NCT06857084

Evaluation Of Outcomes Following Rotator Cuff Repair Using the REGENETEN Bioinductive Implant: A Prospective, Multi-Center Global Registry

Evaluation Of Clinical and Health Economic Outcomes Following Rotator Cuff Repair Using the REGENETEN◊ Bioinductive Implant: A Prospective, Multi-Center Global Registry

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 400 (estimated)
• Sponsor: Smith & Nephew, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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. The Registry will include up to 50 centers in the United Kingdom (UK), Europe, Australia, and up to 400 patients for the initial evaluation. Patients will be treated and evaluated according to standard medical care. Outcome data is collected up to 2 years post-surgery.

Conditions

• Rotator Cuff Injuries

Interventions

Type	Name	Description
DEVICE	Arthroscopic rotator cuff repair with REGENETEN Bioinductive Implant augmentation	Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear. The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue.

Timeline

• Start date: 2020-10-01
• Primary completion: 2025-12-31
• Completion: 2027-12-31
• First posted: 2025-03-04
• Last updated: 2025-03-04

Locations

19 sites across 5 countries: Australia, France, Germany, Italy, United Kingdom

Regulatory

• FDA-regulated device study