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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Shoulder Abduction Brace Against Normal Sling After Arthroscopical Rotator Cuff Suture: a Randomized Monocentric Study

Conditions
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Supraspinatus Injury

Intervention / Treatment
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* Procedure: Brace
* Procedure: Normal sling


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 72 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized 1:1
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brace<br>After surgery the patient must wear the brace for 6 weeks, for the first 3 weeks during day and night and for the following 3 weeks only at night | Procedure: Brace<br>* A brace to be weared according to protocol<br>|
| Experimental: Normal sling<br>After surgery the patient must wear the normal sling for two weeks | Procedure: Normal sling<br>* A normal sling to be weared according to protocol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life assessment | Evaluation of the quality of live in both groups through Constant Quality of Life questionnair up to 6 months | 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 | 6 months |