Changes in Knee Measurements Between Egyptian and Western PopulationkneeNCT03622034
Knee Posterior Femoral Condylar Offset and Tibial Slope of the Egyptian Population
An observational study of Changes in Knee Measurements Between Egyptian and Western Population, run by Assiut University.
Trial summary
this study is to compare the posterior condylar offset , posterior condylar offset ratio and tibial slope of Egyptian population with Asian and Western results.These results may be important to examine if contemporary total knee arthroplasty components match the anatomy of Egyptian populations or they are… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Changes in Knee Measurements Between Egyptian and Western Population
- What is being tested?
- posterior condylar offset measurement
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2018to 1 Dec 2019
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: all adult cases who have proper lateral knee x ray on the registery system of Assiut University Hospital , will be collected. These x rays will be used in this study as posterior condylar offset, posterior condylar offset ratio and tibial slope will be measured on these x rays
Who may be able to join
- Proper lateral knee x ray of adult cases
Who cannot join
- 1. Improper x ray projection
- 2. Retained hardware
- 3. Malunited distal or upper tibia fracture
Trial locations and contacts
No sites are listed yet.
About this study
this study is to compare the posterior condylar offset , posterior condylar offset ratio and tibial slope of Egyptian population with Asian and Western results.These results may be important to examine if contemporary total knee arthroplasty components match the anatomy of Egyptian populations or they are significantly different with the need of different prosthesis designs and geometrics.
Read the detailed description
Lateral knee x rays will be collected from the registry system of Assiut University Hospital through Paxera pacs system . Posterior condylar offset, posterior condylar offset ratio and tibial slope will be measured from the x rays.
In the sagittal plane, the femoral long axis will be drawn with equal distance to the anterior-posterior edges of the femoral shaft. One line will be drawn parallel to the anterior femoral shaft cortex and another parallel to the posterior femoral shaft cortex. A third line will be drawn parallel to the posterior femoral shaft cortex line, but tangent to the most posterior femoral condyles to represent the posterior condylar tangent line. The anterior-posterior dimension of the distal femur is defined as the distance between the anterior femoral shaft cortex line and the posterior femoral condyle tangent line . The posterior femoral condyle offset (PCO) is determined as the distance between the posterior femoral shaft cortex line and the posterior femoral condyle line, that is noted as PCO .The posterior femoral condyle offset ratio (PCOR) is calculated as the ratio of the posterior femoral condyle offset and the anterior-posterior dimension of the distal femur, i.e., PCO/ACP.
Tibial slope will be measured as follows; the tangent to the medial tibial plateau is considered to be the proximal reference line. This is the line connecting the highest anterior and posterior points of the medial plateau. The second reference is the axis of the tibia, defined as a line through the middle of the shaft at 10 and 20 cm. The angle between these two lines is the tibial slope.
Data of the cases will be collected as name, age and gender. The results will be collected and will be compared with those of Asian and Western results. These results may be important to examine if contemporary TKA components match the anatomy of Egyptian populations or they are significantly different with the need of different prosthesis designs and geometrics.
- Being tested
- posterior condylar offset measurement
- Keywords
- knee features, ethnic changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
posterior condylar offset measurementOther
Also called tibial slope measurement
the tangent to the medial tibial plateau is considered to be the proximal reference line. This is the line connecting the highest anterior and posterior points of the medial plateau. The second reference is the axis of the tibia, defined as a line through the middle of the shaft at 10 and 20 cm. The angle between these two lines is the tibial slope
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure posterior condylar offset in the Egyptian population
posterior condylar offset will be measured in a sample of the egyptian people to get the mean measure of posterior condylar offset in the egyptian people
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start1 Sep 2018 (estimated)
- Primary completion1 Sep 2019 (estimated)
- Study completion1 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Changes in Knee Measurements Between Egyptian and Western PopulationStudies 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MBMady, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03622034
- Sponsor's protocol ID
- knee measures
- Acronym
- knee
- Status last verified
- Aug 2018
- First submitted
- 28 Jul 2018
- Last updated
- 9 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kwak DS, Tao QB, Todo M, Jeon I. Determination of representative dimension parameter values of Korean knee joints for knee joint implant design. Proc Inst Mech Eng H. 2012 May;226(5):368-76. doi: 10.1177/0954411912442025.
