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Operative Versus Non-operative Management of Rotator Cuff Tear

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00695981
First Posted: June 12, 2008
Last Update Posted: August 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Academy of Finland
Oulu University Hospital
Information provided by (Responsible Party):
Ilkka Kiviranta, Professor, Central Finland Hospital District
  Purpose

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 Intervention
Rotator Cuff Tear Procedure: Rotator cuff repair Procedure: Conservative treatment

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Ilkka Kiviranta, Professor, Central Finland Hospital District:

Primary Outcome Measures:
  • Change in pain (VAS) and objective shoulder function (Constant score) [ Time Frame: 24 months ]

Secondary Outcome Measures:
  • Change in pain (VAS) and objective shoulder function (Constant score) [ Time Frame: 3 months ]
  • Change in pain (VAS) and objective shoulder function (Constant score) [ Time Frame: 6 months ]
  • Change in pain (VAS) and objective shoulder function (Constant score) [ Time Frame: 12 months ]
  • Change in pain (VAS) and objective shoulder function (Constant score) [ Time Frame: 5 years ]

Estimated Enrollment: 100
Actual Study Start Date: June 2008
Estimated Study Completion Date: June 2023
Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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

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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00695981


Locations
Finland
Central Finland Central Hospital
Jyväskylä, Finland, FIN-40620
Sponsors and Collaborators
Central Finland Hospital District
Academy of Finland
Oulu University Hospital
Investigators
Principal Investigator: Ilkka Kiviranta, MD, PhD Central Finland Health Care District
  More Information

Additional Information:
Publications:

Responsible Party: Ilkka Kiviranta, Professor, Md, PhD, Central Finland Hospital District
ClinicalTrials.gov Identifier: NCT00695981     History of Changes
Other Study ID Numbers: B07103-2
First Submitted: March 17, 2008
First Posted: June 12, 2008
Last Update Posted: August 8, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Ilkka Kiviranta, Professor, Central Finland Hospital District:
Rotator cuff
Arthroscopic surgery
Open surgery
Physiotherapy
Physical therapy
Effectiveness
RCT
cost-effectiveness

Additional relevant MeSH terms:
Rotator Cuff Injuries
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries