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Operative Versus Non-operative Management of Rotator Cuff Tear

Sponsor
Central Finland Hospital District (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT00695981
Collaborator
Academy of Finland (Other), Oulu University Hospital (Other)
100
Enrollment
3
Locations
2
Arms
180
Anticipated Duration (Months)
33.3
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Rotator cuff repair
  • Procedure: Conservative treatment
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Effectiveness and Cost-Effectiveness of Operative and Non-operative Management of Rotator Cuff Tear
Actual Study Start Date :
Jun 1, 2008
Actual Primary Completion Date :
Jan 1, 2017
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in pain (VAS) and objective shoulder function (Constant score) [24 months]

      VAS (0 to 100 mm), Constant score (0 to 100 points)

    Secondary Outcome Measures

    1. Change in pain (VAS) and objective shoulder function (Constant score) [3 months]

      VAS (0 to 100 mm), Constant score (0 to 100 points)

    2. Change in pain (VAS) and objective shoulder function (Constant score) [6 months]

      VAS (0 to 100 mm), Constant score (0 to 100 points)

    3. Change in pain (VAS) and objective shoulder function (Constant score) [12 months]

      VAS (0 to 100 mm), Constant score (0 to 100 points)

    4. Change in pain (VAS) and objective shoulder function (Constant score) [5 years]

      VAS (0 to 100 mm), Constant score (0 to 100 points)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    35 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Helsinki Helsinki Finland
    2 Central Finland Hospital Jyväskylä Finland FIN-40620
    3 Oulu University Hospital Oulu Finland

    Sponsors and Collaborators

    • Central Finland Hospital District
    • Academy of Finland
    • Oulu University Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Juha Paloneva, Md, PhD, Central Finland Hospital District
    ClinicalTrials.gov Identifier:
    NCT00695981
    Other Study ID Numbers:
    • B07103-2
    First Posted:
    Jun 12, 2008
    Last Update Posted:
    Mar 10, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by Juha Paloneva, Md, PhD, Central Finland Hospital District
    Rotator cuff
    Arthroscopic surgery
    Open surgery
    Physiotherapy
    Physical therapy
    Effectiveness
    RCT
    cost-effectiveness
    Additional relevant MeSH terms:
    Rotator Cuff Injuries

    Study Results

    No Results Posted as of Mar 10, 2022