Overview

This trial is active, not recruiting.

Condition rotator cuff tear
Treatments tendon repair with acromioplasty, physiotherapy
Sponsor Martina Hansen's Hospital
Start date September 2004
End date December 2019
Trial size 103 participants
Trial identifier NCT00852657, 430-04149 (REK)

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Open or mini-open tendon repair with acromioplasty
tendon repair with acromioplasty
Open or mini-open tendon repair in combination with an acromioplasty and eventually a tenodesis of the long head of the biceps
(Active Comparator)
Physiotherapy by exercises
physiotherapy
According to a rehabilitation program which was established prior to study start.

Primary Outcomes

Measure
Constant score
time frame: baseline, 6 months, 1, 2, 5, 10 years

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Comparison of Surgical Treatment by Tendon Repair and Physiotherapy in the Treatment of Small and Medium-sized Tears of the Rotator Cuff
Principal investigator Stefan Moosmayer, MD
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 and 5 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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Martina Hansen's Hospital.