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…
ID
Source
Brief title
Condition
- Tendon, ligament and cartilage disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
a difference in change in International Knee Documentation Committee* (IKDC)
questionnaire (subjective form) after 24 months.
Secondary outcome
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.
Background summary
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.
Study 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 design
Open-labeled randomized clinical trial.
Intervention
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 by an exercise
program (standardized protocol) for 9 months. In group b): 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).
Study burden and risks
There is no direct benefit from participation or group relateness. The burden
is primarily time (questionnaires).
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL33702.078.10 |
| OMON | NL-OMON26654 |