Patients, age 18–60, with isolated medial compartment osteoarthritis (OA), concomitant with a varus mechanical axis of the knee, good range of motion and limited ligamentous knee laxity.
Conditions
Interventions
1. Group A: Medial open wedge high tibial osteotomy
2. Group B: Lateral closed wedge high tibial osteotomy.
Both techniques using locking plate fixation and with identical postoperative care.
Sponsors
Erasmus University Medical Center
Rotterdam
The Netherlands
Eligibility
Inclusion criteria
Inclusion criteria: 1. Knee pain located over the medial tibiofemoral compartment of the knee; 2. 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); 3. Radiographic signs of knee OA, defined by a Kellgren & Lawrence score of grade 1-3; 4. Presence of varus malalignment as measured on a whole leg radiograph.
Exclusion criteria
Exclusion criteria: 1. OA of the lateral compartment; 2. Grade-3 collateral ligament laxity; 3. Range of motion of 10°; 5. History of fracture or previous open operation of the lower limb; 6. ACL rupture; 7. Rheumatoid arthritis; 8. 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; 9. Patients from whom it is not sure that they will be able to attend the follow-up measurements; 10. 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, and 24 months postoperatively. | — |
Contacts
Public ContactM. Reijman
Department of Orthopedics PO box 2040
Outcome results
None listed