Shoulder Abduction Brace Against Normal Sling After Arthroscopical Rotator Cuff Suture.

Christian Candrian

Status

Completed

Conditions

Supraspinatus Injury

Treatments

Procedure: Brace

Procedure: Normal sling

Study type

Interventional

Funder types

Other

Identifiers

NCT03445494

ORL-ORT-002

Details and patient eligibility

About

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.

Full 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.

Enrollment

108 patients

Sex

All

Ages

18 to 72 years old

Volunteers

No Healthy Volunteers

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.