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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02670629
Recruitment Status : Completed
First Posted : February 2, 2016
Results First Posted : November 14, 2019
Last Update Posted : December 18, 2019
Sponsor:
Information provided by (Responsible Party):
Carlos A Acosta-Olivo, Universidad Autonoma de Nuevo Leon

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Bone Fractures
Radius Fractures
Closed Fractures
Interventions Procedure: Partial reduction with overriding position
Procedure: Closed anatomic reduction
Enrollment 58
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.
Arm/Group Title Anatomic Closed Reduction + Short Cast Partial Reduction Overriding Position
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 29 29
Completed 29 29
Not Completed 0 0
Arm/Group Title Anatomic Closed Reduction + Short Cast Partial Reduction Overriding Position Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 29 29 58
Hide Baseline Analysis Population Description
We included 29 patients in both arms. All of the patients included in this trial completed the according follow-up.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 29 participants 29 participants 58 participants
8.10  (2.05) 8.59  (2.10) 8.34  (2.10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 29 participants 58 participants
Female
4
  13.8%
11
  37.9%
15
  25.9%
Male
25
  86.2%
18
  62.1%
43
  74.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 29 participants 58 participants
Hispanic or Latino
29
 100.0%
29
 100.0%
58
 100.0%
Not Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Mexico Number Analyzed 29 participants 29 participants 58 participants
29 29 58
1.Primary Outcome
Title Radial Shortening in Degrees - Residual Radiographic Deformities in Terms of the Radial Tilt, Radial Shortening and Radial Variation, Obtained in Both Groups.
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Anatomic Closed Reduction + Short Cast Partial Reduction Overriding Position
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 29 29
Geometric Mean (Standard Deviation)
Unit of Measure: degrees
8.96  (1.2) 8.998  (1.34)
2.Primary Outcome
Title Patients With Residual Radiographic Deformities Obtained in Both Groups.
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Anatomic Closed Reduction + Short Cast Partial Reduction Overriding Position
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 29 29
Measure Type: Number
Unit of Measure: participants
4 1
3.Secondary Outcome
Title 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.
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Anatomic Closed Reduction + Short Cast Partial Reduction Overriding Position
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 29 29
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.4  (0.8) 1.2  (0.7)
4.Secondary Outcome
Title Residual Functional Deficits Assessed by the UEFI (Upper Extremity Functional Index)in Patients With Distal Radius Fractures Treated Without an Anatomical Reduction.
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Anatomic Closed Reduction + Short Cast Partial Reduction Overriding Position
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 29 29
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.78  (0.062) 0.755  (0.059)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Anatomic Closed Reduction + Short Cast, Partial Reduction Overriding Position
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
5.Other Pre-specified Outcome
Title 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.
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Anatomic Closed Reduction + Short Cast Partial Reduction Overriding Position
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 29 29
Mean (Standard Deviation)
Unit of Measure: degrees
Radius valgus 2.5  (0.8) 2.1  (0.7)
Radius Varus 2.1  (0.3) 3.1  (0.5)
Final Ulnar tilt 1.2  (0.08) 2.5  (1.2)
Time Frame The adverse event data was collected for 3 years.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Anatomic Closed Reduction + Short Cast Partial Reduction Overriding Position
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Anatomic Closed Reduction + Short Cast Partial Reduction Overriding Position
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Anatomic Closed Reduction + Short Cast Partial Reduction Overriding Position
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/29 (6.90%)      0/29 (0.00%)    
Musculoskeletal and connective tissue disorders     
Fracture redisplacement after reduction and cast  1 [1]  2/29 (6.90%)  2 0/29 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, Residual Pain
[1]
Two patients in our trial suffered a redisplacement after the fracture was reduced and placed in a cast. One o those patients needed a nail placed in the distal radius because of the fracture instability.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Anatomic Closed Reduction + Short Cast Partial Reduction Overriding Position
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/29 (6.90%)      0/29 (0.00%)    
Musculoskeletal and connective tissue disorders     
Pain  1 [1]  1/29 (3.45%)  1 0/29 (0.00%)  0
Delayed Fracture Healing  2 [2]  1/29 (3.45%)  1 0/29 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, Pain
2
Term from vocabulary, Residual Pain
[1]
One patient in our trial was left with residual pain and was managed with non steroid antiinflammatories.
[2]
One patient has a delayed fracture healing and was left in observation and protected with a sling for 6 weeks posterior to the cast.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Adriana Hernández
Organization: Servicio de Ortopedia y Traumatología . Hospital Universitario "José Eleuterio González"
Phone: 8112901288
EMail: adrianahl@gmail.com
Layout table for additonal information
Responsible Party: Carlos A Acosta-Olivo, Universidad Autonoma de Nuevo Leon
ClinicalTrials.gov Identifier: NCT02670629    
Other Study ID Numbers: OR14-011
First Submitted: January 22, 2016
First Posted: February 2, 2016
Results First Submitted: March 29, 2016
Results First Posted: November 14, 2019
Last Update Posted: December 18, 2019