HealthyNCT04355182
Is Standard 3-degree of External Rotation for Posterior Femoral Cut Relevant for Turkish Population
An observational study of Healthy, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate the posterior condylar angle of the distal femur in Turkish population and its concordance with the current standard prosthesis designs used in total knee arthroplasty and to evaluate anthropometric features of the distal femur in the Turkish population. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2020to 12 Apr 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healty subjects with Turkish ethnic orijin
Who may be able to join
- non-arthritic knees,
Who cannot join
- intra- or extraarticular deformity on the X-rays or MRIs,
- history of previous extremity surgery,
- history of any systemic disease,
- a BMI of 35 or over.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is Standard 3-degree of External Rotation for Posterior Femoral Cut Relevant for Turkish Population: An Anthropometric MRI Study
The aim of this study is to evaluate the posterior condylar angle of the distal femur in Turkish population and its concordance with the current standard prosthesis designs used in total knee arthroplasty and to evaluate anthropometric features of the distal femur in the Turkish population.
Read the detailed description
The investigators would like to measure condylar twist angles(CTA), posterior condylar angles(PCA), femoral mediolateral lengths (fML), medial femoral anteroposterior lengths(fMAP), lateral femoral anteroposterior lengths (fLAP), distances between trochlear groove and fMAP(DBTG-fMAP), distances between trochlear groove and fLAP(DBTG-fLAP), medial and lateral posterior condylar cartilage thicknesses(MPCCT/LPCCT) on the Magnetic Resonance Images (MRI) of 240 knees of 120 Turkish subjects.
- Conditions
- Healthy
- Keywords
- posterior condylar angle, total knee arthroplasty, external rotation, anthropometric measurements, 3 degrees, Turkish population
What is being measured
The primary outcome is the main question the study is designed to answer.
condylar twist angle and posterior condylar angle
The condylar twist angle (CTA) is an angle between anatomical transepicondylar axis (TEA),which lying from medial epicondyle to lateral epicondyle of the distal femur, and posterior condylar axis (PCAx). The posterior condylar angle (PCA) is an angle between surgical TEA, which lying from medial epicondylar sulcus to lateral epicondyle, and PCAx[1].
Measured: about 5 days
Secondary outcomes (4)
mediolateral lenght of the distal femur (fML)
The widest mediolateral lenght of the distal femur (fML) in the axial plane which equal to transepicondylar axis
Measured: about 5 days
medial anteroposterior lengt (fMAP) and lateral anteroposterior lengt (fLAP)
the longest anteropesterior distances of the medial and lateral condyles over the cartilage tissue od the distal femur on the axial images[2].
Measured: about 5 days
Distance between trochlear groove and fMAP (DBTG-fMAP) and distance between trochlear groove and lateral fAP(DBTG- fLAP)
MRI sections obtained 3 cm above the tibiofemoral joint will use for evaluation of deepest point of the trochlear groove.The distance between trochlear groove to fMAP and fLAP
Measured: about 5 days
Medial and lateral posterior condylar cartilage thicknesses (MPCCT/LPCCT)
MPCCT/LPCCT were measured at the deepest point in the axial plan.
Measured: about 5 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2020
- Study start1 Feb 2020
- Primary completion30 Mar 2020
- Study completion12 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nurdan Güngören, Bezmialem Vakif University
- Investigators
- Nurdan Güngören, Principal investigator, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04355182
- Sponsor's protocol ID
- 3586
- Status last verified
- Apr 2020
- First submitted
- 17 Apr 2020
- Last updated
- 22 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Loures FB, Furtado Neto S, Pinto Rde L, Kinder A, Labronici PJ, Goes RF, Marchiori E. Rotational assessment of distal femur and its relevance in total knee arthroplasty: analysis by magnetic resonance imaging. Radiol Bras. 2015 Sep-Oct;48(5):282-6. doi: 10.1590/0100-3984.2014.0037.
