Status:
COMPLETED
Shoulder Abduction Brace Against Normal Sling After Arthroscopical Rotator Cuff Suture.
Lead Sponsor:
Christian Candrian
Collaborating Sponsors:
Clinical Trial Unit Ente Ospedaliero Cantonale
Conditions:
Supraspinatus Injury
Eligibility:
All Genders
18-72 years
Phase:
NA
Brief 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 ...
Detailed Description
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 the...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 10 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 11 2023
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT03445494
Start Date
January 10 2018
End Date
July 11 2023
Last Update
September 7 2023
Active Locations (1)
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1
Ente Ospedaliero Cantonale
Lugano, Switzerland, 6900