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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No split Cast of forearm fractures | Active Comparator | 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. |
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| Univalve Split Cast of forearm fractures | Active Comparator | 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 |
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| Bivalve Split Cast of forearm fractures | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Split Cast of forearm fractures | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | <60 days corresponding to total study time and consistent with outcome 6 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
Specific exclusions
Generic exclusion: "Subjects not meeting all inclusion criteria."
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| Name | Affiliation | Role |
|---|---|---|
| Mark Lee, MD | Connecticut Children's Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Connecticut Children's Medical Center | Hartford | Connecticut | 06016 | United States |
Not sharing individual data. Plan is to publish the data.
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There were no pre-assignment 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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Univalve Split Cast of forearm fractures | Procedure | 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. |
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| Bivalve Split Cast of forearm fractures | Procedure | 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. |
|
| Immediately after cast application (<1 day) |
| Number of Participants With Different Fracture Characteristics | Less than 1 day |
| 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". | one week |
| Number of Patients With Different Fracture Treatments | 4 weeks |
| Number of Participants With Different Cast Complications | Day 1 to day 56 |
| Average Time for First Follow-up Appointment | Average time from reduction and casting to the first follow-up visit. | 1-2 weeks |
| FG001 | 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. |
| FG002 | 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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants | No |
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| 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 | 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. | Posted | Number | participants | <60 days corresponding to total study time and consistent with outcome 6 |
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| 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. | Posted | Mean | Standard Deviation | ratio | Immediately after cast application (<1 day) |
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| Other Pre-specified | Number of Participants With Different Fracture Characteristics | Posted | Count of Participants | Participants | Less than 1 day |
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| 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". | Posted | Count of Participants | Participants | one week |
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| Other Pre-specified | Number of Patients With Different Fracture Treatments | Posted | Number | participants | 4 weeks |
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| Other Pre-specified | Number of Participants With Different Cast Complications | Posted | Number | participants | Day 1 to day 56 |
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| Other Pre-specified | Average Time for First Follow-up Appointment | Average time from reduction and casting to the first follow-up visit. | Posted | Mean | Standard Deviation | days | 1-2 weeks |
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Adverse Events were collected 5 to 10 days, and 6 weeks after the initial cast application. Also captured at visit that occurred at the discretion of the provider.
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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 | 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. | 0 | 20 | 0 | 20 | 0 | 20 |
| EG001 | 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. | 0 | 20 | 0 | 20 | 0 | 20 |
| EG002 | 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. | 0 | 20 | 0 | 20 | 0 | 20 |
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The study was powered to detect a two patient difference in the incidence of cast related compartment syndrome and neurologic injuries between the three casting groups.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr, Mark Lee | Connecticut Children's Medical Center | 860-837-7421 | Mlee01@connecticutchildrens.org |
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| OG002 | 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. |
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| OG002 | 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. |
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| OG002 | 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. |
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| OG002 | 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. |
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| OG002 | 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. |
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| OG002 | 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. |
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