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Regeneten Augmentation for Shoulder Surgery Healing

N/A

Waitlist Available

Led By Gregory Cvetanovich, MD

Research Sponsored by Ohio State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 50 or above

Being treated with subscapularis tenotomy or subscapularis peel

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study Summary

This trial will test whether adding the Regeneten implant to repair the subscapularis tendon after anatomic total shoulder arthroplasty can improve healing rates and clinical outcomes.

Who is the study for?

This trial is for individuals aged 50 or above who need a shoulder replacement and have an intact rotator cuff, confirmed by preoperative exams and imaging. Candidates should be healthy enough to undergo the surgery but cannot participate if they've had prior shoulder surgeries affecting the subscapularis, require complex procedures like reverse arthroplasty, or object to using cow-derived materials.Check my eligibility

What is being tested?

The RESTOR study is testing whether adding a Regeneten implant to standard repair after total shoulder arthroplasty can better heal the subscapularis tendon and improve patient outcomes. Participants will receive either just the standard repair or the standard repair with Regeneten augmentation.See study design

What are the potential side effects?

Potential side effects of using Regeneten may include local inflammation, infection risk at the surgical site, allergic reactions especially in those sensitive to cow-derived products, pain beyond typical post-surgical discomfort, and possible complications leading to additional interventions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 50 years old or older.

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I am undergoing treatment involving surgery on my shoulder tendon.

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My shoulder's rotator cuff, including the subscapularis, is intact as confirmed by scans.

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My shoulder's rotator cuff, including the subscapularis, is healthy as confirmed by scans.

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I am undergoing treatment involving surgery on my shoulder tendon.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Abduction active range of motion as assessed by treating physician

External rotation active range of motion as assessed by treating physician

Range of Motion, Articular

+6 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Standard repairExperimental Treatment1 Intervention

Standard subscapularis repair

Group II: RegenetenActive Control1 Intervention

Standard subscapularis repair with Regeneten augmentation group

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Ohio State UniversityLead Sponsor

827 Previous Clinical Trials

502,676 Total Patients Enrolled

Smith & Nephew, Inc.Industry Sponsor

165 Previous Clinical Trials

22,406 Total Patients Enrolled

Gregory Cvetanovich, MD5.01 ReviewsPrincipal Investigator - Ohio State University

Ohio State University

1 Previous Clinical Trials

110 Total Patients Enrolled

5Patient Review

This surgeon is remarkable. My shoulder was in terrible condition — rotator cuff completely severed, ball of the joint eroded away. The pain was unbearable. I needed a Total Shoulder Replacement. The surgery and follow-up have been practically painless. I would highly recommend him to anyone.

Media Library

Standard repair Clinical Trial Eligibility Overview. Trial Name: NCT04861714 — N/A

Shoulder Replacement Research Study Groups: Standard repair, Regeneten

Shoulder Replacement Clinical Trial 2023: Standard repair Highlights & Side Effects. Trial Name: NCT04861714 — N/A

Standard repair 2023 Treatment Timeline for Medical Study. Trial Name: NCT04861714 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what capacity is recruitment for this research endeavor occurring?

"Affirmative. The data hosted on clinicaltrials.gov show that this medical experiment, first posted July 14th 2020, is currently seeking participants. Fifty patients need to be enrolled at one specific site."

Answered by AI

Are new participants welcome to join the research study at this juncture?

"As per clinicaltrials.gov, this trial is still recruiting participants with the initial posting on July 14th 2020 and most recently updated April 22nd 2021."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Gregory Cvetanovich 2020. "Evaluation of Regeneten Augmentation for Subscapularis Healing After Total Shoulder Arthroplasty (RESTOR)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04861714.