The aims of this research proposal are to detect; 1) which early (degenerative) changes occur in bone, cartilage and menisci in patients with an acute complete ACL rupture, 2) at what point of time after the initial injury do these early changes…
ID
Source
Brief title
Condition
- Tendon, ligament and cartilage disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Degenerative changes in bone, cartilage and menisci evaluated by MRI, DXA scan,
radiographs and biomarkers.
Secondary outcome
not applicable
Background summary
Osteoarthritis (OA) is one of the most frequently occurring disorders of the
locomotor system and a progressive disease leading to severe disability and
pain. The risk of knee OA is extremely high after a rupture of the anterior
cruciate ligament (ACL). So far, the pathophysiology of an ACL rupture leading
to an evident radiologic knee OA remains unknown. Because of the incapability
of radiographs to detect early degenerative changes, more sensitive tools are
necessary to precisely monitor the pathophysiologic process of OA. In the
present proposal we will focus on magnetic resonance imaging, DXA scan, bone
shape modelling, and two biomarkers (CTX-II and osteocalcin).
Study objective
The aims of this research proposal are to detect; 1) which early (degenerative)
changes occur in bone, cartilage and menisci in patients with an acute complete
ACL rupture, 2) at what point of time after the initial injury do these early
changes occur, 3) what is the cascade of changes in bone, cartilage and menisci
in patients with an acute complete ACL rupture and 4) what are major predictors
of these early changes?
Study design
In this study 160 patients with a complete ACL rupture will be included and
prospectively evaluated 1 and 2 years after the initial trauma. To explore
whether it would be worthwhile to evaluate the changes after a longer follow-up
period, additionally cross-sectional measurements will be performed in a group
of 30 patients (4 years post-trauma).
Study burden and risks
A disadvantage for the participating patients is the additional time needed for
the study during the outpatient clinic visits (approxiametely 1 hour), and two
additional visits (after 1 and 2 year). Additional measurements at baselien
are: DXA scan, questionnaires and blood and urine. Additional measurements at 1
and 2 years follow-up are: MRI, DXA scan, vragenlijsten questionnaires and
blood and urine.
Postbus 2040
3000 CA Rotterdam
NL
Postbus 2040
3000 CA Rotterdam
NL
Listed location countries
Age
Inclusion criteria
Patients aged between 18-40 years with a complete ACL rupture (diagnosed by MRI) will be included.
Exclusion criteria
Patients who do not speak the Dutch language; with initial trauma longer than 6 months ago; those with previous ACL injury, or meniscus, collateral ligament, cartilage damage (diagnosis by orthopedic surgeon); those with previous surgery of involved knee; those with disabling co-morbidity; and those with already osteoarthritic changes on MRI are excluded. Besides, those patients who do not want to be informed about unexpected findings will also be excluded.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL21778.078.08 |