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Status unknownNCT03874468Updated Mar 15, 2019

Prevalence of Coronal Femoral Bowing in the Egyptian Arthritic Knee

An observational study in Arthritis Knee, sponsored by Kerolos Naiem Shehata Rofael. Status unknown. Open to participants aged 20 Years to 110 Years. Per ClinicalTrials.gov, last updated 2019-03-15.

Sponsored by Kerolos Naiem Shehata Rofael · Observational

The sponsor has not verified this record recently (last verified Mar 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
400
Ages
20 Years to 110 Years
Sex
All
01

Study summary

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

Read the 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
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Conditions studied

  • Arthritis Knee

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03

In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's planned enrollment of 400 is above the median of 155 across 1,057 observational studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

This is the only study on the registry with Kerolos Naiem Shehata Rofael as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 110 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

-Any advanced Osteoarthritic patient schedual for TKA

Exclusion criteria

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 .
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Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
400 participants (estimated)
Patient registry
No

Interventions

  • DeviceX-ray

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

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What researchers measure

Primary outcomes

  1. To asses the Prevalence Of Coronal Femoral Bowing in Egyptian arthritic knee

    Coronal Femoral Bowing in Egyptian arthritic knee may be prevalent and its effect on TKR will be measured and reported

    Time frame: Baseline

07

Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Kobayashi H, Akamatsu Y, Kumagai K, Kusayama Y, Aratake M, Saito T. Influence of coronal bowing on the lower alignment and the positioning of component in navigation and conventional total knee arthroplasty. Orthop Traumatol Surg Res. 2017 Apr;103(2):251-256. doi: 10.1016/j.otsr.2016.11.017. Epub 2017 Jan 11. PubMed 28087396 ↗
  • Nakano N, Matsumoto T, Hashimura M, Takayama K, Ishida K, Araki D, Matsushita T, Kuroda R, Kurosaka M. Coronal lower limb alignment in normal knees--A radiographic analysis of 797 normal knee subjects. Knee. 2016 Mar;23(2):209-13. doi: 10.1016/j.knee.2015.12.004. Epub 2016 Jan 7. PubMed 26775257 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 15, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03874468
Lead sponsor
Kerolos Naiem Shehata Rofael
Responsible party
Kerolos Naiem Shehata Rofael (Principle investigator, Assiut University) — Sponsor-investigator
First posted
Mar 14, 2019
Start date
May 1, 2019 (estimated)
Primary completion
May 1, 2022 (estimated)
Completion
May 1, 2022 (estimated)
Last update
Mar 15, 2019

Study contacts

kerolos naiem shehata, resident
Contact
kerolosnaiem@gmail.com
01202803982

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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