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

Completed

• Conditions: Varus Gonarthrosis; Gonarthrosis; Primary
• Interventions: Procedure: simultaneous bilateral high tibial osteotomy; Procedure: Staged bilateral high tibial osteotomy

• Registration Number: NCT04399304
• Lead Sponsor: Bezmialem Vakif University

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-11-19
• Primary Completion: 2019-12-19
• Status Verified: 2020-05
• Study Completion: 2020-05-19
• Study First Submitted: 2020-05-19
• Study First Submitted QC: 2020-05-19
• Last Update Submitted: 2020-05-19
• Study First Posted: 2020-05-22
• Last Update Posted: 2020-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• Bilateral primary genu varus gonarthrosis

Exclusion Criteria

• Secondary gonarthrosis

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Simultaneous	simultaneous bilateral high tibial osteotomy	One-stage bilateral high tibial osteotomy
Staged	Staged bilateral high tibial osteotomy	Two-stage bilateral high tibial osteotomy

Primary Outcome Measures

Name	Time	Method
Complications	2 year	Total complications rate

Secondary Outcome Measures

Name	Time	Method
Radiologic assesment	2 year	Changes in corrections degree

Trial Locations

Locations (1)

Bezmialem Vakif University; 🇹🇷 Istanbul, Fatih, Turkey