Cost-effectiveness of two treatment strategies of an anterior cruciate ligament rupture. A randomized clinical study.

Completed

• Conditions: anterior cruciate ligament rupture; insufficient ACL; 10043237

• Registration Number: NL-OMON41488
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 188

Inclusion Criteria

an acute (within 2 months of initial trauma) complete primary ACL rupture (confirmed by MRI, or arthroscopy); age of 18-65 years, and willing to be randomized.

Exclusion Criteria

ACL rupture of the contralateral knee, presence of disorder(s) that affects the activity level of the lower limb, dislocated bucket handle lesion of the meniscus with an extension deficit, or insufficient command of the Dutch language, spoken and/or written.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>a difference in change in International Knee Documentation Committee* (IKDC)<br /><br>questionnaire (subjective form) after 24 months. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>difference in scores after 3, 6, 9, 12 and 24 months of IKDC (objective form),<br /><br>KOOS, Lysholm, Tegner, pain severity (VAS), objective instability (KT-1000,<br /><br>Lachman and pivot shift test), satisfaction with treatment, and quality of life<br /><br>(EQ5D). Besides, differences in medical consumption, adverse events (menisci<br /><br>lesions, complications, and re-interventions), absence from work or decreased<br /><br>productivity at paid and unpaid work, and patient costs (PRODISQ, productivity<br /><br>and Disease Questionnaire), to be able to do cost-effectiveness analysis will<br /><br>be assessed.</p><br>