NCT05380206

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

March 15, 2021

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 12, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 18, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2022

Completed
Last Updated

December 15, 2023

Status Verified

December 1, 2023

Enrollment Period

1.3 years

First QC Date

May 12, 2022

Last Update Submit

December 8, 2023

Conditions

Keywords

KneeOsteoarthritisKnee osteoarthritisknee arthroplastyTotal knee arthroplastyNavigated implantation

Outcome Measures

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

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

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient aged ≥ 18 years 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;

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Chirurgie Orthopédique Pédiatrique - CHU de Strasbourg - France

Strasbourg, 67091, France

Location

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Jean-Yves JENNY, MD, PhD

    Service de Chirurgie Orthopédique Pédiatrique - CHU de Strasbourg - France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2022

First Posted

May 18, 2022

Study Start

March 15, 2021

Primary Completion

July 15, 2022

Study Completion

September 15, 2022

Last Updated

December 15, 2023

Record last verified: 2023-12

Locations