Pediatric Distal Forearm FracturesNCT01101607
Closed Reduction of Distal Forearm Fractures by Pediatric Emergency Medicine Physicians: A Prospective Study
A study testing Distal Forearm Fracture Reduction in people with Pediatric Distal Forearm Fractures, run by InMotion Orthopaedic Research Center at 1 site in United States.
Trial summary
Distal forearm fractures are amongst the most frequently encountered orthopedic injuries in the pediatric emergency department (ED). Immediate closed manipulation and cast immobilization, is still the mainstay of management. Read more about this study
- Who is it for?
- Ages 6 months to 18 years
- Conditions the study is for
- Pediatric Distal Forearm Fractures
- What is being tested?
- Distal Forearm Fracture Reduction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Apr 2010
- 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 6 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- The inclusion criteria will include patients who present to LeBonheur Emergency room with an angulated or displaced distal radius fracture that meet standard orthopaedic criteria for manipulation. Distal forearm will be defined anatomically as the distal third of the radius or ulna.
Who cannot join
- The exclusion criteria will be patients with an open fracture, neurovascular compromise at presentation or who have undergone prior manipulation of their fracture. Prior manipulation of a fracture is defined when a patient has their fracture manipulated at an outlying facility prior to arriving to LeBonhuer emergency room.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Closed Reduction and Cast Immobilization of Distal Radius Fractures by Pediatric Emergency Medicine
Distal forearm fractures are amongst the most frequently encountered orthopedic injuries in the pediatric emergency department (ED). Immediate closed manipulation and cast immobilization, is still the mainstay of management. The initial management of non-displaced or minimally displaced extremity fractures and relocation of uncomplicated joint dislocations is part of the usual practice of emergency medicine. Although focused training in fracture-dislocation reduction techniques is a part of the core curriculum of emergency medicine training programs, there is limited data discussing outcomes following restorative fracture care by pediatric emergency medicine (PEM)physicians.
The primary objective of this study is to compare length-of-stay and clinical outcomes after closed manipulation of uncomplicated, isolated, distal forearm fractures, by PEMs to those after manipulation by pediatric orthopedic surgeons. Our hypothesis is that there is no difference in emergency department length-of-stay when fracture reduction is performed by a PEM versus a post graduate year 3 or 4 orthopedic resident. Secondary outcomes that will be assessed include: loss of reduction needing re-manipulation at follow up, cast related complications, radiographic and functional healing at 6-8 weeks post injury.
Read the detailed description
Pediatric forearm fractures are common injuries and a frequent cause for an emergency room admission. Ward et al have outlined the demands that emergency department coverage places on practicing orthopedic surgeons. Assuming no statistically significant differences in outcomes, there are potential advantages of having PEMs provide restorative fracture care at the initial visit. This practice would permit judicious orthopedic consultation at a time when several emergency department's are facing an "on call" specialist coverage crisis and there exists a nationwide shortage of fellowship trained pediatric orthopedic specialists, in addition to ACGME mandated duty hour restrictions for orthopedic residents.
Pershad et al conducted a retrospective study with historical controls, of 60 patients with distal radius fracture that were reduced by an orthopedic resident or PEM physician. In this review, there were no differences in rates of re-intervention to restore fracture alignment or ED length-of-stay between the two groups.Mean facility charges were lower in the group treated by PEMs.
It is our hypothesis that with goal directed training, PEM physicians can perform closed reduction of uncomplicated distal forearm fractures with outcomes that are similar to when fracture reduction is performed by senior orthopedic resident physicians.
- Conditions
- Pediatric Distal Forearm Fractures
- Being tested
- Distal Forearm Fracture Reduction
- Keywords
- Pediatrics, Distal Forearm fractures, Pediatric Emergency Medicine, Pediatric Orthopedics
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Distal Forearm Fracture ReductionProcedure or surgery
Fracture reduction
| Study group | Role | What they receive |
|---|---|---|
| Pediatric Emergency Physician | Active comparator | Patients randomized to Pediatric Emergency Physician Group will have their fracture reduced by a Pediatric Emergency Physician Receives: Procedure: Distal Forearm Fracture Reduction |
| Orthopaedic physician | Active comparator | Patients to be randomized to Orthopaedic physician Group will have their fracture reduced by an Orthopaedic Physician Receives: Procedure: Distal Forearm Fracture Reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adequate Alignment of the forearm fracture
The primary outcome in this study is the determination of whether there is adequate alignment of the fracture at 5-7 days post-injury. The proportion of patients with adequate alignments will be compared between the Pediatric Emergency Medicine and the Orthopaedic groups.
