Skip to content

Management of Distal Radius Fractures in Children Younger Than 11 Years Old.

Management of Distal Radius Fractures in Children Younger Than 11 Years Old. Comparison Between Two Groups

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02670629
Enrollment
58
Registered
2016-02-02
Start date
2013-01-31
Completion date
2015-12-31
Last updated
2019-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Fractures, Closed Fractures, Radius Fractures

Keywords

Pediatric orthopedics

Brief summary

This fractures have been managed with anatomical reduction performed under anesthesia or using sedatives. In our institution this means prolonged hospital stay, involvement of an anesthesiologist and the use of an special room in the Emergency Department. This research protocol was born after reports were published regarding leaving the fractures in an overriding position and cast with good functional and acceptable radiographical results; said study was observational, providing valuable but limited information about this treatment option. On the other hand, our study is a randomized controlled trial between to groups of patients younger than 11 years old who presented to the Emergency Department with completely displaced distal radius fractures, they were randomly assigned to one of two groups, either a closed anatomic reduction and short cast or a closed overriding alignment and short cast.

Detailed description

Distal radius fractures represent up to 40% of all fractures in pediatric patients, with the most common mechanism being simple falls with the hand and wrist in extension. The standard treatment for this kind of fractures is a closed anatomical reduction and placing a short arm cast for 6 week, with a weekly follow-up paying close attention to re-displacement and consolidation data. This fractures have acceptable deformity angles after the anatomical reduction of up to 15º in the coronal and sagittal plane; in order to perform this reduction, the patient is subject to a sedation under strict monitorization, either in the Emergency Department or in the Surgical Room. In most cases, the patient must stay in the hospital for at least 3 hours after the procedure was performed, in order to be discharged with analgesics and appropriate indications for caring a cast in home. Distal radius fractures in pediatric patients have been managed with anatomical reduction performed under anesthesia or using sedatives. In our institution this means prolonged hospital stay, involvement of an anesthesiologist and the use of aa special room in the Emergency Department. This research protocol was born after reports were published regarding leaving the fractures in an overriding position and cast with good functional and acceptable radiographical results; said study was observational, providing valuable but limited information about this treatment option. On the other hand, our study is a randomized controlled trial between to groups of patients younger than 11 years old who presented to the Emergency Department with completely displaced distal radius fractures, they were randomly assigned to one of two groups, either a closed anatomic reduction and short cast or a closed overriding alignment and short cast. Recent studies have suggested an alternative option for this patients, in which instead of performing a complete reduction, a gentle maneuver is done in order to get partial alignment or overriding fracture, with an strict follow-up and cooperative patients, this method has shown good results in terms of consolidation and deformity angles. The new procedure is performed without anesthesia, instead non-steroid antiinflammatory and analgesics are given to the patient, giving the possibility of an early discharge. The possibility of leaving the patient with an overriding position and having good results is related to recent studies about bone in pediatric patients, especially in those younger than 14 years old. The published observations presume that fracture consolidation and remodeling potential is given by physis presence and the persistence throughout the years. Even more importantly, it is now known that the distal radius is predominantly formed by trabecular bone and a thicker periosteum, conditions that confer this bone a higher consolidation rate and rapid remodeling, leaving permanent deformities and reinterventions as rather rare situations. In terms of aesthetic deformities, 20º of radiological deformity in any plane is required to leave a clinically visible deformity, and even more so, 35º are needed to cause a functional impairment.

Interventions

PROCEDUREPartial 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.

PROCEDUREClosed 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.

Sponsors

Carlos A Acosta-Olivo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
2 Years to 11 Years
Healthy volunteers
No

Inclusion criteria

* Closed Completely displaced distal radius fractures with or without distal ulna fractures

Exclusion criteria

* Pathological Fractures * Multiple Fractures * Previous Fractures in either distal radius * Metabolic Disease * Open Fractures

Design outcomes

Primary

MeasureTime frameDescription
Radial Shortening in Degrees - Residual Radiographic Deformities in Terms of the Radial Tilt, Radial Shortening and Radial Variation, Obtained in Both Groups.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.
Patients With Residual Radiographic Deformities Obtained in Both Groups.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.

