search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


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


- candidate number9089
- NTR NumberNTR2746
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR9-feb-2011
- Secondary IDsNL33702.078.10 CCMO
- Public TitleCost-effectiveness of two treatment strategies of an anterior cruciate ligament rupture. A randomized clinical study.
- Scientific TitleCost-effectiveness of two treatment strategies of an anterior cruciate ligament rupture. A randomized clinical study.
- ACRONYM"COMPARE" (Conservative vs Operative Methods for Patients with ACL Rupture Evaluation)
- hypothesisIs 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?
- Healt Condition(s) or Problem(s) studiedAnterior cruciate ligament, Rupture, Treatment strategies
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mei-2011
- planned closingdate1-apr-2018
- Target number of participants188
- InterventionsPatients 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).
- Primary outcomeClinical 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 outcomeDifference 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.
- TimepointsBaseline, 3 months, 6 months, 9 months, 12 months and 24 months.
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESDrs. V. Eggerding
- CONTACT for SCIENTIFIC QUERIESDrs. V. Eggerding
- Sponsor/Initiator Erasmus Medical Center, Department of Orthopaedics
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryRationale:
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.
- Main changes (audit trail)
- RECORD9-feb-2011 - 4-apr-2016


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl