Locking Plates for Distal Femur Fractures - a Multicenter Case Review

NCT04008940 | Completed

• 1 other identifier: VA_LCP
• Study Type: observational
• Target: 100
• Locations: 2 countries
• Sites: 5

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..

Conditions

Distal Femur Fracture

Keywords

VA-LCP DF; LCP DF; LISS DF; various angle locking plate

Outcome Measures

Primary Outcomes (6)

• 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

Interventions

Distal femur plates DEVICE

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.

Eligibility Criteria

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

You may qualify if:

• 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

Sponsors & Collaborators

• AO Innovation Translation Center: lead

Study Sites (5)

University of California

Sacramento, California, United States

Location

Unknown Facility

Houston, Texas, United States

Location

Inova Orthopedics

Fairfax, Virginia, 22031-4625, United States

Location

Kantonsspital Liestal

Liestal, Basel-Landschaft, Switzerland

Location

Kantonsspital Graubünden

Chur, Kanton Graubünden, Switzerland

Location

MeSH Terms

Conditions

Femoral Fractures, Distal

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Leg Injuries

Study Officials

• Mark Lee, MD

  University of California Davis, Dept. of Orthopaedic Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2019
• First Posted: July 5, 2019
• Study Start: January 1, 2012
• Primary Completion: April 24, 2025
• Study Completion: April 24, 2025
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (3); CH (2)