Clinical Trial

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

Study acronym: IMPACT
Recruiting
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Record status
This record was last updated August 5, 2026 (before its estimated August 15, 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 22 amendments
This ClinicalTrials.gov record has been amended 22 times since 2022-06-29; most recent amendment 2026-01-14.
Status change: Not Yet Recruiting → Recruiting 2022-08-09
Trial Details
NCT Number NCT05444465
Lead Sponsor Smith & Nephew, Inc.
Conditions Rotator Cuff Injuries
Enrollment 234 participants
Start Date 2022-08-30
Primary Completion 2026-08-15 (estimated)
Study Completion 2028-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-08-05