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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04143438
Acronym
EOS-FP2017
Enrollment
6
Registered
2019-10-29
Start date
2020-06-02
Completion date
2022-01-31
Last updated
2022-12-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patellofemoral Dislocation

Keywords

patella, EOS 3D imaging

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.

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.

Sponsors

University Hospital, Montpellier
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
15 Years to No maximum
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

* 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

Design outcomes

Primary

MeasureTime frameDescription
Comparison of patella lateral tilt before and after surgeryDuring the presurgery appointment and up to 6 months after surgeryEfficacy 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

MeasureTime frameDescription
Comparison of patella secondary shifts before and after surgeryDuring the presurgery appointment and up to 6 months after surgeryAnterior (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.
Comparison of patella secondary rotations before and after surgeryDuring the presurgery appointment and up to 6 months after surgeryExternal (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.
Assessment of functional and life quality changes pre- and post-surgeryDuring the presurgery appointment and up to 6 months after surgeryThe Kujala score and 12-Item Short Form Survey (SF12) life quality questionnaire will be answered by the participants before and after the surgery.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026