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: Completed
• Conditions: Distal Femur Fracture
• Intervention / Treatment: Device: Distal femur plates

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 (Estimated): 100

Contacts and Locations

Study Locations

• Switzerland
  • Basel-Landschaft
    • Liestal, Basel-Landschaft, Switzerland
      • Kantonsspital Liestal
  • Kanton Graubünden
    • Chur, Kanton Graubünden, Switzerland
      • Kantonsspital Graubunden
• United States
  • California
    • Sacramento, California, United States
      • University of California
  • Texas
    • Houston, Texas, United States
  • Virginia
    • Fairfax, Virginia, United States, 22031-4625
      • Inova Orthopedics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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

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

Collaborators and Investigators

• Sponsor: AO Innovation Translation Center
• Investigators: Principal Investigator: Mark Lee, MD, University of California Davis, Dept. of Orthopaedic Surgery

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2012
• Primary Completion (Actual): April 24, 2025
• Study Completion (Actual): April 24, 2025

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 (Estimated): September 16, 2025
• Last Update Submitted That Met QC Criteria: September 10, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: VA-LCP DF; LCP DF; LISS DF; various angle locking plate
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Fractures, Bone; Femoral Fractures; Femoral Fractures, Distal
• Other Study ID Numbers: VA_LCP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No