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Accuracy of achieved correction of open versus closed wedge high tibial osteotomies, with locking plate fixatio

Phase 4
Completed
Conditions
arthrosis
multifactorial chronic joint disease
10023213
Registration Number
NL-OMON34209
Lead Sponsor
Erasmus MC, Universitair Medisch Centrum Rotterdam
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
124
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

OA of the lateral compartment, 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, 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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>The main endpoint of the study is difference between the pre-planned correction<br /><br>and the achieved correction both the hip-knee ankle angle and lateralisation of<br /><br>the mechanical axis. The goal of the osteotomy is to achieve a 3-4 degrees<br /><br>overcorrection (valgus) in the frontal plane (Hip Knee Ankle angle). The final<br /><br>achieved correction will be assessed at the whole leg radiograph 6 weeks<br /><br>postoperatively. </p><br>
Secondary Outcome Measures
NameTimeMethod
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