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

NCT04861714 | Active Not Recruiting DMC FDA Device

• 1 other identifier: 2019H0419
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Arthroplasty, Replacement, Shoulder

Outcome Measures

Primary Outcomes (1)

• Subscapularis repair integrity assessed by lift-off test using dynamometry.

  Pounds (lbs) of force that the subject can produce during the lift off test will be recorded.

  12 months post-op

Secondary Outcomes (32)

• Forward elevation active range of motion as assessed by treating physician

  6 weeks

• Forward elevation active range of motion as assessed by treating physician

  3 months

• Forward elevation active range of motion as assessed by treating physician

  6 months

• Forward elevation active range of motion as assessed by treating physician

  12 months

• Abduction active range of motion as assessed by treating physician

  6 weeks

Study Arms (2)

Regeneten

ACTIVE COMPARATOR

Standard subscapularis repair with Regeneten augmentation group

Device: Regeneten

Standard repair

OTHER

Standard subscapularis repair

Procedure: Standard repair

Interventions

Regeneten DEVICE

Augmentation of standard subscapularis repair with regeneten patch

Regeneten

Standard repair PROCEDURE

Standard subscapularis repair

Standard repair

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Revision arthroplasty
• Reverse arthroplasty
• Requiring a lesser tuberosity osteotomy
• Intraoperative identification of rotator cuff tear requiring repair
• Object to using cow derived material
• Prior index shoulder surgery requiring treatment to the subscapularis

Sponsors & Collaborators

• Ohio State University: lead
• Smith & Nephew, Inc.: collaborator

Study Sites (1)

The Ohio State University Sports Medicine Center

Columbus, Ohio, 43221, United States

Location

Study Officials

• Gregory Cvetanovich, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 11, 2021
• First Posted: April 27, 2021
• Study Start: July 14, 2020
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)