Locking Plates for Distal Femur Fractures - a Multicenter Case Review (VA_LCP)

A Retrospective Radiological Analysis of the Mechanical Performance of Different Locking Plates in Distal Femoral Fractures

In order to assess the rate and mode of failure cases observed in patients with distal femur fractures treated with a distal femur plates, anonymized radiographs from those patients will be collected retrospectively.

All available images will reviewed by an expert review board in regards to fracture classification, implant and surgery details, quality of initial reduction and plate positioning as well as the occurrence of mechanical complications and the outcome in terms of fracture healing (if available). Additionally, age and gender as basic demographical data will be collected in a de-identified way..

Study Overview

Status

Active, not recruiting

Intervention / Treatment

Detailed Description

Severely comminuted distal femur fractures can be challenging injuries and usually require surgical treatment with lateral distal plate osteosynthesis.

Anatomically pre-contoured locking plates are commonly used. In 2012, the 4.5mm VA-LCP Curved Condylar Plate for distal femur fractures (VA-LCP DF, Synthes) was introduced offering the option of axis variation of the locking screws.

Recently, a report highlighted cases of implant failure with this implant, cautioning practicing surgeons against the use of this implant in certain type of AO/OTA fracture and dislocation classification 33 fractures (AO/OTA classification).

Based on this report, the current study was designed to perform a retrospective in-depth radiological analysis of all cases distal femur fractures of 4 participating sites in which the VA-LCP DF, the LCP Distal Femur Plate (LCP DF, Synthes) or the 'less invasive stabilization system' for distal femur fractures (LISS DF, Synthes) were used for fracture stabilization. The radiological in-depth analysis will be done by an expert review board with the aim to identify potential causes and risk factors for the failure cases among all cases collected.

This evaluation will contribute to a better understanding of the mechanical performance of distal femur fracture plates and the causes and risk factors for failures.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Baselland
      • Liestal, Baselland, Switzerland
        • Kantonsspital Liestal
    • Graubünden
      • Chur, Graubünden, Switzerland
        • Kantonsspital Graubünden
    • California
      • Sacramento, California, United States
        • University of California

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Age 18 years and older

  • Diagnosis of a distal femur fracture type OTA/AO classification 33-A, -B, -C
  • uni- or bilateral
  • low or high energy trauma
  • Open or closed fractures
  • Surgical treatment with the VA-LCP DF, LISS DF, LCP DF
  • Available radiographical documentation, beginning with the injury radiographs, ending with the documented healing or any documented failure with or without revision surgery (up to a maximum follow-up of 1 year

Description

Inclusion Criteria:

  • Age 18 years and older
  • Diagnosis of a distal femur fracture type OTA/AO classification 33-A, -B, -C
  • uni- or bilateral
  • low or high energy trauma
  • Open or closed fractures
  • Surgical treatment with the VA-LCP DF, LISS DF, LCP DF
  • Available radiographical documentation, beginning with the injury radiographs, ending with the documented healing or any documented failure with or without revision surgery (up to a maximum follow-up of 1 year

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fracture
Time Frame: baseline
type of fracture
baseline
Fracture classification
Time Frame: baseline
AO/OTA classification 33A, -B or C
baseline
Mechanism of injury
Time Frame: baseline
High energy trauma (H) or low energy trauma assessed as H for high and L for low energy trauma
baseline
Implant used
Time Frame: baseline
Implant manufacturer name (VA-LCP DF, LISS DF, LCP DF)
baseline
Open or closed fracture
Time Frame: 1 year
G-A class: Y=open, N=closed
1 year
Bone union in time
Time Frame: baseline until 1 year
weeks to bone union
baseline until 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Mark Lee, MD, University of California Davis, Dept. of Orthopaedic Surgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2012

Primary Completion (Actual)

December 1, 2020

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

April 17, 2019

First Submitted That Met QC Criteria

July 3, 2019

First Posted (Actual)

July 5, 2019

Study Record Updates

Last Update Posted (Actual)

July 20, 2022

Last Update Submitted That Met QC Criteria

July 19, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • VA_LCP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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