Primary objective: Evaluate intraarticular environmental changes related to treatment for focal cartilage lesions in order to increase insight into the chain of events occurring during cartilage regeneration.Secondary Objective(s): Determine theā¦
ID
Source
Brief title
Condition
- Tendon, ligament and cartilage disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint of the study will be 12 months after the surgical procedure.
At this time point we will evaluate the changes in dGEMRIC values, synovial
fluid protein spectrum and clinical questionnaires (KOOS, VAS) at the several
predefined time points. We will also compare the changes in dGEMRIC value and
synovial fluid proteins to the clinical questionnaires.
Secondary outcome
-
Background summary
Articular cartilage trauma and degenerative cartilage disease as occurring
during osteoarthritis (OA) are likely to be two opposite ends of a continuum,
where a disturbance in joint homeostasis, caused by the presence of a cartilage
defect, ultimately leads to a spiral of catabolic cues and generalized
cartilage degradation. It has been suggested that environmental factors
surrounding the cartilage defect causes discrepancy between the results of
regenerative preclinical therapeutic cartilage research and that in clinical
practice. Evaluation of the cartilage biochemistry, using highly sophisticated
MRI techniques, and changes in catabolic and anabolic synovial fluid proteins
before and after regenerative cartilage approaches increases insight in
cartilage regeneration and might identify possible targets for future
regenerative therapies or pretherapeutic interventions.
Study objective
Primary objective: Evaluate intraarticular environmental changes related to
treatment for focal cartilage lesions in order to increase insight into the
chain of events occurring during cartilage regeneration.
Secondary Objective(s): Determine the potential of dGEMRIC as a follow-up tool
for cartilage regeneration by monitoring the changes in T1GD values and
correlating them to clinical questionnaires (KOOS, VAS) and identify changes in
the synovial protein spectrum as related to treatment of focal cartilage
lesions in order to possibly identify prognostic factors or targets for future
therapies.
Study design
All patients included in this study will receive the regular preoperative,
perioperative and postoperative treatment and survey. They will receive an MRI
scan (with dGEMRIC settings) as well as synovial fluid aspiration (to perform
protein array analysis) from the affected knee within 1 month before surgery
and at 3, 9 and 12 months follow-up. At these 4 time points patients will also
be asked to fill out 2 questionnaires (KOOS and VAS). Except for the MRI (at
preoperative, 9 and 12 months after surgery) these interventions are additional
to the standard treatment follow-up.
The dGEMRIC T1 relaxation times will be calculated for the regions of interest
(surgical site), the changes in protein spectrum over time will be analyzed and
the clinical scores (resulting from the questionnaires) will be analyzed.
Study burden and risks
Patients participating in this study, will undergo 4 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 over 18 years of age
Diagnosed focal cartilage lesions
Submitted to either ACI or microfracturing
Exclusion criteria
Contra-indications for gadolinium MRI scanning
Patients with inflammatory rheumatic disease
Patients with (a history of) kidney disease
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 | NL21110.041.08 |