NCT04861714

Evaluation of Regeneten Augmentation for Subscapularis Healing After Total Shoulder Arthroplasty (RESTOR)

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Ohio State University · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate whether augmentation of subscapularis repair with the Regeneten implant after anatomic total shoulder arthroplasty (TSA) can improve rates of subscapularis healing and improve clinical outcomes.

Detailed description

Subscapularis management is an area of controversy in the literature for total shoulder arthroplasty (TSA). Regeneten has been suggested as a bioinductive implant to aid in rotator cuff healing. We hypothesize that applying this technology could aid in obtaining higher rates of subscapularis healing for TSA when utilizing SP or ST, which in turn could lead to improved outcomes.The 50 randomized subjects will be randomized at a 1:1 ratio into the standard subscapularis repair group or the standard repair with Regeneten augmentation group. Subjects will be blinded to their treatment assignment until they complete all study visits. Upon withdraw from the study, termination from the study, or new or recurrent symptoms requiring a subsequent surgical procedure, the blinded assignment will be revealed to the subject. Subjects will be assessed pre-operatively and return post-operatively at Week 2, Weeks 6, Month 3, Month 6, and Year 1. The primary outcome will evaluate subscapularis repair integrity and healing at one year post-op.

Conditions

• Arthroplasty, Replacement, Shoulder

Interventions

Type	Name	Description
DEVICE	Regeneten	Augmentation of standard subscapularis repair with regeneten patch
PROCEDURE	Standard repair	Standard subscapularis repair

Timeline

• Start date: 2020-07-14
• Primary completion: 2026-12-01
• Completion: 2027-04-01
• First posted: 2021-04-27
• Last updated: 2025-07-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study