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 range18 Years – 72 Years
SexALL
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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.