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4DCT, Knee, Femoropatellar InstabilityEDYGNCT03535389

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

A study testing Knee 4DCT in people with 4DCT, Knee, Femoropatellar Instability, run by Central Hospital, Nancy, France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
4DCT, Knee, Femoropatellar Instability
What is being tested?
Knee 4DCT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
No sites listed yet
Study dates
Jun 2019to Jun 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 11Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

No sites are listed yet.

Pedro Augusto GONDIM TEIXEIRA, PhD contact

+33648794931

ped_gt@gmail.com

About this study

Official title: 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

Read the 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)
Being tested
Knee 4DCT

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Knee 4DCTDiagnostic test

    Dynamic knee 4DCT

Study groups in NCT03535389
Study groupRoleWhat they receive
Pathologic groupExperimentalPatients 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)
Receives: Diagnostic Test: Knee 4DCT
Control groupActive comparatorPatients 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
Receives: Diagnostic Test: Knee 4DCT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. • 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);

    Measured: 2 years

  2. Coefficient of variation of patellofemoral tilt angle

    (standard deviation / mean)

    Measured: 2 years

  3. Distance of lateral displacement of the patella (in mm)

    Measured: 2 years

Secondary outcomes (2)
  1. Amplitude (in °) of changes in patellofemoral angle, coefficient of variation of patellofemoral tilt angle and distance of patella lateral displacement (in mm)

    Measured: 2 years

  2. Intra-class correlation coefficient

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 May 2018
  2. Study startJun 2019 (estimated)
  3. Primary completionJun 2019 (estimated)
  4. Study completionJun 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Case-control study, cross-sectional, monocentric, with prospective recruitment.
Masking
Single blind
Who is masked
Investigator
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03535389
Sponsor's protocol ID
2018-A00450-55
Acronym
EDYG
Status last verified
Jun 2019
First submitted
14 May 2018
Last updated
10 Jun 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Knee 4DCT in people with 4DCT, Knee, Femoropatellar Instability, run by Central Hospital, Nancy, France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Pedro Augusto GONDIM TEIXEIRA, PhD (+33648794931, ped_gt@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

• Amplitude (in °) of patellofemoral angle (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2019.

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