Shoulder Abduction Brace Against Normal Sling After Arthroscopical Rotator Cuff Suture. (NCT03445494) | Clinical Trial Compass
CompletedNot Applicable
Shoulder Abduction Brace Against Normal Sling After Arthroscopical Rotator Cuff Suture.
Switzerland108 participantsStarted 2018-01-10
Plain-language summary
The patient undergoes arthroscopic surgery to treat rotator cuff injury. At the end of the surgery, the patient will be randomized into group A (brace) or group B (normal sling).
Both groups will be also treated according to standard of care with physiotherapy and progressive introduction of movements.
Who can participate
Age range
18 Years – 72 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:
* Males or females between 18 and 65 years old;
* Presence of an isolated lesion of supraspinatus that can be documented with the MRI and which can be treated surgically by arthroscopy;
* Presence of a supraspinatus lesion according to the Patte criteria with stage 1, 2 or 3 frontal plane ;
* Presence of adipose degeneration ≤ 2 according to Goutallier;
* Written informed consent to participate in the study
Exclusion Criteria:
* Presence of a lesion of other rotator cuff tendons;
* Previous surgical procedures of the shoulder;
* Presence of a massive lesion, therefore irreparable, of the cuff detected intra-operatively and not observed during preoperative MRI;
* Presence of relapsing shoulder dislocations;
* Presence of lesions of the glenoidine cercine that require intervention;
* Difficulties to follow the rehabilitation programs;
* Presence of neoplastic diseases, metabolic diseases, inflammatory and systemic diseases, autoimmune diseases and immunosuppressed patients;
* State of pregnancy (presumed or established) or breastfeeding.
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.