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Bioinductive Graft

Bioinductive Collagen Graft for Rotator Cuff Tears

N/A
Recruiting
Led By Ivan Wong, MD
Research Sponsored by Ivan Wong
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Magnetic resonance imaging (MRI) proven diagnosis of a large >3cm tear of the shoulder rotator cuff in a competent adult (>18 years of age).
Be older than 18 years old
Must not have
Contracture of the shoulder
Nonvascular surgical sites (MRI proven)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 and 2 years
Awards & highlights

Summary

This trial is testing whether a new technique for repairing large rotator cuff tears is better than the current standard technique. The new technique involves using a graft made of purified collagen from bovine tendons to bridge the gap in the torn tendons and repair the tendon back to the bone.

Who is the study for?
Adults over 18 with MRI-confirmed large rotator cuff tears (>3cm) are eligible for this trial. It's not suitable for those with shoulder cancer, arthritis, certain types of tear and osteoarthritis, high WORC scores, uncontrolled diabetes (Hgb A1C >7%), infections, comprehension issues post-surgery, nonvascular surgical sites, poor nutrition (Alb <30 g/L), inability to consent, pregnancy or shoulder paralysis/contracture.
What is being tested?
The study is testing two treatments for massive rotator cuff tears: debridement surgery alone versus the use of a bioinductive graft made from bovine tendons after debridement. The goal is to see which method offers better function and fewer re-tears one year post-surgery.
What are the potential side effects?
Potential side effects may include pain at the surgery site, infection risks due to the procedure or implant material used in grafting technique. There might also be limited range of motion or discomfort during recovery.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a confirmed large shoulder tear via MRI.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a stiff shoulder that can't move properly.
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My surgery area is not related to blood vessels, confirmed by MRI.
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I have paralysis in my shoulder.
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I have shoulder arthritis or a specific type of shoulder damage.
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I currently have an infection.
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My diabetes is not under control (Hgb A1C >7%).
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I have a tear in my shoulder muscle.
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I have shoulder arthritis.
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I cannot follow or understand post-surgery instructions.
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I am unable to understand and give consent for the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 and 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Healing
Secondary outcome measures
American Shoulder and Elbow Surgeons (ASES) Questionnaire
Disabilities of the Arm Shoulder and Hand (DASH) Questionnaire
EQ5D-5L
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Graft-AugmentedExperimental Treatment1 Intervention
Patients randomized to this group will receive a regular rotator cuff repair where the bursa will be debrided thoroughly, and rotator cuff edges will be shaved down to stable tissue. The rotator cuff will be repaired using multiple single row triple loaded suture anchor placed adjacent to the articular margin. Then, the graft will be delivered to the subacromial space and positioned over the bursal surface of the suprasinatus tendon, ensuring that the lateral edge of the implant will overlap with the head of the humerus. The graft will be fixed with tendon and bone staples.
Group II: Non-augmentedActive Control1 Intervention
Patients randomized to this group will receive a regular rotator cuff repair where the bursa will be debrided thoroughly, and rotator cuff edges will be shaved down to stable tissue. The rotator cuff will be repaired using multiple single row triple loaded suture anchor placed adjacent to the articular margin.

Find a Location

Who is running the clinical trial?

Ivan WongLead Sponsor
1 Previous Clinical Trials
29 Total Patients Enrolled
1 Trials studying Rotator Cuff Tears
29 Patients Enrolled for Rotator Cuff Tears
Smith & Nephew, Inc.Industry Sponsor
167 Previous Clinical Trials
22,032 Total Patients Enrolled
5 Trials studying Rotator Cuff Tears
1,040 Patients Enrolled for Rotator Cuff Tears
Ivan Wong, MDPrincipal InvestigatorOrthopaedic Surgeon
4 Previous Clinical Trials
134 Total Patients Enrolled
1 Trials studying Rotator Cuff Tears
60 Patients Enrolled for Rotator Cuff Tears

Media Library

Regeneten (Bioinductive Graft) Clinical Trial Eligibility Overview. Trial Name: NCT04248751 — N/A
Rotator Cuff Tears Research Study Groups: Non-augmented, Graft-Augmented
Rotator Cuff Tears Clinical Trial 2023: Regeneten Highlights & Side Effects. Trial Name: NCT04248751 — N/A
Regeneten (Bioinductive Graft) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04248751 — N/A
~8 spots leftby Mar 2025
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