Treatment of Small Acute Cuff Tears, a Randomized Study

Overview

The purpose of this project is to compare operative repair of traumatically torn rotator cuff tendon with physiotherapy in a randomized prospective study.

Full Title of Study: “Treatment of Small Acute Full-thickness tears-a Prospective Randomised Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: December 2015

Detailed Description

In clinical practice most patients with a traumatic acute rotator cuff tear are treated with operative repair. The results of surgery are in most cases good but there are also good results in the literature from conservative treatment. So far there has been no prospective randomized comparison between the two treatments. When it comes to degenerative non-traumatic tears, level 1 and 2 studies have not been able to show the superiority of surgery. This study takes place in 2 clinics in Sweden (Linköping and Kalmar). Patients who have no previous shoulder conditions, a trauma to the shoulder and pain and/or inability to lift their arm will undergo magnetic resonance imaging (MRI). If this indicates a full-thickness rotator cuff tear of the cranial part of the rotator cuff the patient will be randomized to surgery or physiotherapy. Surgical intervention is mini-open repair. Follow-up takes place at 3 months, 6 months and 12 months with patient scores taken by a blinded independent physiotherapist. At 12 months a new MRI is conducted as well.

Interventions

  • Procedure: Rotator cuff repair
    • Physiotherapy & Surgery
  • Procedure: Physiotherapy

Arms, Groups and Cohorts

  • Experimental: Physiotherapy & Surgery
    • Mini-open rotator cuff repair
  • Active Comparator: Physiotherapy
    • Structured physiotherapy

Clinical Trial Outcome Measures

Primary Measures

  • Constant-Murley Shoulder Assessment score
    • Time Frame: Twelve months

Secondary Measures

  • Western Ontario Rotator Cuff score
    • Time Frame: Twelve months
    • Shoulder specific, patient reported outcome score
  • MRI
    • Time Frame: Twelve months
    • Magnetic Resonance imaging. Gives a measure of muscle atrophy, fatty infiltration, rerupture and enlargement of the tendon rupture.

Participating in This Clinical Trial

Inclusion Criteria

  • Trauma to the shoulder – Full thickness cranial rotator cuff tear – Operation possible within 3 months Exclusion Criteria:

  • 2 or more rotator cuff tendons involved – Fracture – Dislocation – Previous shoulder condition (symptomatic osteoarthritis (Gleno-humeral (GH) joint, Acromial-Clavicular (AC) joint), frozen shoulder, instability, tumor) – Malignancy – Rheumatic disease – Inability to understand swedish – Substance abuse

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Linkoeping
  • Provider of Information About this Clinical Study
    • Principal Investigator: Hanna Bjornsson, PHD, Orthopeadic shouldersurgeon – University Hospital, Linkoeping
  • Overall Official(s)
    • Lars Adolfsson, Professor, Principal Investigator, Linkoeping University

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