Comparison of Tendon Repair and Physiotherapy in the Treatment of Small and Medium-sized Tears of the Rotator Cuff

March 13, 2023 updated by: Stefan Moosmayer, Martina Hansen's Hospital

Comparison of Surgical Treatment by Tendon Repair and Physiotherapy in the Treatment of Small and Medium-sized Tears of the Rotator Cuff

The purpose of this study is to compare treatment benefits from surgical treatment by tendon repair and from physiotherapy for small and medium-sized rotator cuff tears.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Surgical treatment by tendon repair or physiotherapy are accepted treatment options for small and medium-sized rotator cuff tears, but have never been compared in randomised, controlled studies.

In this study, patients presenting clinical signs together with imaging findings (MRI and sonography) for a full-thickness rotator cuff tear will be randomly allocated to surgery (tendon repair) or physiotherapy. Outcome measuring will be performed by the Constant score, the self report section of the American Shoulder and Elbow Surgeons score (ASES), the Short Form 36 Health Survey (SF-36) and subscores for shoulder motion, pain, strength and patient satisfaction. Scores will be taken at baseline and after 6 months,1, 2, 5, 10 and 15 years by a blinded assessor. All operated shoulders will be controlled by MRI after one year. Patients with no effect from physiotherapy after at least 15 treatment sessions will be offered secondary surgical treatment, and scoring results from last follow-up before surgery will be carried forward to analysis, according to an intention to treat principle.

Study Type

Interventional

Enrollment (Actual)

103

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

  • Norway
      • Sandvika, Norway, 1306
        • Martina Hansen's Hospital

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical history and imaging findings of a rotator cuff tear

Exclusion Criteria:

  • Presence of other local or systemic diseases influencing on shoulder function
  • History of earlier rotator cuff surgery
  • Medical contraindications for surgery

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
Active Comparator: Surgical treatment
Open or mini-open tendon repair with acromioplasty
Procedure: Tendon repair with acromioplasty
Open or mini-open tendon repair in combination with an acromioplasty and eventually a tenodesis of the long head of the biceps
Active Comparator: Physiotherapy
Physiotherapy by exercises
Procedure: Physiotherapy
According to a rehabilitation program which was established prior to study start.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Constant score
Time Frame: baseline, 6 months, 1, 2, 5, 10, 15 years
baseline, 6 months, 1, 2, 5, 10, 15 years

Secondary Outcome Measures

Outcome Measure
Time Frame
self report section of the American Shoulder and Elbow Surgeons score (ASES)
Time Frame: baseline, 6 months, 1, 2, 5, 10, 15 years
baseline, 6 months, 1, 2, 5, 10, 15 years
Short Form 36 Health Survey (SF-36)
Time Frame: baseline, 6 months, 1, 2, 5, 10, 15 years
baseline, 6 months, 1, 2, 5, 10, 15 years
Patient satisfaction
Time Frame: 1, 2, 5, 10, 15 years
1, 2, 5, 10, 15 years

Collaborators and Investigators

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

Sponsor

Martina Hansen's Hospital

Investigators

  • Principal Investigator: Stefan Moosmayer, MD, Martina Hansen's Hospital
  • Study Chair: Hans-Joergen Smith, MD, PhD, University of Oslo, Rikshospitalet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

September 1, 2004

Primary Completion (Actual)

March 1, 2023

Study Completion (Actual)

March 1, 2023

Study Registration Dates

First Submitted

February 26, 2009

First Submitted That Met QC Criteria

February 26, 2009

First Posted (Estimate)

February 27, 2009

Study Record Updates

Last Update Posted (Actual)

March 15, 2023

Last Update Submitted That Met QC Criteria

March 13, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 430-04149 (REK)

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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