Femur FractureNCT00943332
Pediatric Femur Research Project
An observational study of Femur Fracture, run by Washington University School of Medicine at 3 sites in United States.
Trial summary
Current treatment protocol for pediatric femoral shaft fractures is immediate spica casting for patients 6 years and younger and for patients over 6 years and older is percutaneous or open placement of titanium elastic intramedullary nails. Read more about this study
- Who is it for?
- Ages 2 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Femur Fracture
- What is being tested?
- femur fracture repair
- Type of treatment
- Surgery or procedure
- How many people
- 48 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2009to Jan 2018
- 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 2 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Patients will have undergone of the following interventions for the treatment of the femur fracture: spica casting, nancy nailing, or submuscular plating, by a participating physician in the trial. All of these treatments are considered standard of care for this pediatric population.
Who may be able to join
- Child diagnosed with femur fracture between the ages of 2-6 years old
- Patient will undergo surgical intervention for a femur fracture (e.g., submuscular plating, Nancy nailing, casting )
Who cannot join
- Parent refusal to participate for any reason
- Children with neuromuscular disorders having a Gross Motor Function Classification greater than 3
- Pathologic fracture
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Children's Hospital - University Missouri
Columbia, Missouri, 65201
Children's Mercy Hospital
Kansas City, Missouri, 64108
St. Louis Childrens Hospital
St Louis, Missouri, 63110
About this study
Current treatment protocol for pediatric femoral shaft fractures is immediate spica casting for patients 6 years and younger and for patients over 6 years and older is percutaneous or open placement of titanium elastic intramedullary nails. The investigators would like to evaluate the current treatment protocol by comparing those patients 6 years and younger treated with closed reduction and spica casting to those 6 years and younger treated with percutaneous pinned with titanium elastic intramedullary nails or submuscular plating. The investigators will be comparing their post-operative functional level, pain management, impact on family and complications through chart and x-ray reviews. The goal is to improve patient care pre and post-operatively for those who have sustained a femoral shaft fracture 6 years old and younger and increase the knowledge of those residents/physicians who care for this patient population.
- Conditions
- Femur Fracture
- Being tested
- femur fracture repair
- Keywords
- Orthopedic Procedures, Fracture Fixation, Internal, Fracture Fixation, External, femur fracture, pediatrics
- Medical subject headings
- Femoral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
femur fracture repairProcedure or surgery
all participants will have undergone surgical intervention to repair a femur fracture, the investigators will simply be collecting data after the procedure; participants will not be consented until after the procedure
| Study group | Role | What they receive |
|---|---|---|
| spica casting | Not described Receives: Procedure: femur fracture repair | |
| intramedullary nailing | Not described Receives: Procedure: femur fracture repair | |
| submuscualr plating | Not described Receives: Procedure: femur fracture repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact on family
Measured: 6 months
Secondary outcomes (3)
post-operative functional level
Measured: 1 year
pain management
Measured: 6 weeks
complications
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2009 (estimated)
- Study startJun 2009
- Primary completionJan 2018
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femur FractureStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University of Missouri-Columbia, Children's Mercy Hospital Kansas City
- Responsible party
- Sponsor
- Investigators
- J. Eric Gordon, MD, Principal investigator, Washington Univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00943332
- Sponsor's protocol ID
- 09-0819-201105030
- Status last verified
- Apr 2019
- First submitted
- 17 Jul 2009
- Last updated
- 26 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Femur Research Project
- ClinicalTrials.gov ID
- NCT00943332
- Acronym / sponsor ID
- 09-0819-201105030
- Conditions
- Femur Fracture
- Keywords
- Orthopedic Procedures, Fracture Fixation, Internal, Fracture Fixation, External, femur fracture, pediatrics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- University of Missouri-Columbia, Children's Mercy Hospital Kansas City
- Study start
- Jun 2009
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 22 Jul 2009 (estimated)
- 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.
Current treatment protocol for pediatric femoral shaft fractures is immediate spica casting for patients 6 years and younger and for patients over 6 years and older is percutaneous or open placement of titanium elastic intramedullary nails. The investigators would like to evaluate the current treatment protocol by comparing those patients 6 years and younger treated with closed reduction and spica casting to those 6 years and younger treated with percutaneous pinned with titanium elastic intramedullary nails or submuscular plating. The investigators will be comparing their post-operative functional level, pain management, impact on family and complications through chart and x-ray reviews. The goal is to improve patient care pre and post-operatively for those who have sustained a femoral shaft fracture 6 years old and younger and increase the knowledge of those residents/physicians who care for this patient population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| spica casting | – | Procedure: femur fracture repair |
| intramedullary nailing | – | Procedure: femur fracture repair |
| submuscualr plating | – | Procedure: femur fracture repair |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Patients will have undergone of the following interventions for the treatment of the femur fracture: spica casting, nancy nailing, or submuscular plating, by a participating physician in the trial. All of these treatments are considered standard of care for this pediatric population.
Key inclusion criteria (2 listed)
- Child diagnosed with femur fracture between the ages of 2-6 years old
- Patient will undergo surgical intervention for a femur fracture (e.g., submuscular plating, Nancy nailing, casting )
Key exclusion criteria (3 listed)
- Parent refusal to participate for any reason
- Children with neuromuscular disorders having a Gross Motor Function Classification greater than 3
- Pathologic fracture
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 |
|---|---|---|
| femur fracture repairall participants will have undergone surgical intervention to repair a femur fracture, the investigators will simply be collecting data after the procedure; participants will not be consented until after the procedure | Procedure or surgery | intramedullary nailing, spica casting, submuscualr plating |
Primary outcome
Impact on family
Time frame: 6 months
3 secondary outcomes
post-operative functional level
Time frame: 1 year
pain management
Time frame: 6 weeks
complications
Time frame: 2 years
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 26 Apr 2019.
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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.
J. Eric Gordon, MD principal investigator
Washington Univeristy
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Femur Fracture, run by Washington University School of Medicine at 3 sites in United States.
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 2 inclusion and 3 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 26 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
Impact on family (time frame: 6 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 26 Apr 2019.