NCT03874468

Brief 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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2019

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 12, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 14, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

March 15, 2019

Status Verified

March 1, 2019

Enrollment Period

3 years

First QC Date

March 12, 2019

Last Update Submit

March 13, 2019

Conditions

Outcome Measures

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

    Baseline

Interventions

X-rayDEVICE

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

Eligibility Criteria

Age20 Years - 110 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Any advanced Osteoarthritic patient schedual for TKA

You may not qualify if:

  • 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 .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 28087396BACKGROUND
  • 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.

    PMID: 26775257BACKGROUND

MeSH Terms

Interventions

Diagnostic Imaging

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosis

Central Study Contacts

kerolos naiem shehata, resident

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

March 12, 2019

First Posted

March 14, 2019

Study Start

May 1, 2019

Primary Completion

May 1, 2022

Study Completion

May 1, 2022

Last Updated

March 15, 2019

Record last verified: 2019-03