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CompletedNCT04143438EOS-FP2017Updated Dec 14, 2022

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

An interventional study of EOS 3D imaging protocol pre- and post-surgery in Patellofemoral Dislocation, sponsored by University Hospital, Montpellier. Completed at 1 site in France. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2022-12-14.

Sponsored by University Hospital, Montpellier · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
6
Allocation
Not applicable
Ages
15 Years and older
Sex
All
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Study summary

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.

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Conditions studied

  • Patellofemoral Dislocation

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Keywords

  • patella
  • EOS 3D imaging
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In context

Joint Dislocations

190 studies on the registry are indexed under Joint Dislocations; 39 are open to participants now.

This study's enrollment of 6 is below the median of 53 across 120 interventional studies indexed under Joint Dislocations.

Browse Joint Dislocations studies →

Lead sponsor

University Hospital, Montpellier is the lead sponsor of 1,244 studies on the registry; 225 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
15 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
6 participants (actual)

Study arms

  • 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

Interventions

  • ProcedureEOS 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.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: During the presurgery appointment and up to 6 months after surgery

Secondary outcomes

  1. 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.

    Time frame: During the presurgery appointment and up to 6 months after surgery

  2. 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.

    Time frame: During the presurgery appointment and up to 6 months after surgery

  3. 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.

    Time frame: During the presurgery appointment and up to 6 months after surgery

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Study locations

1 site
  • UH Montpellier
    Montpellier, France
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References and documents

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 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 14, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04143438
Lead sponsor
University Hospital, Montpellier
Responsible party
Sponsor
First posted
Oct 29, 2019
Start date
Jun 2, 2020
Primary completion
Jan 31, 2022
Completion
Jan 31, 2022
Last update
Dec 14, 2022

Study contacts

Louis DAGNEAUX
principal investigator · University Hospital, Montpellier

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

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