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

NCT ID: NCT03445494

Last Updated: 2023-09-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-10
• Study Completion Date: 2023-07-11

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.

Conditions

Supraspinatus Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Brace

Intervention Type: PROCEDURE

A brace to be weared according to protocol

Normal sling

After surgery the patient must wear the normal sling for two weeks

Group Type: EXPERIMENTAL

Normal sling

Intervention Type: PROCEDURE

A normal sling to be weared according to protocol

Interventions

Brace

A brace to be weared according to protocol

Intervention Type: PROCEDURE

Normal sling

A normal sling to be weared according to protocol

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 72 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clinical Trial Unit Ente Ospedaliero Cantonale

OTHER

Sponsor Role: collaborator

Christian Candrian

OTHER

Sponsor Role: lead

Responsible Party

Christian Candrian

Deputy Head of Surgery and Orthopedy

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Christian Candrian, MD

Role: STUDY_DIRECTOR

EOC

Locations

Ente Ospedaliero Cantonale

Lugano, , Switzerland

Countries

Switzerland

Other Identifiers

ORL-ORT-002

Identifier Type: -

Identifier Source: org_study_id