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Procedure
Surgical Techniques for Rotator Cuff Tears
N/A
Recruiting
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial will compare two surgical techniques to treat massive rotator cuff tears and measure the outcomes of strength, ROM and patient satisfaction.
Who is the study for?
This trial is for adults over 18 with a confirmed MRI diagnosis of massive rotator cuff tears larger than 5cm, involving two tendons and considered irreparable. Candidates should have less than 50% muscle atrophy. It's not specified who can't join.Check my eligibility
What is being tested?
The study compares two surgical methods for repairing large to massive rotator cuff tears: bridging reconstruction using an acellular human dermal allograft implant versus arthroscopic assisted lower trapezius tendon transfer, assessing their impact on shoulder distance maintenance, strength, motion range, and quality of life.See study design
What are the potential side effects?
While specific side effects are not detailed here, typical risks may include pain at the surgery site, infection risk post-operation, possible limited shoulder movement or weakness during recovery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Acromiohumeral Distance
Secondary outcome measures
Patient-reported Outcomes (PROs)
Range of Motion
Strength
Trial Design
2Treatment groups
Active Control
Group I: Lower Trapezius Tendon TransferActive Control1 Intervention
The lower trapezius tendon transfer arm will consist of patients randomized to this surgical procedure. This is an arthroscopically assisted open procedure that involves harvesting of the lower trapezius muscle tendon and re-grafting it onto to shoulder to repair massive rotator cuff tears.
Group II: Bridging Reconstruction RepairActive Control1 Intervention
The bridging reconstruction repair arm will consist of patients randomized to this surgical procedure. This operation is arthroscopic, and involves the insertion of a human dermal allograft to the rotator cuff, sutured and anchored in a "bridging" fashion to repair massive rotator cuff tears.
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Who is running the clinical trial?
Nova Scotia Health AuthorityLead Sponsor
258 Previous Clinical Trials
83,794 Total Patients Enrolled
1 Trials studying Rotator Cuff Tears
60 Patients Enrolled for Rotator Cuff Tears
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a tear in two tendons that cannot be repaired.I have stiffness and limited movement in my shoulder.I have paralysis in my shoulder.I have shoulder arthritis.I have a tear in my shoulder muscle that cannot be surgically repaired.I have had cancer in the past.My diabetes is not under control (Hgb A1C >7%).I currently have an infection.My MRI shows I have a large tear in my shoulder tendon.I am over 18 years old.I cannot follow or understand post-surgery instructions.
Research Study Groups:
This trial has the following groups:- Group 1: Lower Trapezius Tendon Transfer
- Group 2: Bridging Reconstruction Repair
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 still openings available for enrolment in this trial?
"According to the data published on clinicaltrials.gov, this medical experiment is not presently enrolling patients. Originally posted in September of 2023 and updated lastly on June 22nd 2023, although it's currently inactive there are 116 other studies that require volunteers right now."
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