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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bivalved cast | Other | Circumferential cast will be applied following closed reduction and then bivalved using a cast saw |
|
| Measure | Description | Time Frame |
|---|---|---|
| Loss of Radius Fracture Reduction | The number of participants that experienced radiographic loss of reduction by four weeks post-randomization. | 4 weeks post-randomization |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 4 weeks post-randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Donald Bae, MD | Childrens Hospital Boston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Childrens Hospital Boston | Boston | Massachusetts | 02125 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bivalved Cast | Patients with a displaced distal radius or mid-diaphyseal forearm fracture requiring closed reduction will be immobilized in a bivalved cast |
| FG001 | Circumferential Cast | Patients with a displaced distal radius or mid-diaphyseal forearm fracture requiring closed reduction will be immobilized in a circumferential cast |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Bivalved Cast | Patients with a displaced distal radius or mid-diaphyseal forearm fracture requiring closed reduction will be immobilized in a bivalved cast |
| BG001 | Circumferential Cast |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Loss of Radius Fracture Reduction | The number of participants that experienced radiographic loss of reduction by four weeks post-randomization. | All subjects who completed the four-week follow-up period with no protocol violations. | Posted | Number | participants | 4 weeks post-randomization |
|
Approximately 6 weeks (from time of ED visit to last clinical follow-up visit)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bivalved Cast | Patients with a displaced distal radius or mid-diaphyseal forearm fracture requiring closed reduction will be immobilized in a bivalved cast |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cast saw burn | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Donald Bae | Children's Hospital Boston | 617-355-6808 | donald.bae@childrens.harvard.edu |
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| Circumferential cast | Other | Circumferential cast will be applied following closed reduction |
|
Patients with a displaced distal radius or mid-diaphyseal forearm fracture requiring closed reduction will be immobilized in a circumferential cast
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | 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. | All subjects who completed the four-week follow-up period with no protocol violations. | Posted | Number | participants | Up to 4 weeks post-randomization |
|
|
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| 0 |
| 109 |
| 1 |
| 109 |
| EG001 | Circumferential Cast | Patients with a displaced distal radius or mid-diaphyseal forearm fracture requiring closed reduction will be immobilized in a circumferential cast | 0 | 107 | 0 | 107 |
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| Laceration |
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| Infection |
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