Secondary

MeasureTime frameDescription
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.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.
Residual Functional Deficits Assessed by the UEFI (Upper Extremity Functional Index)in Patients With Distal Radius Fractures Treated Without an Anatomical Reduction.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.

Other

MeasureTime frameDescription
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.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.

Participant flow

Recruitment details

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.

Pre-assignment details

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.

Participants by arm

ArmCount
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.
29
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.
29
Total58

Baseline characteristics

CharacteristicAnatomic Closed Reduction + Short CastPartial Reduction Overriding PositionTotal
Age, Continuous8.10 years
STANDARD_DEVIATION 2.05
8.59 years
STANDARD_DEVIATION 2.1
8.34 years
STANDARD_DEVIATION 2.1
Ethnicity (NIH/OMB)
Hispanic or Latino
29 Participants29 Participants58 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Region of Enrollment
Mexico
29 participants29 participants58 participants
Sex: Female, Male
Female
4 Participants11 Participants15 Participants
Sex: Female, Male
Male
25 Participants18 Participants43 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
2 / 290 / 29
serious
Total, serious adverse events
2 / 290 / 29

Outcome results

Primary

Patients With Residual Radiographic Deformities Obtained in Both Groups.

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.

Time frame: 10 weeks

ArmMeasureValue (NUMBER)
Anatomic Closed Reduction + Short CastPatients With Residual Radiographic Deformities Obtained in Both Groups.4 participants
Partial Reduction Overriding PositionPatients With Residual Radiographic Deformities Obtained in Both Groups.1 participants
Primary

Radial Shortening in Degrees - Residual Radiographic Deformities in Terms of the Radial Tilt, Radial Shortening and Radial Variation, Obtained in Both Groups.

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.

Time frame: 10 weeks

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
Anatomic Closed Reduction + Short CastRadial Shortening in Degrees - Residual Radiographic Deformities in Terms of the Radial Tilt, Radial Shortening and Radial Variation, Obtained in Both Groups.8.96 degreesStandard Deviation 1.2
Partial Reduction Overriding PositionRadial Shortening in Degrees - Residual Radiographic Deformities in Terms of the Radial Tilt, Radial Shortening and Radial Variation, Obtained in Both Groups.8.998 degreesStandard Deviation 1.34
Secondary

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.

The 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.

Time frame: 10 weeks

ArmMeasureValue (MEAN)Dispersion
Anatomic Closed Reduction + Short CastPain 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 scaleStandard Deviation 0.8
Partial Reduction Overriding PositionPain 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.1.2 units on a scaleStandard Deviation 0.7
Secondary

Residual Functional Deficits Assessed by the UEFI (Upper Extremity Functional Index)in Patients With Distal Radius Fractures Treated Without an Anatomical Reduction.

Patients 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.

Time frame: 10 weeks

ArmMeasureValue (MEAN)Dispersion
Anatomic Closed Reduction + Short CastResidual 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 scaleStandard Deviation 0.062
Partial Reduction Overriding PositionResidual Functional Deficits Assessed by the UEFI (Upper Extremity Functional Index)in Patients With Distal Radius Fractures Treated Without an Anatomical Reduction.0.755 units on a scaleStandard Deviation 0.059
p-value: 0.003Chi-squared
Other Pre-specified

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.

Patients 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.

Time frame: 10 weeks

ArmMeasureGroupValue (MEAN)Dispersion
Anatomic Closed Reduction + Short CastAesthetic 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 valgus2.5 degreesStandard Deviation 0.8
Anatomic Closed Reduction + Short CastAesthetic 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 Varus2.1 degreesStandard Deviation 0.3
Anatomic Closed Reduction + Short CastAesthetic 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 tilt1.2 degreesStandard Deviation 0.08
Partial Reduction Overriding PositionAesthetic 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 valgus2.1 degreesStandard Deviation 0.7
Partial Reduction Overriding PositionAesthetic 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 Varus3.1 degreesStandard Deviation 0.5
Partial Reduction Overriding PositionAesthetic 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 tilt2.5 degreesStandard Deviation 1.2

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026