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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04399304
Enrollment
28
Registered
2020-05-22
Start date
2014-11-19
Completion date
2020-05-19
Last updated
2020-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gonarthrosis; Primary, Varus Gonarthrosis

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.

Interventions

PROCEDUREsimultaneous bilateral high tibial osteotomy

One-stage simultaneous bilateral high tibial osteotomy

PROCEDUREStaged bilateral high tibial osteotomy

Two-stage bilateral high tibial osteotomy

Sponsors

Bezmialem Vakif University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Bilateral primary genu varus gonarthrosis

Exclusion criteria

* Secondary gonarthrosis

Design outcomes

Primary

MeasureTime frameDescription
Complications2 yearTotal complications rate

Secondary

MeasureTime frameDescription
Radiologic assesment2 yearChanges in corrections degree

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026