NCT05444465

Use of the REGENETEN™ Bioinductive Implant System in High Grade Partial-thickness Tears

Evaluation of Safety and Efficacy of a Resorbable Collagen Implant in Treatment of High Grade PArtial ThiCkness Tears; A Prospective, Multicenter, Randomized, Control Trial (IMPACT Study)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 234 (estimated)
• Sponsor: Smith & Nephew, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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 Repair' for surgically treating partial-thickness rotator cuff tears.

Detailed description

The primary objective of this study is to evaluate the functional recovery of patients with high grade (\>50%) partial thickness tears at 3 months when treated with either Isolated Bioinductive Repair (IBR) or Completion and Repair (CAR).

Conditions

• Rotator Cuff Injuries

Interventions

Type	Name	Description
DEVICE	Isolated Bioinductive Repair	Isolated Bioinductive repair with REGENETEN™ Bioinductive Implant
PROCEDURE	Completion and Repair	Standard surgical repair using the 'Completion and Repair' technique.

Timeline

• Start date: 2022-08-30
• Primary completion: 2026-08-15
• Completion: 2028-06-30
• First posted: 2022-07-06
• Last updated: 2026-01-15

Locations

20 sites across 6 countries: United States, Australia, Canada, Italy, Spain, United Kingdom

Regulatory

• FDA-regulated device study