To evaluate the reproducibility of the SvdH score (BE and JSN of one hand) of radiographs taken with a mould compared to conventionally acquired images.
ID
Source
Brief title
Condition
- Autoimmune disorders
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome:
- reproducibility of the SvdH score of the hand.
Secondary outcome
Secondary outcomes:
- reproducibility of the BE score of the hand.
- reproducibility of the JSN of the hand.
Background summary
In rheumatoid arthritis (RA) radiographic joint damage of the hands is the most
important structural outcome (and burden) of the disease. To evaluate the joint
damage, bone erosions (BE) and joint space narrowing (JSN; cartilage loss) are
combined to a score, the Sharp van der Heijde (SvdH) score. This score includes
several of the finger joints and wrist joints and comprises a combined score of
BE and JSN. A major problem for this analysis is the limited reproducibility of
acquisition of the radiographic images . Recently a mould was designed that
enables more standardised positioning of the hand and wrist joints. It appeared
from pilot observations that analyses of JSN and BE significantly improve when
using radiographs taken with this mould in comparison to conventional
radiographs. However, it has never been quantitatively studied whether
reproducibility of acquisition is better with a hand mould than without a hand
mould.
Study objective
To evaluate the reproducibility of the SvdH score (BE and JSN of one hand) of
radiographs taken with a mould compared to conventionally acquired images.
Study design
observational study.
Of one hand (the most affected one based on previous knowledge) an additional
radiograph will be taken by using the mould. Patients are asked for an
additional radiograph of both hands without mould (standard) and the same hand
with mould after 3 months (a time span where there is no relevant progression
of joint damage) when they visit the Rheumatology department again in clinical
practice for DMARD control.
Study burden and risks
Of one hand an additional radiograph will be taken by using the mould. Patients
are asked for an additional radiograph of both hands without mould (the
standard) and the same hand with mould within 3 months when they visit the
Rheumatology department again in clinical practice for DMARD control. This will
result in a minimal increase in X-ray exposure which is considered acceptable
(report attached). There will be no direct benefit for the patients involved.
Knowledge may improve acquisition of hand X-ray images in the future to improve
evaluation of joint damage for patients with RA.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
Diagnosis of rheumatoid arthritis
Age >18 years
Radiographic hand image acquisition in regular care needed
Revisit three months later within regular care
Capable of giving informed consent
Informed Consent signed
Exclusion criteria
Other diseases than RA
No hand radiographs in regular care needed
No revisit in regular care needed within 3 months later
Not capable of giving informed consent
No Informed Consent signed
Those with hand radiographs taken more than once a year (which is regular care)
Design
Recruitment
Medical products/devices used
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 | NL45487.041.13 |