PubMed 22720389Mahfouz M, Abdel Fatah EE, Bowers LS, Scuderi G. Three-dimensional morphology of the knee reveals ethnic differences. Clin Orthop Relat Res. 2012 Jan;470(1):172-85. doi: 10.1007/s11999-011-2089-2.
PubMed 21948324Bellemans J, Carpentier K, Vandenneucker H, Vanlauwe J, Victor J. The John Insall Award: Both morphotype and gender influence the shape of the knee in patients undergoing TKA. Clin Orthop Relat Res. 2010 Jan;468(1):29-36. doi: 10.1007/s11999-009-1016-2. Epub 2009 Aug 8.
PubMed 19669385Conley S, Rosenberg A, Crowninshield R. The female knee: anatomic variations. J Am Acad Orthop Surg. 2007;15 Suppl 1:S31-6. doi: 10.5435/00124635-200700001-00009.
PubMed 17766787DiBennardo R, Taylor JV. Sex assessment of the femur: a test of a new method. Am J Phys Anthropol. 1979 May;50(4):635-7. doi: 10.1002/ajpa.1330500415.
PubMed 464035Leszko F, Hovinga KR, Lerner AL, Komistek RD, Mahfouz MR. In vivo normal knee kinematics: is ethnicity or gender an influencing factor? Clin Orthop Relat Res. 2011 Jan;469(1):95-106. doi: 10.1007/s11999-010-1517-z.
PubMed 20814773Abdelnasser MK, Abdelhameed MA, Bassem M, Adam MF, Bakr HM, Khalifa YE. Sexual dimorphism of the posterior condylar offset of the femur and the medial posterior slope of the tibia in non-arthritic knees of Egyptian adults: an MRI study. J Orthop Surg Res. 2023 May 12;18(1):353. doi: 10.1186/s13018-023-03833-2.
PubMed 37173701Abdelnasser MK, Khalifa AA, Bassem M, Abdelhameed MA, Adam MF, Bakr HM, Khalifa YE. Anthropometric measurements of non-arthritic knees in an Egyptian population: an MRI-based study. J Orthop Surg Res. 2021 Sep 8;16(1):552. doi: 10.1186/s13018-021-02708-8.
PubMed 34496904
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Knee Posterior Femoral Condylar Offset and Tibial Slope of the Egyptian Population
- ClinicalTrials.gov ID
- NCT03622034
- Acronym / sponsor ID
- knee / knee measures
- Keywords
- knee features, ethnic changes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2018 (estimated)
- Primary completion
- 1 Sep 2019 (estimated)
- Study completion
- 1 Dec 2019 (estimated)
- First posted
- 9 Aug 2018 (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.
this study is to compare the posterior condylar offset , posterior condylar offset ratio and tibial slope of Egyptian population with Asian and Western results.These results may be important to examine if contemporary total knee arthroplasty components match the anatomy of Egyptian populations or they are significantly different with the need of different prosthesis designs and geometrics.
Detailed description
Lateral knee x rays will be collected from the registry system of Assiut University Hospital through Paxera pacs system . Posterior condylar offset, posterior condylar offset ratio and tibial slope will be measured from the x rays.
In the sagittal plane, the femoral long axis will be drawn with equal distance to the anterior-posterior edges of the femoral shaft. One line will be drawn parallel to the anterior femoral shaft cortex and another parallel to the posterior femoral shaft cortex. A third line will be drawn parallel to the posterior femoral shaft cortex line, but tangent to the most posterior femoral condyles to represent the posterior condylar tangent line. The anterior-posterior dimension of the distal femur is defined as the distance between the anterior femoral shaft cortex line and the posterior femoral condyle tangent line . The posterior femoral condyle offset (PCO) is determined as the distance between the posterior femoral shaft cortex line and the posterior femoral condyle line, that is noted as PCO .The posterior femoral condyle offset ratio (PCOR) is calculated as the ratio of the posterior femoral condyle offset and the anterior-posterior dimension of the distal femur, i.e., PCO/ACP.
Tibial slope will be measured as follows; the tangent to the medial tibial plateau is considered to be the proximal reference line. This is the line connecting the highest anterior and posterior points of the medial plateau. The second reference is the axis of the tibia, defined as a line through the middle of the shaft at 10 and 20 cm. The angle between these two lines is the tibial slope.