Measured: 5-7 days post-injury
Secondary outcomes (1)
Complications
Secondary outcomes to be assessed include incidence of failed apposition needing remanipulation at follow-up, cast-related complications, radiographic and functional healing at 6-8 weeks post-injury, length of stay in the emergency department, and facility charges. Comparisons between the two treatment groups (PEM and OP) will also be made with respect to each of these outcome variables.
Measured: 6-8 weeks post-injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2010 (estimated)
- Study startApr 2008
- Primary completionAug 2009
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pediatric Distal Forearm 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- InMotion Orthopaedic Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Tennessee, Le Bonheur Children's Hospital, Campbell Clinic
- Investigators
- Jay Pershad, MD, Study director, University of Tennessee Health SciencesShehma Khan, MD, Principal investigator, University of Tennessee Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01101607
- Sponsor's protocol ID
- MHIRB 2008-006
- Status last verified
- Apr 2010
- First submitted
- 8 Apr 2010
- Last updated
- 12 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Ward WT, Eberson CP, Otis SA, Wallace CD, Wellisch M, Warman JR, Leitch KK, Epps HR, Richards BS. Pediatric orthopaedic practice management: the role of midlevel providers. J Pediatr Orthop. 2008 Dec;28(8):795-8. doi: 10.1097/BPO.0b013e318183249f. No abstract available.
PubMed 19034167Ward WT, Rihn JA. Demographic and financial implications of pediatric emergency department fracture manipulation. J Pediatr Orthop. 2007 Dec;27(8):877-81. doi: 10.1097/BPO.0b013e3181558c4d.
PubMed 18209607Pershad J, Williams S, Wan J, Sawyer JR. Pediatric distal radial fractures treated by emergency physicians. J Emerg Med. 2009 Oct;37(3):341-4. doi: 10.1016/j.jemermed.2008.08.030. Epub 2009 Feb 6.
PubMed 19201136
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Closed Reduction and Cast Immobilization of Distal Radius Fractures by Pediatric Emergency Medicine
- ClinicalTrials.gov ID
- NCT01101607
- Acronym / sponsor ID
- MHIRB 2008-006
- Conditions
- Pediatric Distal Forearm Fractures
- Keywords
- Pediatrics, Distal Forearm fractures, Pediatric Emergency Medicine, Pediatric Orthopedics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- InMotion Orthopaedic Research CenterUniversity, hospital or other
- Collaborators
- University of Tennessee, Le Bonheur Children's Hospital, Campbell Clinic
- Study start
- Apr 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 12 Apr 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.
Distal forearm fractures are amongst the most frequently encountered orthopedic injuries in the pediatric emergency department (ED). Immediate closed manipulation and cast immobilization, is still the mainstay of management. The initial management of non-displaced or minimally displaced extremity fractures and relocation of uncomplicated joint dislocations is part of the usual practice of emergency medicine. Although focused training in fracture-dislocation reduction techniques is a part of the core curriculum of emergency medicine training programs, there is limited data discussing outcomes following restorative fracture care by pediatric emergency medicine (PEM)physicians.
The primary objective of this study is to compare length-of-stay and clinical outcomes after closed manipulation of uncomplicated, isolated, distal forearm fractures, by PEMs to those after manipulation by pediatric orthopedic surgeons. Our hypothesis is that there is no difference in emergency department length-of-stay when fracture reduction is performed by a PEM versus a post graduate year 3 or 4 orthopedic resident. Secondary outcomes that will be assessed include: loss of reduction needing re-manipulation at follow up, cast related complications, radiographic and functional healing at 6-8 weeks post injury.
