In-vivo visualization of TMC articular cartilage using intra-articular fiber-optic OCT during TMC arthroscopy.
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To assess the feasibility of peroperative OCT as a clinical diagnostic tool in
patients with early stage OA of the TMC joint during TMC arthroscopy.
Secondary outcome
- Quantification of cartilage thickness and roughness of the articular surface
- Detection of pathologic cartilage tissue befitting early TMC OA
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 will
focus the use of Optical Coherence Tomography (OCT) for visualization of TMC
articular cartilage during TMC artroscopy in patients with clinical symptoms of
TMC OA without radiological evidence supporting the diagnosis.
Study objective
In-vivo visualization of TMC articular cartilage using intra-articular
fiber-optic OCT during TMC arthroscopy.
Study design
A prospective observational study
Study burden and risks
During TMC arthroscopy, the thin fiber-optic OCT probe wil be introduced into
the joint through (the readily made) TMC arthroscopy portals after which
high-resolution images of the articular surface will be acquired. The OCT
imaging system has been cleared for use on human subjects and is used in daily
practice in cardiology and in research settings in urology. As such, the use of
this imaging system and non-destructive imaging technique is considered safe.
To accurately depict the intra-articular position of the OCT probe during the
experiment, a 3D-RX scan of the TMC joint will be made (see document K5 for
radiation advice). Extra manoeuvres taken in view of this study will lengthen
the operative procedure with 15 minutes approximately.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
- Over 18 years of age
- Clinical Symptoms of TMC OA
- Scheduled fo TMC joint arthroscopy
- No convincing radiologic evidence for TMC OA on plain radiographs (Eaton-Littler stage 0-1)
Exclusion criteria
- Not able to understand the written informed consent
- Contraindications for surgery
- Previous TMC joint surgery
- Under 18 years of age
- (Radiologically) Evident TMC OA (Eaton-Littler stage >1), rendering TMC arthroscopy an obsolete procedure.
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 | NL47381.018.13 |