Data of the cases will be collected as name, age and gender. The results will be collected and will be compared with those of Asian and Western results. These results may be important to examine if contemporary TKA components match the anatomy of Egyptian populations or they are significantly different with the need of different prosthesis designs and geometrics.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- all adult cases who have proper lateral knee x ray on the registery system of Assiut University Hospital , will be collected. These x rays will be used in this study as posterior condylar offset, posterior condylar offset ratio and tibial slope will be measured on these x rays
Key inclusion criteria (1 listed)
- Proper lateral knee x ray of adult cases
Key exclusion criteria (3 listed)
- 1. Improper x ray projection
- 2. Retained hardware
- 3. Malunited distal or upper tibia fracture
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 |
|---|---|---|
| posterior condylar offset measurementAlso: tibial slope measurementthe tangent to the medial tibial plateau is considered to be the proximal reference line. This is the line connecting the highest anterior and posterior points of the medial plateau. The second reference is the axis of the tibia, defined as a line through the middle of the shaft at 10 and 20 cm. The angle between these two lines is the tibial slope | Other | – |
Primary outcome
Measure posterior condylar offset in the Egyptian population
Time frame: one year
posterior condylar offset will be measured in a sample of the egyptian people to get the mean measure of posterior condylar offset in the egyptian people
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2018.
- Background: PubMed 22720389Kwak DS, Tao QB, Todo M, Jeon I. Determination of representative dimension parameter values of Korean knee joints for knee joint implant design. Proc Inst Mech Eng H. 2012 May;226(5):368-76. doi: 10.1177/0954411912442025.
- Background: PubMed 21948324Mahfouz M, Abdel Fatah EE, Bowers LS, Scuderi G. Three-dimensional morphology of the knee reveals ethnic differences. Clin Orthop Relat Res. 2012 Jan;470(1):172-85. doi: 10.1007/s11999-011-2089-2.
- Background: PubMed 19669385Bellemans J, Carpentier K, Vandenneucker H, Vanlauwe J, Victor J. The John Insall Award: Both morphotype and gender influence the shape of the knee in patients undergoing TKA. Clin Orthop Relat Res. 2010 Jan;468(1):29-36. doi: 10.1007/s11999-009-1016-2. Epub 2009 Aug 8.
- Background: PubMed 17766787Conley S, Rosenberg A, Crowninshield R. The female knee: anatomic variations. J Am Acad Orthop Surg. 2007;15 Suppl 1:S31-6. doi: 10.5435/00124635-200700001-00009.
- Background: PubMed 464035DiBennardo R, Taylor JV. Sex assessment of the femur: a test of a new method. Am J Phys Anthropol. 1979 May;50(4):635-7. doi: 10.1002/ajpa.1330500415.
- Background: PubMed 20814773Leszko F, Hovinga KR, Lerner AL, Komistek RD, Mahfouz MR. In vivo normal knee kinematics: is ethnicity or gender an influencing factor? Clin Orthop Relat Res. 2011 Jan;469(1):95-106. doi: 10.1007/s11999-010-1517-z.
- Derived from this study: PubMed 37173701Abdelnasser MK, Abdelhameed MA, Bassem M, Adam MF, Bakr HM, Khalifa YE. Sexual dimorphism of the posterior condylar offset of the femur and the medial posterior slope of the tibia in non-arthritic knees of Egyptian adults: an MRI study. J Orthop Surg Res. 2023 May 12;18(1):353. doi: 10.1186/s13018-023-03833-2.
- Derived from this study: PubMed 34496904Abdelnasser MK, Khalifa AA, Bassem M, Abdelhameed MA, Adam MF, Bakr HM, Khalifa YE. Anthropometric measurements of non-arthritic knees in an Egyptian population: an MRI-based study. J Orthop Surg Res. 2021 Sep 8;16(1):552. doi: 10.1186/s13018-021-02708-8.
- Individual participant dataSharing planned: Undecided
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Changes in Knee Measurements Between Egyptian and Western Population, run by Assiut University.
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 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: status not confirmed, as of the sponsor's last update on 9 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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 Michael B. Mady, M.B.B.ch (01004880799, michael24792@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure posterior condylar offset in the Egyptian population (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03622034, which also lists 8 linked publications.
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 9 Aug 2018.