"arthrosis" "multifactorial chronic joint disease"
Conditions
Interventions
A Randomized Control Trial comparing open and closed wedge HTO*s, both using
locking plate fixation and with identical postoperative care.
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 more than 20 mm on a VAS score (range 0 to 100 mm), radiographic signs of knee OA, defined by a Kellgren & Lawrence score of grade 1-3, and presence of varus malalignment as measured on a whole leg radiograph.
Exclusion criteria
Exclusion criteria: OA of the lateral compartment, grade-3 collateral ligament laxity, range of motion of 10°, history of fracture or previous open operation of the lower limb, ACL rupture, rheumatoid arthritis, patients with a contralateral HTO 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 main endpoint of the study is difference between the pre-planned correction and the achieved correction both the hip-knee ankle angle and lateralisation of the mechanical axis. The goal of the osteotomy is to achieve a 3-4 degrees overcorrection (valgus) in the frontal plane (Hip Knee Ankle angle). The final achieved correction will be assessed at the whole leg radiograph 6 weeks postoperatively. | — |
Secondary
| Measure | Time frame |
|---|---|
| Difference in the following outcome parameter after 6 weeks, 12 and 24 months and 5 years, in pain severity (Visual Analogue Scale; VAS), Knee injury and Osteoarthritis Outcome Score (KOOS), Hospital for Special Surgery scale (HSS). Also difference in complications, side effects, and medicine consumption will be assessed. A blinded physical examination (bandage over the whole proximal tibia) of the knee will be performed (stability of the medial and lateral collateral ligaments, and range of motion). A true lateral radiograph of the knee in at least 30 degrees of flexion will be used to determine the length of the patella tendon according to Insall-Salvati (IS ratio). The posterior inclination angle of the tibia plateau (PI) will be measured on a lateral radiograph according to Moore-Harvey. Bone mineral density of the medial and lateral compartment of the tibia (predefined regions of interest) will be assessed by DXA scan. A DXA scan will be performed preoperatively and postoperatively at 6 weeks, 12 and 24 months. Whole leg radiographs will be made preoperatively and direct postoperatively, followed by 6 weeks, 24 months, and five years postoperatively. | — |
Countries
Netherlands
Outcome results
None listed