Assessment of Surgical Correction of Patello-femoral Instability by EOS 3D Kinematics (EOS-FP2017)

Assessment of surgical correction of patello-femoral instability by EOS 3D kinematics

Study Overview

• Status: Completed
• Conditions: Patellofemoral Dislocation
• Intervention / Treatment: Procedure: EOS 3D imaging protocol pre- and post-surgery

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 Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montpellier, France
    • UH Montpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Undergoing EOS 3D imaging; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: Louis DAGNEAUX, University Hospital, Montpellier

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2020
• Primary Completion (Actual): January 31, 2022
• Study Completion (Actual): January 31, 2022

Study Registration Dates

• First Submitted: October 22, 2019
• First Submitted That Met QC Criteria: October 25, 2019
• First Posted (Actual): October 29, 2019

Study Record Updates

• Last Update Posted (Estimate): December 14, 2022
• Last Update Submitted That Met QC Criteria: December 13, 2022
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: patella; EOS 3D imaging
• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Joint Dislocations
• Other Study ID Numbers: RECHMPL17_0383; UF 9892 (Other Identifier: CHU de Montpellier)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No