arthrosis osteoarthritis
Conditions
Interventions
Patients will be randomized in group (a) treatment with an orthopaedic
un-loader knee brace
or in group (b) a high tibial osteotomy.
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: knee pain located over the medial tibiofemoral compartment of the knee, knee pain for more than 3 months, with a severity of the knee pain of 3 on a NRS score or higher (range 0 to 10), radiographic signs of medial knee OA, defined by a Kellgren & Lawrence score of grade 1 or higher, and presence of varus malalignment as measured on a whole leg radiograph.
Exclusion criteria
Exclusion criteria: OA of lateral compartment, rheumatoid arthritis, grade-3 collateral ligament laxity, range of motion of 10°, history of fracture or previous open operation of the lower limb, patients that already used a orthopaedic knee brace for knee OA in the same knee, patients with a contralateral high tibial osteotomy will be excluded if the first knee has been included in this trial; thus, if both knees are symptomatic, only the first knee will be included, patients from whom it is not sure that they will be able to attend the follow-up measurements, insufficient command of the Dutch language, spoken and/or written.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study is the knee pain after one year of follow-up assessed with the pain subscale of the Knee injury and Osteoarthritis Outcome Score. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints in the study are difference in the following outcome parameters: pain severity (Numerical Rating scale; NRS), other KOOS subscales, Hospital for Special Surgery scale (HSS), quality of life (EQ5-D), and physical activity scores (SQUASH). Other outcomes are pain medication use, side effects, difference in direct and indirect costs (PRODISC), change in cartilage quality of the medial and lateral compartment of the tibia (semi-quantitative and quantitative MRI scores), changes of bone mineral density of the medial and lateral compartment of the tibia (DXA scan), mechanical axis of the limb (whole leg radiographs) and serum and urine (osteoarthritis biomarker, genetic profile) will be collected and bone remodelling activity (SPECT CT scan). | — |
Countries
Netherlands
Outcome results
None listed