New MRI Measurement of Patellar Height in Knee Extension - IES-EV Control Study

The measurement of the patellar height is essential to decide and quantify the surgical correction to be made. The classic index is that of Cato and Deschamps. It has the advantage of its simplicity, with the measurement on a simple profile radiograph of the ratio between the distance from the patella to the tibia and the length of the patella. However, it has the disadvantage of measuring this height in relation to the tibia when the dislocation is located at the level of the patello-trochlear joint. The MRI index of sagittal patellar engagement on the trochlea (IES), described in 2012, does not have this drawback but it does not appear to be reliable: its value depends, in fact, on the flexion of the knee. This flexion, required by the MRI, is variable and is not specified by the radiologist. It is due to the use of an "antenna" that surrounds and lifts the knee.

The hypothesis of the study is that it is possible to determine and validate a new IES, in knee extension and therefore reproducible, thanks to the measurement of knee flexion on MRI. The precise value of this flexion can allow a virtual correction of the original IES to obtain, by mathematical calculation, the new IES in virtual extension.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patellar instability, usually manifested by recurrent patellar dislocations, is a complex multifactorial pathology. Its treatment associates surgical gestures chosen according to a precise evaluation of the factors of the instability. Five factors are decisive, varying from one subject to another: rupture of the medial patellofemoral ligament, dysplasia of the trochlea, excessive lateralization of the anterior tibial tuberosity (ATT), external torsion of the ATT and patella alta, object of this study. The patella, when it is alta, is an important factor of instability because it is abnormally located above the trochlea in extension of the knee and is no longer guided at the start of flexion: it risks not engaging in the trochlear rail and thus to dislocate at the start of flexion.

The measurement of the patellar height is essential to decide and quantify the surgical correction to be made. The classic index is that of Cato and Deschamps. It has the advantage of its simplicity, with the measurement on a simple profile radiograph of the ratio between the distance from the patella to the tibia and the length of the patella. However, it has the disadvantage of measuring this height in relation to the tibia when the dislocation is located at the level of the patello-trochlear joint. The MRI index of sagittal patellar engagement on the trochlea (IES), described in 2012, does not have this drawback but it does not appear to be reliable: its value depends, in fact, on the flexion of the knee. This flexion, required by the MRI, is variable and is not specified by the radiologist. It is due to the use of an "antenna" that surrounds and lifts the knee.

The hypothesis of the study is that it is possible to determine and validate a new IES, in knee extension and therefore reproducible, thanks to the measurement of knee flexion on MRI. The precise value of this flexion can allow a virtual correction of the original IES to obtain, by mathematical calculation, the new IES in virtual extension.

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Antony, France
        • Hopital Prive d'Antony

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Subject with knee MRI

Description

Inclusion Criteria:

  • Subject, male or female, over 18 years old
  • Subject with an MRI
  • Subject without patellar pathology, in particular without patellar instability
  • Subject having been informed and not objecting to the use of his data

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy volunteers
Healthy volunteers without any patellar injury
Knee MRI imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Index of sagittal engagement of the patella (IES)
Time Frame: 1 day
Measurement of a MRI index of sagittal engagement of the patella (IES) in knee extension at 0°
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2022

Primary Completion (Actual)

May 30, 2023

Study Completion (Actual)

May 30, 2023

Study Registration Dates

First Submitted

December 13, 2022

First Submitted That Met QC Criteria

December 13, 2022

First Posted (Actual)

December 21, 2022

Study Record Updates

Last Update Posted (Actual)

April 18, 2024

Last Update Submitted That Met QC Criteria

April 17, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RGDS-2019-12-064

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Knee Injuries

Clinical Trials on MRI imaging

3
Subscribe