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

Gonarthrosis; Primary Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04399304
• Other study ID #: 45446446-020-5169
• Status: Completed
• Start date: November 19, 2014
• Est. completion date: May 19, 2020

Study information

• Verified date: May 2020
• Source: Bezmialem Vakif University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: May 19, 2020
• Est. primary completion date: December 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Bilateral primary genu varus gonarthrosis

Exclusion Criteria:

• Secondary gonarthrosis

Related Conditions & MeSH terms

• Gonarthrosis; Primary
• Osteoarthritis
• Osteoarthritis, Knee
• Varus Gonarthrosis

Intervention

Procedure:
• simultaneous bilateral high tibial osteotomy
One-stage simultaneous bilateral high tibial osteotomy
• Staged bilateral high tibial osteotomy
Two-stage bilateral high tibial osteotomy

Locations

Country	Name	City	State
Turkey	Bezmialem Vakif University	Istanbul	Fatih

Sponsors (1)

Lead Sponsor	Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complications	Total complications rate	2 year
Secondary	Radiologic assesment	Changes in corrections degree	2 year