Operative Versus Non-operative Management of Rotator Cuff Tear

February 11, 2024 updated by: Juha Paloneva, Central Finland Hospital District

The Effectiveness and Cost-Effectiveness of Operative and Non-operative Management of Rotator Cuff Tear

This study aims at determining the effectiveness and cost-effectiveness of surgical management of full-thickness rotator cuff tears compared to conservative treatment. The research setting is prospective, randomised, and controlled.

The aim of the study is to search out evidence based data of indications for rotator cuff repair. The investigators also aim at offering patients the most efficient and effective treatment and reduce the number of operations that do not have sufficient effectiveness. The data obtained will facilitate developing guidelines for referrals to a specialist when rotator cuff tear is suspected.

The investigators hypothesize that there are subgroups of patients suffering from rotator cuff tears that benefit from surgery whereas other subgroups are best treated conservatively.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Subgroup analyses:

  • age
  • sex
  • duration of symptoms
  • presence of trauma before symptoms
  • size of tear
  • degenerative findings
  • other findings in MRI or arthroscopy
  • type of operation
  • co-morbidities
  • occupation
  • pain (VAS)
  • objective shoulder function
  • activities of daily living

Study Type

Interventional

Enrollment (Estimated)

100

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

  • Finland
      • Helsinki, Finland
        • University of Helsinki
      • Jyväskylä, Finland, FIN-40620
        • Central Finland Hospital
      • Oulu, Finland
        • Oulu University 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

35 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • age over 35 years old
  • duration of symptoms at least three months despite of non-operative treatment
  • the patient accepts both treatment options (operative and conservative)
  • a full-thickness rotator cuff tear in MRI arthrography

Exclusion Criteria:

  • previous shoulder operations
  • too high risk for operation
  • any disease or social problem reducing the ability to co-operate
  • rheumatoid arthritis
  • severe arthrosis of the glenohumeral or acromioclavicular joint
  • irreparable rotator cuff tear (including rotator cuff tear arthropathy)
  • progressive malign disease
  • adhesive capsulitis
  • high-energy trauma before symptoms
  • cervical syndrome
  • shoulder instability

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Rotator cuff repair
Surgery following a 3 months period of active non-operative treatment
Procedure: Rotator cuff repair
Rotator cuff repair + physical therapy according to a standardized protocol
Other Names:
  • Arthroscopic or open rotator cuff repair
Active Comparator: Conservative treatment
Physiotherapy according to a standardized protocol following a 3 months period of active non-operative treatment
Procedure: Conservative treatment
Physiotherapy according to a standardized protocol
Other Names:
  • Physical therapy
  • Non-operative treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in pain (VAS) and objective shoulder function (Constant score)
Time Frame: 24 months
VAS (0 to 100 mm), Constant score (0 to 100 points)
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in pain (VAS) and objective shoulder function (Constant score)
Time Frame: 3 months
VAS (0 to 100 mm), Constant score (0 to 100 points)
3 months
Change in pain (VAS) and objective shoulder function (Constant score)
Time Frame: 6 months
VAS (0 to 100 mm), Constant score (0 to 100 points)
6 months
Change in pain (VAS) and objective shoulder function (Constant score)
Time Frame: 12 months
VAS (0 to 100 mm), Constant score (0 to 100 points)
12 months
Change in pain (VAS) and objective shoulder function (Constant score)
Time Frame: 5 years
VAS (0 to 100 mm), Constant score (0 to 100 points)
5 years

Collaborators and Investigators

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

Sponsor

Central Finland Hospital District

Collaborators

Oulu University Hospital
Academy of Finland

Investigators

  • Principal Investigator: Juha Paloneva, MD, PhD, Central Finland Health Care District, University of Eastern Finland

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

Helpful Links

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 (Actual)

June 1, 2008

Primary Completion (Actual)

January 1, 2017

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

March 17, 2008

First Submitted That Met QC Criteria

June 11, 2008

First Posted (Estimated)

June 12, 2008

Study Record Updates

Last Update Posted (Actual)

February 13, 2024

Last Update Submitted That Met QC Criteria

February 11, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B07103-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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