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

Supraspinatus Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03445494
• Other study ID #: ORL-ORT-002
• Status: Completed
• Phase: N/A
• Start date: January 10, 2018
• Est. completion date: July 11, 2023

Study information

• Verified date: September 2023
• Source: Ente Ospedaliero Cantonale, Bellinzona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: July 11, 2023
• Est. primary completion date: July 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 72 Years

Eligibility

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.

Related Conditions & MeSH terms

• Supraspinatus Injury

Intervention

Procedure:
• Brace
A brace to be weared according to protocol
• Normal sling
A normal sling to be weared according to protocol

Locations

Country	Name	City	State
Switzerland	Ente Ospedaliero Cantonale	Lugano

Sponsors (2)

Lead Sponsor	Collaborator
Christian Candrian	Clinical Trial Unit Ente Ospedaliero Cantonale

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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