Patellofemoral DislocationEOS-FP2017NCT04143438
Assessment of Surgical Correction of Patello-femoral Instability by EOS 3D Kinematics
A study testing EOS 3D imaging protocol pre- and post-surgery in people with Patellofemoral Dislocation, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Assessment of surgical correction of patello-femoral instability by EOS 3D kinematics Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Patellofemoral Dislocation
- What is being tested?
- EOS 3D imaging protocol pre- and post-surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jun 2020to 31 Jan 2022
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age above 15 years and 3 months (minimal age to be allowed for adult orthopedic surgery in the hospital)
- Patients with patello-femoral instability (at least one patella dislocation)
- Patients with corrective surgery planned
- Patients must be covered by public health insurance
- Signed informed consent form by the patient or by the parents or legal guardian of the patient (if patient is under 18)
Who cannot join
- Previous existing surgery for patella instability on the same knee
- Previous existing surgery on the extensor apparatus of the knee
- Female patients with pregnancy
- Patients deprived of liberty by administrative or court order
Trial locations and contacts
1 site in 1 country.
About this study
Assessment of surgical correction of patello-femoral instability by EOS 3D kinematics
Read the detailed description
Patella instability induces repetitive patella dislocation, which impairs day-to-day life. Surgery is commonly used to stabilise the patella during knee flexion. However proofs of efficacy of surgery on patello-femoral kinematics have not yet been found. Analysis of the patello-femoral kinematics is crucial to understand, assess et correct the patella instability. The investigators have developed, validated and published a 3D analysis method from biplanar X-rays (EOS 3D imaging). Our aim in this study is to assess the correction of the patello-femoral kinematics after surgery using the EOS 3D imaging method.
- Conditions
- Patellofemoral Dislocation
- Being tested
- EOS 3D imaging protocol pre- and post-surgery
- Keywords
- patella, EOS 3D imaging
- Medical subject headings
- Patella Fracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EOS 3D imaging protocol pre- and post-surgeryProcedure or surgery
Patients will undergo a EOS 3D Imaging protocol before and 6 months after undergoing patello-femoral surgery. This protocol is already used routinely in the hospital before every patello-femoral surgery.
| Study group | Role | What they receive |
|---|---|---|
| Undergoing EOS 3D imaging | Experimental | Patients with patello-femoral instability will undergo EOS 3D Imaging protocol before and after undergoing corrective surgery Receives: Procedure: EOS 3D imaging protocol pre- and post-surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of patella lateral tilt before and after surgery
Efficacy of corrective surgery on patello-femoral instability will be assessed by measuring the patella lateral tilt (Ry) with the knee bending at 0, 20 and 45 degrees, before and after surgery. This measurement will be done using the EOS 3D Imaging technique.
Measured: During the presurgery appointment and up to 6 months after surgery
Secondary outcomes (3)
Comparison of patella secondary shifts before and after surgery
Anterior (Tx), distal (Ty) and lateral (Tz) patella shifts, with the knee bending at 0, 20 and 45 degrees will be measured, before and after surgery. This measurement will be done using the EOS 3D Imaging technique.
Measured: During the presurgery appointment and up to 6 months after surgery
Comparison of patella secondary rotations before and after surgery
External (Rx) and flexion (Rz) rotation of the patella, with the knee bending at 0, 20 and 45 degrees will be measured, before and after surgery. This measurement will be done using the EOS 3D Imaging technique.
Measured: During the presurgery appointment and up to 6 months after surgery
Assessment of functional and life quality changes pre- and post-surgery
The Kujala score and 12-Item Short Form Survey (SF12) life quality questionnaire will be answered by the participants before and after the surgery.
Measured: During the presurgery appointment and up to 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2019
- Study start2 Jun 2020
- Primary completion31 Jan 2022
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patellofemoral DislocationStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Louis DAGNEAUX, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04143438
- Sponsor's protocol ID
- RECHMPL17_0383
- Other IDs
- UF 9892
- Acronym
- EOS-FP2017
- Status last verified
- Jun 2020
- First submitted
- 22 Oct 2019
- Last updated
- 14 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dagneaux L, Thoreux P, Eustache B, Canovas F, Skalli W. Sequential 3D analysis of patellofemoral kinematics from biplanar x-rays: In vitro validation protocol. Orthop Traumatol Surg Res. 2015 Nov;101(7):811-8. doi: 10.1016/j.otsr.2015.07.017. Epub 2015 Oct 26.
