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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Arthroplasty, Replacement, Shoulder
• Intervention / Treatment: Device: Regeneten; Procedure: Standard repair

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.

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michael Keller; Phone Number: 614-293-2410; Email: michael.keller@osumc.edu
• Study Contact Backup: Name: Angela Pedroza, MPH; Phone Number: 614-293-7952; Email: angela.pedroza@osumc.edu

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43221
      • The Ohio State University Sports Medicine Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Regeneten; Standard subscapularis repair with Regeneten augmentation group	Device: Regeneten; Augmentation of standard subscapularis repair with regeneten patch
Other: Standard repair; Standard subscapularis repair	Procedure: Standard repair; Standard subscapularis repair

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Forward elevation active range of motion as assessed by treating physician	The amount of forward elevation range of motion will be reported in degrees from 0-180.	6 weeks
Forward elevation active range of motion as assessed by treating physician	The amount of forward elevation range of motion will be reported in degrees from 0-180.	3 months
Forward elevation active range of motion as assessed by treating physician	The amount of forward elevation range of motion will be reported in degrees from 0-180.	6 months
Forward elevation active range of motion as assessed by treating physician	The amount of forward elevation range of motion will be reported in degrees from 0-180.	12 months
Abduction active range of motion as assessed by treating physician	The amount of abduction range of motion will be reported in degrees from 0-180.	6 weeks
Abduction active range of motion as assessed by treating physician	The amount of abduction range of motion will be reported in degrees from 0-180.	3 months
Abduction active range of motion as assessed by treating physician	The amount of abduction range of motion will be reported in degrees from 0-180.	6 months
Abduction active range of motion as assessed by treating physician	The amount of abduction range of motion will be reported in degrees from 0-180.	12 months
External rotation active range of motion as assessed by treating physician	The amount of external rotation range of motion will be reported in degrees from 0-180.	6 weeks
External rotation active range of motion as assessed by treating physician	The amount of external rotation range of motion will be reported in degrees from 0-180.	3 months
External rotation active range of motion as assessed by treating physician	The amount of external rotation range of motion will be reported in degrees from 0-180.	6 months
External rotation active range of motion as assessed by treating physician	The amount of external rotation range of motion will be reported in degrees from 0-180.	12 months
Internal rotation active range of motion as assessed by treating physician	The amount of internal rotation range of motion will be reported in vertebrae level the thumb reaches from 0, 0°; 1, hip; 2, buttocks; 3, sacrum; 4, L4-L5; 5, L1-L3; 6, T8-T12; 7, T7 or higher.	6 weeks
Internal rotation active range of motion as assessed by treating physician	The amount of internal rotation range of motion will be reported in vertebrae level the thumb reaches from 0, 0°; 1, hip; 2, buttocks; 3, sacrum; 4, L4-L5; 5, L1-L3; 6, T8-T12; 7, T7 or higher.	3 months
Internal rotation active range of motion as assessed by treating physician	The amount of internal rotation range of motion will be reported in vertebrae level the thumb reaches from 0, 0°; 1, hip; 2, buttocks; 3, sacrum; 4, L4-L5; 5, L1-L3; 6, T8-T12; 7, T7 or higher.	6 months
Internal rotation active range of motion as assessed by treating physician	The amount of internal rotation range of motion will be reported in vertebrae level the thumb reaches from 0, 0°; 1, hip; 2, buttocks; 3, sacrum; 4, L4-L5; 5, L1-L3; 6, T8-T12; 7, T7 or higher.	12 months
Patient reported clinical outcome scores on the American Shoulder and Elbow Surgeon Evaluation (ASES)	The American Shoulder and Elbow Surgeons (ASES) score is composed of a patient-reported portion and a physician assessment.The ASES tool includes a patient-reported score with visual analog scale for pain and functional subscales ranging from 0 (worse pain and function loss) to 50 (no pain and excellent function). Both scores are summed for a maximum score of 100.	6 weeks
Patient reported clinical outcome scores on the American Shoulder and Elbow Surgeon Evaluation (ASES)	The American Shoulder and Elbow Surgeons (ASES) score is composed of a patient-reported portion and a physician assessment.The ASES tool includes a patient-reported score with visual analog scale for pain and functional subscales ranging from 0 (worse pain and function loss) to 50 (no pain and excellent function). Both scores are summed for a maximum score of 100.	3 months
