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Completed

NCT Number: NCT04143438

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

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

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Key information

Conditions

Patellofemoral Dislocation Fractures, Bone Knee Fractures Patella Fracture Wounds and Injuries

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UH Montpellier

Montpellier, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EOS 3D imaging protocol pre- and post-surgery

Procedure

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Comparison of patella secondary shifts before and after surgery

    Time frame: 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.

  2. Comparison of patella secondary rotations before and after surgery

    Time frame: 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.

  3. Assessment of functional and life quality changes pre- and post-surgery

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Acronym: EOS-FP2017

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 29, 2019
Registry last updated
Dec 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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