Fracture of Shaft of Radius and/or Ulna, Fracture of Upper Limb, Level Unspecified, Metaphyseal Fracture of Bone of Upper Limb
Conditions
Keywords
Fracture of the upper limb
Brief summary
This study aims to examine the need for univalve or bivalve splitting of casts in pediatric patients with forearm fractures following closed reduction and cast application in a randomized, prospective fashion.
Detailed description
Following cast application, little is known regarding the need to split the cast, either in a univalve (a split along a single side of the cast) or bivalve (a split along both sides of the cast) fashion. Theoretically, the splitting of the cast allows for expansion and soft tissue swelling. However, review of the literature yields a paucity of evidence demonstrating the efficacy of splitting a cast. In a study by Nietosvaara et. al, a retrospective examination of 109 pediatric patients initially treated with closed cylindrical casting for closed forearm fractures were evaluated. Of these 109 patients, one-sixth required the initial cast to be split, trimmed, or removed secondary to post-traumatic swelling. However, the splitting of a cast is not without risks in itself. Once the initial swelling dissipates, a univalved or bivalved cast can become excessively loose. This loosening has been associated with a loss of reduction. If the loss or reduction is substantial, it may require a re-reduction or operation to correct. In addition, with every use of the cast saw a patient is placed at risk for iatrogenic cast saw injury. Thermal burns and abrasions from cast saws can cause lifelong emotional and physical scars for a patient. They can also be an inciting event for litigation against the hospital and or provider, with settlements averaging greater than $12,000 per centimeter of cast saw injury.
Interventions
PROCEDURENo Split Cast of forearm fractures
Enroll 20 patients per arm: patients who present for long arm casts after closed reduction of forearm fractures will be randomized to one of 3 arms. Patients randomized to No Split Cast will have a cast that is not split, this is known as closed cast. The cast will be applied according to our Standard of Care casting. Patients will be then undergo follow-up for clinical and radiographic examinations based on the routine fracture management protocol for approximately 3 months.
PROCEDUREUnivalve Split Cast of forearm fractures
Enroll 20 patients per arm: patients who present for long arm casts after closed reduction of forearm fractures will be randomized to one of 3 arms. Patients randomized to Univalve Cast will have a cast that is split on only one side of the cast, this is known as univalve cast. The cast will be applied according to our Standard of Care casting. Patients will be then undergo follow-up for clinical and radiographic examinations based on the routine fracture management protocol for approximately 3 months.
PROCEDUREBivalve Split Cast of forearm fractures
Enroll 20 patients per arm: patients who present for long arm casts after closed reduction of forearm fractures will be randomized to one of 3 arms. Patients randomized to Bivalve Cast will have a cast that is split on both sides of the cast, this is known as bivalve cast. The cast will be applied according to our Standard of Care casting. Patients will be then undergo follow-up for clinical and radiographic examinations based on the routine fracture management protocol for approximately 3 months.
Sponsors
Connecticut Children's Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* A closed isolated radial and/or ulna fracture of the forearm inclusive of metaphyseal and/or shaft level fractures. * Forearm fractures that require closed reduction (with or without conscious sedation) * Patients between the ages of 3 and 12 years old
Exclusion criteria
1. Specific exclusions * Age less than 3 or greater than 12 * Patients presenting with an associated neurological or vascular injury caused by the fracture * Patients presenting with an open fracture * Patients requiring operative treatment following the initial fracture evaluation * Ipsilateral upper extremity fracture * Patients intubated or with a pre-existing condition that prevents them from verbalizing symptoms of discomfort 2. Generic exclusion: Subjects not meeting all inclusion criteria.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complication Rate of the Cast Type | <60 days corresponding to total study time and consistent with outcome 6 | This data will be able to help physicians and ER personnel help this patient population with the least number of cast complications and therefore allow for a more efficient use of resources since cast modifications could be minimized. Metrics used to characterize complications are the radiographic union used to determine speed of healing and the number of unplanned ER or clinic visits for cast modifications. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Different Fracture Characteristics | Less than 1 day | — |
| Pain Levels | one week | Pain levels were assessed using the validated Wong-Baker FACES visual pain rating scale. This scale presents a total of 6 options for pain- none, 1, 2, 3, 4, and 5- with 5 corresponding to the greatest amount of pain. During the analysis it was decided to group these into 5 categories: No pain which was equal to those selecting none, Mild corresponding to those selecting 1, Moderate pain corresponding to those that selected either 2 or 3, and Severe pain corresponding to those that selected either 4 or 5. Patients with no response were placed into the group no response. |
| Cast Index | Immediately after cast application (<1 day) | The cast index is a measure of potential for cast failure described by Chess et al. in 1994. The cast index is calculated as the sagittal width measure divided by the coronal cast width measure at the fracture site. A ratio between these measures of 0.7 or greater for pediatric forearms is considered acceptable. For each patient in this study the cast index was calculated as described above. The average cast index for each of the 3 groups was then presented as the final result. |
| Number of Participants With Different Cast Complications | Day 1 to day 56 | — |
| Average Time for First Follow-up Appointment | 1-2 weeks | Average time from reduction and casting to the first follow-up visit. |
| Number of Patients With Different Fracture Treatments | 4 weeks | — |
Countries
United States
Participant flow
Recruitment details
60 patients between ages 3 to 13 with closed shaft or distal third radius and ulna fracture requiring reduction were enrolled at Connecticut Children's Medical Center Emergency room between 2013 and 2015.