Detailed description
Pediatric forearm fractures are common injuries and a frequent cause for an emergency room admission. Ward et al have outlined the demands that emergency department coverage places on practicing orthopedic surgeons. Assuming no statistically significant differences in outcomes, there are potential advantages of having PEMs provide restorative fracture care at the initial visit. This practice would permit judicious orthopedic consultation at a time when several emergency department's are facing an "on call" specialist coverage crisis and there exists a nationwide shortage of fellowship trained pediatric orthopedic specialists, in addition to ACGME mandated duty hour restrictions for orthopedic residents.
Pershad et al conducted a retrospective study with historical controls, of 60 patients with distal radius fracture that were reduced by an orthopedic resident or PEM physician. In this review, there were no differences in rates of re-intervention to restore fracture alignment or ED length-of-stay between the two groups.Mean facility charges were lower in the group treated by PEMs.
It is our hypothesis that with goal directed training, PEM physicians can perform closed reduction of uncomplicated distal forearm fractures with outcomes that are similar to when fracture reduction is performed by senior orthopedic resident physicians.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pediatric Emergency Physician | Active comparator | Procedure: Distal Forearm Fracture ReductionPatients randomized to Pediatric Emergency Physician Group will have their fracture reduced by a Pediatric Emergency Physician |
| Orthopaedic physician | Active comparator | Procedure: Distal Forearm Fracture ReductionPatients to be randomized to Orthopaedic physician Group will have their fracture reduced by an Orthopaedic Physician |
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- The inclusion criteria will include patients who present to LeBonheur Emergency room with an angulated or displaced distal radius fracture that meet standard orthopaedic criteria for manipulation. Distal forearm will be defined anatomically as the distal third of the radius or ulna.
Key exclusion criteria (2 listed)
- The exclusion criteria will be patients with an open fracture, neurovascular compromise at presentation or who have undergone prior manipulation of their fracture. Prior manipulation of a fracture is defined when a patient has their fracture manipulated at an outlying facility prior to arriving to LeBonhuer emergency room.
- -
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 |
|---|---|---|
| Distal Forearm Fracture ReductionFracture reduction | Procedure or surgery | Orthopaedic physician, Pediatric Emergency Physician |
Primary outcome
Adequate Alignment of the forearm fracture
Time frame: 5-7 days post-injury
The primary outcome in this study is the determination of whether there is adequate alignment of the fracture at 5-7 days post-injury. The proportion of patients with adequate alignments will be compared between the Pediatric Emergency Medicine and the Orthopaedic groups.
1 secondary outcome
Complications
Time frame: 6-8 weeks post-injury
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 12 Apr 2010.
- Background: PubMed 19034167Ward WT, Eberson CP, Otis SA, Wallace CD, Wellisch M, Warman JR, Leitch KK, Epps HR, Richards BS. Pediatric orthopaedic practice management: the role of midlevel providers. J Pediatr Orthop. 2008 Dec;28(8):795-8. doi: 10.1097/BPO.0b013e318183249f. No abstract available.
- Background: PubMed 18209607Ward WT, Rihn JA. Demographic and financial implications of pediatric emergency department fracture manipulation. J Pediatr Orthop. 2007 Dec;27(8):877-81. doi: 10.1097/BPO.0b013e3181558c4d.
- Background: PubMed 19201136Pershad J, Williams S, Wan J, Sawyer JR. Pediatric distal radial fractures treated by emergency physicians. J Emerg Med. 2009 Oct;37(3):341-4. doi: 10.1016/j.jemermed.2008.08.030. Epub 2009 Feb 6.
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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.
Jay Pershad, MD study director
University of Tennessee Health Sciences
Shehma Khan, MD principal investigator
University of Tennessee Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Distal Forearm Fracture Reduction in people with Pediatric Distal Forearm Fractures, run by InMotion Orthopaedic Research Center 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 2 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 12 Apr 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 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?
Adequate Alignment of the forearm fracture (time frame: 5-7 days post-injury). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01101607, which also lists 3 linked publications.
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 12 Apr 2010.