ong head biceps tenodesis or tenotomy in arthroscopic rotator cuff repair: An international multicenter prospective randomized clinical trial.

Completed

• Conditions: Long head bicepstendon pathology; rotatorcuff surgery; 10043237; 10005944

• Registration Number: NL-OMON44133
• Lead Sponsor: Onze Lieve Vrouwe Gasthuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 98

Inclusion Criteria

Patients older than 50 years who are indicated to undergo repair of a moderately sized rotator cuff (infraspinatus and/or supraspinatus) tendon rupture (sized smaller than 3cm measured using an arthroscopic ruler), who are encountered with an inflamed, unstable or partially torn LHB tendon.
Patients need to be able to read and write in Dutch or English language in order to complete the questionnaires, and sign informed consent.

Exclusion Criteria

Patients are excluded form this study in case of an acute, traumatic or partial thickness rotator cuff rupture, or in case a full thickness tear is larger than 3 cm measured using an arthroscopic ruler.
Patients are also excluded when the origo of the bicepstendon has an hour-glass aspect or in case of accompanying subscapularis tendon rupture.
Pre-operative X-ray of the involved shoulder revealing acromion to humeral head distance measuring 6mm or smaller or osteoarthritis also excludes patients from participation to this study.
Any prior surgery to the involved shoulder leads to exclusion from participation in this study. Dementia or inability to complete questionnaires and assessments excludes patients form this study as well.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Patient evaluation is conducted with a focus on overall shoulder function, as<br /><br>evaluated with the Constant score. In addition, the Dutch Oxford Shoulder Test<br /><br>and the Disabilities of the Arm Shoulder and Hand questionnaire will be<br /><br>assessed. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Other evaluations concern: cosmetic appearance evaluated by the **Popeye**<br /><br>deformity, arm cramping pain, elbow flexion strength (measured with a hand<br /><br>dynamometer), and quality of life and cost-utility (evaluated with the EQ-5D).</p><br>