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

The Ohio State University

Status: Active, not recruiting

Conditions: Arthroplasty, Replacement, Shoulder

Treatments: Procedure: Standard repair; Device: Regeneten

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04861714

2019H0419

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients healthy enough to undergo primary anatomic TSA
2. Being treated with subscapularis tenotomy or subscapularis peel.
3. Age 50 or above
4. Intact rotator cuff including subscapularis as determined by preoperative examination and imaging (typically preoperative CT, MRI if indicated or available).

Exclusion criteria

1. Revision arthroplasty
2. Reverse arthroplasty
3. Requiring a lesser tuberosity osteotomy
4. Intraoperative identification of rotator cuff tear requiring repair
5. Object to using cow derived material
6. Prior index shoulder surgery requiring treatment to the subscapularis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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75 participants in 2 patient groups

Regeneten

Active Comparator group

Description:

Standard subscapularis repair with Regeneten augmentation group

Treatment:

Device: Regeneten

Standard repair

Other group

Description:

Standard subscapularis repair

Treatment:

Procedure: Standard repair