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Bioinductive Patch

Bioinductive Patch for Rotator Cuff Tears

Phase 4
Recruiting
Led By Stephanie J Muh, MC
Research Sponsored by Henry Ford Health System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Indicated and scheduled for arthroscopic rotator cuff repair.
Full-thickness medium (1-3 cm), large (3-5 cm), and massive (>5 cm) rotator cuff tears involving the supraspinatus and/or infraspinatus tendons demonstrated on magnetic resonance or ultrasound imaging.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years postoperative
Awards & highlights

Study Summary

This trial is testing a new way to fix a rotator cuff tear, to see if it results in a higher rate of repair integrity.

Who is the study for?
This trial is for adults over 18 who have medium to massive full-thickness rotator cuff tears, confirmed by imaging, and haven't improved after at least 6 weeks of physical therapy. It's not for those with previous shoulder surgeries (other than diagnostic arthroscopy), active infections, planned open shoulder repairs, acute injuries, small or partial tears, subscapularis tendon involvement, or autoimmune conditions.Check my eligibility
What is being tested?
The study compares two ways to fix a torn rotator cuff in the shoulder: standard arthroscopic repair versus the same procedure plus a Bioinductive Implant. The main goal is to see if the implant helps maintain the repair after one year using ultrasound checks.See study design
What are the potential side effects?
Possible side effects include discomfort from surgery and risks associated with implants such as inflammation or reaction at the implant site. Ultrasound used for imaging is generally safe but may cause mild discomfort during use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am scheduled for a shoulder surgery to repair the rotator cuff.
Select...
I have a medium to massive tear in my shoulder's rotator cuff, confirmed by imaging.
Select...
I have long-term shoulder tendon tears.
Select...
I am 18 years old or older.
Select...
I have tried physical therapy for over 6 weeks without improvement.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years postoperative
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years postoperative for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rotator cuff repair integrity
Secondary outcome measures
Complications
PROMs scores for depression
PROMs scores for upper extremity function
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Study GroupExperimental Treatment3 Interventions
Identical surgical treatment as control group plus bio-inductive patch implant. Ultrasound postoperatively at 1 year.
Group II: Control GroupActive Control2 Interventions
Surgical treatment alone, consisting of arthroscopic rotator cuff repair. Ultrasound postoperatively at 1 year.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
arthroscopic rotator cuff repair
2016
N/A
~60
Bioinductive implant
2016
N/A
~640
Ultrasound Imaging
2018
Completed Phase 4
~730

Find a Location

Who is running the clinical trial?

Smith & Nephew, Inc.Industry Sponsor
165 Previous Clinical Trials
22,498 Total Patients Enrolled
Henry Ford Health SystemLead Sponsor
300 Previous Clinical Trials
2,100,049 Total Patients Enrolled
Stephanie J Muh, MCPrincipal InvestigatorHenry Ford Health

Media Library

Regeneten Bioinductive Implant (Bioinductive Patch) Clinical Trial Eligibility Overview. Trial Name: NCT05439850 — Phase 4
Cuff Tear Arthropathy Research Study Groups: Control Group, Study Group
Cuff Tear Arthropathy Clinical Trial 2023: Regeneten Bioinductive Implant Highlights & Side Effects. Trial Name: NCT05439850 — Phase 4
Regeneten Bioinductive Implant (Bioinductive Patch) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05439850 — Phase 4
Cuff Tear Arthropathy Patient Testimony for trial: Trial Name: NCT05439850 — Phase 4

Frequently Asked Questions

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

Has the regulatory body given clearance to arthroscopic rotator cuff repair?

"The arthroscopic rotator cuff repair has been approved and its safety thus rated a 3 on our rating system. This is because it's classified as a Phase 4 trial at Power."

Answered by AI

Are there currently any opportunities to partake in this research endeavor?

"The clinical trial is currently in the recruitment phase, as evidenced by the information published on clinicaltrials.gov. This medical experiment was initiated on August 16th 2022 and has been revised most recently on October 17th 2022."

Answered by AI

What is the population size of this experimentation?

"Yes, according to the information hosted on clinicaltrials.gov, this study is currently enlisting volunteers. It was posted on August 16th 2022 and amended most recently on October 17th 2022; 78 patients need to be signed up from a single site."

Answered by AI

Who else is applying?

What state do they live in?
District of Columbia
Maryland
What site did they apply to?
Henry Ford Health
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I have had a severely torn rotator cuff for 8 years, no one will fix it as it's cost is $$$ , and my insurance won't cover it either, would love to get the chance to get it fixed finally....... I'll fly out there if you except me.....
PatientReceived 1 prior treatment
~23 spots leftby Dec 2024