Clinical trials: Massive Rotator Cuff Tears
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
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 Tears
InSpace Accelerated Rehabilitation Study
This is a prospective, parallel group, open-label, multi- center, randomized study to assess two accelerated rehabilitation programs for use with the InSpace device in the treatment of full thickness Massive, Irreparable Rotator…
- Trial name
- iAccelerate (NCT05329584)
- Testing
- InSpace Subacromial Tissue Spacer
- Where
- 11 sites in United States
- Volunteers
- 160 people, healthy volunteers welcome
- Sponsor
- Stryker Endoscopy
Rotator Cuff Tear
InSpace™ System Over Rotator Cuff Repair in Comparison to Repair Alone.
This is a post-marketing study to further assess the safety and effectiveness of the InSpace™ in the study population in comparison to surgical RCT repair.
- Trial name
- NCT02210910
- Testing
- InSpace™ system over repair, Best Repair of torn Rotator Cuff
- Where
- Israel
- Volunteers
- 39 people
- Sponsor
- OrthoSpace Ltd.
Rotator Cuff Injuries
Evaluation Of Outcomes Following Rotator Cuff Repair Using the REGENETEN Bioinductive Implant
This prospective, single-arm, multicenter registry is being conducted to collect real world post-market data from patients who are undergoing rotator cuff repair using the REGENETEN◊ Bioinductive Implant System.
- Trial name
- RePaRe (NCT06857084)
- Testing
- Arthroscopic rotator cuff repair with REGENETEN Bioinductive Implant augmentation
- Where
- 22 sites in Australia, Germany and 2 more
- Volunteers
- 400 people
- Sponsor
- Smith & Nephew, Inc.
Full-thickness Rotator Cuff Tear
InSpace™ System in Comparison to Best Repair of Massive Rotator Cuff Tear.
This is a post-marketing study to further assess the safety and effectiveness of the InSpace™ device implantation in comparison to surgical repair of full thickness Massive Rotator Cuff Tear .
- Trial name
- NCT02208440
- Testing
- Best Repair of torn Rotator Cuff, InSpace™ system
- Where
- United Kingdom
- Volunteers
- 14 people
- Sponsor
- OrthoSpace Ltd.
Massive Rotator Cuff Tears, Massive Rotator Cuff Tear
Voll Non-Degradable Shoulder Spacer FIH Study
The Voll Non-Degradable Shoulder Spacer First-in-Human study aims to evaluate the initial safety, effectiveness, and clinical outcomes of a non-degradable shoulder spacer in over 50 years old patients with symptomatic massive…
- Trial name
- NCT07745647
- Testing
- Voll Non-Degradable Shoulder Spacer
- Where
- Israel
- Volunteers
- 10 people
- Sponsor
- Voll Medical Technologies Ltd.
Rotator Cuff Tears, Rheumatoid Arthritis Shoulder
Shoulder iD™ Primary Reversed Glenoid Outcomes Clinical Study
The goal of the Shoulder iD™ Primary Reversed Glenoid Outcomes Clinical Study is to collect safety and performance data on the commercially available Shoulder iD™ Primary Reversed Glenoid device.
- Conditions
- Rotator Cuff Tears, Rheumatoid Arthritis Shoulder, Osteoarthritis Shoulder, Avascular Necrosis of the Head of Humerus
- Trial name
- SiD (NCT05868148)
- Testing
- Shoulder iD™ Primary Reversed Glenoid
- Where
- 5 sites in United States
- Volunteers
- 200 people
- Sponsor
- Stryker Trauma and Extremities
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.
Full- Thickness Massive RCT (MRCT) of at Least 5 cm in Diameter Including Fatty Infiltration Grade III or IV
InSpace™ System in Comparison to Best Repair of Massive Rotator Cuff Tear.
This is a post-marketing study to further assess the safety and effectiveness of the InSpace™ device implantation in comparison to surgical repair of full thickness Massive Rotator Cuff Tear .
- Trial name
- NCT01890733
- Testing
- Best Repair of torn Rotator Cuff, InSpace™ system
- Where
- Italy
- Volunteers
- 5 people
- Sponsor
- OrthoSpace Ltd.
Rotator Cuff Tear
InSpace™ System in Comparison to Best Repair of Massive Rotator Cuff Tear
This is a post-marketing study to further assess the safety and effectiveness of the InSpace™ device implantation in comparison to surgical repair of full thickness Massive Rotator Cuff Tear .
- Trial name
- NCT02211183
- Testing
- Best Repair of torn Rotator Cuff, InSpace™ system
- Where
- Spain
- Volunteers
- 4 people
- Sponsor
- OrthoSpace Ltd.
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 Tear
InSpace™ System Implantation in a Procedure Under Local Anesthesia
The study objective is to assess the feasibility, efficacy and safety of the InSpace™ Device implantation in a surgical procedure under local anesthesia using arthroscopic and/or fluoroscopic visualization of the affected…
- Trial name
- NCT02208453
- Testing
- InSpace Implantation
- Where
- Italy
- Volunteers
- 45 people
- Sponsor
- OrthoSpace Ltd.