Should a patient with medial knee osteoarthritis be operated? A RCT
- Conditions
- arthrosisosteoarthritis10023213
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 124
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.
OA of lateral compartment, rheumatoid arthritis, grade-3 collateral ligament laxity, range of motion of < 100°, a flexion contracture 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint of the study is the knee pain after one year of follow-up<br /><br>assessed with the pain subscale of the Knee injury and Osteoarthritis Outcome<br /><br>Score. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints in the study are difference in the following outcome<br /><br>parameters: pain severity (Numerical Rating scale; NRS), other KOOS subscales,<br /><br>Hospital for Special Surgery scale (HSS), quality of life (EQ5-D), and physical<br /><br>activity scores (SQUASH). Other outcomes are pain medication use, side effects,<br /><br>difference in direct and indirect costs (PRODISC), change in cartilage quality<br /><br>of the medial and lateral compartment of the tibia (semi-quantitative and<br /><br>quantitative MRI scores), changes of bone mineral density of the medial and<br /><br>lateral compartment of the tibia (DXA scan), mechanical axis of the limb (whole<br /><br>leg radiographs) and serum and urine (osteoarthritis biomarker, genetic<br /><br>profile) will be collected and bone remodelling activity (SPECT CT scan).</p><br>