Treatment of Small Acute Cuff Tears, a Randomized Study

February 7, 2014 updated by: Hanna Bjornsson, University Hospital, Linkoeping

Treatment of Small Acute Full-thickness tears-a Prospective Randomised Controlled Trial

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Linköping, Sweden, 58185
        • Recruiting
        • Orthopedic Clinic, Linköping University Hospital
        • Contact:
        • Principal Investigator:
          • Hanna Hallgren, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Physiotherapy & Surgery
Mini-open rotator cuff repair
Procedure: Physiotherapy
Procedure: Rotator cuff repair
Physiotherapy & Surgery
Active Comparator: Physiotherapy
Structured physiotherapy
Procedure: Physiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Constant-Murley Shoulder Assessment score
Time Frame: Twelve months
Twelve months

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Euro-Qol-five-Dimensions (EQ-5D)
Time Frame: Twelve months
Quality of life assessment
Twelve months
Patient Global Impression of Change (PGIC)
Time Frame: Twelve months
Patients Global impression of Change
Twelve months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Linkoeping

Investigators

  • Principal Investigator: Lars Adolfsson, Professor, Linkoeping University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

November 1, 2017

Study Registration Dates

First Submitted

February 4, 2014

First Submitted That Met QC Criteria

February 7, 2014

First Posted (Estimate)

February 11, 2014

Study Record Updates

Last Update Posted (Estimate)

February 11, 2014

Last Update Submitted That Met QC Criteria

February 7, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • acutecufftearhannahallgren

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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