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Operative Versus Non-operative Management of Rotator Cuff Tear

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Central Finland Hospital District
Sponsor:
Collaborators:
Academy of Finland
Oulu University Hospital
Information provided by (Responsible Party):
Ilkka Kiviranta, Professor, Central Finland Hospital District
ClinicalTrials.gov Identifier:
NCT00695981
First received: March 17, 2008
Last updated: January 28, 2014
Last verified: January 2014
  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 surgery
Procedure: Non-operative treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effectiveness and Cost-Effectiveness of Operative and Non-operative Management of Rotator Cuff Tear

Further study details as provided by Central Finland Hospital District:

Primary Outcome Measures:
  • Change in pain (VAS) and objective shoulder function (Constant score) [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in pain (VAS) and objective shoulder function (Constant score) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Change in pain (VAS) and objective shoulder function (Constant score) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change in pain (VAS) and objective shoulder function (Constant score) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change in pain (VAS) and objective shoulder function (Constant score) [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: June 2008
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Rotator cuff repair
Surgery
Procedure: Rotator cuff repair surgery
Rotator cuff repair + physical therapy according to a standardized protocol
Other Name: Arthroscopic or open rotator cuff repair
Active Comparator: Conservative treatment
Physical therapy according to a standardized protocol
Procedure: Non-operative treatment
Physiotherapy according to a standardized protocol
Other Name: Physical therapy

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

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00695981

Contacts
Contact: Juha Paloneva, MD, PhD 358-14-269-1811 juha.paloneva@ksshp.fi
Contact: Ilkka Kiviranta, MD, PhD 358-50-427-1807 ilkka.kiviranta@helsinki.fi

Locations
Finland
Central Finland Central Hospital Recruiting
Jyväskylä, Finland, FIN-40620
Contact: Juha Paloneva, MD, PhD    +358 14 2691811    juha.paloneva@ksshp.fi   
Principal Investigator: Juha Paloneva, MD, PhD         
Sub-Investigator: Sanna Koskela, MD         
Sub-Investigator: Hannu Kautiainen         
Sub-Investigator: Timo Järvelä, MD, PhD         
Sub-Investigator: Ylinen Jari, MD, PhD         
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
Study First Received: March 17, 2008
Last Updated: January 28, 2014
Health Authority: Finland: Ethics Committee

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

ClinicalTrials.gov processed this record on November 25, 2014