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

Christian Candrian108 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

108

Conditions

Supraspinatus Injury

Interventions

BracePROCEDURE

A brace to be weared according to protocol

Normal slingPROCEDURE

A normal sling to be weared according to protocol

Eligibility

Sex: ALLMin age: 18 YearsMax age: 72 Years

Medical Language ↔ Plain English

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.

Locations (1)

Ente Ospedaliero Cantonale

Lugano, Switzerland

Outcomes

Primary Outcomes

Efficacy in the rehabilitative therapy

The primary objective of the study is to evaluate two different rehabilitative therapies. Efficacy is measured with a pre and post MRI

Time frame: 6 months

Secondary Outcomes

Quality of life assessment

Evaluation of the quality of live in both groups through Constant Quality of Life questionnair up to 6 months

Time frame: 6 months

re-rupture rate of the supraspinatus tendon

Evaluation of the re-rupture of the supraspinatus tendon though a follow up MRI at 6 months

Time frame: 6 months

Data from ClinicalTrials.gov

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