Cartilage damage Focal cartilage lesion
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
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
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Netherlands