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

NCT03445494 | Completed

• 1 other identifier: ORL-ORT-002
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Supraspinatus Injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Quality of life assessment

  6 months

• re-rupture rate of the supraspinatus tendon

  6 months

Study Arms (2)

Brace

EXPERIMENTAL

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

Normal sling

EXPERIMENTAL

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

Procedure: Normal sling

Interventions

Brace PROCEDURE

A brace to be weared according to protocol

Brace

Normal sling PROCEDURE

A normal sling to be weared according to protocol

Normal sling

Eligibility Criteria

• Age: 18 Years - 72 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Christian Candrian: lead
• Clinical Trial Unit Ente Ospedaliero Cantonale: collaborator

Study Sites (1)

Ente Ospedaliero Cantonale

Lugano, 6900, Switzerland

Location

MeSH Terms

Interventions

Braces

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Study Officials

• Christian Candrian, MD

  EOC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy Head of Surgery and Orthopedy

Model Details: randomized 1:1

Study Record Dates

• First Submitted: January 22, 2018
• First Posted: February 26, 2018
• Study Start: January 10, 2018
• Primary Completion: July 11, 2023
• Study Completion: July 11, 2023
• Last Updated: September 7, 2023

Record last verified: 2023-09

Locations

CH (1)