Trial Outcomes & Findings for Management of Distal Radius Fractures in Children Younger Than 11 Years Old. (NCT NCT02670629)
NCT ID: NCT02670629
Last Updated: 2019-12-18
Results Overview
The cast was removed afer 6 weeks and rehabilitation in house was started as soon as the pain was over. The simple X rays were evaluated with the Montoya Classification, which stratifies the patients with regards of time until radiographic consolidation and bone remodeling. The radial tilt, radial shortening and radial variation was recorded and compared with the control group. This radiologic measures were reported in terms of degrees and millimeters were needed.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
58 participants
Primary outcome timeframe
10 weeks
Results posted on
2019-12-18
Participant Flow
The patients in this research study were those admitted to the Emergency department of the Hospital Universitario "José Eleuterio González" between July 1, 2014 and December 1, 2015 with a diagnosis of a acute completely displaced distal radius fractures who matched our inclusion criteria.
Patients who had additional fractures or injuries, as well as those who sustained an open distal radius fractures were excluded from the trial before the assignment of groups. Other exclusion criteria included bone diseases, pathological fractures and chronic fractures.
Participant milestones
| Measure |
Anatomic Closed Reduction + Short Cast
Patients in this group were treated by performing a closed anatomic reduction under anesthesia by using sedatives and then placing the child in a short arm cast for 6 weeks. The follow up was done at week 1, 3, 6 and 10 with new X rays in each consult.
The intervention in this control group was performing a closed anatomic reduction under anesthesia.
Closed anatomic reduction: The patient was subjected to an anatomic reduction; this means that the fracture was completely reduced, after this, the patient was placed in a short arm cast for 6 weeks.
|
Partial Reduction Overriding Position
Patients in this group were only given oral medications, the fracture was not reduced, instead it was left with a partial reduction with overriding position placed in a short arm cast for 6 weeks. The follow up was done at week 1, 3, 6 and 10 with new X rays in each consult.
The intervention in this control group was not performing a closed anatomic reduction under anesthesia.
Partial reduction with overriding position: The patient was subjected to an alignment instead of an anatomic reduction; this means that the fracture was left in an overriding position, after this, the patient was placed in a short arm cast for 6 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
29
|
|
Overall Study
COMPLETED
|
29
|
29
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Management of Distal Radius Fractures in Children Younger Than 11 Years Old.
Baseline characteristics by cohort
| Measure |
Anatomic Closed Reduction + Short Cast
n=29 Participants
Patients in this group were treated by performing a closed anatomic reduction under anesthesia by using sedatives and then placing the child in a short arm cast for 6 weeks. The follow up was done at week 1, 3, 6 and 10 with new X rays in each consult.
The intervention in this control group was performing a closed anatomic reduction under anesthesia.
Closed anatomic reduction: The patient was subjected to an anatomic reduction; this means that the fracture was completely reduced, after this, the patient was placed in a short arm cast for 6 weeks.
|
Partial Reduction Overriding Position
n=29 Participants
Patients in this group were only given oral medications, the fracture was not reduced, instead it was left with a partial reduction with overriding position placed in a short arm cast for 6 weeks. The follow up was done at week 1, 3, 6 and 10 with new X rays in each consult.
The intervention in this control group was not performing a closed anatomic reduction under anesthesia.
Partial reduction with overriding position: The patient was subjected to an alignment instead of an anatomic reduction; this means that the fracture was left in an overriding position, after this, the patient was placed in a short arm cast for 6 weeks.
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
8.10 years
STANDARD_DEVIATION 2.05 • n=5 Participants
|
8.59 years
STANDARD_DEVIATION 2.10 • n=7 Participants
|
8.34 years
STANDARD_DEVIATION 2.10 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
29 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
29 participants
n=5 Participants
|
29 participants
n=7 Participants
|
58 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 10 weeksThe cast was removed afer 6 weeks and rehabilitation in house was started as soon as the pain was over. The simple X rays were evaluated with the Montoya Classification, which stratifies the patients with regards of time until radiographic consolidation and bone remodeling. The radial tilt, radial shortening and radial variation was recorded and compared with the control group. This radiologic measures were reported in terms of degrees and millimeters were needed.
