- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05659316
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
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
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: AURELIE COURTIN
- Phone Number: +33 1 87 86 22 79
- Email: aurelie.courtin@ramsaysante.fr
Study Locations
-
-
-
Antony, France
- Hopital Prive d'Antony
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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
-
Mayo ClinicCompletedArthroplasty, Replacement, Knee | Injuries, KneeUnited States
-
Wake Forest University Health SciencesTerminatedInjuries, KneeUnited States
-
Poitiers University HospitalWithdrawn
-
Universidad de ZaragozaUnknownAnterior Cruciate Ligament Injuries | Injuries, Knee | Prevention & ControlSpain
-
Tissue Regenix LtdNot yet recruitingMultiligament Knee Injuries
-
Istituto Ortopedico RizzoliNot yet recruitingStiffness of Knee, Not Elsewhere Classified | Knee FracturesItaly
-
Medipol UniversityRecruitingKnee Osteoarthritis | Knee Injuries | Knee Arthritis | Knee DiseaseTurkey
-
Technical University of MunichCompleted
-
University of PittsburghMayo Clinic; University of Missouri-Columbia; Washington University School of... and other collaboratorsRecruitingKnee Dislocations | Multiple Ligament Knee InjuriesUnited States
-
University of PennsylvaniaCompletedSurgery | Opioid Use | Orthopedic Surgery | Neurosurgery | Acute Injuries KneeUnited States
Clinical Trials on MRI imaging
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingProstate CarcinomaUnited States
-
OHSU Knight Cancer InstituteNational Cancer Institute (NCI); University of Iowa; Oregon Health and Science... and other collaboratorsRecruiting
-
American College of RadiologyPennsylvania Department of HealthCompleted
-
Emory UniversityNational Cancer Institute (NCI); National Institutes of Health (NIH)CompletedMetastatic Malignant Neoplasm in the Brain | Invasive Malignant NeoplasmUnited States
-
Children's Hospital Los AngelesRecruitingTBI (Traumatic Brain Injury) | Hypoxic-Ischemic Encephalopathy | Hemodynamic Instability | TBI | HIEUnited States
-
GCS Ramsay Santé pour l'Enseignement et la RechercheRecruitingShoulder InjuriesFrance
-
Heuron Inc.Recruiting
-
Ohio State University Comprehensive Cancer CenterWithdrawn
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingBrain NeoplasmUnited States
-
Sidney Kimmel Comprehensive Cancer Center at Johns...Recruiting