Trial Outcomes & Findings for Is Univalving or Bivalving of Long Arm Casts for Forearm Fractures Necessary? (NCT NCT02614690)
NCT ID: NCT02614690
Last Updated: 2022-01-14
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
<60 days corresponding to total study time and consistent with outcome 6
Results posted on
2022-01-14
Participant Flow
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.
There were no pre-assignment details.
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
No Split Cast of Forearm Fractures
n=20 Participants
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.
|
Univalve Split Cast of Forearm Fractures
n=20 Participants
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.
|
Bivalve Split Cast of Forearm Fractures
n=20 Participants
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.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
8.6 years
STANDARD_DEVIATION 3.818376618 • n=20 Participants
|
8.1 years
STANDARD_DEVIATION 5.515432893 • n=20 Participants
|
9.0 years
STANDARD_DEVIATION 4.737615434 • n=20 Participants
|
8.5 years
STANDARD_DEVIATION 3.7 • n=60 Participants
|
|
Sex: Female, Male
Sex · Female
|
4 Participants
n=20 Participants
|
6 Participants
n=20 Participants
|
8 Participants
n=20 Participants
|
18 Participants
n=60 Participants
|
|
Sex: Female, Male
Sex · Male
|
16 Participants
n=20 Participants
|
14 Participants
n=20 Participants
|
12 Participants
n=20 Participants
|
42 Participants
n=60 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
20 Participants
n=20 Participants
|
20 Participants
n=20 Participants
|
20 Participants
n=20 Participants
|
60 Participants
n=60 Participants
|
PRIMARY outcome
Timeframe: <60 days corresponding to total study time and consistent with outcome 6This 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.
Outcome measures
| Measure |
No Split Cast of Forearm Fractures
n=20 Participants
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.
|
Univalve Split Cast of Forearm Fractures
n=20 Participants
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.
|
Bivalve Split Cast of Forearm Fractures
n=20 Participants
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.
|
|---|---|---|---|
|
Complication Rate of the Cast Type
|
9 participants
|
12 participants
|
8 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
Outcome measures
| Measure |
No Split Cast of Forearm Fractures
n=20 Participants
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.
|
Univalve Split Cast of Forearm Fractures
n=20 Participants
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.
|
Bivalve Split Cast of Forearm Fractures
n=20 Participants
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.
|
|---|---|---|---|
|
Cast Index
|
.88 ratio
Standard Deviation 0.11
|
.90 ratio
Standard Deviation 0.09
|
.83 ratio
Standard Deviation 0.05
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Less than 1 dayOutcome measures
| Measure |
No Split Cast of Forearm Fractures
n=20 Participants
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.
|
Univalve Split Cast of Forearm Fractures
n=20 Participants
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.
|
Bivalve Split Cast of Forearm Fractures
n=20 Participants
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.
|
|---|---|---|---|
|
Number of Participants With Different Fracture Characteristics
Distal Radius/Ulna
|
10 Participants
|
8 Participants
|
13 Participants
|
|
Number of Participants With Different Fracture Characteristics
Distal Third Radius/Ulna
|
5 Participants
|
4 Participants
|
5 Participants
|
|
Number of Participants With Different Fracture Characteristics
Midshaft Radius/Ulna
|
3 Participants
|
6 Participants
|
2 Participants
|
|
Number of Participants With Different Fracture Characteristics
Proximal Third Radius/Ulna
|
2 Participants
|
2 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: one weekPain 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".
Outcome measures
| Measure |
No Split Cast of Forearm Fractures
n=20 Participants
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.
|
Univalve Split Cast of Forearm Fractures
n=20 Participants
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.
|
Bivalve Split Cast of Forearm Fractures
n=20 Participants
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.
|
|---|---|---|---|
|
Pain Levels
No pain
|
12 Participants
|
9 Participants
|
12 Participants
|
|
Pain Levels
Mild Pain
|
2 Participants
|
0 Participants
|
3 Participants
|
|
Pain Levels
Moderate pain
|
2 Participants
|
5 Participants
|
1 Participants
|
|
Pain Levels
Severe pain
|
1 Participants
|
3 Participants
|
3 Participants
|
|
Pain Levels
No response
|
3 Participants
|
3 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 4 weeksOutcome measures
| Measure |
No Split Cast of Forearm Fractures
n=20 Participants
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.
|
Univalve Split Cast of Forearm Fractures
n=20 Participants
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.
|
Bivalve Split Cast of Forearm Fractures
n=20 Participants
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.
|
|---|---|---|---|
|
Number of Patients With Different Fracture Treatments
Wedge for loss of reduction
|
4 participants
|
10 participants
|
6 participants
|
|
Number of Patients With Different Fracture Treatments
Surgical stabilization
|
0 participants
|
1 participants
|
0 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 to day 56Outcome measures
| Measure |
No Split Cast of Forearm Fractures
n=20 Participants
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.
|
Univalve Split Cast of Forearm Fractures
n=20 Participants
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.
|
Bivalve Split Cast of Forearm Fractures
n=20 Participants
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.
|
|---|---|---|---|
|
Number of Participants With Different Cast Complications
Compartment syndrome
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Different Cast Complications
Cast saw abrasions
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Different Cast Complications
Unplanned Office Visits
|
2 participants
|
1 participants
|
1 participants
|
|
Number of Participants With Different Cast Complications
Unplanned Cast Modifications Visits
|
3 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Different Cast Complications
Surgical Stablization
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Different Cast Complications
Cast Wedged
|
4 participants
|
10 participants
|
6 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1-2 weeksAverage time from reduction and casting to the first follow-up visit.
Outcome measures
| Measure |
No Split Cast of Forearm Fractures
n=20 Participants
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.
|
Univalve Split Cast of Forearm Fractures
n=20 Participants
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.
|
Bivalve Split Cast of Forearm Fractures
n=20 Participants
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.
|
|---|---|---|---|
|
Average Time for First Follow-up Appointment
|
5.9 days
Standard Deviation 2.1
|
6.4 days
Standard Deviation 1.7
|
5.8 days
Standard Deviation 2.3
|
Adverse Events
No Split Cast of Forearm Fractures
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Univalve Split Cast of Forearm Fractures
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Bivalve Split Cast of Forearm Fractures
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place