Pre-assignment details
There were no pre-assignment details.
Participants by arm
| Arm | Count |
|---|---|
| No Split Cast of Forearm Fractures Patient will have a No split cast long arm cast applied after a closed reduction of forearm fractures. The cast will not be split. 20 patients will be randomized to this arm.
No Split Cast of forearm fractures: Enroll 20 patients per arm: patients who present for long arm casts after closed reduction of forearm fractures will be randomized to one of 3 arms. Patients randomized to No Split Cast will have a cast that is not split, this is known as closed cast. The cast will be applied according to our Standard of Care casting. Patients will be then undergo follow-up for clinical and radiographic examinations based on the routine fracture management protocol for approximately 3 months. | 20 |
| Univalve Split Cast of Forearm Fractures Patients will have a Univalve Split Cast long arm cast applied after undergoing closed reduction of of forearm fractures. This is a cast that is split on only one side of the cast. 20 patients will be randomized to this arm
Univalve Split Cast of forearm fractures: Enroll 20 patients per arm: patients who present for long arm casts after closed reduction of forearm fractures will be randomized to one of 3 arms. Patients randomized to Univalve Cast will have a cast that is split on only one side of the cast, this is known as univalve cast. The cast will be applied according to our Standard of Care casting. Patients will be then undergo follow-up for clinical and radiographic examinations based on the routine fracture management protocol for approximately 3 months. | 20 |
| Bivalve Split Cast of Forearm Fractures Patients will have a Bivalve Split Cast long arm cast applied after they have undergone a closed reduction of of forearm fractures. This is a cast that will be split on both sides of the cast. 20 patients will be randomized to the bivalve split arm cast.
Bivalve Split Cast of forearm fractures: Enroll 20 patients per arm: patients who present for long arm casts after closed reduction of forearm fractures will be randomized to one of 3 arms. Patients randomized to Bivalve Cast will have a cast that is split on both sides of the cast, this is known as bivalve cast. The cast will be applied according to our Standard of Care casting. Patients will be then undergo follow-up for clinical and radiographic examinations based on the routine fracture management protocol for approximately 3 months. | 20 |
| Total | 60 |
Baseline characteristics
| Characteristic | Univalve Split Cast of Forearm Fractures | Bivalve Split Cast of Forearm Fractures | Total | No Split Cast of Forearm Fractures |
|---|---|---|---|---|
| Age, Continuous | 8.1 years STANDARD_DEVIATION 5.515432893 | 9.0 years STANDARD_DEVIATION 4.737615434 | 8.5 years STANDARD_DEVIATION 3.7 | 8.6 years STANDARD_DEVIATION 3.818376618 |
| Race and Ethnicity Not Collected | — | — | 0 Participants | — |
| Region of Enrollment United States | 20 Participants | 20 Participants | 60 Participants | 20 Participants |
| Sex: Female, Male Sex Female | 6 Participants | 8 Participants | 18 Participants | 4 Participants |
| Sex: Female, Male Sex Male | 14 Participants | 12 Participants | 42 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 | 0 / 20 |
Outcome results
Primary
Complication Rate of the Cast Type
This data will be able to help physicians and ER personnel help this patient population with the least number of cast complications and therefore allow for a more efficient use of resources since cast modifications could be minimized. Metrics used to characterize complications are the radiographic union used to determine speed of healing and the number of unplanned ER or clinic visits for cast modifications.
