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Allograft
Shoulder Surgery for Rotator Cuff Tears (SCR Trial)
N/A
Waitlist Available
Led By Ivan H Wong, MD
Research Sponsored by Nova Scotia Health Authority
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
MRI proven diagnosis of a large or massive (>3cm), two-tendon (supraspinatus and infraspinatus) tear of the shoulder rotator cuff
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
SCR Trial Summary
This trial compares two methods of shoulder surgery for repairing large tears in the rotator cuff.
Who is the study for?
This trial is for individuals with a confirmed MRI diagnosis of large or massive rotator cuff tears involving two tendons in the shoulder. Candidates should not have severe shoulder issues, uncontrolled diabetes, infections, cancer, or be pregnant. A good nutritional state and no paralysis or contracture of the affected shoulder are required.Check my eligibility
What is being tested?
The study aims to compare two surgical techniques for repairing massive rotator cuff tears: bridging reconstruction and superior capsular reconstruction using GRAFTJACKET™ allograft (human dermal tissue).See study design
What are the potential side effects?
Potential side effects may include pain at the surgery site, inflammation, infection risk increase due to grafting material used in repair procedures, stiffness or difficulty moving the shoulder after surgery.
SCR Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My MRI shows a large tear in two tendons of my shoulder.
SCR Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maintenance of Acromiohumeral Distance
Secondary outcome measures
Changes in Patient Reported Outcomes using the Western Ontario Rotator Cuff Index (WORC)
Changes in Shoulder Range of Motion After Surgery
Changes in Shoulder Strength After Surgery
SCR Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Bridging Rotator Cuff GroupExperimental Treatment2 Interventions
Bridging Rotator Cuff Reconstruction of massive rotator cuff tear using GRAFTJACKET™ allograft.
Group II: Superior Capsular GroupActive Control1 Intervention
Superior Capsular Reconstruction of massive rotator cuff tear
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Who is running the clinical trial?
Nova Scotia Health AuthorityLead Sponsor
258 Previous Clinical Trials
83,794 Total Patients Enrolled
2 Trials studying Rotator Cuff Tears
120 Patients Enrolled for Rotator Cuff Tears
Ivan H Wong, MDPrincipal InvestigatorNova Scotia Health Authority
2 Previous Clinical Trials
400 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a stiff shoulder that doesn't move well.I have a shoulder condition due to a tendon tear.I have shoulder arthritis.My diabetes is not under control.My MRI shows a large tear in two tendons of my shoulder.I currently have an infection.I have cancer.My MRI shows surgery sites without blood vessel issues.I have paralysis in my shoulder.
Research Study Groups:
This trial has the following groups:- Group 1: Superior Capsular Group
- Group 2: Bridging Rotator Cuff Group
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.
Are there any opportunities for people to participate in this research protocol?
"As corroborated by clinicaltrials.gov, this medical trial is presently searching for participants and was initially published on the 1st of May 2018; though its details have since been updated as recently as 7th March 2022."
Answered by AI
To what extent has this clinical trial been populated with participants?
"Affirmative, clinicaltrials.gov verifies that this experiment is in the process of enrolling participants. This trial was first announced on May 1st 2018 and since then has been updated most recently on March 7th 2022. 60 patients are necessary at a single site for completion of the study."
Answered by AI
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