To gain insight in cartilage and joint biology immediately and up to one year after knee joint distraction using advanced imaging and synovial fluid aspiration, and to additionally measure the change in sodium concentration in cartilage after knee…
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The changes in GAG content of the cartilage;
the changes in joint homeostasis that facilitates cartilage repair after knee
joint distraction, with a focus on growth factors, proteases, pro-inflammatory
cytokines, and mesenchymal stem cells;
the changes in sodium concentration of the cartilage.
Secondary outcome
* Relation between imaging parameters and synovial fluid changes
Background summary
Knee joint distraction (KJD) is a surgical treatment of severe knee OA meant to
postpone a total knee arthroplasty (TKA) and has shown significant benefit as
well as cartilage regeneration for treated patients in multiple studies.
Multiple studies have been performed to understand the underlying mechanisms,
including quantitative MRI imaging (dGEMRIC and T2-mapping) and synovial fluid
(SF) aspirations. However, the relatively new 7T META-scanner has the ability
to perform gagCEST and sodium imaging, which are techniques that do not require
contrast and are related to the GAG content in cartilage. This allows us to
gain additional insight in the structure and characteristics of the cartilage
that is regenerated after KJD. Furthermore, imaging has so far only been
performed before and at least one year after treatment, giving no information
on the short to medium-term changes, while SF aspirations have not been done in
the months after treatment, likewise giving no information on medium to
long-term changes. In this study we want to fill this information gap by
including more time points and by performing qualitative MRI scans and SF
aspirations at the same time points, in order to relate joint homeostasis
results from SF with changes seen in cartilage on the MRI scans.
Study objective
To gain insight in cartilage and joint biology immediately and up to one year
after knee joint distraction using advanced imaging and synovial fluid
aspiration, and to additionally measure the change in sodium concentration in
cartilage after knee joint distraction.
Study design
Prospective explorative study, with joint fluid sampling and MRI scans
Study burden and risks
Patients will be treated in regular practice by knee joint distraction and have
no direct benefit of participating in this study. Results will help to
elucidate the underlying mechanisms by which cartilage tissue repair is
initiated (as observed during joint distraction) and may provide tools for
improvement of (novel) cartilage repair strategies. The MRI scans do not expose
the patients to additional risks, while the SF aspirations have a potential
(although considered small) chance on diminished clinical effect and an
intra-articular infection, although both have not occurred in the previous SF
study in KJD patients (NL51539.041.15).
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
Patients with knee joint degeneration (osteoarthritis) eligible in regular
clinical practice for knee joint distraction.
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
- Good knowledge of the Dutch language
- Signed informed consent
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
- Not eligible for MRI, in response to the MRI safety checklist
- Metal present in the treated knee
- Knee width > 14 cm
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 | NL69657.041.19 |