Effects of Osteotomies Around the Knee on Cartilage Glycosaminoglycan Content Using dGEMRIC Non-invasive Imaging
Condition: Medial Compartment Osteoarthritis of the Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Observational

Summary: 
      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.
    

Detailed description: 
      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.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        All patients above 18 years with osteoarthritis of the knee and a future planned osteotomy
        of the tibia or femur are eligible for participation in this study.
      
Keywords: osteoarthritis; knee; high wedge tibial osteotomy; dGEMRIC