Safety of Bilateral HTO: One-Stage vs.Two-Stage: A Randomized Controlled Study
1 other identifier
observational
28
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Nov 2014
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 19, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 19, 2019
CompletedFirst Submitted
Initial submission to the registry
May 19, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 19, 2020
CompletedFirst Posted
Study publicly available on registry
May 22, 2020
CompletedMay 22, 2020
May 1, 2020
5.1 years
May 19, 2020
May 19, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Complications
Total complications rate
2 year
Secondary Outcomes (1)
Radiologic assesment
2 year
Study Arms (2)
Simultaneous
One-stage bilateral high tibial osteotomy
Staged
Two-stage bilateral high tibial osteotomy
Interventions
One-stage simultaneous bilateral high tibial osteotomy
Eligibility Criteria
Patients with bilateral genu varus gonarthrosis operated by the tertiary step hospital high-volume knee surgeons
You may qualify if:
- Bilateral primary genu varus gonarthrosis
You may not qualify if:
- Secondary gonarthrosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bezmialem Vakif University
Istanbul, Fatih, 34000, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, Resident Doctor in Orthopaedic Surgery
Study Record Dates
First Submitted
May 19, 2020
First Posted
May 22, 2020
Study Start
November 19, 2014
Primary Completion
December 19, 2019
Study Completion
May 19, 2020
Last Updated
May 22, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will not share