Shoulder Abduction Brace Against Normal Sling After Arthroscopical Rotator Cuff Suture: a Randomized Monocentric Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Supraspinatus Injury
- Sponsor
- Christian Candrian
- Enrollment
- 108
- Locations
- 1
- Primary Endpoint
- Efficacy in the rehabilitative therapy
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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 also treated according to standard of care with physiotherapy and progressive introduction of movements.
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 then perform only passive movements according to pain for the first 6 weeks supported by the physiotherapy, according to standard therapy. The following six weeks passive movements will be associated with active movements . No brace nor normal sling will be used anymore. Patients are in study for 6 months. During this period quality of life and pain questionnaires are submitted to the patients and a MRI will be done at the end of the study.
Investigators
Christian Candrian
Deputy Head of Surgery and Orthopedy
Ente Ospedaliero Cantonale, Bellinzona
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Efficacy in the rehabilitative therapy
Time Frame: 6 months
The primary objective of the study is to evaluate two different rehabilitative therapies. Efficacy is measured with a pre and post MRI
Secondary Outcomes
- re-rupture rate of the supraspinatus tendon(6 months)
- Quality of life assessment(6 months)