Morphological and Biomechanical Analysis of Knee Four Dimensional CT (4DCT) in Femoropatellar Instability (EDYG)

Morphological and Biomechanical Analysis of Knee 4DCT in Femoropatellar Instability

To compare the radiological parameters measured by dynamic four dimensional CT (4DCT) in the analysis of patellofemoral involvement of subjects (amplitude of patellofemoral tilt angle variations, coefficient of variation of the same angle, distance of lateral displacement of the patella ) in patients with patellofemoral clinical syndrome to those free of this syndrome (= control group).

It is expected that the amplitude of patellofemoral tilt angle changes, its coefficient of variation, and the patella lateral displacement distance differ between the 2 groups compared. This result would clarify the potential value of dynamic 4D CT in the diagnosis of PFI

Study Overview

• Status: Unknown
• Conditions: 4DCT, Knee, Femoropatellar Instability
• Intervention / Treatment: Diagnostic test: Knee 4DCT

Detailed Description

Patellofemoral instability (PFI) is frequent, causing chronic knee pain, functional impotence or disability because it is associated with the development of early patellofemoral osteoarthritis. PFI are classically classified into three types: anterior pain syndrome (SR, without structural abnormality), potential patellar instability (with structural anomaly favoring, but no history of patellar dislocation) and objective patellar instability (with structural abnormality and history of patellar dislocation). Diagnosis of the disease outside objective patellar instability is difficult at present, and objective criteria are lacking to determine management and evaluate the rehabilitation program of these patients.

Radiographic assessment of the knee is the diagnostic method of reference to objectify patellar patellofemoral instability and to look for contributing factors including signs of trochlear dysplasia, and remains the initial method of exploration of a patellar syndrome. Static imaging reveals signs of objective instability (patellar luxation, fracture stigmas) or favorite factors (trochlear dysplasia, increased distance of anterior tibial tuberosity / trochlear throat).

Nevertheless, some important elements in the pathophysiology of patellofemoral instability such as patellar tilt and lateral displacement of the patella are essentially dynamic and vary according to the degree of flexion-extension of the knee. Our hypothesis is that the variation of these parameters during the movements could make it possible to improve the diagnosis of patellar instabilities without favoring structural anomaly and the follow-up of the patients who benefit from a patellofemoral reeducation program.

Some authors propose functional MRI of the knee with static acquisitions during different movements. Nevertheless, no validated technique allows the study of biodynamic anomalies in real time. The dynamic knee scanner is not very radiating and the knee is not very radio-sensitive. This technique could therefore represent an interesting alternative allowing dynamic analysis of patellar displacements during knee flexion and patellar engagement. Finally, new methods of post-processing CT images based on registration and automatic segmentation of bone structures are available for clinical application. This type of tool allows a semi-automatic quantification of patellar displacements that could provide objective evaluation criteria for patients with patellofemoral instability. In 2016, a Swedish team published a study on the feasibility of five patients performing a quantitative semi-automatic dynamic scanner analysis of patellofemoral flexion-extension joint movement. This shows the value of evaluating this method in a larger population with a control group

Main objective: To compare the radiological parameters measured by dynamic 4D CT in the analysis of patellofemoral involvement of subjects (amplitude of patellofemoral tilt angle variations, coefficient of variation of the same angle, distance of lateral displacement of the patella ) in patients with patellofemoral clinical syndrome (= Cas group) to those free of this syndrome (= control group).

It is expected that the amplitude of patellofemoral tilt angle changes, its coefficient of variation, and the patella lateral displacement distance differ between the 2 groups compared. This result would clarify the potential value of dynamic 4D CT in the diagnosis of PFI.

Secondary objectives:

1. compare, in the pathologic group, the radiological parameters measured by 4D dynamic CT (coefficient of variation, amplitude of the patellofemoral tilt angle and distance of patella lateral displacement) according to the type of patellofemoral instability ( anterior pain syndrome, potential patellar femoro instability and "objective" femoro-patellar instability) obtained by conventional imaging (static CT).
2. To estimate the interobserver reproducibility of the radiological parameters measured by 4D dynamic CT during image post-treatment in all patients (measurement of patellofemoral angle of flap angle and distance of patella lateral displacement)

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient between 18 and 60 years old
• giving consent

• Mandatory affiliation to a social security scheme

  • patients with clinical symptoms of femoropatellar instability addressed for a knee CT scan

Pathologic group:

• Consultant at our institution's imaging department for the realization of a knee scanner as part of routine care.
• Presenting clinical PFI syndrome (Patellofemoral instability diagnosis based on physical examination, history and Kujala score)

Control group:

• Consultant at our institution's imaging department for osteo-articular pathologies other than PFI (non-fracture trauma, vascular pathologies, degenerative or soft tissues).
• Does not have any clinical PFI syndrome
• Matched (1: 1 ratio) to PFI patients by age (+/- 40 years) and sex

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pathologic group; Patients addressed to our imaging department for the realization of a knee scanner as part of routine care and presenting clinical PFI syndrome (Patellofemoral instability diagnosis based on physical examination, history and Kujala score)	Diagnostic test: Knee 4DCT; Dynamic knee 4DCT
Active Comparator: Control group; Patients addressed to our imaging department for osteo-articular pathologies other than patellofemoral instability (non-fracture trauma, vascular pathologies, degenerative or soft tissues).; Does not have any clinical PFI syndrome; Matched (1: 1 ratio) to PFI patients by age (+/- 40 years) and sex	Diagnostic test: Knee 4DCT; Dynamic knee 4DCT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
• Amplitude (in °) of patellofemoral angle	Amplitude of changes in patellofemoral angle measured by 4D dynamic CT in the analysis of patellofemoral involvement in the 2 subgroups (Cases and controls);	2 years
Coefficient of variation of patellofemoral tilt angle	(standard deviation / mean)	2 years
Distance of lateral displacement of the patella (in mm)		2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Amplitude (in °) of changes in patellofemoral angle, coefficient of variation of patellofemoral tilt angle and distance of patella lateral displacement (in mm)	2 years
Intra-class correlation coefficient	2 years

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2019
• Primary Completion (Anticipated): June 1, 2019
• Study Completion (Anticipated): June 1, 2020

Study Registration Dates

• First Submitted: May 14, 2018
• First Submitted That Met QC Criteria: May 14, 2018
• First Posted (Actual): May 24, 2018

Study Record Updates

• Last Update Posted (Actual): June 10, 2019
• Last Update Submitted That Met QC Criteria: June 7, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 2018-A00450-55

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No