Outcome measures
| Measure |
Anatomic Closed Reduction + Short Cast
n=29 Participants
Patients in this group were treated by performing a closed anatomic reduction under anesthesia by using sedatives and then placing the child in a short arm cast for 6 weeks. The follow up was done at week 1, 3, 6 and 10 with new X rays in each consult.
The intervention in this control group was performing a closed anatomic reduction under anesthesia.
Closed anatomic reduction: The patient was subjected to an anatomic reduction; this means that the fracture was completely reduced, after this, the patient was placed in a short arm cast for 6 weeks.
|
Partial Reduction Overriding Position
n=29 Participants
Patients in this group were only given oral medications, the fracture was not reduced, instead it was left with a partial reduction with overriding position placed in a short arm cast for 6 weeks. The follow up was done at week 1, 3, 6 and 10 with new X rays in each consult.
The intervention in this control group was not performing a closed anatomic reduction under anesthesia.
Partial reduction with overriding position: The patient was subjected to an alignment instead of an anatomic reduction; this means that the fracture was left in an overriding position, after this, the patient was placed in a short arm cast for 6 weeks.
|
|---|---|---|
|
Radial Shortening in Degrees - Residual Radiographic Deformities in Terms of the Radial Tilt, Radial Shortening and Radial Variation, Obtained in Both Groups.
|
8.96 degrees
Standard Deviation 1.2
|
8.998 degrees
Standard Deviation 1.34
|
PRIMARY outcome
Timeframe: 10 weeksThe cast was removed afer 6 weeks and rehabilitation in house was started as soon as the pain was over. The simple X rays were evaluated with the Montoya Classification, which stratifies the patients with regards of time until radiographic consolidation and bone remodeling. The radial tilt, radial shortening and radial variation was recorded and compared with the control group. This radiologic measures were reported in terms of degrees and millimeters were needed.
Outcome measures
| Measure |
Anatomic Closed Reduction + Short Cast
n=29 Participants
Patients in this group were treated by performing a closed anatomic reduction under anesthesia by using sedatives and then placing the child in a short arm cast for 6 weeks. The follow up was done at week 1, 3, 6 and 10 with new X rays in each consult.
The intervention in this control group was performing a closed anatomic reduction under anesthesia.
Closed anatomic reduction: The patient was subjected to an anatomic reduction; this means that the fracture was completely reduced, after this, the patient was placed in a short arm cast for 6 weeks.
|
Partial Reduction Overriding Position
n=29 Participants
Patients in this group were only given oral medications, the fracture was not reduced, instead it was left with a partial reduction with overriding position placed in a short arm cast for 6 weeks. The follow up was done at week 1, 3, 6 and 10 with new X rays in each consult.
The intervention in this control group was not performing a closed anatomic reduction under anesthesia.
Partial reduction with overriding position: The patient was subjected to an alignment instead of an anatomic reduction; this means that the fracture was left in an overriding position, after this, the patient was placed in a short arm cast for 6 weeks.
|
|---|---|---|
|
Patients With Residual Radiographic Deformities Obtained in Both Groups.
|
4 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 10 weeksThe Visual Analogue Scale (VAS) was used in order to assess the residual pain in the experimental group, this is, in patients with distal radius fractures treated without an anatomical reduction, this was later compared to the results obtained in the group in which a reduction was performed. Minimum value 0 maximum value 10. Higher score means a worse outcome.
Outcome measures
| Measure |
Anatomic Closed Reduction + Short Cast
n=29 Participants
Patients in this group were treated by performing a closed anatomic reduction under anesthesia by using sedatives and then placing the child in a short arm cast for 6 weeks. The follow up was done at week 1, 3, 6 and 10 with new X rays in each consult.
The intervention in this control group was performing a closed anatomic reduction under anesthesia.
Closed anatomic reduction: The patient was subjected to an anatomic reduction; this means that the fracture was completely reduced, after this, the patient was placed in a short arm cast for 6 weeks.
|
Partial Reduction Overriding Position
n=29 Participants
Patients in this group were only given oral medications, the fracture was not reduced, instead it was left with a partial reduction with overriding position placed in a short arm cast for 6 weeks. The follow up was done at week 1, 3, 6 and 10 with new X rays in each consult.
