Clinical trial NCT00852657: Comparison of Tendon Repair and Physiotherapy in the Treatment of Small and Medium-sized Tears of the Rotator Cuff
Official title: Comparison of Surgical Treatment by Tendon Repair and Physiotherapy in the Treatment of Small and Medium-sized Tears of the Rotator Cuff
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rotator Cuff Tear
Keywords: Rotator cuff tear
surgical repair
Physiotherapy
Treatment benefit
Surgery
Lead sponsor: Martina Hansen's Hospital
Sponsor class: OTHER
First posted: 2009-02-27
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Constant score
timeFrame: baseline, 6 months, 1, 2, 5, 10, 15 years
Secondary outcomes:
measure: self report section of the American Shoulder and Elbow Surgeons score (ASES)
timeFrame: baseline, 6 months, 1, 2, 5, 10, 15 years
measure: Short Form 36 Health Survey (SF-36)
timeFrame: baseline, 6 months, 1, 2, 5, 10, 15 years
measure: Patient satisfaction
timeFrame: 1, 2, 5, 10, 15 years
Other outcomes:
Locations:
city: Sandvika
country: Norway
facility: Martina Hansen's Hospital
Study officials:
affiliation: Martina Hansen's Hospital
name: Stefan Moosmayer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Oslo, Rikshospitalet
name: Hans-Joergen Smith, MD, PhD
role: STUDY_CHAIR
References:
citation: 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. J Bone Joint Surg Br. 2010 Jan;92(1):83-91. doi: 10.1302/0301-620X.92B1.22609.
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 Am. 2014 Sep 17;96(18):1504-14. doi: 10.2106/JBJS.M.01393.
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):1050-1060. doi: 10.2106/JBJS.18.01373.