Operative Versus Non-operative Management of Rotator Cuff Tear

Central Finland Hospital District

Status: Active, not recruiting

Conditions: Rotator Cuff Tear

Treatments: Procedure: Rotator cuff repair; Procedure: Conservative treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT00695981

B07103-2

Details and patient eligibility

About

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.

Full 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

Enrollment: 100 estimated patients

Sex: All

Ages: 35+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Rotator cuff repair

Active Comparator group

Description:

Surgery following a 3 months period of active non-operative treatment

Treatment:

Procedure: Rotator cuff repair

Conservative treatment

Active Comparator group

Description:

Physiotherapy according to a standardized protocol following a 3 months period of active non-operative treatment

Treatment:

Procedure: Conservative treatment