Clinical trial NCT04143438: Assessment of Surgical Correction of Patello-femoral Instability by EOS 3D Kinematics
Official title: Assessment of Surgical Correction of Patello-femoral Instability by EOS 3D Kinematics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patellofemoral Dislocation
Keywords: patella
EOS 3D imaging
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2019-10-29
Enrollment: 6
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Comparison of patella lateral tilt before and after surgery
timeFrame: During the presurgery appointment and up to 6 months after surgery
Secondary outcomes:
measure: Comparison of patella secondary shifts before and after surgery
timeFrame: During the presurgery appointment and up to 6 months after surgery
measure: Comparison of patella secondary rotations before and after surgery
timeFrame: During the presurgery appointment and up to 6 months after surgery
measure: Assessment of functional and life quality changes pre- and post-surgery
timeFrame: During the presurgery appointment and up to 6 months after surgery
Other outcomes:
Locations:
city: Montpellier
country: France
facility: UH Montpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Louis DAGNEAUX
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.