Validation of the gagCEST protocol with histology as golden standard. Detection of (or a reproducible gradation of) the cartilage defects based on the gagCEST MRI measurements for (early) diagnosis and monitoring of osteoarthritis.
ID
Source
Brief title
Condition
- Tendon, ligament and cartilage disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Validation of the gagCEST protocol with histology as golden standard
Detection of (or a reproducible gradation of) the cartilage defects based on
the gagCEST MRI measurements for (early) diagnosis and monitoring of
osteoarthritis.
Secondary outcome
Relate the cartilage thickness on the clinically relevant morphological MRI
with the MTR asymmetry spectrum based on the gagCEST MRI.
Background summary
With our aging society, prevalence of degenerative diseases, like
osteoarthritis (OA), has increased dramatically. Osteoarthritis is a
degenerative joint disease, which mainly affects the articular cartilage.
Osteoarthritis of the knee is one of five leading causes of disability among
non-institutionalized adults and it leads to high costs for society: the
estimated hospital expenditures in 2009 were 28.5 billion dollars and the
job-related OA costs are estimated to 3.4 to 13.2 billion per year. In the
Netherlands, almost 600.000 patients suffer from OA and 160.000 new cases are
diagnosed every year. Since cartilage tissue has a limited ability to
regenerate, early identification of cartilage damage improves chances of
successful treatment and prognosis.
The gagCEST protocol is an emerging diagnostic technologies for cartilage
defects. Previous in-house research showed promising results and we hope to
extend this to clinical practice. The next step is a pilot study, to prove the
clinical feasibility and added value of gagCEST on 7T MRI. The UMC Utrecht is
one of the few hospitals in the Netherlands equipped with a 7T MRI and this
study is using these facilities and their possibilities to its full extent, in
a way to provide better diagnosis and treatment monitoring for OA.
Nowadays, often an arthroscopy of the knee is used to assess the cartilage
quality in patients with suspected cartilage damage or OA. We hope to replace
the arthroscopy with a gagCEST MRI protocol. Therefore, this study will compare
the cartilage scoring of a gagCEST protocol with the cartilage scoring of an
arthroscopy.
Study objective
Validation of the gagCEST protocol with histology as golden standard. Detection
of (or a reproducible gradation of) the cartilage defects based on the gagCEST
MRI measurements for (early) diagnosis and monitoring of osteoarthritis.
Study design
This study is divided into two cohorts. For the first cohort (TKA cohort),
patients from the department of orthopaedics who are scheduled to undergo a
total knee arthroplasty (TKA) are included. These patients have severe
cartilage damage and need a new knee. These patients will be recruited during
outpatient clinic sessions or from the planned/scheduled operation list. The
department of orthopaedics performs more than 100 TKA*s annually, which should
be enough to recruit the number of patients required for this study.
The second cohort (arthroscopy cohort) includes patients from the department of
orthopaedics who are scheduled for an arthroscopy because of suspected
cartilage damage. These patient will be recruited during outpatient clinic
sessions or from the planned/scheduled operation list. The department of
orthopaedics performs more than 300 arthroscopies annually and this should be
enough to recruit the number of patients required for this study.
This study is a single center pilot study, for which we aim to recruit 26
patients, 13 in both cohorts.
Study burden and risks
No extra risks involved.
Heidelberglaan 100
Utrecht 3508GA
NL
Heidelberglaan 100
Utrecht 3508GA
NL
Listed location countries
Age
Inclusion criteria
Patients who are planned to undergo a total knee arthroplasty because of severe cartilage damage or patients who are planned to undergo an arthroscopy because of suspected cartilage damage.
Exclusion criteria
Patients with previous knee surgery. Patients with other prostheses or metal objects/hardware. Patients with contra-indications to MRI scanning according to hospitals 7T MRI screening guideline of the UMC Utrecht
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 | NL55298.041.15 |