Overview

This trial is active, not recruiting.

Condition rotator cuff tear
Treatments rotator cuff repair, conservative treatment
Sponsor Central Finland Hospital District
Collaborator Academy of Finland
Start date June 2008
End date March 2017
Trial size 100 participants
Trial identifier NCT00695981, B07103-2

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Surgery following a 3 months period of active non-operative treatment
rotator cuff repair Arthroscopic or open rotator cuff repair
Rotator cuff repair + physical therapy according to a standardized protocol
(Active Comparator)
Physiotherapy according to a standardized protocol following a 3 months period of active non-operative treatment
conservative treatment Physical therapy
Physiotherapy according to a standardized protocol

Primary Outcomes

Measure
Change in pain (VAS) and objective shoulder function (Constant score)
time frame: 24 months

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 35 years old.

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

Additional Information

Official title The Effectiveness and Cost-Effectiveness of Operative and Non-operative Management of Rotator Cuff Tear
Principal investigator Ilkka Kiviranta, MD, PhD
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
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Central Finland Hospital District.