ULTRABRAID PLUS SUTURE, ULTRABRAID SUTURE
- Where
- 4 sites in Canada
- Volunteers
- 82 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
Partial Thickness Rotator Cuff Tears
Efficacy and Safety Study of TPX-115 on Partial-thickness Rotator Cuff Tear
The goal of this study is to evaluate the efficacy and safety of allogeneic dermal fibroblasts (TPX-115) compared to placebo in patients with Partial-Thickness Rotator Cuff Tear(PTRCT).
- Trial name
- NCT07219654
- Testing
- TPX-115, Cryopreserving hyaluronic acid medium, Saline
- Where
- 3 sites in United States
- Volunteers
- 60 people
- Sponsor
- Tego Science, 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 Tears
Safety and Efficacy of Rotator Cuff Function Restoration Balloon in Irreparable Rotator Cuff Tear
This study is a prospective, multicenter, randomized, controlled clinical study aiming to evaluate the safety and efficacy of the rotator cuff function restoration balloon in patients with irreparable rotator cuff tear compared…
- Trial name
- NCT04538001
- Testing
- Balloon implantation, Rotator cuff repair
- Volunteers
- 112 people
- Sponsor
- Shanghai MicroPort Medical (Group) Co., Ltd.
Rotator Cuff Tear
Effectiveness of the Ivivi Torino II, Pulsed Radio Frequency Device, on Narcotic Use, Pain and Quality of Life Following Shoulder Arthroscopic Rotator Cuff Repair.
To determine the effectiveness of non-thermal PRF delivered with the Ivivi Torino II on narcotic use, pain, and health-related quality of life following shoulder arthroscopic rotator cuff surgery comparing: Active treatment…
- Trial name
- NCT01507818
- Testing
- Ivivi Torino II
- Where
- 3 sites in United States
- Volunteers
- 37 people
- Sponsor
- Amp Orthopedics, Inc.
Massive Rotator Cuff Tear
Voll Degradable Shoulder Spacer FIH Study
The Voll Degradable Shoulder Spacer First-in-Human study aims to evaluate the initial safety, effectiveness, and clinical outcomes of a degradable shoulder spacer in over 50 years old patients with symptomatic massive rotator…
- Trial name
- NCT07208448
- Testing
- Voll Degradable Shoulder Spacer
- Where
- 4 sites in Israel, Italy
- Volunteers
- 20 people
- Sponsor
- Voll Medical Technologies Ltd.
Full-thickness Rotator Cuff Tear
Dermal Allograft Augmentation of Large and Massive Rotator Cuff Tears
The purpose of this study is to compare postoperative healing of large and massive rotator cuff tears with preoperative MRI confirmed fatty infiltration stage II and higher repaired with or without dermal allograft augmentation…
- Trial name
- NCT05981833
- Testing
- Repair with DAA (dermal allograft augmentation)
- Where
- 4 sites in United States
- Volunteers
- 120 people
- Sponsor
- Arthrex, Inc.
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
Rotator Cuff Injuries
Use of the REGENETEN™ Bioinductive Implant System in High Grade Partial-thickness Tears
The purpose of the study is to assess whether the REGENETEN™ Bioinductive Implant allows patients to get back to their everyday activities quicker than if the tendon is repaired by the standard repair technique 'Completion and…
- Trial name
- IMPACT (NCT05444465)
- Testing
- Isolated Bioinductive Repair, Completion and Repair
- Where
- 20 sites in United States, Australia and 4 more
- Volunteers
- 234 people
- Sponsor
- Smith & Nephew, Inc.
Rotator Cuff Tear
Regenexx™ SD Versus Exercise Therapy for Rotator Cuff Tears
The primary objective of this study is to compare the improvement in subject-reported clinical outcomes, for Regenexx SD treatment vs.
- Trial name
- NCT01788683
- Testing
- Regenexx SD, Exercise Therapy
- Where
- United States
- Volunteers
- 51 people
- Sponsor
- Regenexx, LLC
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