Patient reported clinical outcome scores on the American Shoulder and Elbow Surgeon Evaluation (ASES)	The American Shoulder and Elbow Surgeons (ASES) score is composed of a patient-reported portion and a physician assessment.The ASES tool includes a patient-reported score with visual analog scale for pain and functional subscales ranging from 0 (worse pain and function loss) to 50 (no pain and excellent function). Both scores are summed for a maximum score of 100.	6 months
Patient reported clinical outcome scores- American Shoulder and Elbow Surgeon Evaluation (ASES)	The American Shoulder and Elbow Surgeons (ASES) score is composed of a patient-reported portion and a physician assessment.The ASES tool includes a patient-reported score with visual analog scale for pain and functional subscales ranging from 0 (worse pain and function loss) to 50 (no pain and excellent function). Both scores are summed for a maximum score of 100.	12 months
Patient reported clinical outcome scores- Visual Analog Scale (VAS)	The visual analog scale for pain is a straight line with one end meaning no pain and the other end meaning the worst pain imaginable. A patient marks a point on the line that matches the amount of pain he or she feels. Score ranges from 0-100mm where 0mm= no pain and 100mm=extreme pain.	6 weeks
Patient reported clinical outcome scores- Visual Analog Scale (VAS)	The visual analog scale for pain is a straight line with one end meaning no pain and the other end meaning the worst pain imaginable. A patient marks a point on the line that matches the amount of pain he or she feels. Score ranges from 0-100mm where 0mm= no pain and 100mm=extreme pain.	3 months
Patient reported clinical outcome scores- Visual Analog Scale (VAS)	The visual analog scale for pain is a straight line with one end meaning no pain and the other end meaning the worst pain imaginable. A patient marks a point on the line that matches the amount of pain he or she feels. Score ranges from 0-100mm where 0mm= no pain and 100mm=extreme pain.	6 months
Patient reported clinical outcome scores- Visual Analog Scale (VAS)	The visual analog scale for pain is a straight line with one end meaning no pain and the other end meaning the worst pain imaginable. A patient marks a point on the line that matches the amount of pain he or she feels. Score ranges from 0-100mm where 0mm= no pain and 100mm=extreme pain.	12 months
Patient reported clinical outcome scores- Simple shoulder test (SST)	The simple shoulder test is a series of 12 "yes" or "no" questions the patient answers about the function of the involved shoulder. Answers of 'yes' receive a score of 1 and answers of 'no' receive a score of 0. Scores range from 0-12 where 0=no function and 12=full function.	6 weeks
Patient reported clinical outcome scores- Simple shoulder test (SST)	The simple shoulder test is a series of 12 "yes" or "no" questions the patient answers about the function of the involved shoulder. Answers of 'yes' receive a score of 1 and answers of 'no' receive a score of 0. Scores range from 0-12 where 0=no function and 12=full function.	3 months
Patient reported clinical outcome scores- Simple shoulder test (SST)	The simple shoulder test is a series of 12 "yes" or "no" questions the patient answers about the function of the involved shoulder. Answers of 'yes' receive a score of 1 and answers of 'no' receive a score of 0. Scores range from 0-12 where 0=no function and 12=full function.	6 months
Patient reported clinical outcome scores- Simple shoulder test (SST)	The simple shoulder test is a series of 12 "yes" or "no" questions the patient answers about the function of the involved shoulder. Answers of 'yes' receive a score of 1 and answers of 'no' receive a score of 0. Scores range from 0-12 where 0=no function and 12=full function.	12 months
Patient reported clinical outcome scores- Simple shoulder value (SST)	The simple shoulder value is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder, which would score 100%.	6 weeks
Patient reported clinical outcome scores- Simple shoulder value (SST)	The simple shoulder value is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder, which would score 100%.	3 months
Patient reported clinical outcome scores- Simple shoulder value (SST)	The simple shoulder value is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder, which would score 100%.	6 months
Patient reported clinical outcome scores- Simple shoulder value (SST)	The simple shoulder value is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder, which would score 100%.	12 months

Collaborators and Investigators

• Sponsor: Ohio State University
• Collaborators: Smith & Nephew, Inc.
• Investigators: Principal Investigator: Gregory Cvetanovich, MD, Ohio State University

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2020
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: February 11, 2021
• First Submitted That Met QC Criteria: April 22, 2021
• First Posted (Actual): April 27, 2021

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 13, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2019H0419

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No IPD will be shared with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes