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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON41488

Enrollment

188

Registered

2010-10-25

Start date

2011-05-01

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

anterior cruciate ligament rupture

Interventions

Patients will be randomized in a) *early surgery group* or b) *more conservative management group*. In group a): ACL reconstruction will be performed within 4-6 weeks after inclusion study, followed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
a difference in change in International Knee Documentation Committee* (IKDC) questionnaire (subjective form) after 24 months.	—

Secondary

Measure	Time frame
difference in scores after 3, 6, 9, 12 and 24 months 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.	—

Measure

Time frame

difference in scores after 3, 6, 9, 12 and 24 months 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.

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)