Tibial FracturesNCT01926795
Immobilization Versus Observation in Children With Toddler's Fractures: a Prospective Randomized Controlled Trial
A study testing Short leg cast and No Immobilization in people with Tibial Fractures, run by Prisma Health-Upstate at 1 site in United States.
Trial summary
Toddler's fractures of the tibia are by definition non-displaced and of a stable pattern. Children have thickened periosteum compared with adults, which therefore may impart stability to the fracture without the need for additional immobilization. Read more about this study
- Who is it for?
- Ages 1 year to 5 years
- Conditions the study is for
- Tibial Fractures
- What is being tested?
- Short leg cast and No Immobilization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Feb 2015
- Phase
- Interventional
- 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 1 year to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- • Children ages 1-5 years old with radiographic evidence of a non-displaced spiral or oblique fracture of the tibial shaft or metaphysis.
Who cannot join
- • Children with clinical suspicion but lack of radiographic evidence for toddler's fracture
- Fractures displaced >2mm
- Open fractures
- Pathologic fracture
- Fractures involving the physis
- Previous fracture of the ipsilateral extremity
Show all 14Show fewer
- Concomitant fracture involving the ipsilateral or contralateral leg
- Concomitant head injury
- Non-ambulatory children (i.e., those who have not yet begun to walk)
- Children with bone-metabolism disorders (i.e., osteogenesis imperfect, rickets)
- Children who are geographically prohibited from following up in our system
- Children whose caregivers are not proficient in English
- Presentation >7 days from injury
- Cases considered to be non-accidental trauma
Trial locations and contacts
1 site in 1 country.
United States1 site
Greenville Hospital System
Greenville, South Carolina, 29605
About this study
Toddler's fractures of the tibia are by definition non-displaced and of a stable pattern. Children have thickened periosteum compared with adults, which therefore may impart stability to the fracture without the need for additional immobilization. The goal of the study is to evaluate whether or not there is a difference in children treated with and without cast immobilization in regards to time to ambulation; perceived pain; difficulty in dressing \& bathing; radiographic displacement or angulation; and time missed from work or daycare. Our null hypothesis is that there will be no difference in clinical or radiographic outcomes between the groups.
- Conditions
- Tibial Fractures
- Being tested
- Short leg cast, No Immobilization
- Keywords
- toddler's fracture, tibial fracture, children
- Medical subject headings
- Tibial Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short leg castProcedure or surgery
No ImmobilizationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Short Leg Cast | Active comparator | Patient will be placed in a short leg cast for approximately 3 weeks or until radiographic union Receives: Procedure: Short leg cast |
| No immobilization | Experimental | No cast or splint will be applied to the injured extremity Receives: Procedure: No Immobilization |
| Observational | Other | Patient will be treated based on the parents comfort. This arm will consist of individuals in which the parent/guardian did not agree to randomization, but did consent for observational follow-up regardless of treatment. Receives: Procedure: Short leg cast; Procedure: No Immobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days to Ambulation
Recorded in parent journal, date of first ambulation without assistance.
Measured: 12 weeks
Secondary outcomes (1)
Fracture displacement
Displacement of the fracture greater than 2 mm in any direction.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2013 (estimated)
- Study startJun 2013
- Primary completionFeb 2014
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tibial FracturesStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prisma Health-Upstate
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael L Beckish, MD, Principal investigator, Greenville Hospital System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01926795
- Sponsor's protocol ID
- Pro00025178
- Status last verified
- Apr 2015
- First submitted
- 19 Aug 2013
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immobilization Versus Observation in Children With Toddler's Fractures: a Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01926795
- Acronym / sponsor ID
- Pro00025178
- Conditions
- Tibial Fractures
- Keywords
- toddler's fracture, tibial fracture, children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Prisma Health-UpstateUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 21 Aug 2013 (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.
Toddler's fractures of the tibia are by definition non-displaced and of a stable pattern. Children have thickened periosteum compared with adults, which therefore may impart stability to the fracture without the need for additional immobilization. The goal of the study is to evaluate whether or not there is a difference in children treated with and without cast immobilization in regards to time to ambulation; perceived pain; difficulty in dressing \& bathing; radiographic displacement or angulation; and time missed from work or daycare. Our null hypothesis is that there will be no difference in clinical or radiographic outcomes between the groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Short Leg Cast | Active comparator | Procedure: Short leg castPatient will be placed in a short leg cast for approximately 3 weeks or until radiographic union |
| No immobilization | Experimental | Procedure: No ImmobilizationNo cast or splint will be applied to the injured extremity |
| Observational | Other | Procedure: Short leg cast, Procedure: No ImmobilizationPatient will be treated based on the parents comfort. This arm will consist of individuals in which the parent/guardian did not agree to randomization, but did consent for observational follow-up regardless of treatment. |
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- • Children ages 1-5 years old with radiographic evidence of a non-displaced spiral or oblique fracture of the tibial shaft or metaphysis.
Key exclusion criteria (14 listed)
- • Children with clinical suspicion but lack of radiographic evidence for toddler's 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 |
|---|---|---|
| Short leg cast | Procedure or surgery | Observational, Short Leg Cast |
| No Immobilization | Procedure or surgery | No immobilization, Observational |
Primary outcome
Days to Ambulation
Time frame: 12 weeks
Recorded in parent journal, date of first ambulation without assistance.
1 secondary outcome
Fracture displacement
Time frame: 12 weeks
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 7 Apr 2015.
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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.
Michael L Beckish, MD principal investigator
Greenville Hospital System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Short leg cast and No Immobilization in people with Tibial Fractures, run by Prisma Health-Upstate at 1 site 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 1 inclusion and 14 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 7 Apr 2015. 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 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?
Days to Ambulation (time frame: 12 weeks). 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 7 Apr 2015.