The primary objective is to determine feasibility of DRUJ cartilage quantification on ultra high field strength 7T MRI by imaging healthy volunteers and OA patients. Feasibility means succesfull imaging DRUJ cartilage for all subjects. The two…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
gewricht en kraakbeen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameter/endpoint is the DRUJ cartilage quality. Healthy cartilage
and injured cartilage will be compared on the 7T MR images, descriptively for
morphology and quantitatively for composition.
Secondary outcome
Investigate the trend in correlation of qualitative imaging to:
- Pain.
- Disability.
- Range of motion.
- Healthy versus OA patients.
- Assess reproducibility in obtaining the quantified imaging parameters.
Background summary
The aim of the current feasibility study is to explore the possibilities of
ultra high field 7Tesla (7T) MRI to quantify the distal radioulnar joint (DRUJ)
cartilage quality. In the development and evaluation of cartilage repair
techniques, non-invasive diagnostic tools to study cartilage quality in both a
qualitative/ descriptive and in a quantitative way are essential. Qualitative
study on cartilage quality describes the morphology. By quantifying the DRUJ
cartilage, the composition of the cartilage can be determined. MRI at an ultra
high field strength of 7T is likely to be superior over high field 3T MRI for
the quantification of DRUJ cartilage, by T2 mapping, T1rho, Diffusion-weighted
imaging and gag-CEST for example. Advantages of 7T over 3T for these
quantitative sequences are the higher distinctive capacity, the higher
achievable signal to noise ratio (SNR), the higher spatial resolution and the
more limited scan time. The higher SNR at 7T can be used to gain a better
descriptive, morphological image of the DRUJ cartilage.
The hypothesis is that the morphology and composition of DRUJ cartilage can be
assessed and quantified on ultra high field 7T MRI.
Study objective
The primary objective is to determine feasibility of DRUJ cartilage
quantification on ultra high field strength 7T MRI by imaging healthy
volunteers and OA patients. Feasibility means succesfull imaging DRUJ cartilage
for all subjects. The two groups will undergo 7T MRI. The objective is to
quantify DRUJ cartilage and compare results of all the 20 patients with
cartilage damage to the results of the healthy cartilage of the volunteers.
Quantitative and qualitative sequences will be used. Secondary objectives are
applicable on qualitative imaging. Secondary objectives of the study are
qualitative imaging performance and investigating trends in quantitative values
with respect to pain, disability scores and range of motion. In addition,
clinical modalities such as pain, disability and range of motion can be
compared between the healthy volunteers and patients with damaged or OA
cartilage. Data from literature are not useful to investigate the primary
objective of this feasibility study and a power analysis cannot be done. The
data now obtained could possibly be used as reference values for future
research on the applications of cartilage restoration.
Study design
Feasibility study of observational research.
Study burden and risks
The patient group will undergo a 7T MRI scan in addition to the normal
outpatient clinical routine.
The group of healthy volunteers will undergo history taking which consists of
questions concerning the pain score, disability, occupation. They will also
undergo a physical examination of the wrist which consists of determining the
range of motion, an instability test, painful crepitus testing. Also they will
have a 7T MRI scan.
A MRI scan is based on magnetism field and therefore undergoing a 7T MRI scan
implies a negligible risk.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
Volunteers:
Adults (> 18 years old) and mentally competent.
No ulnar sided wrist pain, previous surgery or trauma of the wrist.;Patients:
Adults (>18 years old) and mentally competent.
Symptomatic DRUJ complaints regarding cartilage damage, OA or pre-OA.
Patients that will undergo DRUJ replacement surgery (ulnar head prosthesis) or have DRUJ instability.
Exclusion criteria
o Impossibility to undergo MRI (claustrophobia, implants or metal objects in or around the body that are not accepted for ultra high field strength MRI)
o <18 years old and mentally incompetent
o Previous wrist surgery
o Previous trauma (applicable to the volunteers group)
o 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 | NL46783.041.13 |