Medial Compartment Osteoarthritis of the Knee Clinical Trial
Official title:
Effects of Osteotomies Around the Knee on Cartilage Glycosaminoglycan Content Using dGEMRIC Non-invasive Imaging, a Pilot Study
Medial compartment osteoarthritis of the knee is commonly treated by a surgical intervention called 'high tibial osteotomy' (VTO). Although it has repeatedly been shown that pain improves following this procedure, it is unknown how cartilage quality is affected by the procedure. In this study, a recently developed MRI technique is used to evaluate changes in cartilage quality before and after the surgery. Changes in MRI signals are correlated to subjective improvements (score lists). 10 patients participate in this study. Approval has been granted by the Medical Ethical Committee of the University Medical Center Utrecht. All participants are required to give informed consent before participation.
Rationale: Medial compartment osteoarthritis (OA) of the knee is an invalidating disorder and
leads to pain, decreased range of motion and inactivity. Two procedures aiming at maintaining
original cartilage are the high tibial osteotomy (HTO) and the femur osteotomy. However,
effects of this procedure on cartilage quality are not known.
Recently, a new technique has been developed which enables analysing changes in cartilage
composition in vivo: the dGEMRIC. The dGEMRIC-technique is based on binding of negatively
charged contrast agent Gadolinium (Gd(DPTA)2) to the glycosaminoglycans in the knee
cartilage. The T1-signal reflects the gadolinium uptake by the proteoglycans of the knee and
thus provides us with an indicative parameter of the cartilage quality. Visualising changes
in cartilage composition enables better pre-operative patient selection as well as optimal
timing of the operative procedure.
Objective: Primary objective: Evaluate changes in cartilage glycosaminoglycan content using
dGEMRIC, in patients with osteoarthritis of the knee undergoing axial correction (HTO, femur
osteotomy). Secondary objective: Correlate quantitative MRI data to subjective symptom scores
(KOOS, WOMAC, VAS, Knee Society Score)
Study design: This study is a prospective observational study.
Study population: Ten patients will be included satisfying the following inclusion criteria:
- Both males and females older than 18 years
- Indication as set by treating physician for operative procedure around the knee: HTO
(high tibial osteotomy), femoral osteotomy
Main study parameters/endpoints: In addition to their regular treatment, patients will
receive an MRI scan with dGEMRIC settings before and 9 months after the surgical procedure,
after removal of orthopaedic hardware. They will further receive questionnaires (VAS, WOMAC,
KOOS, Knee Society Scale) before the surgical procedure and at 6,12, and 24 months after the
surgical procedure.
Nature and extent of the burden and risks associated with participation, benefit and group
relatedness: In addition to their regular treatment, patients participating in this study
will undergo two MRI scans of their knee. Performing of these scans will take about 4 hours.
Further, orthopaedic hardware will be removed in daycare before the second MRI (burden: 1
day). Patients are asked to fill out questionnaires before- and after their surgical
treatment. Filling out these questionnaires will take around 20 minutes per time moment (4 in
total). Risks associated with the MRI scan are the very infrequently occurring allergic
reactions to the contrast agent, which is used to depict the cartilage. Risks associated with
removal of orthopaedic hardware at 9 months and not different than removal of hardware at a
later stage: infection, bleeding, allergic reaction, dental damage or paresthesias.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT00284622 -
HTO With and Without Arthroscopy
|
Phase 2 | |
| Withdrawn |
NCT01614288 -
High Tibial Osteotomy (HTO) With or Without Arthroscopy of the Knee Joint
|
N/A |