NCT00695981

Operative Versus Non-operative Management of Rotator Cuff Tear

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Central Finland Hospital District · Academic / Other
• Sex: All
• Age: 35 Years
• Healthy volunteers: Not accepted

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.

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

Conditions

• Rotator Cuff Tear

Interventions

Type	Name	Description
PROCEDURE	Rotator cuff repair	Rotator cuff repair + physical therapy according to a standardized protocol
PROCEDURE	Conservative treatment	Physiotherapy according to a standardized protocol

Timeline

• Start date: 2008-06-01
• Primary completion: 2017-01-01
• Completion: 2028-06-01
• First posted: 2008-06-12
• Last updated: 2024-08-22

Locations

3 sites across 1 country: Finland