Regeneten for Shoulder Replacement Arthroplasty

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
The Ohio State University Sports Medicine Center, Columbus, OHShoulder Replacement ArthroplastyRegeneten - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

1 Primary · 9 Secondary · Reporting Duration: 12 months

12 months
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
Range of Motion, Articular
Patient reported clinical outcome scores- American Shoulder and Elbow Surgeon Evaluation (ASES)
Patient reported clinical outcome scores- Simple shoulder test (SST)
Patient reported clinical outcome scores- Simple shoulder value (SST)
Patient reported clinical outcome scores- Visual Analog Scale (VAS)
12 months post-op
Subscapularis repair integrity assessed by lift-off test using dynamometry.
6 months
Patient reported clinical outcome scores on the American Shoulder and Elbow Surgeon Evaluation (ASES)

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
RTSA with subscapularis repair
1
Benzyl Peroxide
3
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Trial Design

1 Treatment Group

Regeneten
1 of 1

Active Control

50 Total Participants · 1 Treatment Group

Primary Treatment: Regeneten · No Placebo Group · N/A

Regeneten
Device
ActiveComparator Group · 1 Intervention: Regeneten · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months

Who is running the clinical trial?

Smith & Nephew, Inc.Industry Sponsor
157 Previous Clinical Trials
21,792 Total Patients Enrolled
Ohio State UniversityLead Sponsor
728 Previous Clinical Trials
458,989 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.

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have had a specific surgery called subscapularis tenotomy or subscapularis peel.
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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