Trial Outcomes & Findings for Trial of Ultrasound Guidance for Reduction of Pediatric Forearm Fractures (NCT NCT03097757)
NCT ID: NCT03097757
Last Updated: 2023-01-09
Results Overview
To compare the number of patients requiring repeat reduction procedure between the experimental group (ultrasound guided fracture reduction) and control group (standard of care forearm fracture reduction).
TERMINATED
NA
4 participants
From initiation of bone setting procedure, an average of 10-20 minutes
2023-01-09
Participant Flow
Participant milestones
| Measure |
Fracture Reduction Without Ultrasound
Fracture reduction as per standard of care involves closed fracture reduction without real-time imaging, or with c-arm or portable x-ray. Closed reduction of a fractured bone. Closed reduction is a procedure to set (reduce) a broken bone without surgery. This allows the bone to grow back together. It works best when it is done as soon as possible after the bone breaks.
Standard of care fracture reduction: Closed reduction of a fractured bone.
|
Fracture Reduction With Ultrasound
Ultrasound guided Fracture reduction involves closed fracture reduction with the use of real-time ultrasound imaging, prior to, during and after the reduction procedure. C-arm or portable x-ray may also be used as an adjunct.
Ultrasound - guided fracture reduction: Ultrasound will be used as a real-time imaging modality to guide forearm fracture reduction.
Standard of care fracture reduction: Closed reduction of a fractured bone.
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
|
Overall Study
COMPLETED
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trial of Ultrasound Guidance for Reduction of Pediatric Forearm Fractures
Baseline characteristics by cohort
| Measure |
Fracture Reduction Without Ultrasound
n=2 Participants
Fracture reduction as per standard of care involves closed fracture reduction without real-time imaging, or with c-arm or portable x-ray. Closed reduction of a fractured bone. Closed reduction is a procedure to set (reduce) a broken bone without surgery. This allows the bone to grow back together. It works best when it is done as soon as possible after the bone breaks.
Standard of care fracture reduction: Closed reduction of a fractured bone.
|
Fracture Reduction With Ultrasound
n=2 Participants
Ultrasound guided Fracture reduction involves closed fracture reduction with the use of real-time ultrasound imaging, prior to, during and after the reduction procedure. C-arm or portable x-ray may also be used as an adjunct.
Ultrasound - guided fracture reduction: Ultrasound will be used as a real-time imaging modality to guide forearm fracture reduction.
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From initiation of bone setting procedure, an average of 10-20 minutesPopulation: Data were not collected/aggregated and therefore data analysis was not conducted as only 4 patients were enrolled into the study (2 into each Arm/Group). Per protocol, the plan was to enroll 56 patients into each of the two study Arms/Groups (n=112). Allocation of patients into each arm was to have been conducted by a computer-generated permuted block randomization scheme to mitigate experimental error contributed by inexperience using the ultrasound guidance at the start of the study.
To compare the number of patients requiring repeat reduction procedure between the experimental group (ultrasound guided fracture reduction) and control group (standard of care forearm fracture reduction).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: After completing the bone setting procedure and validation via ultrasound, an average of 2 minutesPopulation: Data were not collected/aggregated and therefore data analysis was not conducted as only 4 patients were enrolled into the study (2 into each Arm/Group). Per protocol, the plan was to enroll 56 patients into each of the two study Arms/Groups (n=112). Allocation of patients into each arm was to have been conducted by a computer-generated permuted block randomization scheme to mitigate experimental error contributed by inexperience using the ultrasound guidance at the start of the study.
Based on a questionnaire asking: For the experimental Arm/Group (fracture reduction with ultrasound): 1. Ease of fracture reduction on 5-point scale (ranging from 1 = easy to 5 = very difficult) 2. Ease of using ultrasonography on 5-point scale (ranging from 1=easy to 5 = very difficult) 3. Was ultrasound helpful in completing fracture reduction? Assessed on a trinary option of a) yes, b) no, c) uncertain For the Control Arm/Group (fracture reduction without ultrasound): 1. Ease of fracture reduction on 5-point scale (ranging from 1 = easy to 5 = very difficult) 2. Do you think real-time imaging would have been helpful for this reduction? Assessed based on a trinary option of a) yes, b) no, c) uncertain
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From initiation of bone setting procedure, an average of 10-20 minutesPopulation: Data were not collected/aggregated and therefore data analysis was not conducted as only 4 patients were enrolled into the study (2 into each Arm/Group). Per protocol, the plan was to enroll 56 patients into each of the two study Arms/Groups (n=112). Allocation of patients into each arm was to have been conducted by a computer-generated permuted block randomization scheme to mitigate experimental error contributed by inexperience using the ultrasound guidance at the start of the study.
To compare the adequacy of reduction between the experimental and control Arm/Group by a composite assessment of the degree of angulation and displacement on post reduction x-rays. The acceptable degree of angulation will be the same in both Arms/Groups. The acceptable degree of angulation based on age is less than 20 degrees' angulation for patients younger than 10 years of age and less than 10 degrees' angulation for patients older than 10 years of age. To compare the adequacy of reduction between the experimental and control Arm/Group by measuring and comparing the degree of displacement on the post reduction x-rays.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From initiation of bone setting procedure, an average of 10-20 minutesPopulation: Data were not collected/aggregated and therefore data analysis was not conducted as only 4 patients were enrolled into the study (2 into each Arm/Group). Per protocol, the plan was to enroll 56 patients into each of the two study Arms/Groups (n=112). Allocation of patients into each arm was to have been conducted by a computer-generated permuted block randomization scheme to mitigate experimental error contributed by inexperience using the ultrasound guidance at the start of the study.
To compare the time for the fracture reduction procedure between the experimental and control Arm/Group.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From initiation of bone setting procedure, an average of 10-20 minutesPopulation: Data were not collected/aggregated and therefore data analysis was not conducted as only 4 patients were enrolled into the study (2 into each Arm/Group). Per protocol, the plan was to enroll 56 patients into each of the two study Arms/Groups (n=112). Allocation of patients into each arm was to have been conducted by a computer-generated permuted block randomization scheme to mitigate experimental error contributed by inexperience using the ultrasound guidance at the start of the study.
To compare the number of patients requiring operative repair after reduction between the experimental and control Arm/Group.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From initiation of bone setting procedure, an average of 10-20 minutesPopulation: Data were not collected/aggregated and therefore data analysis was not conducted as only 4 patients were enrolled into the study (2 into each Arm/Group). Per protocol, the plan was to enroll 56 patients into each of the two study Arms/Groups (n=112). Allocation of patients into each arm was to have been conducted by a computer-generated permuted block randomization scheme to mitigate experimental error contributed by inexperience using the ultrasound guidance at the start of the study.
To compare the post-reduction ultrasound, including measurement of degree of angulation and displacement, for each patient.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From initiation of bone setting procedure, an average of 10-20 minutesPopulation: Data were not collected/aggregated and therefore data analysis was not conducted as only 4 patients were enrolled into the study (2 into each Arm/Group). Per protocol, the plan was to enroll 56 patients into each of the two study Arms/Groups (n=112). Allocation of patients into each arm was to have been conducted by a computer-generated permuted block randomization scheme to mitigate experimental error contributed by inexperience using the ultrasound guidance at the start of the study.
To compare the post-reduction x-ray interpretation, including measurement of degree of angulation and displacement on the x-raym for each patient.
Outcome measures
Outcome data not reported
Adverse Events
Fracture Reduction Without Ultrasound
Fracture Reduction With Ultrasound
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