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

M

Martina Hansen's Hospital

Status

Completed

Conditions

Rotator Cuff Tear

Treatments

Procedure: Physiotherapy
Procedure: Tendon repair with acromioplasty

Study type

Interventional

Funder types

Other

Identifiers

NCT00852657
430-04149 (REK)

Details and patient eligibility

About

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.

Full 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.

Enrollment

103 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

103 participants in 2 patient groups

Surgical treatment
Active Comparator group
Description:
Open or mini-open tendon repair with acromioplasty
Treatment:
Procedure: Tendon repair with acromioplasty
Physiotherapy
Active Comparator group
Description:
Physiotherapy by exercises
Treatment:
Procedure: Physiotherapy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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