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OpenTrials
Completed

NCT Number: NCT05380206

Functional Knee Phenotypes of Patients Operated on for Total Knee Arthroplasty

The aim of this study was to analyze the coronal alignment of a large population of patients undergoing total knee arthroplasty using a modern classification of the knee phenotypes found in a population of non-osteoarthritic patients.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Service de Chirurgie Orthopédique Pédiatrique - CHU de Strasbourg - France

Strasbourg, 67091, France

About this study

Methods Five hundred and four navigated total knee arthroplasties will be analyzed. The following angles will be measured with a computer image free navigation system: medial femorotibial mechanical angle without stress and with maximum manual stress to reduce deformation, and medial distal femoral mechanical angle. The native medial distal femoral and medial proximal tibial angles will be calculated. The data will be analyzed as numerical and categorical data. These data will be then compared with those published in a non-arthritic population, considered as a control group.

The main criterion will be the percentage of subjects with normal overall coronal alignment, defined by the association of a normal native medial distal femoral angle and a normal native medial proximal tibial angle. The secondary criteria will be the percentages of subjects with normal medial femorotibial mechanical angle, normal native medial distal femoral angle and normal native medial proximal tibial angle. The influence of gender on primary and secondary criteria in the study group will be analyzed. The most frequent phenotypes in the study group will be identified.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient aged ≥ 18 years
  • Patient operated between 01/01/2011 to 02/28/2021 by two experienced surgeons of a total knee prosthesis using a navigation system without image (OrthoPilot ®, Aesculap, Tuttlingen, FRG) allowing to measure during the intervention the anatomical parameters of the subject before implantation;
  • Records including a complete intraoperative anatomical analysis;
  • Subject who has not expressed his opposition, after being informed, to the reuse of his data for the purposes of this research.

Exclusion criteria

  • Subject who expressed their opposition to participating in the study
  • Impossibility of giving the subject informed information (difficulties in understanding the subject, etc.)
  • Incomplete or absent anatomical analysis
  • Subject under guardianship, curatorship or safeguard of justice

Treatment and study plan

Primary outcomes

  1. Percentage of subjects with normal overall coronal alignment, defined by the association of a normal native medial distal femoral angle and a normal native medial proximal tibial angle

    Time frame: Files analysed retrospectively from January 01, 2011 to February 28, 2021 will be examined]

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Official study title

Functional Knee Phenotypes of Patients Operated on for Total Knee Arthroplasty. Comparison With a Reference Non Arthritic Population

Acronym: FP-Knee

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 18, 2022
Registry last updated
Dec 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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