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Clinical Trials/NCT04143438
NCT04143438
Completed
Not Applicable

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

University Hospital, Montpellier1 site in 1 country6 target enrollmentJune 2, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Patellofemoral Dislocation
Sponsor
University Hospital, Montpellier
Enrollment
6
Locations
1
Primary Endpoint
Comparison of patella lateral tilt before and after surgery
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2, 2020
End Date
January 31, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Comparison of patella lateral tilt before and after surgery

Time Frame: During the presurgery appointment and up to 6 months 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.

Secondary Outcomes

  • Comparison of patella secondary shifts before and after surgery(During the presurgery appointment and up to 6 months after surgery)
  • Assessment of functional and life quality changes pre- and post-surgery(During the presurgery appointment and up to 6 months after surgery)
  • Comparison of patella secondary rotations before and after surgery(During the presurgery appointment and up to 6 months after surgery)

Study Sites (1)

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