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

Patellofemoral Dislocation Clinical Trial

— EOS-FP2017  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04143438
• Other study ID #: RECHMPL17_0383
• Secondary ID: UF 9892
• Status: Completed
• Phase: N/A
• Start date: June 2, 2020
• Est. completion date: January 31, 2022

Study information

• Verified date: June 2020
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Patellofemoral Dislocation

Intervention

Procedure:
• EOS 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.

Locations

Country	Name	City	State
France	UH Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

References & Publications (1)

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

Outcome

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