A Clinical Research on Repair of Massive-large Rotator Cuff Tears (NCT05214651) | Clinical Trial Compass
UnknownNot Applicable
A Clinical Research on Repair of Massive-large Rotator Cuff Tears
China52 participantsStarted 2022-06-08
Plain-language summary
The study is designed as a randomized controlled trial, a total of 52 participants with large - massive rotator cuff tears will be prospectively enrolled and randomly divided into 2 groups according to the applied repairing technique: novel double row technique group and suture bridge double row technique group. The functional outcome was measured at the preoperatively, 3, 6, 12 and 24 months postoperatively, using the visual analog scale (VAS) for pain, active and passive ROM, Constant score, American Shoulder and Elbow Surgeons (ASES) score, and University of California Los Angeles shoulder score (UCLA). The anatomic outcome was evaluated using magnetic resonance imaging at 3, 6, 12 and 24 months postoperatively. The clinical results were compared between the novel double row technique group and suture bridge double row technique group.
Who can participate
Age range
17 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* preoperative magnetic resonance imaging (MRI) diagnosis of a large - massive sized rotator cuff tear (\>3cm), which was confirmed during operation
* chronic tear
* older than 17 years and younger than 75 years
* without surgical contraindications and willing to participate
Exclusion Criteria:
* poor quality rotator cuff and irreparable tear
* severe glenohumeral arthritis
* previous shoulder surgery
* accompanied by dislocation or fracture of shoulder
* refusal to participate
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The retear rate of large to massive rotator cuff tears
Timeframe: The incidence of retear during 24 months postoperatively