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

Not Applicable

Completed

• Conditions: Supraspinatus Injury
• Interventions: Procedure: Brace; Procedure: Normal sling

• Registration Number: NCT03445494
• Lead Sponsor: Christian Candrian

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.

Study Timeline

• Study Start: 2018-01-10
• Study First Submitted: 2018-01-22
• Study First Submitted QC: 2018-02-20
• Study First Posted: 2018-02-26
• Primary Completion: 2023-07-11
• Study Completion: 2023-07-11
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-06
• Last Update Posted: 2023-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Brace	Brace	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
Normal sling	Normal sling	After surgery the patient must wear the normal sling for two weeks

Primary Outcome Measures

Name	Time	Method
Efficacy in the rehabilitative therapy	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 Outcome Measures

Name	Time	Method
re-rupture rate of the supraspinatus tendon	6 months	Evaluation of the re-rupture of the supraspinatus tendon though a follow up MRI at 6 months
Quality of life assessment	6 months	Evaluation of the quality of live in both groups through Constant Quality of Life questionnair up to 6 months

Trial Locations

Locations (1)

Ente Ospedaliero Cantonale; 🇨🇭 Lugano, Switzerland