Gonarthrosis; PrimaryNCT04399304
Safety of Bilateral HTO: One-Stage vs.Two-Stage: A Randomized Controlled Study
An observational study of Gonarthrosis; Primary and Varus Gonarthrosis, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Gonarthrosis; Primary, Varus Gonarthrosis
- What is being tested?
- simultaneous bilateral high tibial osteotomy and Staged bilateral high tibial osteotomy
- Type of treatment
- Surgery or procedure
- How many people
- 28 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Nov 2014to 19 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with bilateral genu varus gonarthrosis operated by the tertiary step hospital high-volume knee surgeons
Who may be able to join
- Bilateral primary genu varus gonarthrosis
Who cannot join
- Secondary gonarthrosis
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bezmialem Vakif University
Istanbul, Fatih, 34000
About this study
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.
Read the 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.
- Conditions
- Gonarthrosis; Primary, Varus Gonarthrosis
- Being tested
- simultaneous bilateral high tibial osteotomy, Staged bilateral high tibial osteotomy
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
simultaneous bilateral high tibial osteotomyProcedure or surgery
One-stage simultaneous bilateral high tibial osteotomy
Staged bilateral high tibial osteotomyProcedure or surgery
Two-stage bilateral high tibial osteotomy
| Study group | Role | What they receive |
|---|---|---|
| Simultaneous | One-stage bilateral high tibial osteotomy Receives: Procedure: simultaneous bilateral high tibial osteotomy | |
| Staged | Two-stage bilateral high tibial osteotomy Receives: Procedure: Staged bilateral high tibial osteotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications
Total complications rate
Measured: 2 year
Secondary outcomes (1)
Radiologic assesment
Changes in corrections degree
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2020
- Study start19 Nov 2014
- Primary completion19 Dec 2019
- Study completion19 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gonarthrosis; PrimaryStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Orkhan Aliyev, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04399304
- Sponsor's protocol ID
- 45446446-020-5169
- Status last verified
- May 2020
- First submitted
- 19 May 2020
- Last updated
- 22 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Bilateral HTO: One-Stage vs.Two-Stage: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04399304
- Acronym / sponsor ID
- 45446446-020-5169
- Conditions
- Gonarthrosis; Primary, Varus Gonarthrosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 19 Nov 2014 (actual)
- Primary completion
- 19 Dec 2019 (actual)
- Study completion
- 19 May 2020 (actual)
- First posted
- 22 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simultaneous | – | Procedure: simultaneous bilateral high tibial osteotomyOne-stage bilateral high tibial osteotomy |
| Staged | – | Procedure: Staged bilateral high tibial osteotomyTwo-stage bilateral high tibial osteotomy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with bilateral genu varus gonarthrosis operated by the tertiary step hospital high-volume knee surgeons
Key inclusion criteria (1 listed)
- Bilateral primary genu varus gonarthrosis
Key exclusion criteria (1 listed)
- Secondary gonarthrosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| simultaneous bilateral high tibial osteotomyOne-stage simultaneous bilateral high tibial osteotomy | Procedure or surgery | Simultaneous |
| Staged bilateral high tibial osteotomyTwo-stage bilateral high tibial osteotomy | Procedure or surgery | Staged |
Primary outcome
Complications
Time frame: 2 year
Total complications rate
1 secondary outcome
Radiologic assesment
Time frame: 2 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gonarthrosis; Primary and Varus Gonarthrosis, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complications (time frame: 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2020.