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NCT Number: NCT00852657

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

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.

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Key information

Conditions

Rotator Cuff Tear Rotator Cuff Injuries Rupture Shoulder Injuries Tendon Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Martina Hansen's Hospital

Sandvika, 1306, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tendon repair with acromioplasty

Procedure

Open or mini-open tendon repair in combination with an acromioplasty and eventually a tenodesis of the long head of the biceps

physiotherapy

Procedure

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

Primary outcomes

  1. Constant score

    Time frame: baseline, 6 months, 1, 2, 5, 10, 15 years

Secondary outcomes

  1. self report section of the American Shoulder and Elbow Surgeons score (ASES)

    Time frame: baseline, 6 months, 1, 2, 5, 10, 15 years

  2. Short Form 36 Health Survey (SF-36)

    Time frame: baseline, 6 months, 1, 2, 5, 10, 15 years

  3. Patient satisfaction

    Time frame: 1, 2, 5, 10, 15 years

Sponsors and collaborators

Lead sponsor

Vestre Viken Hospital Trust

Other

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2023
Study completion
2023
First posted
Feb 27, 2009
Registry last updated
Mar 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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