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

NCT04143438 | Completed

• 2 other identifiers: RECHMPL17_0383UF 9892
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Patellofemoral Dislocation

Keywords

patella; EOS 3D imaging

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Comparison of patella secondary shifts before and after 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

• Assessment of functional and life quality changes pre- and post-surgery

  During the presurgery appointment and up to 6 months after surgery

Study Arms (1)

Undergoing EOS 3D imaging

EXPERIMENTAL

Patients with patello-femoral instability will undergo EOS 3D Imaging protocol before and after undergoing corrective surgery

Procedure: EOS 3D imaging protocol pre- and post-surgery

Interventions

EOS 3D imaging protocol pre- and post-surgery PROCEDURE

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.

Undergoing EOS 3D imaging

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

UH Montpellier

Montpellier, France

Location

Related 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.

  PMID: 26514850 BACKGROUND

MeSH Terms

Conditions

Patella Fracture

Interventions

Postoperative Period

Condition Hierarchy (Ancestors)

Knee Fractures; Fractures, Bone; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Perioperative Period; Surgical Procedures, Operative; Patient Care; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Louis DAGNEAUX

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2019
• First Posted: October 29, 2019
• Study Start: June 2, 2020
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: December 14, 2022

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)