Locking Plates for Distal Femur Fractures - a Multicenter Case Review

Distal Femur Fracture Clinical Trial

— VA_LCP  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04008940
• Other study ID #: VA_LCP
• Status: Active, not recruiting
• Start date: January 2012
• Est. completion date: June 2023

Study information

• Verified date: July 2022
• Source: AO Innovation Translation Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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..

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: June 2023
• Est. primary completion date: December 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Distal Femur Fracture
• Femoral Fractures
• Fractures, Bone

Intervention

Device:
• Distal femur plates
By assessing the rate and mode of mechanical failures we aim to identify risk factors for mechanical failures among the analysed plate types. This, finally, is depending on the overall number of cases and number of failure cases.

Locations

Country	Name	City	State
Switzerland	Kantonsspital Graubünden	Chur	Graubünden
Switzerland	Kantonsspital Liestal	Liestal	Baselland
United States	University of California	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
AO Clinical Investigation and Publishing Documentation

Countries where clinical trial is conducted

United States,  Switzerland, 

Outcome

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