Time frame: <60 days corresponding to total study time and consistent with outcome 6
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| No Split Cast of Forearm Fractures | Complication Rate of the Cast Type | 9 participants |
| Univalve Split Cast of Forearm Fractures | Complication Rate of the Cast Type | 12 participants |
| Bivalve Split Cast of Forearm Fractures | Complication Rate of the Cast Type | 8 participants |
Other Pre-specified
Average Time for First Follow-up Appointment
Average time from reduction and casting to the first follow-up visit.
Time frame: 1-2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Split Cast of Forearm Fractures | Average Time for First Follow-up Appointment | 5.9 days | Standard Deviation 2.1 |
| Univalve Split Cast of Forearm Fractures | Average Time for First Follow-up Appointment | 6.4 days | Standard Deviation 1.7 |
| Bivalve Split Cast of Forearm Fractures | Average Time for First Follow-up Appointment | 5.8 days | Standard Deviation 2.3 |
Other Pre-specified
Cast Index
The cast index is a measure of potential for cast failure described by Chess et al. in 1994. The cast index is calculated as the sagittal width measure divided by the coronal cast width measure at the fracture site. A ratio between these measures of 0.7 or greater for pediatric forearms is considered acceptable. For each patient in this study the cast index was calculated as described above. The average cast index for each of the 3 groups was then presented as the final result.
Time frame: Immediately after cast application (<1 day)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Split Cast of Forearm Fractures | Cast Index | .88 ratio | Standard Deviation 0.11 |
| Univalve Split Cast of Forearm Fractures | Cast Index | .90 ratio | Standard Deviation 0.09 |
| Bivalve Split Cast of Forearm Fractures | Cast Index | .83 ratio | Standard Deviation 0.05 |
Other Pre-specified
Number of Participants With Different Cast Complications
Time frame: Day 1 to day 56
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| No Split Cast of Forearm Fractures | Number of Participants With Different Cast Complications | Surgical Stablization | 0 participants |
| No Split Cast of Forearm Fractures | Number of Participants With Different Cast Complications | Unplanned Office Visits | 2 participants |
| No Split Cast of Forearm Fractures | Number of Participants With Different Cast Complications | Cast Wedged | 4 participants |
| No Split Cast of Forearm Fractures | Number of Participants With Different Cast Complications | Compartment syndrome | 0 participants |
| No Split Cast of Forearm Fractures | Number of Participants With Different Cast Complications | Unplanned Cast Modifications Visits | 3 participants |
| No Split Cast of Forearm Fractures | Number of Participants With Different Cast Complications | Cast saw abrasions | 0 participants |
| Univalve Split Cast of Forearm Fractures | Number of Participants With Different Cast Complications | Unplanned Cast Modifications Visits | 0 participants |
| Univalve Split Cast of Forearm Fractures | Number of Participants With Different Cast Complications | Surgical Stablization | 1 participants |
| Univalve Split Cast of Forearm Fractures | Number of Participants With Different Cast Complications | Cast saw abrasions | 0 participants |
| Univalve Split Cast of Forearm Fractures | Number of Participants With Different Cast Complications | Cast Wedged | 10 participants |
| Univalve Split Cast of Forearm Fractures | Number of Participants With Different Cast Complications | Compartment syndrome | 0 participants |
| Univalve Split Cast of Forearm Fractures | Number of Participants With Different Cast Complications | Unplanned Office Visits | 1 participants |
| Bivalve Split Cast of Forearm Fractures | Number of Participants With Different Cast Complications | Cast Wedged | 6 participants |
| Bivalve Split Cast of Forearm Fractures | Number of Participants With Different Cast Complications | Compartment syndrome | 0 participants |
| Bivalve Split Cast of Forearm Fractures | Number of Participants With Different Cast Complications | Cast saw abrasions | 0 participants |
| Bivalve Split Cast of Forearm Fractures | Number of Participants With Different Cast Complications | Unplanned Office Visits | 1 participants |
| Bivalve Split Cast of Forearm Fractures | Number of Participants With Different Cast Complications | Unplanned Cast Modifications Visits | 1 participants |
| Bivalve Split Cast of Forearm Fractures | Number of Participants With Different Cast Complications | Surgical Stablization | 0 participants |
Other Pre-specified
Number of Participants With Different Fracture Characteristics
Time frame: Less than 1 day
