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OpenTrials
Completed

NCT Number: NCT03445494

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

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.

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Key information

Age range

18 year–72 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ente Ospedaliero Cantonale

Lugano, 6900, Switzerland

About this 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 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Brace

Procedure

A brace to be weared according to protocol

Normal sling

Procedure

A normal sling to be weared according to protocol

Primary outcomes

  1. Efficacy in the rehabilitative therapy

    Time frame: 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 outcomes

  1. Quality of life assessment

    Time frame: 6 months

    Evaluation of the quality of live in both groups through Constant Quality of Life questionnair up to 6 months

  2. re-rupture rate of the supraspinatus tendon

    Time frame: 6 months

    Evaluation of the re-rupture of the supraspinatus tendon though a follow up MRI at 6 months

Sponsors and collaborators

Lead sponsor

Christian Candrian

Other

Collaborators

  • Clinical Trial Unit Ente Ospedaliero Cantonale

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Feb 26, 2018
Registry last updated
Sep 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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