To image cartilage of the TMC joint in patients with TMC OA by means of OCT and 7T MRI. To subsequently compare both methods to histopathology which will serve as a reference standard.
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Visualization of TMC cartilage (degeneration) in advanced osteoarthritis using
7T MRI and OCT.
Secondary outcome
Secondary study parameters are (differences in) measured cartilage thickness,
cartilage volume/surface and surface fibrillation between OCT, 7T MRI and
histology.
Background summary
Osteoarthritis (OA) of the trapeziometacarpal (TMC) joint is an important cause
of pain and disability, affecting a large number of patients in society.
Diagnosis is usually made on clinical symptoms and the radiograph-based
Eaton-Littler classification. Recent research has shown that the interobserver
agreement between radiologists and hand surgeons concerning staging of TMC OA
based on radiographs is moderate at best. The same was observed for
case-specific treatment choices between hand surgeons. Moreover, it is known
that the articular cartilage, which cannot be visualized on radiographs, is the
primary location where changes in early OA occur. Consequently, diagnosis of
TMC OA is frequently made in a more advanced stage of the disease, which often
comprises irreversible damage to the affected joint, rendering reconstructive
surgery necessary. Advances in OA imaging of the TMC joint are needed to ensure
a more solid foundation for choosing a therapeutic strategy. This study
investigates the feasibility of 7 Tesla Magnetic Resonance Imaging (7T MRI) and
Optical Coherence Tomography (OCT) in TMC cartilage imaging in patients with
known TMC OA, which will be correlated to histopathologic findings.
Study objective
To image cartilage of the TMC joint in patients with TMC OA by means of OCT and
7T MRI. To subsequently compare both methods to histopathology which will serve
as a reference standard.
Study design
A prospective observational study
Study burden and risks
Participants are invited to undergo a pre-operative 7T MRI scan of the affected
wrist at the University Medical Centrum Utrecht (UMCU), in addition to the
routine clinical work-up. MRI research is regarded as safe, mild discomforts
such as dizziness and nausea have been reported. During the scheduled
arthroplasty procedure, the trapezium bone will be removed as part of the
(normal) reconstructive procedure. Subsequently, the removed trapezium will be
scanned using OCT and processed into histologic slides, for which informed
consent will be required from the participating patients.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
- Age 18 years or older
- Clinical symptoms of trapeziometacarpal osteoarthritis
- Patients is or will be scheduled for trapeziometacarpal joint arthroplasty
- Radiologic evidence for trapeziometacarpal osteoarthritis of at least stage 2 according to the Eaton-Littler classification
Exclusion criteria
- Not able to understand the written informed consent
- Contra-indications for MRI research
- Contraindications for surgery
- Under 18 years of age
- Radiologic evidence for TMC OA, of less than stage 2 according to the Eaton-Littler classification
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 | NL42248.018.12 |