Cost-effectiveness of two treatment strategies of an anterior cruciate ligament rupture. A randomized clinical study.
Completed
- Conditions
- ACL, anterior cruciate ligament , rupture, treatment options, VKB, Voorste kruisband ruptuur, behandelmogelijkheden,
- Registration Number
- NL-OMON26654
- Lead Sponsor
- Prof. dr. J.A.N. Verhaar (Chair Department of Orthopaedics at Erasmus MC )
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 166
Inclusion Criteria
1. MRI proven ACL tear and/or on physical examination high suspection of ACL tear;
2. Age 18-65;
Exclusion Criteria
1. Associated PCL injury or injury to the lateral/posterolateral ligament complex with significantly increased laxity;
2. Pregnancy;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical effect in change in International Knee Documentation Committee” (IKDC) questionnaire over a period of 24 months between the early surgical group and the more conservative treatment group.
- Secondary Outcome Measures
Name Time Method Difference in scores of IKDC (objective form), KOOS, Lysholm, Tegner, pain severity (VAS), objective instability (KT-1000, Lachman and pivot shift test), satisfaction with treatment, and quality of life (EQ5D). Besides, differences in medical consumption, adverse events (menisci lesions, complications, and re-interventions), absence from work or decreased productivity at paid and unpaid work, and patient costs (PRODISQ, productivity and Disease Questionnaire), to be able to do cost-effectiveness analysis will be assessed.