Locking Plates for Distal Femur Fractures - a Multicenter Case Review

Active, not recruiting

• Conditions: Distal Femur Fracture

• Registration Number: NCT04008940
• Lead Sponsor: AO Innovation Translation Center

Brief Summary

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..

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 Timeline

• Study Start: 2012-01
• Study First Submitted: 2019-04-17
• Study First Submitted QC: 2019-07-03
• Study First Posted: 2019-07-05
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-13
• Last Update Posted: 2025-02-14
• Primary Completion: 2025-10
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (4)

Kantonsspital Graubünden; 🇨🇭 Chur, Graubünden, Switzerland

Kantonsspital Liestal; 🇨🇭 Liestal, Baselland, Switzerland

Inova Orthopedics; 🇺🇸 Fairfax, Virginia, United States

University of California; 🇺🇸 Sacramento, California, United States