The objective of the study is to determine the validity of MRI imaging to quantify changes in the CMC 1 joint in patients with osteoarthritis and how do these changes relate to functional status. The validity will be determined by comparison with…
ID
Source
Brief title
Condition
- Tendon, ligament and cartilage disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Index test: MRI
Reference test: histological characterization of bone, cartilage and synovial
tissue
Secondary outcome
A number of characteristics thumb functioning such as strength, range of
motion, coordination and the ability to perform daily life task with the hand.
Background summary
MRI imaging could optimise early detection of hand osteo-arthritis by depicting
non-ossified structures such as cartilage, ligaments, synovial fluid, and
peri-articlular tendons. MRI imaging could therefore help to find etiological
different subgroups and different stages of disease progression, supporting the
development of new treatment regimes. This proposal is part of a series of
projects to develop semi-quantitative and quantitative scoring systems with the
aim of diagnosing different subgroups of osteo-arthritis and different stages
of disease progression by MR imaging.
Study objective
The objective of the study is to determine the validity of MRI imaging to
quantify changes in the CMC 1 joint in patients with osteoarthritis and how do
these changes relate to functional status. The validity will be determined by
comparison with findings during surgery and by histological characterization of
bone, cartilage and synovial tissue obtained during surgery.
Study design
This is a cross-sectional diagnostic cohort study of 20 patients with hand
osteo-arthritis that are scheduled for surgical intervention. MR imaging will
be compared to characterization of involved tissues such as cartilage, bone and
synovial tissue. This tissue will be obtained during a surgical intervention
(trapezectomy or joint replacement) that the patients are scheduled for. The
operations that are performed are standard surgical interventions for hand
osteo-arthritis. No additional surgical procedures are necessary to obtain the
tissue needed to validate the MRI findings.
To compare MRI findings with observations during surgery, the surgeon will
score quality of tissue (bone, cartilage, joint space, tendons) and shape of
the tissue. In addition, a professional photographer will take images for
post-surgery evaluation.
Study burden and risks
The chirugical intervention is not adapted for this study and no additional
interventions will be needed to obtain the tissue for histological
characterization. The burden for the patients is mainly the three-hour duration
of the study. The study includes MR imaging and a number of measures to
determine the level of functioning of the hand. No risks have been reported for
MR imaging and the hand function measures.
Postbus 2040
3000 CA Rotterdam
Nederland
Postbus 2040
3000 CA Rotterdam
Nederland
Listed location countries
Age
Inclusion criteria
CMC1 osteoarthritis patients scheduled for trapezectomy or joint replacement at the Erasmus MC.
Exclusion criteria
Patients will be excluded if they have any contra indications for MRI scanning, such as the presence of a pacemaker, metals in their body or pregnancy.
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 | NL19114.078.07 |