The intervention in this control group was not performing a closed anatomic reduction under anesthesia.
Partial reduction with overriding position: The patient was subjected to an alignment instead of an anatomic reduction; this means that the fracture was left in an overriding position, after this, the patient was placed in a short arm cast for 6 weeks.
|
|---|---|---|
|
Pain Assessed by the Visual Analogue Scale (VAS) in Patients With Distal Radius Fractures Treated Without an Anatomical Reduction in Comparison to Those Treated With Anatomical Reduction.
|
3.4 units on a scale
Standard Deviation 0.8
|
1.2 units on a scale
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: 10 weeksPatients were evaluated using a modified Upper Extremity Functional Index (UEFI) scale fot the appropriate age in order to assess functional deficits in the fractured limb in patients with distal radius fractures treated without an anatomical reduction. Evaluates the impairment the subject perceives they encounter when performing 20 types of activities of daily living. Each of the 20 actions in the UEFI is evaluated on a 5-point scale. Minimum Value 0 maximum value 4 per action, where 0 indicates most severe limitation and 80 suggests least limitation.
Outcome measures
| Measure |
Anatomic Closed Reduction + Short Cast
n=29 Participants
Patients in this group were treated by performing a closed anatomic reduction under anesthesia by using sedatives and then placing the child in a short arm cast for 6 weeks. The follow up was done at week 1, 3, 6 and 10 with new X rays in each consult.
The intervention in this control group was performing a closed anatomic reduction under anesthesia.
Closed anatomic reduction: The patient was subjected to an anatomic reduction; this means that the fracture was completely reduced, after this, the patient was placed in a short arm cast for 6 weeks.
|
Partial Reduction Overriding Position
n=29 Participants
Patients in this group were only given oral medications, the fracture was not reduced, instead it was left with a partial reduction with overriding position placed in a short arm cast for 6 weeks. The follow up was done at week 1, 3, 6 and 10 with new X rays in each consult.
The intervention in this control group was not performing a closed anatomic reduction under anesthesia.
Partial reduction with overriding position: The patient was subjected to an alignment instead of an anatomic reduction; this means that the fracture was left in an overriding position, after this, the patient was placed in a short arm cast for 6 weeks.
|
|---|---|---|
|
Residual Functional Deficits Assessed by the UEFI (Upper Extremity Functional Index)in Patients With Distal Radius Fractures Treated Without an Anatomical Reduction.
|
1.78 units on a scale
Standard Deviation 0.062
|
0.755 units on a scale
Standard Deviation 0.059
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 10 weeksPatients were evaluated in comparison to the other extremity in terms of clinically evident deformity and appearance. Varus, Valgus, antecurvatum and recurvatum was measured and recorded appropriately. This was later compared to the data obtained in those patients who were treated with an anatomic reduction.
Outcome measures
| Measure |
Anatomic Closed Reduction + Short Cast
n=29 Participants
Patients in this group were treated by performing a closed anatomic reduction under anesthesia by using sedatives and then placing the child in a short arm cast for 6 weeks. The follow up was done at week 1, 3, 6 and 10 with new X rays in each consult.
The intervention in this control group was performing a closed anatomic reduction under anesthesia.
Closed anatomic reduction: The patient was subjected to an anatomic reduction; this means that the fracture was completely reduced, after this, the patient was placed in a short arm cast for 6 weeks.
|
Partial Reduction Overriding Position
n=29 Participants
Patients in this group were only given oral medications, the fracture was not reduced, instead it was left with a partial reduction with overriding position placed in a short arm cast for 6 weeks. The follow up was done at week 1, 3, 6 and 10 with new X rays in each consult.
The intervention in this control group was not performing a closed anatomic reduction under anesthesia.
Partial reduction with overriding position: The patient was subjected to an alignment instead of an anatomic reduction; this means that the fracture was left in an overriding position, after this, the patient was placed in a short arm cast for 6 weeks.
|
|---|---|---|
|
Aesthetic Results Measured by Clinical Radial Alignment in Degrees in Patients With Distal Radius Fractures Treated Without an Anatomical Reduction in Comparison to Those Treated With Anatomical Reduction in Both Groups.
