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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00852657
Other study ID # 430-04149 (REK)
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2004
Est. completion date March 2023

Study information

Verified date March 2023
Source Martina Hansen's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 103
Est. completion date March 2023
Est. primary completion date March 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Procedure:
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
Physiotherapy
According to a rehabilitation program which was established prior to study start.

Locations

Country Name City State
Norway Martina Hansen's Hospital Sandvika

Sponsors (1)

Lead Sponsor Collaborator
Martina Hansen's Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (3)

Moosmayer S, Lund G, Seljom U, Svege I, Hennig T, Tariq R, Smith HJ. Comparison between surgery and physiotherapy in the treatment of small and medium-sized tears of the rotator cuff: A randomised controlled study of 103 patients with one-year follow-up. — View Citation

Moosmayer S, Lund G, Seljom US, Haldorsen B, Svege IC, Hennig T, Pripp AH, Smith HJ. At a 10-Year Follow-up, Tendon Repair Is Superior to Physiotherapy in the Treatment of Small and Medium-Sized Rotator Cuff Tears. J Bone Joint Surg Am. 2019 Jun 19;101(12 — View Citation

Moosmayer S, Lund G, Seljom US, Haldorsen B, Svege IC, Hennig T, Pripp AH, Smith HJ. Tendon repair compared with physiotherapy in the treatment of rotator cuff tears: a randomized controlled study in 103 cases with a five-year follow-up. J Bone Joint Surg — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Constant score baseline, 6 months, 1, 2, 5, 10, 15 years
Secondary self report section of the American Shoulder and Elbow Surgeons score (ASES) baseline, 6 months, 1, 2, 5, 10, 15 years
Secondary Short Form 36 Health Survey (SF-36) baseline, 6 months, 1, 2, 5, 10, 15 years
Secondary Patient satisfaction 1, 2, 5, 10, 15 years
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