Proximal Femoral FractureNCT03975868
Risk Factors for Cut-out After Internal Fixation of Trochanteric Fractures in Elderly Subjects.
An observational study of Proximal Femoral Fracture, run by Fondation Ophtalmologique Adolphe de Rothschild.
Trial summary
Proximal femoral fracture is associated with severe morbidity and mortality and high socioeconomic costs. The main mechanical complication of internal fixation in trochanteric fracture is lag-screw cut-out through the femoral head. Several factors are involved, but remain controversial. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Proximal Femoral Fracture
- What is being tested?
- Analysis of associated factors for cut-out in internal fixation of extracapsular proximal femoral fracture.
- How many people
- 228 participants
- Where
- No sites listed yet
- Study dates
- Jul 2009to 31 Mar 2015
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients over 75 years old operated on for extracapsular proximal femoral fracture.
Who may be able to join
- Patients over 75 years of age
- Operated on for extracapsular proximal femoral fracture
- After bodyheight fall
Who cannot join
- Intra-capsular fractures
- trochantero-diaphyseal fractures
- subtrochanteric fractures
- fractures involving pathological bone
About this study
Proximal femoral fracture is associated with severe morbidity and mortality and high socioeconomic costs. The main mechanical complication of internal fixation in trochanteric fracture is lag-screw cut-out through the femoral head. Several factors are involved, but remain controversial. The aim of the present study was to determine risk factors for cut-out in internal fixation of extracapsular proximal femoral fracture.
- Conditions
- Proximal Femoral Fracture
- Being tested
- Analysis of associated factors for cut-out in internal fixation of extracapsular proximal femoral fracture.
- Keywords
- Cut-out, Gamma nail, Lag-screw, Tip-apex distance, Trochanteric fracture
- Medical subject headings
- Proximal Femoral Fractures, Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analysis of associated factors for cut-out in internal fixation of extracapsular proximal femoral fracture.Other
Identification of factors for mechanical failure of internal fixation of extracapsular proximal femoral fracture in over 75 year olds
What is being measured
The primary outcome is the main question the study is designed to answer.
Mechanical failure defined by varus fracture collapse and lag-screw cut-out with extrusion through the femoral head
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2019
- Study startJul 2009
- Primary completion31 Mar 2015
- Study completion31 Mar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proximal Femoral FractureStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 228 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03975868
- Sponsor's protocol ID
- 30342858
- Status last verified
- Jun 2019
- First submitted
- 4 Jun 2019
- Last updated
- 5 Jun 2019
- Results posted
- 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 5 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Cut-out After Internal Fixation of Trochanteric Fractures in Elderly Subjects.
- ClinicalTrials.gov ID
- NCT03975868
- Acronym / sponsor ID
- 30342858
- Conditions
- Proximal Femoral Fracture
- Keywords
- Cut-out, Gamma nail, Lag-screw, Tip-apex distance, Trochanteric fracture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- Jul 2009 (actual)
- Primary completion
- 31 Mar 2015 (actual)
- Study completion
- 31 Mar 2015 (actual)
- First posted
- 5 Jun 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.
Proximal femoral fracture is associated with severe morbidity and mortality and high socioeconomic costs. The main mechanical complication of internal fixation in trochanteric fracture is lag-screw cut-out through the femoral head. Several factors are involved, but remain controversial. The aim of the present study was to determine risk factors for cut-out in internal fixation of extracapsular proximal femoral fracture.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients over 75 years old operated on for extracapsular proximal femoral fracture.
Key inclusion criteria (3 listed)
- Patients over 75 years of age
- Operated on for extracapsular proximal femoral fracture
- After bodyheight fall
Key exclusion criteria (4 listed)
- Intra-capsular fractures
- trochantero-diaphyseal fractures
- subtrochanteric fractures
- fractures involving pathological bone
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 |
|---|---|---|
| Analysis of associated factors for cut-out in internal fixation of extracapsular proximal femoral fracture.Identification of factors for mechanical failure of internal fixation of extracapsular proximal femoral fracture in over 75 year olds | Other | – |
Primary outcome
Mechanical failure defined by varus fracture collapse and lag-screw cut-out with extrusion through the femoral head
Time frame: 3 months
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 5 Jun 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Proximal Femoral Fracture, run by Fondation Ophtalmologique Adolphe de Rothschild.
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 3 inclusion and 4 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 5 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Mechanical failure defined by varus fracture collapse and lag-screw cut-out with extrusion through the femoral head (time frame: 3 months). 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 5 Jun 2019.