Displaced Forearm Fractures
Conditions
Keywords
Casting techniques, Bivalved cast, Circumferential cast, Displaced distal radius fracture, Children
Brief 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. 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.
Interventions
OTHERBivalved cast
Circumferential cast will be applied following closed reduction and then bivalved using a cast saw
OTHERCircumferential cast
Circumferential cast will be applied following closed reduction
Sponsors
Boston Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
* Displaced distal radius or mid-diaphyseal forearm fracture * fracture requires closed reduction and cast immobilization * Age 4-16 years * Skeletally immature
Exclusion criteria
* Failed closed reduction * Acute fracture \> 1 week old * Refracture injury * Fracture requires surgical treatment * Significant soft tissue swelling * Associated neurovascular compromise * Plastic deformation injuries
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Loss of Radius Fracture Reduction | 4 weeks post-randomization | The number of participants that experienced radiographic loss of reduction by four weeks post-randomization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Compartment Syndrome or Neurovascular Compromise, Saw Burns and/or Lacerations | Up to 4 weeks post-randomization | The number of participants that experienced compartment syndrome or neurovascular compromise, saw burn and/or laceration within four weeks post-randomization. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bivalved Cast Patients with a displaced distal radius or mid-diaphyseal forearm fracture requiring closed reduction will be immobilized in a bivalved cast | 101 |
| Circumferential Cast Patients with a displaced distal radius or mid-diaphyseal forearm fracture requiring closed reduction will be immobilized in a circumferential cast | 101 |
| Total | 202 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 1 |
| Overall Study | Protocol Violation | 5 | 5 |
Baseline characteristics
| Characteristic | Circumferential Cast | Bivalved Cast | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 101 Participants | 101 Participants | 202 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 10 years STANDARD_DEVIATION 6 | 9 years STANDARD_DEVIATION 6 | 10 years STANDARD_DEVIATION 3 |
| Region of Enrollment United States | 101 participants | 101 participants | 202 participants |
| Sex: Female, Male Female | 33 Participants | 34 Participants | 67 Participants |
| Sex: Female, Male Male | 68 Participants | 67 Participants | 135 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 109 | 0 / 107 |
| serious Total, serious adverse events | 0 / 109 | 0 / 107 |
Outcome results
Primary
Loss of Radius Fracture Reduction
The number of participants that experienced radiographic loss of reduction by four weeks post-randomization.
Time frame: 4 weeks post-randomization
Population: All subjects who completed the four-week follow-up period with no protocol violations.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bivalved Cast | Loss of Radius Fracture Reduction | Loss of reduction | 35 participants |
| Bivalved Cast | Loss of Radius Fracture Reduction | No Loss of reduction | 66 participants |
| Circumferential Cast | Loss of Radius Fracture Reduction | Loss of reduction | 35 participants |
| Circumferential Cast | Loss of Radius Fracture Reduction | No Loss of reduction | 66 participants |
Comparison: The frequency of loss of reduction during the study period was compared across casting groups using a two-sided chi-square test with alpha = 0.05.p-value: 1Chi-squared
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.
Time frame: Up to 4 weeks post-randomization
Population: All subjects who completed the four-week follow-up period with no protocol violations.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bivalved Cast | Compartment Syndrome or Neurovascular Compromise, Saw Burns and/or Lacerations | Compartment syndrome | 0 participants |
| Bivalved Cast | Compartment Syndrome or Neurovascular Compromise, Saw Burns and/or Lacerations | Cast saw burn | 0 participants |
| Bivalved Cast | Compartment Syndrome or Neurovascular Compromise, Saw Burns and/or Lacerations | Laceration | 0 participants |
| Bivalved Cast | Compartment Syndrome or Neurovascular Compromise, Saw Burns and/or Lacerations | Infection | 0 participants |
| Circumferential Cast | Compartment Syndrome or Neurovascular Compromise, Saw Burns and/or Lacerations | Infection | 0 participants |
| Circumferential Cast | Compartment Syndrome or Neurovascular Compromise, Saw Burns and/or Lacerations | Compartment syndrome | 0 participants |
| Circumferential Cast | Compartment Syndrome or Neurovascular Compromise, Saw Burns and/or Lacerations | Laceration | 0 participants |
| Circumferential Cast | Compartment Syndrome or Neurovascular Compromise, Saw Burns and/or Lacerations | Cast saw burn | 0 participants |