Osteoarthritis
Conditions
Brief summary
A prospective, randomised, controlled trial compared two different techniques of high tibial osteotomy with a lateral closing wedge or a medial opening wedge, stabilised by a Puddu plate. The clinical outcome and radiological results were examined at one year.
Detailed description
A prospective, randomised, controlled trial compared two different techniques of high tibial osteotomy with a lateral closing wedge or a medial opening wedge, stabilised by a Puddu plate. The clinical outcome and radiological results were examined at one year. The primary outcome measure was the achievement of an overcorrection of valgus of 4°. Secondary outcome measures were the severity of pain (visual analogue scale), knee function (Hospital for Special Surgery score), and walking distance.
Interventions
PROCEDUREOpening-wedge HTO
Opening-wedge high tibial osteotomy fixated with a Puddu plate
PROCEDUREClosing-wedge HTO
Closing-wedge high tibial osteotomy fixated with two staples
Sponsors
Erasmus Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Radiological OA, medial joint pain and varus malalignment
Exclusion criteria
* Symptomatic OA of the lateral compartment, rheumatoid arthritis, ROM \<100, collateral ligament laxity, history of fracture of previous open operation of the lower limb and a flexion contracture \> 10 degrees.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The achievement of an overcorrection of valgus of 4°. | one year | The achieved correction will be determined on a whole leg radiograph. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severity of pain | one year | Severity of pain will be measured with the visual analogue scale |
| Knee function | one year | Knee function will be measured with the Hospital for Special Surgery score |
| Walking distance | one year | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with adverse events | one year | Number of participants with adverse events; infection, loss of correction, hardware removal, implant failure, pseudoarthrosis, peroneal nerve injury. |
Countries
Netherlands
Outcome results
None listed