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.
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.
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- 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.
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:
- 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).
- 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)
- Conditions
- 4DCT, Knee, Femoropatellar Instability
- 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 group | Role | What they receive |
|---|---|---|
| Pathologic group | Experimental | 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) Receives: Diagnostic Test: Knee 4DCT |
| Control group | Active comparator | 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 Receives: Diagnostic Test: Knee 4DCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
• 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
Coefficient of variation of patellofemoral tilt angle
(standard deviation / mean)
Measured: 2 years
Distance of lateral displacement of the patella (in mm)
Measured: 2 years
Secondary outcomes (2)
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
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.
- First posted24 May 2018
- Study startJun 2019 (estimated)
- Primary completionJun 2019 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 4DCT, Knee, Femoropatellar InstabilityStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morphological and Biomechanical Analysis of Knee 4DCT in Femoropatellar Instability
- ClinicalTrials.gov ID
- NCT03535389
- Acronym / sponsor ID
- EDYG / 2018-A00450-55
- Conditions
- 4DCT, Knee, Femoropatellar Instability
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Jun 2019 (estimated)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 24 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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:
- 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).
- 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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Case-control study, cross-sectional, monocentric, with prospective recruitment.
| Arm | Type | Receives |
|---|---|---|
| Pathologic group | Experimental | Diagnostic Test: Knee 4DCTPatients 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) |
| Control group | Active comparator | Diagnostic Test: Knee 4DCTPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patient between 18 and 60 years old
- giving consent
- Mandatory affiliation to a social security scheme
- 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)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Knee 4DCTDynamic knee 4DCT | Diagnostic test | Control group, Pathologic group |
Primary outcome
• Amplitude (in °) of patellofemoral angle
Time frame: 2 years
Amplitude of changes in patellofemoral angle measured by 4D dynamic CT in the analysis of patellofemoral involvement in the 2 subgroups (Cases and controls);
Coefficient of variation of patellofemoral tilt angle
Time frame: 2 years
(standard deviation / mean)
Distance of lateral displacement of the patella (in mm)
Time frame: 2 years
2 secondary outcomes
Amplitude (in °) of changes in patellofemoral angle, coefficient of variation of patellofemoral tilt angle and distance of patella lateral displacement (in mm)
Time frame: 2 years
Intra-class correlation coefficient
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2019.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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.