No registrations found.
ID
Source
Brief title
Health condition
ACL, anterior cruciate ligament , rupture, treatment options, VKB, Voorste kruisband ruptuur, behandelmogelijkheden,
Sponsors and support
Intervention
Outcome measures
Primary outcome
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
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.
Background summary
Rationale:
A rupture of the anterior cruciate ligament (ACL) is a common sports related injury. Significant controversy exists regarding the management of the ACL insufficient knee. Usual care in the Netherlands varies between two widely used strategies, namely; early surgical intervention or a more conservative strategy. Both strategies are financially compensated by the health insurance in the Netherlands. Till date there are no studies investigating the cost-effectiveness of different management strategies of ACL ruptures.
Objective:
To assess whether there is a clinical relevant effect (and cost-effectiveness) in change in International Knee Documentation Committee” questionnaire over a period of 24 months of an early surgical intervention versus a more conservative management of patients with a complete ACL rupture.
Study population:
Patients are eligible in the age of 18 to 65 years consulting an orthopedic surgeon with an acute (within 2 months of initial trauma) complete primary ACL rupture.
Intervention:
Patients will be randomized in:
1. “Early surgery group”;
2. “More conservative management group”. In group 1 ACL reconstruction will be performed within 4-6 weeks after inclusion study, followed by an exercise program (standardized protocol) for 9 months. In group 2 the primary treatment option is rehabilitation training for 3-4 months followed by assessment of knee function and quality of life. If repeated episodes of giving way in spite of rehabilitation occurs or the patient is not satisfied for any reason, a late reconstruction can be performed (delayed surgery).
Countries of recruitment: The Netherlands.
Study objective
Is there a clinical relevant difference in change in International Knee Documentation Committee” (IKDC) questionnaire over a period of 24 months of an early surgical intervention versus a more conservative management of patients with a complete ACL rupture?
Study design
Baseline, 3 months, 6 months, 9 months, 12 months and 24 months.
Intervention
Patients will be randomized in:
1. “Early surgery group”: ACL reconstruction will be performed within 4-6 weeks after inclusion study, followed by an exercise program (standardized protocol) for 9 months;
2. “More conservative management group”: The primary treatment option is rehabilitation training for 3-4 months followed by assessment of knee function and quality of life. If repeated episodes of giving way in spite of rehabilitation occurs or the patient is not satisfied for any reason, a late
reconstruction can be performed (delayed surgery).
PO Box 2040
M. Reijman
Rotterdam 3000 CA
The Netherlands
010-7033642
m.reijman@erasmusmc.nl
PO Box 2040
M. Reijman
Rotterdam 3000 CA
The Netherlands
010-7033642
m.reijman@erasmusmc.nl
Inclusion criteria
1. MRI proven ACL tear and/or on physical examination high suspection of ACL tear;
2. Age 18-65;
3. Patient agreement with randomisation;
4. Trauma within 2 months of inclusion.
Exclusion criteria
1. Associated PCL injury or injury to the lateral/posterolateral ligament complex with significantly increased laxity;
2. Pregnancy;
3. Patient is unlikely to complete study through 2-year follow-up;
4. Insufficient command of the Dutch language, spoken and/or written;
5. Presence of disorder(s) that affects the activity level of the lower limb;
6. Malalignment of the hip knee ankle axis which requires intervention.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL2618 |
| NTR-old | NTR2746 |
| CCMO | NL33702.078.10 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON41488 |