PubMed 26514850
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Surgical Correction of Patello-femoral Instability by EOS 3D Kinematics
- ClinicalTrials.gov ID
- NCT04143438
- Acronym / sponsor ID
- EOS-FP2017 / RECHMPL17_0383
- Conditions
- Patellofemoral Dislocation
- Keywords
- patella, EOS 3D imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 2 Jun 2020 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 29 Oct 2019 (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.
Assessment of surgical correction of patello-femoral instability by EOS 3D kinematics
Detailed description
Patella instability induces repetitive patella dislocation, which impairs day-to-day life. Surgery is commonly used to stabilise the patella during knee flexion. However proofs of efficacy of surgery on patello-femoral kinematics have not yet been found. Analysis of the patello-femoral kinematics is crucial to understand, assess et correct the patella instability. The investigators have developed, validated and published a 3D analysis method from biplanar X-rays (EOS 3D imaging). Our aim in this study is to assess the correction of the patello-femoral kinematics after surgery using the EOS 3D imaging method.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Undergoing EOS 3D imaging | Experimental | Procedure: EOS 3D imaging protocol pre- and post-surgeryPatients with patello-femoral instability will undergo EOS 3D Imaging protocol before and after undergoing corrective surgery |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Age above 15 years and 3 months (minimal age to be allowed for adult orthopedic surgery in the hospital)
- Patients with patello-femoral instability (at least one patella dislocation)
- Patients with corrective surgery planned
- Patients must be covered by public health insurance
- Signed informed consent form by the patient or by the parents or legal guardian of the patient (if patient is under 18)
Key exclusion criteria (4 listed)
- Previous existing surgery for patella instability on the same knee
- Previous existing surgery on the extensor apparatus of the knee
- Female patients with pregnancy
- Patients deprived of liberty by administrative or court order
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 |
|---|---|---|
| EOS 3D imaging protocol pre- and post-surgeryPatients will undergo a EOS 3D Imaging protocol before and 6 months after undergoing patello-femoral surgery. This protocol is already used routinely in the hospital before every patello-femoral surgery. | Procedure or surgery | Undergoing EOS 3D imaging |
Primary outcome
Comparison of patella lateral tilt before and after surgery
Time frame: During the presurgery appointment and up to 6 months after surgery
Efficacy of corrective surgery on patello-femoral instability will be assessed by measuring the patella lateral tilt (Ry) with the knee bending at 0, 20 and 45 degrees, before and after surgery. This measurement will be done using the EOS 3D Imaging technique.
3 secondary outcomes
Comparison of patella secondary shifts before and after surgery
Time frame: During the presurgery appointment and up to 6 months after surgery
Comparison of patella secondary rotations before and after surgery
Time frame: During the presurgery appointment and up to 6 months after surgery
Assessment of functional and life quality changes pre- and post-surgery
Time frame: During the presurgery appointment and up to 6 months after surgery
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 14 Dec 2022.
- Background: PubMed 26514850Dagneaux L, Thoreux P, Eustache B, Canovas F, Skalli W. Sequential 3D analysis of patellofemoral kinematics from biplanar x-rays: In vitro validation protocol. Orthop Traumatol Surg Res. 2015 Nov;101(7):811-8. doi: 10.1016/j.otsr.2015.07.017. Epub 2015 Oct 26.
- 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.
Louis DAGNEAUX principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EOS 3D imaging protocol pre- and post-surgery in people with Patellofemoral Dislocation, run by University Hospital, Montpellier 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 5 inclusion and 4 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 14 Dec 2022. 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?
Comparison of patella lateral tilt before and after surgery (time frame: During the presurgery appointment and up to 6 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04143438, which also lists 1 linked publication.
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 14 Dec 2022.