Safety of Bilateral HTO: One-Stage vs.Two-Stage: A Randomized Controlled Study

Study Overview
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Brief Summary
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In this study, bilateral simultaneous high tibial osteotomy (HTO) was compared with staged bilateral HTO in terms of complications. We did not use any grafts to support the osteotomy line and the patients were mobilized immediately with a full load on a postoperative day 1. And our hypothesis is that bilateral simultaneous applications are safe in comparison to the staged ones in terms of complications.

Detailed Description
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Knee osteoarthritis is the most common orthopedic chronic disease, and varus knee abnormalities can often be related. The load from the medial tibiofemoral joint increases significantly in varus alignment disorder and it plays an important role in the structural progression of knee osteoarthritis. Varus malalignment and patients with medial tibiofemoral disease comprise a common patient subset. The probability of progressing to severe disease is 3 to 4 times higher in these patients compared to those with a neutral knee alignment. Although the long-term results of high tibial osteotomy are well documented, but data on bilateral simultaneous HTO are insufficient. In general, staged surgery is preferred in bilateral cases due to the difficult rehabilitation, healing of the osteotomy line, and complications related to surgery. Advances in post-surgical rehabilitation have been made due to increased confidence in stability due to improvements in the technology of plates.The advantages of an bilateral simulatneous HTO is single administration of anesthesia, total shortening of the hospitalization periof and reduced costs.

Official Title
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Safety of Bilateral HTO: One-Stage vs.Two-Stage: A Randomized Controlled Study

Conditions
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Gonarthrosis; Primary, Varus Gonarthrosis

Intervention / Treatment
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* Procedure: simultaneous bilateral high tibial osteotomy
* Procedure: Staged bilateral high tibial osteotomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Bilateral primary genu varus gonarthrosis Exclusion Criteria: Secondary gonarthrosis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Simultaneous<br>One-stage bilateral high tibial osteotomy | Procedure: simultaneous bilateral high tibial osteotomy<br>* One-stage simultaneous bilateral high tibial osteotomy<br>|
| Staged<br>Two-stage bilateral high tibial osteotomy | Procedure: Staged bilateral high tibial osteotomy<br>* Two-stage bilateral high tibial osteotomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications | Total complications rate | 2 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiologic assesment | Changes in corrections degree | 2 year |