Radius valgus
|
2.5 degrees
Standard Deviation 0.8
|
2.1 degrees
Standard Deviation 0.7
|
|
Aesthetic Results Measured by Clinical Radial Alignment in Degrees in Patients With Distal Radius Fractures Treated Without an Anatomical Reduction in Comparison to Those Treated With Anatomical Reduction in Both Groups.
Radius Varus
|
2.1 degrees
Standard Deviation 0.3
|
3.1 degrees
Standard Deviation 0.5
|
|
Aesthetic Results Measured by Clinical Radial Alignment in Degrees in Patients With Distal Radius Fractures Treated Without an Anatomical Reduction in Comparison to Those Treated With Anatomical Reduction in Both Groups.
Final Ulnar tilt
|
1.2 degrees
Standard Deviation 0.08
|
2.5 degrees
Standard Deviation 1.2
|
Adverse Events
Anatomic Closed Reduction + Short Cast
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Partial Reduction Overriding Position
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Anatomic Closed Reduction + Short Cast
n=29 participants at risk
Patients in this group were treated by performing a closed anatomic reduction under anesthesia by using sedatives and then placing the child in a short arm cast for 6 weeks. The follow up was done at week 1, 3, 6 and 10 with new X rays in each consult.
The intervention in this control group was performing a closed anatomic reduction under anesthesia.
Closed anatomic reduction: The patient was subjected to an anatomic reduction; this means that the fracture was completely reduced, after this, the patient was placed in a short arm cast for 6 weeks.
|
Partial Reduction Overriding Position
n=29 participants at risk
Patients in this group were only given oral medications, the fracture was not reduced, instead it was left with a partial reduction with overriding position placed in a short arm cast for 6 weeks. The follow up was done at week 1, 3, 6 and 10 with new X rays in each consult.
The intervention in this control group was not performing a closed anatomic reduction under anesthesia.
Partial reduction with overriding position: The patient was subjected to an alignment instead of an anatomic reduction; this means that the fracture was left in an overriding position, after this, the patient was placed in a short arm cast for 6 weeks.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Fracture redisplacement after reduction and cast
|
6.9%
2/29 • Number of events 2 • The adverse event data was collected for 3 years.
|
0.00%
0/29 • The adverse event data was collected for 3 years.
|
Other adverse events
| Measure |
Anatomic Closed Reduction + Short Cast
n=29 participants at risk
Patients in this group were treated by performing a closed anatomic reduction under anesthesia by using sedatives and then placing the child in a short arm cast for 6 weeks. The follow up was done at week 1, 3, 6 and 10 with new X rays in each consult.
The intervention in this control group was performing a closed anatomic reduction under anesthesia.
Closed anatomic reduction: The patient was subjected to an anatomic reduction; this means that the fracture was completely reduced, after this, the patient was placed in a short arm cast for 6 weeks.
|
Partial Reduction Overriding Position
n=29 participants at risk
Patients in this group were only given oral medications, the fracture was not reduced, instead it was left with a partial reduction with overriding position placed in a short arm cast for 6 weeks. The follow up was done at week 1, 3, 6 and 10 with new X rays in each consult.
The intervention in this control group was not performing a closed anatomic reduction under anesthesia.
Partial reduction with overriding position: The patient was subjected to an alignment instead of an anatomic reduction; this means that the fracture was left in an overriding position, after this, the patient was placed in a short arm cast for 6 weeks.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Pain
|
3.4%
1/29 • Number of events 1 • The adverse event data was collected for 3 years.
|
0.00%
0/29 • The adverse event data was collected for 3 years.
|
|
Musculoskeletal and connective tissue disorders
Delayed Fracture Healing
|
3.4%
1/29 • Number of events 1 • The adverse event data was collected for 3 years.
|
0.00%
0/29 • The adverse event data was collected for 3 years.
|
Additional Information
Dr. Adriana Hernández
Servicio de Ortopedia y Traumatología . Hospital Universitario "José Eleuterio González"
Phone: 8112901288
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place