- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04399304
Safety of Bilateral HTO: One-Stage vs.Two-Stage: A Randomized Controlled Study
May 19, 2020 updated by: Orkhan Aliyev, Bezmialem Vakif University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
28
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Fatih
-
Istanbul, Fatih, Turkey, 34000
- Bezmialem Vakif University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with bilateral genu varus gonarthrosis operated by the tertiary step hospital high-volume knee surgeons
Description
Inclusion Criteria:
- Bilateral primary genu varus gonarthrosis
Exclusion Criteria:
- Secondary gonarthrosis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Simultaneous
One-stage bilateral high tibial osteotomy
|
One-stage simultaneous bilateral high tibial osteotomy
|
Staged
Two-stage bilateral high tibial osteotomy
|
Two-stage bilateral high tibial osteotomy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complications
Time Frame: 2 year
|
Total complications rate
|
2 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Radiologic assesment
Time Frame: 2 year
|
Changes in corrections degree
|
2 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 19, 2014
Primary Completion (Actual)
December 19, 2019
Study Completion (Actual)
May 19, 2020
Study Registration Dates
First Submitted
May 19, 2020
First Submitted That Met QC Criteria
May 19, 2020
First Posted (Actual)
May 22, 2020
Study Record Updates
Last Update Posted (Actual)
May 22, 2020
Last Update Submitted That Met QC Criteria
May 19, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 45446446-020-5169
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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