Distal Femur FractureVA_LCPNCT04008940
Locking Plates for Distal Femur Fractures - a Multicenter Case Review
An observational study of Distal Femur Fracture, run by AO Innovation Translation Center at 5 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Distal Femur Fracture
- What is being tested?
- Distal femur plates
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Jan 2012to 24 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States3 sites
Inova Orthopedics
Fairfax, Virginia, 22031-4625
Study site
Houston, Texas
University of California
Sacramento, California
Switzerland2 sites
Kantonsspital Graubünden
Chur, Kanton Graubünden
Kantonsspital Liestal
Liestal, Basel-Landschaft
About this study
Official title: 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..
Read the 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.
- Conditions
- Distal Femur Fracture
- Being tested
- Distal femur plates
- Keywords
- VA-LCP DF, LCP DF, LISS DF, various angle locking plate
- Medical subject headings
- Femoral Fractures, Distal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Distal femur platesDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Fracture
type of fracture
Measured: baseline
Fracture classification
AO/OTA classification 33A, -B or C
Measured: baseline
Mechanism of injury
High energy trauma (H) or low energy trauma assessed as H for high and L for low energy trauma
Measured: baseline
Implant used
Implant manufacturer name (VA-LCP DF, LISS DF, LCP DF)
Measured: baseline
Open or closed fracture
G-A class: Y=open, N=closed
Measured: 1 year
Bone union in time
weeks to bone union
Measured: baseline until 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study startJan 2012
- Primary completion24 Apr 2025
- Study completion24 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Femur FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AO Innovation Translation Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark Lee, MD, Principal investigator, University of California Davis, Dept. of Orthopaedic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04008940
- Sponsor's protocol ID
- VA_LCP
- Acronym
- VA_LCP
- Status last verified
- Sep 2025
- First submitted
- 17 Apr 2019
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Radiological Analysis of the Mechanical Performance of Different Locking Plates in Distal Femoral Fractures
- ClinicalTrials.gov ID
- NCT04008940
- Acronym / sponsor ID
- VA_LCP / VA_LCP
- Conditions
- Distal Femur Fracture
- Keywords
- VA-LCP DF, LCP DF, LISS DF, various angle locking plate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- AO Innovation Translation CenterUniversity, hospital or other
- Study start
- Jan 2012 (actual)
- Primary completion
- 24 Apr 2025 (actual)
- Study completion
- 24 Apr 2025 (actual)
- First posted
- 5 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Distal femur platesBy 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. | Device | – |
Primary outcome
Fracture
Time frame: baseline
type of fracture
Fracture classification
Time frame: baseline
AO/OTA classification 33A, -B or C
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
Implant used
Time frame: baseline
Implant manufacturer name (VA-LCP DF, LISS DF, LCP DF)
Open or closed fracture
Time frame: 1 year
G-A class: Y=open, N=closed
Bone union in time
Time frame: baseline until 1 year
weeks to bone union
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Lee, MD principal investigator
University of California Davis, Dept. of Orthopaedic Surgery
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Distal Femur Fracture, run by AO Innovation Translation Center at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fracture (time frame: baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.