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

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

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.

Study Overview

• Status: Completed
• Conditions: Supraspinatus Injury
• Intervention / Treatment: Procedure: Brace; Procedure: Normal sling

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 Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christian Candrian, MD; Phone Number: +41 (0) 91 811 61 23; Email: christian.candrian@eoc.ch
• Study Contact Backup: Name: Francesco Marbach, MD; Phone Number: +41 (0) 91 811 6744; Email: francesco.marbach@eoc.ch

Study Locations

• Switzerland
  • Lugano, Switzerland, 6900
    • Ente Ospedaliero Cantonale

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 72 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Procedure: Brace; A brace to be weared according to protocol
Experimental: Normal sling; After surgery the patient must wear the normal sling for two weeks	Procedure: Normal sling; A normal sling to be weared according to protocol

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Christian Candrian
• Collaborators: Clinical Trial Unit Ente Ospedaliero Cantonale
• Investigators: Study Director: Christian Candrian, MD, EOC

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2018
• Primary Completion (Actual): July 11, 2023
• Study Completion (Actual): July 11, 2023

Study Registration Dates

• First Submitted: January 22, 2018
• First Submitted That Met QC Criteria: February 20, 2018
• First Posted (Actual): February 26, 2018

Study Record Updates

• Last Update Posted (Actual): September 7, 2023
• Last Update Submitted That Met QC Criteria: September 6, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: ORL-ORT-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No