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| No Split Cast of Forearm Fractures | Number of Participants With Different Fracture Characteristics | Distal Radius/Ulna | 10 Participants |
| No Split Cast of Forearm Fractures | Number of Participants With Different Fracture Characteristics | Distal Third Radius/Ulna | 5 Participants |
| No Split Cast of Forearm Fractures | Number of Participants With Different Fracture Characteristics | Midshaft Radius/Ulna | 3 Participants |
| No Split Cast of Forearm Fractures | Number of Participants With Different Fracture Characteristics | Proximal Third Radius/Ulna | 2 Participants |
| Univalve Split Cast of Forearm Fractures | Number of Participants With Different Fracture Characteristics | Proximal Third Radius/Ulna | 2 Participants |
| Univalve Split Cast of Forearm Fractures | Number of Participants With Different Fracture Characteristics | Distal Radius/Ulna | 8 Participants |
| Univalve Split Cast of Forearm Fractures | Number of Participants With Different Fracture Characteristics | Midshaft Radius/Ulna | 6 Participants |
| Univalve Split Cast of Forearm Fractures | Number of Participants With Different Fracture Characteristics | Distal Third Radius/Ulna | 4 Participants |
| Bivalve Split Cast of Forearm Fractures | Number of Participants With Different Fracture Characteristics | Proximal Third Radius/Ulna | 0 Participants |
| Bivalve Split Cast of Forearm Fractures | Number of Participants With Different Fracture Characteristics | Distal Third Radius/Ulna | 5 Participants |
| Bivalve Split Cast of Forearm Fractures | Number of Participants With Different Fracture Characteristics | Midshaft Radius/Ulna | 2 Participants |
| Bivalve Split Cast of Forearm Fractures | Number of Participants With Different Fracture Characteristics | Distal Radius/Ulna | 13 Participants |
Other Pre-specified
Number of Patients With Different Fracture Treatments
Time frame: 4 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| No Split Cast of Forearm Fractures | Number of Patients With Different Fracture Treatments | Wedge for loss of reduction | 4 participants |
| No Split Cast of Forearm Fractures | Number of Patients With Different Fracture Treatments | Surgical stabilization | 0 participants |
| Univalve Split Cast of Forearm Fractures | Number of Patients With Different Fracture Treatments | Wedge for loss of reduction | 10 participants |
| Univalve Split Cast of Forearm Fractures | Number of Patients With Different Fracture Treatments | Surgical stabilization | 1 participants |
| Bivalve Split Cast of Forearm Fractures | Number of Patients With Different Fracture Treatments | Wedge for loss of reduction | 6 participants |
| Bivalve Split Cast of Forearm Fractures | Number of Patients With Different Fracture Treatments | Surgical stabilization | 0 participants |
Other Pre-specified
Pain Levels
Pain levels were assessed using the validated Wong-Baker FACES visual pain rating scale. This scale presents a total of 6 options for pain- none, 1, 2, 3, 4, and 5- with 5 corresponding to the greatest amount of pain. During the analysis it was decided to group these into 5 categories: No pain which was equal to those selecting none, Mild corresponding to those selecting 1, Moderate pain corresponding to those that selected either 2 or 3, and Severe pain corresponding to those that selected either 4 or 5. Patients with no response were placed into the group no response.
Time frame: one week
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| No Split Cast of Forearm Fractures | Pain Levels | Severe pain | 1 Participants |
| No Split Cast of Forearm Fractures | Pain Levels | Moderate pain | 2 Participants |
| No Split Cast of Forearm Fractures | Pain Levels | No pain | 12 Participants |
| No Split Cast of Forearm Fractures | Pain Levels | Mild Pain | 2 Participants |
| No Split Cast of Forearm Fractures | Pain Levels | No response | 3 Participants |
| Univalve Split Cast of Forearm Fractures | Pain Levels | Moderate pain | 5 Participants |
| Univalve Split Cast of Forearm Fractures | Pain Levels | No pain | 9 Participants |
| Univalve Split Cast of Forearm Fractures | Pain Levels | Mild Pain | 0 Participants |
| Univalve Split Cast of Forearm Fractures | Pain Levels | Severe pain | 3 Participants |
| Univalve Split Cast of Forearm Fractures | Pain Levels | No response | 3 Participants |
| Bivalve Split Cast of Forearm Fractures | Pain Levels | No response | 1 Participants |
| Bivalve Split Cast of Forearm Fractures | Pain Levels | Severe pain | 3 Participants |
| Bivalve Split Cast of Forearm Fractures | Pain Levels | No pain | 12 Participants |
| Bivalve Split Cast of Forearm Fractures | Pain Levels | Moderate pain | 1 Participants |
| Bivalve Split Cast of Forearm Fractures | Pain Levels | Mild Pain | 3 Participants |