Clinical trial NCT04861714: Evaluation of Regeneten Augmentation for Subscapularis Healing After Total Shoulder Arthroplasty (RESTOR)
Official title: Evaluation of Regeneten Augmentation for Subscapularis Healing After Total Shoulder Arthroplasty (RESTOR)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Arthroplasty, Replacement, Shoulder
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: Smith & Nephew, Inc.
First posted: 2021-04-27
Enrollment: 75
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Subscapularis repair integrity assessed by lift-off test using dynamometry.
timeFrame: 12 months post-op
Secondary outcomes:
measure: Forward elevation active range of motion as assessed by treating physician
timeFrame: 6 weeks
measure: Forward elevation active range of motion as assessed by treating physician
timeFrame: 3 months
measure: Forward elevation active range of motion as assessed by treating physician
timeFrame: 6 months
measure: Forward elevation active range of motion as assessed by treating physician
timeFrame: 12 months
measure: Abduction active range of motion as assessed by treating physician
timeFrame: 6 weeks
measure: Abduction active range of motion as assessed by treating physician
timeFrame: 3 months
measure: Abduction active range of motion as assessed by treating physician
timeFrame: 6 months
measure: Abduction active range of motion as assessed by treating physician
timeFrame: 12 months
measure: External rotation active range of motion as assessed by treating physician
timeFrame: 6 weeks
measure: External rotation active range of motion as assessed by treating physician
timeFrame: 3 months
measure: External rotation active range of motion as assessed by treating physician
timeFrame: 6 months
measure: External rotation active range of motion as assessed by treating physician
timeFrame: 12 months
measure: Internal rotation active range of motion as assessed by treating physician
timeFrame: 6 weeks
measure: Internal rotation active range of motion as assessed by treating physician
timeFrame: 3 months
measure: Internal rotation active range of motion as assessed by treating physician
timeFrame: 6 months
measure: Internal rotation active range of motion as assessed by treating physician
timeFrame: 12 months
measure: Patient reported clinical outcome scores on the American Shoulder and Elbow Surgeon Evaluation (ASES)
timeFrame: 6 weeks
measure: Patient reported clinical outcome scores on the American Shoulder and Elbow Surgeon Evaluation (ASES)
timeFrame: 3 months
measure: Patient reported clinical outcome scores on the American Shoulder and Elbow Surgeon Evaluation (ASES)
timeFrame: 6 months
measure: Patient reported clinical outcome scores- American Shoulder and Elbow Surgeon Evaluation (ASES)
timeFrame: 12 months
measure: Patient reported clinical outcome scores- Visual Analog Scale (VAS)
timeFrame: 6 weeks
measure: Patient reported clinical outcome scores- Visual Analog Scale (VAS)
timeFrame: 3 months
measure: Patient reported clinical outcome scores- Visual Analog Scale (VAS)
timeFrame: 6 months
measure: Patient reported clinical outcome scores- Visual Analog Scale (VAS)
timeFrame: 12 months
measure: Patient reported clinical outcome scores- Simple shoulder test (SST)
timeFrame: 6 weeks
measure: Patient reported clinical outcome scores- Simple shoulder test (SST)
timeFrame: 3 months
measure: Patient reported clinical outcome scores- Simple shoulder test (SST)
timeFrame: 6 months
measure: Patient reported clinical outcome scores- Simple shoulder test (SST)
timeFrame: 12 months
measure: Patient reported clinical outcome scores- Simple shoulder value (SST)
timeFrame: 6 weeks
measure: Patient reported clinical outcome scores- Simple shoulder value (SST)
timeFrame: 3 months
measure: Patient reported clinical outcome scores- Simple shoulder value (SST)
timeFrame: 6 months
measure: Patient reported clinical outcome scores- Simple shoulder value (SST)
timeFrame: 12 months
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Sports Medicine Center
state: Ohio
Study officials:
affiliation: Ohio State University
name: Gregory Cvetanovich, MD
role: PRINCIPAL_INVESTIGATOR
References: