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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.
Must not have
Patient scheduled for open or mini-open rotator cuff repair
Prior surgery of affected shoulder (except diagnostic arthroscopy)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years postoperative
Awards & highlights
Summary
This trial compares standard rotator cuff surgery with and without a special patch that helps the tendon heal. It targets patients who haven't improved with other treatments. The patch is expected to improve healing by encouraging tendon regrowth.
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.
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.
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 belowSelect...
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am scheduled for a specific shoulder surgery.
Select...
I have had surgery on my shoulder before, but only for diagnosis.
Select...
I have a partial tear in my shoulder's rotator cuff.
Select...
I have a small tear in my shoulder tendon.
Select...
I have a tear in my shoulder's subscapularis tendon.
Select...
I have a recent and sudden shoulder injury.
Select...
I currently have an infection.
Select...
I have an autoimmune or rheumatologic disorder like rheumatoid arthritis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years postoperative
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years postoperative
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Rotator cuff repair integrity
Secondary study objectives
Complications
PROMs scores for depression
PROMs scores for upper extremity function
+4 moreTrial 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
~760
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Cuff Tear Arthropathy include surgical interventions such as arthroscopic rotator cuff repair, often augmented with bioinductive implants, and non-surgical options like physical therapy and injections of platelet-rich plasma (PRP). Bioinductive implants promote tissue regeneration and healing by providing a scaffold that encourages the growth of new tendon-like tissue, which can improve the integrity of the rotator cuff repair.
PRP injections work by delivering a high concentration of growth factors that accelerate tissue repair and reduce inflammation. These mechanisms are crucial for Cuff Tear Arthropathy patients as they aim to restore shoulder function, reduce pain, and prevent further degeneration of the shoulder joint.
Find a Location
Who is running the clinical trial?
Smith & Nephew, Inc.Industry Sponsor
167 Previous Clinical Trials
22,048 Total Patients Enrolled
5 Trials studying Rotator Cuff Tears
1,038 Patients Enrolled for Rotator Cuff Tears
Henry Ford Health SystemLead Sponsor
310 Previous Clinical Trials
2,168,931 Total Patients Enrolled
1 Trials studying Rotator Cuff Tears
70 Patients Enrolled for Rotator Cuff Tears
Stephanie J Muh, MCPrincipal InvestigatorHenry Ford Health
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am scheduled for a shoulder surgery to repair the rotator cuff.I am 18 years old or older.I have had surgery on my shoulder before, but only for diagnosis.I have a partial tear in my shoulder's rotator cuff.I have a small tear in my shoulder tendon.I have tried physical therapy for over 6 weeks without improvement.I have a tear in my shoulder's subscapularis tendon.I have a medium to massive tear in my shoulder's rotator cuff, confirmed by imaging.I currently have an infection.I am scheduled for a specific shoulder surgery.I have a recent and sudden shoulder injury.I have long-term shoulder tendon tears.I have cancer.I have an autoimmune or rheumatologic disorder like rheumatoid arthritis.
Research Study Groups:
This trial has the following groups:- Group 1: Control Group
- Group 2: Study Group
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Rotator Cuff Tears Patient Testimony for trial: Trial Name: NCT05439850 — Phase 4
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