To identify intraarticular parameters related to the initiation and course of development of articular cartilage lesions after knee trauma.
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint will be the detection of development of an articular cartilage
lesion at 12 months after trauma as detected by conventional MRI
The changes in intraarticular parameters (defined as the dGEMRIC value and
synovial fluid cytokine concentration) within 4 weeks and at 4 months after
trauma will be analyzed for their predictive value and/or causal role in the
development of an articular cartilage defect 1 year after trauma (as determined
from conventional MRI images by an experienced orthopaedic surgeon). Cytokine
synovial fluid levels at 12 months will possibly reveal factors instrumental in
maintenance or progression of the cartilage lesion at this time point.
Secondary outcome
Secondary endpoint parameters will be the relation between cytokine
concentration (determined from synovial fluid) and cartilage quality
(determined from the dGEMRIC values) and the relation between the clinical
questionnaire scores on the one hand and cytokine concentrations and dGEMRIC
values on the other hand.
Background summary
Articular cartilage damage is related to knee trauma, however it is unclear
which factors initiate this process. Monitoring the changes during the process
from knee trauma to articular cartilage lesion and tissue disorganization, with
subsequent degeneration, will unravel new prognostic factors and provide
insight into those responsible for initiation and progression of disease,
leading to future therapeutic targets to slow or reverse this degenerative
process.
Study objective
To identify intraarticular parameters related to the initiation and course of
development of articular cartilage lesions after knee trauma.
Study design
The proposed study is a prospective, explorative observational and etiological
pilot study.
All included patients will receive a dGEMRIC MRI scan (an innovative measure of
the proteoglycan content in articular cartilage) of their traumatic knee within
4 weeks after trauma and at 4 and 12 months after trauma. At the same time
points we will also collect synovial fluid (by intra-articular aspiration after
the dGEMRIC scan) from the traumatic knee for the biochemical analysis of
cytokine levels and ask the patient to fill out the KOOS and Lysholm
questionnaires and the VAS pain scale. At 12 months after trauma the patients
will also receive a conventional MRI scan to analyze the presence of articular
cartilage lesions.
Study burden and risks
Patients participating in this study will undergo 3 dGEMRIC scans of their
knee. These scans will take about 30 minutes in total to perform. At 12 months
after knee trauma each patient will receive an additional conventional MRI
scan. Synovial fluid will be aspirated from the affected knee after the dGEMRIC
scan. Next to this, patients will also be asked to fill out several
questionnaires which will take around 15 minutes. Complications for both MRI
and synovial fluid aspiration seldom occur.
Heidelberglaan 100
3584CX Utrecht
Nederland
Heidelberglaan 100
3584CX Utrecht
Nederland
Listed location countries
Age
Inclusion criteria
- Patients older than 18 years of age
- Patients with an acute knee trauma with related effusion or haemarthrosis presenting at the emergency room or outpatient clinic.
See page 12 study protocol
Exclusion criteria
- Patients with knee effusion or haemarthrosis not related to trauma.
- Patients with an abnormal kidney function.
- Patients with a known anaphylactic response to Gadolinium or related substances.
- Risk groups for MRI scanning due to the magnetic field or contrast agent, like patients with pacemakers, nerve stimulators, metal particles, stents, clips or implants, (possible) pregnancy or who are breast feeding.
See study protocol page 12
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 | NL31357.041.10 |