Type II Supracondylar FracturesNCT00207870
Type II Supracondylar Fractures in Children
An observational study of Type II Supracondylar Fractures, run by Children's Healthcare of Atlanta at 1 site in United States.
Trial summary
Supracondylar fractures are the most common elbow fractures in children. In the current orthopedic literature crossed pinning and lateral-only entry techniques are co-gold standards of operative treatment. Read more about this study
- Who is it for?
- Ages 3 to 10 years
- Conditions the study is for
- Type II Supracondylar Fractures
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Sep 2008
- 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 3 to 10 years
- All sexes
- No healthy volunteers
- Child
Study population: all patients less than 10 with a supracondylar fx
Who may be able to join
- Closed, Gartland's type III extension supracondylar humerus fractures requiring closed reduction and pinning.
Who cannot join
- Age greater than ten
- Open fracture
- Need for open reduction in the operating room
- Need for vascular repair of the ipsilateral extremity
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Healthcare of Atlanta at Scottish Rite
Atlanta, Georgia, 30342
About this study
Official title: Comparison of Crossed Pin Versus Lateral-Entry Pin Fixation for Type II Supracondylar Fractures in Children: A Prospective, Randomized Trial
Supracondylar fractures are the most common elbow fractures in children. In the current orthopedic literature crossed pinning and lateral-only entry techniques are co-gold standards of operative treatment. The crossed pinning technique has been shown to be biomechanically superior especially under torsional loading but has a higher incidence of iatrogenic injury to the ulnar nerve. All studies comparing these techniques to date have been either biomechanical or retrospective in nature. A randomized, controlled, prospective study comparing these two popular techniques has not been performed.
The purpose of this study is to prospectively evaluate the amount of displacement incurred when treating type III supracondylar humerus fractures in children with crossed pinning versus lateral-entry only technique. Overall complication rate, loss of reduction, iatrogenic neurovascular injury, and pin tract infection rates between the two cohorts will be evaluated. The study population will comprise all patients less than ten years of age presenting to Scottish Rite Hospital during the study period with a type III supracondylar fracture managed by the Children's Healthcare of Atlanta Orthopedic Group. All patients will be randomized to one specific treatment arm based on surgeon preference established at the onset of the study. The hypothesis to be tested is that no difference in amount of displacement or overall complication rate is present between these two techniques. Radiographic parameters measured pre-operatively, immediately post-operatively and four weeks post-operatively will be quantitatively evaluated and compared. Chart reviews to determine complications during the treatment period will be made. Pre-study power analysis and post-study statistical analysis will be performed.
Read the detailed description
Pre-operative consent forms for study participation will be reviewed with all families at the time of the pre-operative visit. Screening will be performed at the time of evaluation in the emergency room. Patients will be assigned to a particular group based on the surgeon that performs their surgery. Each surgeon at the onset of the study will commit to one technique of operative management with the understanding that this technique may be abandoned by the surgeon in any case where it is felt to be inadequate. Changing technique will be considered a failure of the technique. Data regarding the treatment will be collected from the chart and x-rays at the time of treatment and at follow up visits in the orthopedic office.
- Conditions
- Type II Supracondylar Fractures
- Keywords
- Type II Supracondylar Fracture, Orthopaedics
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startOct 2006
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type II Supracondylar 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
- Observational
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Healthcare of Atlanta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Blanco, MD, Principal investigator, Children's Orthopaedics of Atlanta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00207870
- Sponsor's protocol ID
- Type II Supracondylar FX
- Status last verified
- Jul 2011
- First submitted
- 13 Sep 2005
- Last updated
- 22 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Crossed Pin Versus Lateral-Entry Pin Fixation for Type II Supracondylar Fractures in Children: A Prospective, Randomized Trial
- ClinicalTrials.gov ID
- NCT00207870
- Acronym / sponsor ID
- Type II Supracondylar FX
- Conditions
- Type II Supracondylar Fractures
- Keywords
- Type II Supracondylar Fracture, Orthopaedics
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Children's Healthcare of AtlantaUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 21 Sep 2005 (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.
Supracondylar fractures are the most common elbow fractures in children. In the current orthopedic literature crossed pinning and lateral-only entry techniques are co-gold standards of operative treatment. The crossed pinning technique has been shown to be biomechanically superior especially under torsional loading but has a higher incidence of iatrogenic injury to the ulnar nerve. All studies comparing these techniques to date have been either biomechanical or retrospective in nature. A randomized, controlled, prospective study comparing these two popular techniques has not been performed.
The purpose of this study is to prospectively evaluate the amount of displacement incurred when treating type III supracondylar humerus fractures in children with crossed pinning versus lateral-entry only technique. Overall complication rate, loss of reduction, iatrogenic neurovascular injury, and pin tract infection rates between the two cohorts will be evaluated. The study population will comprise all patients less than ten years of age presenting to Scottish Rite Hospital during the study period with a type III supracondylar fracture managed by the Children's Healthcare of Atlanta Orthopedic Group. All patients will be randomized to one specific treatment arm based on surgeon preference established at the onset of the study. The hypothesis to be tested is that no difference in amount of displacement or overall complication rate is present between these two techniques. Radiographic parameters measured pre-operatively, immediately post-operatively and four weeks post-operatively will be quantitatively evaluated and compared. Chart reviews to determine complications during the treatment period will be made. Pre-study power analysis and post-study statistical analysis will be performed.
Detailed description
Pre-operative consent forms for study participation will be reviewed with all families at the time of the pre-operative visit. Screening will be performed at the time of evaluation in the emergency room. Patients will be assigned to a particular group based on the surgeon that performs their surgery. Each surgeon at the onset of the study will commit to one technique of operative management with the understanding that this technique may be abandoned by the surgeon in any case where it is felt to be inadequate. Changing technique will be considered a failure of the technique. Data regarding the treatment will be collected from the chart and x-rays at the time of treatment and at follow up visits in the orthopedic office.
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- all patients less than 10 with a supracondylar fx
Key inclusion criteria (1 listed)
- Closed, Gartland's type III extension supracondylar humerus fractures requiring closed reduction and pinning.
Key exclusion criteria (4 listed)
- Age greater than ten
- Open fracture
- Need for open reduction in the operating room
- Need for vascular repair of the ipsilateral extremity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2014.
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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.
John Blanco, MD principal investigator
Children's Orthopaedics of Atlanta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type II Supracondylar Fractures, run by Children's Healthcare of Atlanta 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 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: withdrawn, as of the sponsor's last update on 22 Jul 2014. 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 was withdrawn before enrolling participants, so there are no results.
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.
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 22 Jul 2014.