joint degeneration osteoarthritis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients with medial or lateral tibio-femoral compartmental OA considered for HTO according to regular clinical practice, Age
Exclusion criteria
Exclusion criteria: Mechanic axis-deviation of less than 10 degrees Psychological inabilities or difficult to instruct Not able to undergo MRI examination according to standard checklists Inflammatory or rheumatoid arthritis present or in history Post traumatic fibrosis due to fracture of the tibial plateau Bone-to-bone contact in the joint (absence of any joint space on X-ray) Surgical treatment of the involved knee
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Cartilage changes determined by decrease in area of denuded bone using quantitative MRI analyses (according to Eckstein) at 2 years (blinded evaluation). | — |
Secondary
| Measure | Time frame |
|---|---|
| - Cartilage changes determined by X-rays (joint space width using KIDA), additional quantitative MRI parameters (Eckstein), and biochemical markers analyses (blinded evaluation). - Clinical efficacy over time by self assessed questionnaire (KOOS score for pain, other symptoms, function in daily living, function in sports and recreation, and knee related quality of life) and VAS for pain (non-blinded). - Medical consumption and non-medical costs related to disease and treatment are estimated by a questionnaire (custom made). Quality of life is evaluated by questionnaires (EQ-5D) (non-blinded). | — |
Countries
Netherlands