Operative Versus Non-operative Management of Rotator Cuff Tear

Not Applicable

Active, not recruiting

• Conditions: Rotator Cuff Tear
• Interventions: Procedure: Conservative treatment; Procedure: Rotator cuff repair

• Registration Number: NCT00695981
• Lead Sponsor: Central Finland Hospital District

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.

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 Timeline

• Study First Submitted: 2008-03-17
• Study Start: 2008-06
• Study First Submitted QC: 2008-06-11
• Study First Posted: 2008-06-12
• Primary Completion: 2017-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-21
• Last Update Posted: 2024-08-22
• Study Completion: 2028-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conservative treatment	Conservative treatment	Physiotherapy according to a standardized protocol following a 3 months period of active non-operative treatment
Rotator cuff repair	Rotator cuff repair	Surgery following a 3 months period of active non-operative treatment

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Change in pain (VAS) and objective shoulder function (Constant score)	5 years	VAS (0 to 100 mm), Constant score (0 to 100 points)

Trial Locations

Locations (3)

Oulu University Hospital; 🇫🇮 Oulu, Finland

University of Helsinki; 🇫🇮 Helsinki, Finland

Central Finland Hospital; 🇫🇮 Jyväskylä, Finland