Assessment of Surgical Correction of Patello-femoral Instability by EOS 3D Kinematics

Study Overview
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Brief Summary
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Assessment of surgical correction of patello-femoral instability by EOS 3D kinematics

Detailed Description
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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.

Official Title
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Assessment of Surgical Correction of Patello-femoral Instability by EOS 3D Kinematics

Conditions
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Patellofemoral Dislocation

Intervention / Treatment
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* Procedure: EOS 3D imaging protocol pre- and post-surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Undergoing EOS 3D imaging<br>Patients with patello-femoral instability will undergo EOS 3D Imaging protocol before and after undergoing corrective surgery | Procedure: EOS 3D imaging protocol pre- and post-surgery<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | During the presurgery appointment and up to 6 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | During the presurgery appointment and up to 6 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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patella, EOS 3D imaging