Genu VarumNCT06288100
The Effect of Open Wedge High Tibial Osteotomy on the Posterior Tibial Slope In Skeletally Mature Patient
An observational study of Genu Varum, run by Al-Azhar University at 1 site in Egypt.
Trial summary
High tibial osteotomy has been established as an efficient surgical intervention for young patients with uni-compartmental osteoarthritis of the knee. The principle of this surgery involves the realignment of the lower extremity to shift the load distribution from the medial compartment into the lateral compartment… Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Genu Varum
- What is being tested?
- Observation
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 1 Jan 2024
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Data Collection: The study and patients were collected according to number of patients, sex, age, Bodi Mass Index , Range of Motion ,type of plate \& Screws used , Degree of deformity . Digital radiography, functional scores, software was used for statistical analysis. compare the Posterior Tibial Slope between the different Posterior Tibial Slope sides and sexes. One-way analysis of variance was used to compare the Posterior Tibial Slope between the different age groups. Posterior Tibial Slope was evaluated in all studies according to radiographic.
Who may be able to join
- Age: 20 : 65 years
- Genuvarus deformity
- 70° of range of motion
- Medial uni-compartmental osteoarthritis.
Who cannot join
- Posterior instability (relating to the posterior cruciate ligament)
- Body Mass Index under 30
- Sever Genuvarus > 20 degree
Trial locations and contacts
1 site in 1 country.
About this study
High tibial osteotomy has been established as an efficient surgical intervention for young patients with uni-compartmental osteoarthritis of the knee. The principle of this surgery involves the realignment of the lower extremity to shift the load distribution from the medial compartment into the lateral compartment, thus leading to a decrease in symptoms related to medial compartment knee Osteoarthritis However, medial opening wedge high tibial osteotomy is also known to affect the posterior tibial slope angle , and it is reported that posterior tibial slope angle increases after medial opening wedge high tibial osteotomy .
Read the detailed description
High tibial osteotomy has been established as an efficient surgical intervention for young patients with uni-compartmental osteoarthritis of the knee. Medial opening wedge high tibial osteotomy is a well established surgery for patients with medial compartment knee osteoarthritis its most notable advantages include the precision of intraoperative angular correction, absence of the risk of peroneal nerve palsy in fibular osteotomy, absence of leg shortening, and preservation of bone stock.
The principle of this surgery involves the realignment of the lower extremity to shift the load distribution from the medial compartment into the lateral compartment, thus leading to a decrease in symptoms related to medial compartment knee Osteoarthritis However, medial opening wedge high tibial osteotomy is also known to affect the posterior tibial slope angle , and it is reported that posterior tibial slope angle increases after medial opening wedge high tibial osteotomy .
Satisfactory outcomes after surgery require optimal realignment both in the sagittal and coronal planes; in fact, poor realignment could lead to unsatisfactory clinical outcomes. An unintentional increase in posterior tibial slope angle after medial opening wedge high tibial osteotomy may influence knee kinematics and stability in the sagittal plane, which could lead to anterior translation of the tibial plateau, anterior shift of the tibiofemoral contact area, and subsequent redistribution of pressure into the posterior tibial plateau (particularly in knees with injured anterior cruciate ligaments). These conditions could result in articular cartilage degradation and further knee disability
- Conditions
- Genu Varum
- Being tested
- Observation
- Medical subject headings
- Genu Varum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
- Measure changes in tibial slope after medial opening wedge High tibial osteotomy in Skeletally mature patient with unicompartmental osteoarthitis and genuvarus knee
- Evaluate the effect of tibial slope angle change on the clinical outcome at 1 year .
| Study group | Role | What they receive |
|---|---|---|
| Observations | number of patients, sex, age, Bodi Mass Index , Range of Motion ,type of plate \& Screws used , Degree of deformity .
Digital radiography (General Electric Healthcare ) functional scores software T-tests, One-way analysis of variance. Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Effect of Open Wedge High Tibial Osteotomy on the Posterior Tibial Slope In Skeletally Mature Patient
Measure changes in tibial slope after medial opening wedge High tibial osteotomy in Skeletally mature patient with unicompartmental osteoarthitis and genuvarus knee Evaluate the effect of tibial slope angle change on the clinical outcome at 1 year
Measured: Measure Posterior tibial slope by X Ray in Lateral View and Evaluate the effect of tibial slope angle change on the clinical outcome at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2024
- Study start1 Jan 2023
- Primary completion31 Dec 2023
- Study completion1 Jan 2024
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 Al-Azhar 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Abdelfattah Abbas, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06288100
- Sponsor's protocol ID
- OWHTOPTS
- Status last verified
- Feb 2024
- First submitted
- 15 Feb 2024
- Last updated
- 1 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Open Wedge High Tibial Osteotomy on the Posterior Tibial Slope In Skeletally Mature Patient
- ClinicalTrials.gov ID
- NCT06288100
- Acronym / sponsor ID
- OWHTOPTS
- Conditions
- Genu Varum
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 1 Mar 2024 (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.
