Effects of Osteotomies Around the Knee on Cartilage Glycosaminoglycan Content Using dGEMRIC Non-invasive Imaging
Medial Compartment Osteoarthritis of the Knee
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Effects of Osteotomies Around the Knee on Cartilage Glycosaminoglycan Content Using dGEMRIC Non-invasive Imaging, a Pilot Study|
- MRI T1 signal, change from baseline [ Time Frame: Change from baseline 9 months after surgery (HTO) ] [ Designated as safety issue: No ]MRI T1 signal is deducted from dGEMRIC measurements
- KOOS clinical score, change from baseline [ Time Frame: Change from baseline 9 months after surgery (HTO) ] [ Designated as safety issue: No ]Knee and Osteoarthritis Outcome Score (clinical score, completed by all participants)
|Study Start Date:||July 2007|
|Estimated Study Completion Date:||February 2011|
|Estimated Primary Completion Date:||February 2011 (Final data collection date for primary outcome measure)|
Patients with medial compartment osteoarthritis of the knee
Patients with medial compartment osteoarthritis of the knee, as proven by x-rays and clinical examination
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01269944
|University Medical Center Utrecht|
|Utrecht, Netherlands, 3584 CX|
|Study Chair:||Daniel B Saris, MD, PhD||University Medical Center Utrecht, the Netherlands|