Knee InjuriesNCT05659316
New MRI Measurement of Patellar Height in Knee Extension - IES-EV Control Study
An observational study of Knee Injuries, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Knee Injuries
- What is being tested?
- MRI imaging
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 15 Apr 2022to 30 May 2023
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subject with knee MRI
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this 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.
Read the 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.
- Conditions
- Knee Injuries
- Being tested
- MRI imaging
- Medical subject headings
- Knee Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI imagingOther
Knee MRI imaging
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Healthy volunteers without any patellar injury Receives: Other: MRI imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Index of sagittal engagement of the patella (IES)
Measurement of a MRI index of sagittal engagement of the patella (IES) in knee extension at 0°
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start15 Apr 2022
- Primary completion30 May 2023
- Study completion30 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee InjuriesStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05659316
- Sponsor's protocol ID
- RGDS-2019-12-064
- Status last verified
- Apr 2024
- First submitted
- 13 Dec 2022
- Last updated
- 18 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New MRI Measurement of Patellar Height in Knee Extension - IES-EV Control Study
- ClinicalTrials.gov ID
- NCT05659316
- Acronym / sponsor ID
- RGDS-2019-12-064
- Conditions
- Knee Injuries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 15 Apr 2022 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 21 Dec 2022 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | – | Other: MRI imagingHealthy volunteers without any patellar injury |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subject with knee MRI
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| MRI imagingKnee MRI imaging | Other | Healthy volunteers |
Primary outcome
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°
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Injuries, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in 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 4 inclusion and 1 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: finished, as of the sponsor's last update on 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Index of sagittal engagement of the patella (IES) (time frame: 1 day). 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 18 Apr 2024.