High tibial osteotomy has been established as an efficient surgical intervention for young patients with uni-compartmental osteoarthritis of the knee. The principle of this surgery involves the realignment of the lower extremity to shift the load distribution from the medial compartment into the lateral compartment, thus leading to a decrease in symptoms related to medial compartment knee Osteoarthritis However, medial opening wedge high tibial osteotomy is also known to affect the posterior tibial slope angle , and it is reported that posterior tibial slope angle increases after medial opening wedge high tibial osteotomy .
Detailed description
High tibial osteotomy has been established as an efficient surgical intervention for young patients with uni-compartmental osteoarthritis of the knee. Medial opening wedge high tibial osteotomy is a well established surgery for patients with medial compartment knee osteoarthritis its most notable advantages include the precision of intraoperative angular correction, absence of the risk of peroneal nerve palsy in fibular osteotomy, absence of leg shortening, and preservation of bone stock.
The principle of this surgery involves the realignment of the lower extremity to shift the load distribution from the medial compartment into the lateral compartment, thus leading to a decrease in symptoms related to medial compartment knee Osteoarthritis However, medial opening wedge high tibial osteotomy is also known to affect the posterior tibial slope angle , and it is reported that posterior tibial slope angle increases after medial opening wedge high tibial osteotomy .
Satisfactory outcomes after surgery require optimal realignment both in the sagittal and coronal planes; in fact, poor realignment could lead to unsatisfactory clinical outcomes. An unintentional increase in posterior tibial slope angle after medial opening wedge high tibial osteotomy may influence knee kinematics and stability in the sagittal plane, which could lead to anterior translation of the tibial plateau, anterior shift of the tibiofemoral contact area, and subsequent redistribution of pressure into the posterior tibial plateau (particularly in knees with injured anterior cruciate ligaments). These conditions could result in articular cartilage degradation and further knee disability
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observations | – | Other: Observationnumber of patients, sex, age, Bodi Mass Index , Range of Motion ,type of plate \& Screws used , Degree of deformity . Digital radiography (General Electric Healthcare ) functional scores software T-tests, One-way analysis of variance. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Data Collection: The study and patients were collected according to number of patients, sex, age, Bodi Mass Index , Range of Motion ,type of plate \& Screws used , Degree of deformity . Digital radiography, functional scores, software was used for statistical analysis. compare the Posterior Tibial Slope between the different Posterior Tibial Slope sides and sexes. One-way analysis of variance was used to compare the Posterior Tibial Slope between the different age groups. Posterior Tibial Slope was evaluated in all studies according to radiographic.
Key inclusion criteria (4 listed)
- Age: 20 : 65 years
- Genuvarus deformity
- 70° of range of motion
- Medial uni-compartmental osteoarthritis.
Key exclusion criteria (3 listed)
- Posterior instability (relating to the posterior cruciate ligament)
- Body Mass Index under 30
- Sever Genuvarus > 20 degree
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 |
|---|---|---|
| Observation1. Measure changes in tibial slope after medial opening wedge High tibial osteotomy in Skeletally mature patient with unicompartmental osteoarthitis and genuvarus knee 2. Evaluate the effect of tibial slope angle change on the clinical outcome at 1 year . | Other | Observations |
Primary outcome
The Effect of Open Wedge High Tibial Osteotomy on the Posterior Tibial Slope In Skeletally Mature Patient
Time frame: Measure Posterior tibial slope by X Ray in Lateral View and Evaluate the effect of tibial slope angle change on the clinical outcome at 1 year
Measure changes in tibial slope after medial opening wedge High tibial osteotomy in Skeletally mature patient with unicompartmental osteoarthitis and genuvarus knee Evaluate the effect of tibial slope angle change on the clinical outcome at 1 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 1 Mar 2024.
Related trials for Genu Varum
Active, not recruitingObservational study
Evaluation of Medium Cross-linked Polyethylene With and Without Vitamin E for Total Knee Arthroplasty
Osteoarthritis, Knee, Arthritis, Rheumatoid
Not yet recruitingObservational study
Radiological Comparison Between Single-Leg and Double-Leg Stance in the Assessment of Genu Varum: Pre- and Postoperative Evaluation and Functional Outcomes
Genu Varum
Not yet recruiting
Kinematic vs Mechanical Alignment in High Tibial Osteotomy
Osteo Arthritis of the Knee, Genu Varum
Not yet recruiting
TO Plate Fixation vs. External Fixator Comparison (HTO Plate vs. ExFix Study)
Medial Compartment Osteoarthritis, Genu Varum
Not yet recruiting
Effects of Hip Blood Flow Restriction and Shockwave Therapy on Q-Angle and Plantar Pressure in Adults With Genu Varum
Genu Varum
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 Genu Varum, run by Al-Azhar 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 4 inclusion and 3 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 1 Mar 2024. 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?
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 Effect of Open Wedge High Tibial Osteotomy on the Posterior Tibial Slope In Skeletally Mature Patient (time frame: Measure Posterior tibial slope by X Ray in Lateral View and Evaluate the effect of tibial slope angle change on the clinical outcome at 1 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 1 Mar 2024.