Prevalence of Coronal Femoral Bowing in the Egyptian Arthritic Knee

March 13, 2019 updated by: Kerolos Naiem Shehata Rofael
To Detect the Prevalence Of Coronal Femoral Bowing in Egyptian arthritic knee. The restoration of normal coronal alignment of the lower extremity is very important to surgeons who perform reconstructive surgery of the knee, such as total knee arthroplasty (TKA). The importance of achieving normal coronal alignment of the lower extremity after TKA is widely recognized . TKAs with coronal malalignment tend to fail earlier than those with neutral alignment. 8 Coronal alignment is considered key to the function and longevity of a TKA. However, most studies do not consider femoral and tibial anatomical features such as coronal femoral bowing and the effects of these features and subsequent alignment on function after TKA are unclear investigators therefore determined the prevalence of coronal femoral bowing, femoral condylar orientation (mLDFA ) , and tibia plateau inclination (mMPTA ) in osteoarthritic Egyptian population

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Radiological methods :

1) standing anteroposterior radiographs of the full-length lower limb with patients in the standing position. ( HKA Long Film Radiographs ).

Measurements :

  1. mechanical hip-knee-ankle axis (HKA) angle: the angle formed by the mechanical axes of the femur and tibia
  2. anatomical hip-knee-ankle axis (HKA) angle: the angle formed by the anatomical axes of the femur and tibia
  3. For condylar orientation : the mechanical lateral distal femoral angle (mLDFA) was defined as an angle formed by the mechanical axis of the femur and the line connecting the distal ends of the medial and lateral femoral condyles of the femur.
  4. For tibia plateau inclination : the mechanical lateral proximal tibial angle (mLPTA) was defined as an angle formed by the mechanical axis of the tibia and the articular surface of the proximal tibia .
  5. Coronal femoral bowing Using the method of Yau et al. : the femoral diaphysis was divided into four equal parts, . Because Yau et al. didn't exactly describe the femoral diaphysis, we had defined the femoral diaphysis from the lower border of the lesser trochanter to upper border of the distal femoral segment which is defined by a square whose sides have the same length as the widest part of the femoral condyle so called rule of square (from the lowest level of the lesser trochanter to 5 cm above the lowest level of the lateral femoral condyle), and the midpoint of the endosteal intramedullary canal was depicted in each quarter. The angulation between midlines drawn in the proximal and distal quarters of the femoral diaphysis will be measured

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 110 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

any Egyptian patient who suffer from advanced osteoarthritis schedual for TKR at any age ,any sex

Description

Inclusion Criteria:

-Any advanced Osteoarthritic patient schedual for TKA

Exclusion Criteria:

  • History of femoral or tibial fracture or osteotomy around the knee .
  • Presence of a congenital anomaly in the femur or tibia .
  • History of prior knee or hip arthroplasty .
  • Diagnosis other than primary osteoarthritis (RA-inflmmatory arthritis..etc) .
  • Position in radiographs preventing complete evaluation of radiographic variables .

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
To asses the Prevalence Of Coronal Femoral Bowing in Egyptian arthritic knee
Time Frame: Baseline
Coronal Femoral Bowing in Egyptian arthritic knee may be prevalent and its effect on TKR will be measured and reported
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kerolos Naiem Shehata Rofael

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 12, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 14, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 15, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • coronal femoral Bowing

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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