Genu VarumNCT01122017
A Modified (Retro-Tubercle) Opening Wedge High Tibial Osteotomy Versus the Conventional Technique
A study testing Retro-Tubercle Opening-Wedge High Tibial Osteotomy in people with Genu Varum, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial summary
The present study was conducted among a group of Iranian patients suffering from varus knee in order to compare advantages and disadvantages of ROWHTO (Retro-Tubercle Opening Wedge High Tibial Osteotomy) technique when compared with previously described approaches of opening-wedge osteotomy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Genu Varum
- What is being tested?
- Retro-Tubercle Opening-Wedge High Tibial Osteotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteIran
- Study dates
- Jan 2006to Nov 2008
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- symptomatic varus deformity of the knee with 2 or more degrees of anatomical axis varus without ligament injury
Who cannot join
- fractures through compartments of the knee or the patella
- osteoarthritis other than in the medial compartment
- 10 degrees or more extension lag
- tibial malrotation
Trial locations and contacts
1 site in 1 country.
Iran1 site
Shahid Beheshti University of Medical Sciences
Tehran, Tehran Province
About this study
The present study was conducted among a group of Iranian patients suffering from varus knee in order to compare advantages and disadvantages of ROWHTO (Retro-Tubercle Opening Wedge High Tibial Osteotomy) technique when compared with previously described approaches of opening-wedge osteotomy.
Read the detailed description
There are various methods for correcting varus deformity; therefore the best surgical method must be individualized. We concluded that in a varus knee where only correction in the coronal plane without patella infra, changes in Q- angle, tibial plateau inclination is all that is needed, a retro- tubercle medial opening- wedge osteotomy is the preferred approach.
- Conditions
- Genu Varum
- Being tested
- Retro-Tubercle Opening-Wedge High Tibial Osteotomy
- Medical subject headings
- Genu Varum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retro-Tubercle Opening-Wedge High Tibial OsteotomyProcedure or surgery
Retro-Tubercle Opening-Wedge High Tibial Osteotomy (ROWHTO) is among the latest approaches for the treatment of varus deformity of knee.
| Study group | Role | What they receive |
|---|---|---|
| Medial Opening-Wedge Osteotomy | Experimental | Medial Opening-Wedge Osteotomy (MOWO) is an approach for the correction of malalignment of the knee Receives: Procedure: Retro-Tubercle Opening-Wedge High Tibial Osteotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patellar length (in mm)to the patellar tendon length (in mm)
The length of the patella (in its longest diameter on a lateral x-ray) to the length of the patellar tendon is referred as Insall-Salvati index
Measured: up to 13 months
The proportion of patellar articular surface length (in mm)to the patella-tibial plateau distance (in mm)
The length of the articular surface of the patella to the distance from the patella to the tibial plateau is referred as Blackburne-Peel index.
Measured: up to 13 months
Secondary outcomes (2)
Quadriceps angle in degree
The angle between the quadriceps vector and the line of pull of the patellar tendon from the centre of the patella to the tibial tubercle.
Measured: up to 13 months
Inclination of proximal tibial plateau in degree
The angle between articular surface and lateral longitudinal axis of tibia.
Measured: up to 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2010 (estimated)
- Study startJan 2006
- Primary completionFeb 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genu VarumStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Mohammad Reza Abbasian, Dr., Principal investigator, Shahid Beheshti University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01122017
- Sponsor's protocol ID
- SBMU-400/435
- Status last verified
- Apr 2010
- First submitted
- 1 Dec 2009
- Last updated
- 13 May 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Modified (Retro-Tubercle) Opening Wedge High Tibial Osteotomy Versus the Conventional Technique
- ClinicalTrials.gov ID
- NCT01122017
- Acronym / sponsor ID
- SBMU-400/435
- Conditions
- Genu Varum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Feb 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 12 May 2010 (estimated)
- 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.
The present study was conducted among a group of Iranian patients suffering from varus knee in order to compare advantages and disadvantages of ROWHTO (Retro-Tubercle Opening Wedge High Tibial Osteotomy) technique when compared with previously described approaches of opening-wedge osteotomy.
Detailed description
There are various methods for correcting varus deformity; therefore the best surgical method must be individualized. We concluded that in a varus knee where only correction in the coronal plane without patella infra, changes in Q- angle, tibial plateau inclination is all that is needed, a retro- tubercle medial opening- wedge osteotomy is the preferred approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Medial Opening-Wedge Osteotomy | Experimental | Procedure: Retro-Tubercle Opening-Wedge High Tibial OsteotomyMedial Opening-Wedge Osteotomy (MOWO) is an approach for the correction of malalignment of the knee |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- symptomatic varus deformity of the knee with 2 or more degrees of anatomical axis varus without ligament injury
Key exclusion criteria (4 listed)
- fractures through compartments of the knee or the patella
- osteoarthritis other than in the medial compartment
- 10 degrees or more extension lag
- tibial malrotation
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 |
|---|---|---|
| Retro-Tubercle Opening-Wedge High Tibial OsteotomyRetro-Tubercle Opening-Wedge High Tibial Osteotomy (ROWHTO) is among the latest approaches for the treatment of varus deformity of knee. | Procedure or surgery | Medial Opening-Wedge Osteotomy |
Primary outcome
The proportion of patellar length (in mm)to the patellar tendon length (in mm)
Time frame: up to 13 months
The length of the patella (in its longest diameter on a lateral x-ray) to the length of the patellar tendon is referred as Insall-Salvati index
The proportion of patellar articular surface length (in mm)to the patella-tibial plateau distance (in mm)
Time frame: up to 13 months
The length of the articular surface of the patella to the distance from the patella to the tibial plateau is referred as Blackburne-Peel index.
2 secondary outcomes
Quadriceps angle in degree
Time frame: up to 13 months
Inclination of proximal tibial plateau in degree
Time frame: up to 13 months
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 13 May 2010.
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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.
Mohammad Reza Abbasian, Dr. principal investigator
Shahid Beheshti University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Retro-Tubercle Opening-Wedge High Tibial Osteotomy in people with Genu Varum, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
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 4 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 13 May 2010. 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 Iran. 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?
The proportion of patellar length (in mm)to the patellar tendon length (in mm) (time frame: up to 13 months). The study lists 2 primary outcomes in all. 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 13 May 2010.