Displaced Forearm FracturesNCT00823823
Randomized Trial of Casting Techniques for Displaced Forearm Fractures
A study testing Bivalved cast and Circumferential cast in people with Displaced Forearm Fractures, run by Boston Children's Hospital at 1 site in United States.
Trial summary
It is recognized that fractures of the distal radius and forearm occur in approximately one in 100 children and adolescents every year. Though closed manipulation and cast immobilization of displaced injuries is the mainstay of treatment in the majority of cases, the optimal type of cast remains debatable. Read more about this study
- Who is it for?
- Ages 4 to 16 years
- Conditions the study is for
- Displaced Forearm Fractures
- What is being tested?
- Bivalved cast and Circumferential cast
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Aug 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 4 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Displaced distal radius or mid-diaphyseal forearm fracture
- fracture requires closed reduction and cast immobilization
- Age 4-16 years
- Skeletally immature
Who cannot join
- Failed closed reduction
- Acute fracture > 1 week old
- Refracture injury
- Fracture requires surgical treatment
- Significant soft tissue swelling
- Associated neurovascular compromise
- Plastic deformation injuries
Trial locations and contacts
1 site in 1 country.
United States1 site
Childrens Hospital Boston
Boston, Massachusetts, 02125
About this study
Official title: Randomized Trial of Bivalved and Circumferential Casting for Displaced Forearm Fractures in Children
It is recognized that fractures of the distal radius and forearm occur in approximately one in 100 children and adolescents every year. Though closed manipulation and cast immobilization of displaced injuries is the mainstay of treatment in the majority of cases, the optimal type of cast remains debatable. Though well-molded casts theoretically provide the best ability to maintain fracture alignment, risks of circumferential immobilization in acute injuries include neurovascular compromise. Splitting, or bivalving, casts may reduce these risks, but the effect on fracture stability is unknown. The proposed investigation seeks to address the simple question of whether circumferential or bivalved casts provide the best outcomes.
- Conditions
- Displaced Forearm Fractures
- Being tested
- Bivalved cast, Circumferential cast
- Keywords
- Casting techniques, Bivalved cast, Circumferential cast, Displaced distal radius fracture, Children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bivalved castOther
Circumferential cast will be applied following closed reduction and then bivalved using a cast saw
Circumferential castOther
Circumferential cast will be applied following closed reduction
| Study group | Role | What they receive |
|---|---|---|
| Bivalved cast | Active comparator | Patients with a displaced distal radius or mid-diaphyseal forearm fracture requiring closed reduction will be immobilized in a bivalved cast Receives: Other: Bivalved cast |
| Circumferential cast | Active comparator | Patients with a displaced distal radius or mid-diaphyseal forearm fracture requiring closed reduction will be immobilized in a circumferential cast Receives: Other: Circumferential cast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Loss of Radius Fracture Reduction
The number of participants that experienced radiographic loss of reduction by four weeks post-randomization.
Measured: 4 weeks post-randomization
Secondary outcomes (1)
Compartment Syndrome or Neurovascular Compromise, Saw Burns and/or Lacerations
The number of participants that experienced compartment syndrome or neurovascular compromise, saw burn and/or laceration within four weeks post-randomization.
Measured: Up to 4 weeks post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionJun 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Displaced Forearm FracturesStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Donald Bae, Boston Children's Hospital
- Investigators
- Donald Bae, MD, Principal investigator, Childrens Hospital Boston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00823823
- Sponsor's protocol ID
- 08-09-0430
- Status last verified
- Sep 2014
- First submitted
- 15 Jan 2009
- Last updated
- 9 Sep 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Bivalved and Circumferential Casting for Displaced Forearm Fractures in Children
- ClinicalTrials.gov ID
- NCT00823823
- Acronym / sponsor ID
- 08-09-0430
- Conditions
- Displaced Forearm Fractures
- Keywords
- Casting techniques, Bivalved cast, Circumferential cast, Displaced distal radius fracture, Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 16 Jan 2009 (estimated)
- Results
- Posted 9 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It is recognized that fractures of the distal radius and forearm occur in approximately one in 100 children and adolescents every year. Though closed manipulation and cast immobilization of displaced injuries is the mainstay of treatment in the majority of cases, the optimal type of cast remains debatable. Though well-molded casts theoretically provide the best ability to maintain fracture alignment, risks of circumferential immobilization in acute injuries include neurovascular compromise. Splitting, or bivalving, casts may reduce these risks, but the effect on fracture stability is unknown. The proposed investigation seeks to address the simple question of whether circumferential or bivalved casts provide the best outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bivalved cast | Active comparator | Other: Bivalved castPatients with a displaced distal radius or mid-diaphyseal forearm fracture requiring closed reduction will be immobilized in a bivalved cast |
| Circumferential cast | Active comparator | Other: Circumferential castPatients with a displaced distal radius or mid-diaphyseal forearm fracture requiring closed reduction will be immobilized in a circumferential cast |
Who may qualify
- Ages
- 4 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Displaced distal radius or mid-diaphyseal forearm fracture
- fracture requires closed reduction and cast immobilization
- Age 4-16 years
- Skeletally immature
Key exclusion criteria (7 listed)
- Failed closed reduction
- Acute fracture > 1 week old
- Refracture injury
- Fracture requires surgical treatment
- Significant soft tissue swelling
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 |
|---|---|---|
| Bivalved castCircumferential cast will be applied following closed reduction and then bivalved using a cast saw | Other | Bivalved cast |
| Circumferential castCircumferential cast will be applied following closed reduction | Other | Circumferential cast |
Primary outcome
Loss of Radius Fracture Reduction
Time frame: 4 weeks post-randomization
The number of participants that experienced radiographic loss of reduction by four weeks post-randomization.
1 secondary outcome
Compartment Syndrome or Neurovascular Compromise, Saw Burns and/or Lacerations
Time frame: Up to 4 weeks post-randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Displaced Forearm Fractures
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Treatment of Olecranon Fractures in the Elderly
Olecranon Fracture
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The With Or Without Olecranon K-wires Trial
Olecranon Fracture
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Time to Healing in Displaced Pediatric Diaphyseal Forearm Fractures Treated With Bioabsorbable Compared to Titanium Intramedullary Nails
Forearm Injuries, Radius Fractures
Recruiting
Casting Versus Percutaneus Pinning Treatment of Pediatric Overriding Distal Forearm Fractures
Pediatric Overriding Distal Metaphyseal Radius Fractures
Active, not recruiting
Is Casting of Displaced Pediatric Distal Forearm Fractures Non-inferior to Reduction in General Anesthesia?
Distal Forearm Fracture, Distal Radius Fracture
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.
Donald Bae, MD principal investigator
Childrens Hospital Boston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bivalved cast and Circumferential cast in people with Displaced Forearm Fractures, run by Boston Children's Hospital 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 4 inclusion and 7 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 9 Sep 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?
Yes. Results are posted in the registry (first posted 9 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Loss of Radius Fracture Reduction (time frame: 4 weeks post-randomization). 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 9 Sep 2014.