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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 and 2 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I have a confirmed large shoulder tear via MRI.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 and 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 and 2 years
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 moreTrial 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.
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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
165 Previous Clinical Trials
22,405 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a confirmed large shoulder tear via MRI.I have been diagnosed with cancer.I have a stiff shoulder that can't move properly.My surgery area is not related to blood vessels, confirmed by MRI.I have paralysis in my shoulder.I have shoulder arthritis or a specific type of shoulder damage.I currently have an infection.My diabetes is not under control (Hgb A1C >7%).I have a tear in my shoulder muscle.I have shoulder arthritis.You are pregnant.I cannot follow or understand post-surgery instructions.I am unable to understand and give consent for the study.
Research Study Groups:
This trial has the following groups:- Group 1: Non-augmented
- Group 2: Graft-Augmented
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment in this clinical trial currently available?
"According to the clinicaltrials.gov database, this medical trial is currently recruiting constituents. The study was initially advertised on January 1st 2021 and its latest iteration occurred on March 7th 2022."
Answered by AI
How many participants have been enlisted in this clinical experiment thus far?
"Affirmative, the clinical trial is actively recruiting participants. According to information hosted on clinicaltrials.gov, it was initially posted on January 1st 2021 and last amended on March 7th 2022. The project aims to enrol 76 patients at one location."
Answered by AI
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