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Functional Knee Phenotypes of Patients Operated on for Total Knee Arthroplasty

NCT ID: NCT05380206

Last Updated: 2023-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-15

Study Completion Date

2022-09-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Osteoarthritis, Knee

Keywords

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Knee Osteoarthritis Knee osteoarthritis knee arthroplasty Total knee arthroplasty Navigated implantation

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Yves JENNY, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Service de Chirurgie Orthopédique Pédiatrique - CHU de Strasbourg - France

Locations

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Service de Chirurgie Orthopédique Pédiatrique - CHU de Strasbourg - France

Strasbourg, , France

Site Status

Countries

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France

Other Identifiers

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8193

Identifier Type: -

Identifier Source: org_study_id