Primary Objective: To improve the detection of trauma related articular cartilage matrix damage by using a new contrast enhanced MRI technique.Secondary Objective(s): To evaluate the intraarticular changes (like proteoglycan content, disturbances in…
ID
Source
Brief title
Condition
- Tendon, ligament and cartilage disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary study parameter will be the change in dGEMRIC value at 4 and 12 months
after the trauma as related to the first (<5 weeks after trauma) dGEMRIC scan.
Secondary outcome
Secondary parameters of this study will be the intraarticular changes after
knee trauma as related to the clinical and functional condition of the patient
(measured with specific questionnaires). We will use a correlation analysis to
determine the association between the clinical condition of the patient and
(changes in) cytokine spectrum, biomarkers and proteoglycan content (as
parameters of cartilage quality)
Background summary
Knee trauma with subsequent hemarthrosis is related to damage of intraarticular
structures, like articular cartilage. In addition, in vitro studies proved that
high impact loading (f.e. during knee trauma) results in a significant
proteoglycan loss from articular cartilage. These events are likely to induce a
disturbance of joint homeostasis which enhances disease progression. Monitoring
the changes occurring during the process from knee trauma to cartilage
disorganization and subsequent damage would provide insight into the disease
initiating factors and those with a progressive influence.
Study objective
Primary Objective:
To improve the detection of trauma related articular cartilage matrix damage by
using a new contrast enhanced MRI technique.
Secondary Objective(s):
To evaluate the intraarticular changes (like proteoglycan content, disturbances
in cytokine levels and biomarkers) after cartilage trauma to obtain an idea
about the trauma related disorganization of the intraarticular environment as
an initiating factor of cartilage damage and further degeneration
Study design
Prospective observational pilot study
All included patients will receive a dGEMRIC MRI scan of their traumatic knee
within 5 weeks from trauma and at 4 and 12 months follow-up. At the same time
points we will also collect synovial fluid from the traumatic knee (by
intra-articular aspiration) and ask the patient to fill out the KOOS en VAS
questionnaire.
Study burden and risks
Patients participating in this study will undergo 3 MRI scans of their knee
with special dGEMRIC settings. Each scan will take about 30 minutes to perform.
Synovial fluid will also be aspirated from the affected knee before each MRI
scan is obtained. Next to this patients will also be asked to fill out several
questionnaires (KOOS and VAS) 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 must be older than 18 years of age.
-Patients must have an acute or recent (< 5 weeks old) knee trauma with hemarthrosis
Exclusion criteria
-Patients with diagnosed inflammatory rheumatic disease.
-Not trauma related hemathrosis.
-Contra-indications for gadolinium contrast MRI (abnormal kidney function)
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 | NL24908.041.08 |