Comparison of Tendon Repair and Physiotherapy in the Treatment of Small and Medium-sized Tears of the Rotator Cuff

Not Applicable

Completed

• Conditions: Rotator Cuff Tear
• Interventions: Procedure: Tendon repair with acromioplasty; Procedure: Physiotherapy

• Registration Number: NCT00852657
• Lead Sponsor: Martina Hansen's Hospital

Brief Summary

The purpose of this study is to compare treatment benefits from surgical treatment by tendon repair and from physiotherapy for small and medium-sized rotator cuff tears.

Detailed Description

Surgical treatment by tendon repair or physiotherapy are accepted treatment options for small and medium-sized rotator cuff tears, but have never been compared in randomised, controlled studies.

In this study, patients presenting clinical signs together with imaging findings (MRI and sonography) for a full-thickness rotator cuff tear will be randomly allocated to surgery (tendon repair) or physiotherapy. Outcome measuring will be performed by the Constant score, the self report section of the American Shoulder and Elbow Surgeons score (ASES), the Short Form 36 Health Survey (SF-36) and subscores for shoulder motion, pain, strength and patient satisfaction. Scores will be taken at baseline and after 6 months,1, 2, 5, 10 and 15 years by a blinded assessor. All operated shoulders will be controlled by MRI after one year. Patients with no effect from physiotherapy after at least 15 treatment sessions will be offered secondary surgical treatment, and scoring results from last follow-up before surgery will be carried forward to analysis, according to an intention to treat principle.

Study Timeline

• Study Start: 2004-09
• Study First Submitted: 2009-02-26
• Study First Submitted QC: 2009-02-26
• Study First Posted: 2009-02-27
• Status Verified: 2023-03
• Primary Completion: 2023-03
• Study Completion: 2023-03
• Last Update Submitted: 2023-03-13
• Last Update Posted: 2023-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

Inclusion Criteria

• Clinical history and imaging findings of a rotator cuff tear

Exclusion Criteria

• Presence of other local or systemic diseases influencing on shoulder function
• History of earlier rotator cuff surgery
• Medical contraindications for surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surgical treatment	Tendon repair with acromioplasty	Open or mini-open tendon repair with acromioplasty
Physiotherapy	Physiotherapy	Physiotherapy by exercises

Primary Outcome Measures

Name	Time	Method
Constant score	baseline, 6 months, 1, 2, 5, 10, 15 years

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction	1, 2, 5, 10, 15 years
self report section of the American Shoulder and Elbow Surgeons score (ASES)	baseline, 6 months, 1, 2, 5, 10, 15 years
Short Form 36 Health Survey (SF-36)	baseline, 6 months, 1, 2, 5, 10, 15 years

Trial Locations

Locations (1)

Martina Hansen's Hospital; 🇳🇴 Sandvika, Norway