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Early detection and monitoring of articular cartilage damage following knee trauma

Early detection and monitoring of articular cartilage damage following knee trauma - Early detection of cartilage damage

Status
Unknown
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON34785
Enrollment
10
Registered
2010-05-26
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cartilage damage Focal cartilage lesion

Interventions

None listed

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

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

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)