Femoral Shaft FracturePhase 2NCT01190696
Titanium Elastic Nailing Versus Hip Spica Cast in Treatment of Femoral Fractures in Children
A Phase 2 study testing titanium elastic nailing and Hip spica casting in people with Femoral Shaft Fracture, run by Isfahan University of Medical Sciences at 1 site in Iran.
Trial summary
The purpose of this study is to determine which method is better for treatment of femoral fracture in children in outcomes. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Femoral Shaft Fracture
- What is being tested?
- titanium elastic nailing and Hip spica casting
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteIran
- Study dates
- Feb 2009to Jan 2010
- Phase
- Phase 2
- 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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- patients 6-12 years old with femoral shaft fracture without exclusion criteria
Who cannot join
- Segmental, Winquist type III and IV comminuted fractures, previously diagnosed neuromuscular disease (e.g., cerebral palsy), metabolic bone disorders (e.g. osteomalacia), or pathological fractures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Surgical Method Versus Casting for Treatment of Femoral Fracture in Children
The purpose of this study is to determine which method is better for treatment of femoral fracture in children in outcomes.
Read the detailed description
There is no consensus on treatment of closed femoral shaft fractures in children 6-12years old. We aimed to compare hip spica cast with titanium elastic nailing (TEN) in the treatment of femoral shaft fractures in children.
- Conditions
- Femoral Shaft Fracture
- Being tested
- titanium elastic nailing, Hip spica casting
- Keywords
- Spica Cast, TEN, Femoral Shaft Fracture, Children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
titanium elastic nailingProcedure or surgery
Also called TEN
we inserted titanium nail in femoral fractures retrogradely
Hip spica castingDevice
Also called TEN
we applied cast for three weeks in patients with femoral shaft fracture
| Study group | Role | What they receive |
|---|---|---|
| hip spica casting | Other | Patients in the spica cast group treated with skeletal traction and spica cast applied for them Receives: Device: Hip spica casting |
| titanium elasting nailing | Other | For patients in the Titanium Elasting Nailing group, the nail applied retrogradely in femoral shaft fracture Receives: Procedure: titanium elastic nailing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay
identification of Length of hospital stay (days)for patients who treated with titanium elastic nailing or casting
Measured: at 1 months post-operatively
Secondary outcomes (3)
the time to walking with aids
identification of the time to walking with aids in patients who treated with titanium elastic nailing or casting
Measured: at 1 months post-operatively
parent's satisfaction
identification of parent's satisfaction with questionnair in patients who treated with titanium elastic nailing or casting
Measured: at 1 months post-operatively
the time absent from school
identification of the time absent from school in patients who treated with titanium elasting nailing or casting
Measured: at 1 months post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2010 (estimated)
- Study startFeb 2009
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoral Shaft 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isfahan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- hamidreza shemshaki, MD, Study chair, MD,research comittee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01190696
- Sponsor's protocol ID
- ASD-1213-5
- Status last verified
- Feb 2009
- First submitted
- 27 Aug 2010
- Last updated
- 30 Aug 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Surgical Method Versus Casting for Treatment of Femoral Fracture in Children
- ClinicalTrials.gov ID
- NCT01190696
- Acronym / sponsor ID
- ASD-1213-5
- Conditions
- Femoral Shaft Fracture
- Keywords
- Spica Cast, TEN, Femoral Shaft Fracture, Children
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Isfahan University of Medical SciencesUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 30 Aug 2010 (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.
The purpose of this study is to determine which method is better for treatment of femoral fracture in children in outcomes.
Detailed description
There is no consensus on treatment of closed femoral shaft fractures in children 6-12years old. We aimed to compare hip spica cast with titanium elastic nailing (TEN) in the treatment of femoral shaft fractures in children.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hip spica casting | Other | Device: Hip spica castingPatients in the spica cast group treated with skeletal traction and spica cast applied for them |
| titanium elasting nailing | Other | Procedure: titanium elastic nailingFor patients in the Titanium Elasting Nailing group, the nail applied retrogradely in femoral shaft fracture |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- patients 6-12 years old with femoral shaft fracture without exclusion criteria
Key exclusion criteria (1 listed)
- Segmental, Winquist type III and IV comminuted fractures, previously diagnosed neuromuscular disease (e.g., cerebral palsy), metabolic bone disorders (e.g. osteomalacia), or pathological fractures.
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 |
|---|---|---|
| titanium elastic nailingAlso: TENwe inserted titanium nail in femoral fractures retrogradely | Procedure or surgery | titanium elasting nailing |
| Hip spica castingAlso: TENwe applied cast for three weeks in patients with femoral shaft fracture | Device | hip spica casting |
Primary outcome
Length of hospital stay
Time frame: at 1 months post-operatively
identification of Length of hospital stay (days)for patients who treated with titanium elastic nailing or casting
3 secondary outcomes
the time to walking with aids
Time frame: at 1 months post-operatively
parent's satisfaction
Time frame: at 1 months post-operatively
the time absent from school
Time frame: at 1 months post-operatively
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 30 Aug 2010.
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Feasibility of Structured Resistance Training After Lower Extremity Fracture
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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.
hamidreza shemshaki, MD study chair
MD,research comittee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing titanium elastic nailing and Hip spica casting in people with Femoral Shaft Fracture, run by Isfahan University of Medical Sciences at 1 site in Iran.
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 1 inclusion and 1 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 30 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Length of hospital stay (time frame: at 1 months post-operatively). 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 30 Aug 2010.