- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04008940
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
Conditions
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
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
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Baselland
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Liestal, Baselland, Switzerland
- Kantonsspital Liestal
-
-
Graubünden
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Chur, Graubünden, Switzerland
- Kantonsspital Graubünden
-
-
-
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California
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Sacramento, California, United States
- University of California
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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
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
Investigators
- Principal Investigator: Mark Lee, MD, University of California Davis, Dept. of Orthopaedic Surgery
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
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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-
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