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

Not Applicable

Completed

• Conditions: Patellofemoral Dislocation
• Interventions: Procedure: EOS 3D imaging protocol pre- and post-surgery

• Registration Number: NCT04143438
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

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 Timeline

• Study First Submitted: 2019-10-22
• Study First Submitted QC: 2019-10-25
• Study First Posted: 2019-10-29
• Status Verified: 2020-06
• Study Start: 2020-06-02
• Primary Completion: 2022-01-31
• Study Completion: 2022-01-31
• Last Update Submitted: 2022-12-13
• Last Update Posted: 2022-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Undergoing EOS 3D imaging	EOS 3D imaging protocol pre- and post-surgery	Patients with patello-femoral instability will undergo EOS 3D Imaging protocol before and after undergoing corrective surgery

Primary Outcome Measures

Name	Time	Method
Comparison of patella lateral tilt before and after surgery	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.

Secondary Outcome Measures

Name	Time	Method
Comparison of patella secondary shifts before and after surgery	During the presurgery appointment and up to 6 months 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.
Assessment of functional and life quality changes pre- and post-surgery	During the presurgery appointment and up to 6 months after 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.
Comparison of patella secondary rotations before and after surgery	During the presurgery appointment and up to 6 months 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.

Trial Locations

Locations (1)

UH Montpellier; 🇫🇷 Montpellier, France