PubMed 26543278Kim TK, Phillips M, Bhandari M, Watson J, Malhotra R. Erratum to: What Differences in Morphologic Features of the Knee Exist Among Patients of Various Races? A Systematic Review. Clin Orthop Relat Res. 2017 May;475(5):1507. doi: 10.1007/s11999-017-5301-1. No abstract available.
PubMed 28255946
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Standard 3-degree of External Rotation for Posterior Femoral Cut Relevant for Turkish Population: An Anthropometric MRI Study
- ClinicalTrials.gov ID
- NCT04355182
- Acronym / sponsor ID
- 3586
- Conditions
- Healthy
- Keywords
- posterior condylar angle, total knee arthroplasty, external rotation, anthropometric measurements, 3 degrees, Turkish population
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 12 Apr 2020 (actual)
- First posted
- 21 Apr 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.
The aim of this study is to evaluate the posterior condylar angle of the distal femur in Turkish population and its concordance with the current standard prosthesis designs used in total knee arthroplasty and to evaluate anthropometric features of the distal femur in the Turkish population.
Detailed description
The investigators would like to measure condylar twist angles(CTA), posterior condylar angles(PCA), femoral mediolateral lengths (fML), medial femoral anteroposterior lengths(fMAP), lateral femoral anteroposterior lengths (fLAP), distances between trochlear groove and fMAP(DBTG-fMAP), distances between trochlear groove and fLAP(DBTG-fLAP), medial and lateral posterior condylar cartilage thicknesses(MPCCT/LPCCT) on the Magnetic Resonance Images (MRI) of 240 knees of 120 Turkish subjects.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healty subjects with Turkish ethnic orijin
Key inclusion criteria (1 listed)
- non-arthritic knees,
Key exclusion criteria (4 listed)
- intra- or extraarticular deformity on the X-rays or MRIs,
- history of previous extremity surgery,
- history of any systemic disease,
- a BMI of 35 or over.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
condylar twist angle and posterior condylar angle
Time frame: about 5 days
The condylar twist angle (CTA) is an angle between anatomical transepicondylar axis (TEA),which lying from medial epicondyle to lateral epicondyle of the distal femur, and posterior condylar axis (PCAx). The posterior condylar angle (PCA) is an angle between surgical TEA, which lying from medial epicondylar sulcus to lateral epicondyle, and PCAx[1].
4 secondary outcomes
mediolateral lenght of the distal femur (fML)
Time frame: about 5 days
medial anteroposterior lengt (fMAP) and lateral anteroposterior lengt (fLAP)
Time frame: about 5 days
Distance between trochlear groove and fMAP (DBTG-fMAP) and distance between trochlear groove and lateral fAP(DBTG- fLAP)
Time frame: about 5 days
Medial and lateral posterior condylar cartilage thicknesses (MPCCT/LPCCT)
Time frame: about 5 day
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 Apr 2020.
- Background: PubMed 26543278Loures FB, Furtado Neto S, Pinto Rde L, Kinder A, Labronici PJ, Goes RF, Marchiori E. Rotational assessment of distal femur and its relevance in total knee arthroplasty: analysis by magnetic resonance imaging. Radiol Bras. 2015 Sep-Oct;48(5):282-6. doi: 10.1590/0100-3984.2014.0037.
- Background: PubMed 28255946Kim TK, Phillips M, Bhandari M, Watson J, Malhotra R. Erratum to: What Differences in Morphologic Features of the Knee Exist Among Patients of Various Races? A Systematic Review. Clin Orthop Relat Res. 2017 May;475(5):1507. doi: 10.1007/s11999-017-5301-1. No abstract available.
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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.
Nurdan Güngören principal investigator
Bezmialem Vakif University
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 Healthy, 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 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 22 Apr 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?
condylar twist angle and posterior condylar angle (time frame: about 5 days). 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 NCT04355182, which also lists 2 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 22 Apr 2020.