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

Rotator Cuff Tear Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00852657
• Other study ID #: 430-04149 (REK)
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Tear

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