Genu VarumNCT03065738
Effect of RO On GB During TKR Severe Varus Deformity
A study testing tibial reduction osteotomy in total knee replacement in people with Genu Varum and Knee Osteoarthritis, run by Assiut University at 1 site in Egypt.
Trial summary
Effect Of Reduction Osteotomy On Gap Balancing During Total Knee Replacement For Severe Varus Deformity Read more about this study
- Who is it for?
- Ages 55 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Genu Varum, Knee Osteoarthritis
- What is being tested?
- tibial reduction osteotomy in total knee replacement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2017to 1 Feb 2018
- 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 55 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with severe varus deformity more than 15 degrees (long film-mechanical axis)
- Patients with bone defect of medial tibial condyle
Who cannot join
- Patients with extra-articular deformity
- Patients with valgus deformity
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assiut University School of medicine Vice Dean for Research and Post-Graduate Studies
Asyut, 71515
Yasser Khalifa, MD, 002-01005673622, Ykhalifa67@hotmail.com
Hatem Bakr, MD, 002-01001010830, hatem_bakr@hotmail.com
About this study
Official title: Effect Of Reduction Osteotomy On Gap Balancing During Total Knee Replacement For Severe Varus Deformity
Effect Of Reduction Osteotomy On Gap Balancing During Total Knee Replacement For Severe Varus Deformity
Read the detailed description
Severe varus deformity with a tibio femoral angle of 15° or more as measured on full-length weight-bearing radiographs necessitates extensive release of the medial structures to gain neutral limb alignment during total knee arthroplasty (TKA). progressive releases of the medial structures are performed until medial and lateral envelopes are equally balanced. This technique, however, faces a risk of over-release and subsequent instability, ultimately resulting in the use of a thicker polyethylene insert or even a constrained-type prosthesis. Reduction osteotomy is known as a soft tissue-sparing technique for soft tissue balancing, and it is capable of reducing the amount of release required to balance the knee and of preventing over release of medial structures. Dixon et al . and Mullaji et al . proposed the effectiveness of down-sizing the tibial component in the case of knees with severe varus deformity Aim of the work: Assess the effect of reduction osteotomy on gab balancing during total knee arthroplasty for severe varus deformity -What is the amount of deformity correction achieved with reduction osteotomy during TKA in varus knees? - What is the correlation of amount of deformity correction achieved to the amount of bone osteotomized and the degree of varus deformity?
- Conditions
- Genu Varum, Knee Osteoarthritis
- Being tested
- tibial reduction osteotomy in total knee replacement
- Keywords
- reduction osteotomy, knee arthroplasty
- Medical subject headings
- Genu Varum, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tibial reduction osteotomy in total knee replacementOther
reduction osteotomy :downsizing of tibial tray with lateralization
| Study group | Role | What they receive |
|---|---|---|
| osteoarthritis knee ,severe varus deformity | Experimental | reduction osteotomy in total knee replacement Receives: Other: tibial reduction osteotomy in total knee replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
HKA angle
standing A.P radiograph
Measured: immediate post operative
Secondary outcomes (1)
functional outcome by knee society score
by knee society score
Measured: one year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2017
- Study start1 Jan 2017
- Primary completion1 Jan 2018 (estimated)
- Study completion1 Feb 2018 (estimated)
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.
- More trials run by Assiut 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasser E khalifa, Assiut University
- Investigators
- Hatem Bakr, MD, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03065738
- Sponsor's protocol ID
- Alaa Safwat Taha
- Status last verified
- Feb 2017
- First submitted
- 31 Jan 2017
- Last updated
- 13 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Reduction Osteotomy On Gap Balancing During Total Knee Replacement For Severe Varus Deformity
- ClinicalTrials.gov ID
- NCT03065738
- Acronym / sponsor ID
- Alaa Safwat Taha
- Conditions
- Genu Varum, Knee Osteoarthritis
- Keywords
- reduction osteotomy, knee arthroplasty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jan 2018 (estimated)
- Study completion
- 1 Feb 2018 (estimated)
- First posted
- 28 Feb 2017 (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.
Effect Of Reduction Osteotomy On Gap Balancing During Total Knee Replacement For Severe Varus Deformity
Detailed description
Severe varus deformity with a tibio femoral angle of 15° or more as measured on full-length weight-bearing radiographs necessitates extensive release of the medial structures to gain neutral limb alignment during total knee arthroplasty (TKA). progressive releases of the medial structures are performed until medial and lateral envelopes are equally balanced. This technique, however, faces a risk of over-release and subsequent instability, ultimately resulting in the use of a thicker polyethylene insert or even a constrained-type prosthesis. Reduction osteotomy is known as a soft tissue-sparing technique for soft tissue balancing, and it is capable of reducing the amount of release required to balance the knee and of preventing over release of medial structures. Dixon et al . and Mullaji et al . proposed the effectiveness of down-sizing the tibial component in the case of knees with severe varus deformity Aim of the work: Assess the effect of reduction osteotomy on gab balancing during total knee arthroplasty for severe varus deformity -What is the amount of deformity correction achieved with reduction osteotomy during TKA in varus knees? - What is the correlation of amount of deformity correction achieved to the amount of bone osteotomized and the degree of varus deformity?
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| osteoarthritis knee ,severe varus deformity | Experimental | Other: tibial reduction osteotomy in total knee replacementreduction osteotomy in total knee replacement |
Who may qualify
- Ages
- 55 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with severe varus deformity more than 15 degrees (long film-mechanical axis)
- Patients with bone defect of medial tibial condyle
Key exclusion criteria (2 listed)
- Patients with extra-articular deformity
- Patients with valgus deformity
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 |
|---|---|---|
| tibial reduction osteotomy in total knee replacementreduction osteotomy :downsizing of tibial tray with lateralization | Other | osteoarthritis knee ,severe varus deformity |
Primary outcome
HKA angle
Time frame: immediate post operative
standing A.P radiograph
1 secondary outcome
functional outcome by knee society score
Time frame: one year follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Genu Varum
Active, not recruitingObservational study
Evaluation of Medium Cross-linked Polyethylene With and Without Vitamin E for Total Knee Arthroplasty
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Radiological Comparison Between Single-Leg and Double-Leg Stance in the Assessment of Genu Varum: Pre- and Postoperative Evaluation and Functional Outcomes
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Kinematic vs Mechanical Alignment in High Tibial Osteotomy
Osteo Arthritis of the Knee, Genu Varum
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TO Plate Fixation vs. External Fixator Comparison (HTO Plate vs. ExFix Study)
Medial Compartment Osteoarthritis, Genu Varum
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Effects of Hip Blood Flow Restriction and Shockwave Therapy on Q-Angle and Plantar Pressure in Adults With Genu Varum
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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.
Hatem Bakr, MD study director
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tibial reduction osteotomy in total knee replacement in people with Genu Varum and Knee Osteoarthritis, run by Assiut University at 1 site in Egypt.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 13 Mar 2017. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alaa Safwat, Msc (002-01067655744, alaasafwat84@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HKA angle (time frame: immediate post operative). 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 Mar 2017.