Patellofemoral Dislocation Clinical Trial
— EOS-FP2017Official title:
Assessment of Surgical Correction of Patello-femoral Instability by EOS 3D Kinematics
Verified date | June 2020 |
Source | University Hospital, Montpellier |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Assessment of surgical correction of patello-femoral instability by EOS 3D kinematics
Status | Completed |
Enrollment | 6 |
Est. completion date | January 31, 2022 |
Est. primary completion date | January 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 15 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | UH Montpellier | Montpellier |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Montpellier |
France,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 |
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