Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE January 22, 2016
First Posted Date  ICMJE February 2, 2016
Results First Submitted Date  ICMJE March 29, 2016
Results First Posted Date  ICMJE November 14, 2019
Last Update Posted Date December 18, 2019
Study Start Date  ICMJE January 2013
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 2, 2019)
  • Radial Shortening in Degrees - Residual Radiographic Deformities in Terms of the Radial Tilt, Radial Shortening and Radial Variation, Obtained in Both Groups. [ Time Frame: 10 weeks ]
    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.
  • Patients With Residual Radiographic Deformities Obtained in Both Groups. [ Time Frame: 10 weeks ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 27, 2016)
Residual radiographic deformities and The radial tilt, radial shortening and radial variation, obtained in patients distal radius fractures treated without an anatomical reduction [ Time Frame: 10 weeks ]
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 23, 2019)
  • 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. [ Time Frame: 10 weeks ]
    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.
  • Residual Functional Deficits Assessed by the UEFI (Upper Extremity Functional Index)in Patients With Distal Radius Fractures Treated Without an Anatomical Reduction. [ Time Frame: 10 weeks ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 27, 2016)
  • Pain assessed by the Visual Analogue Scale (VAS) in patients with distal radius fractures treated without an anatomical reduction [ Time Frame: 10 weeks ]
    The VAS was used in order to assess the residual pain in the experimental group.
  • Residual functional deficits assessed by the UEFI (Upper Extremity Functional Index)in patients with distal radius fractures treated without an anatomical reduction [ Time Frame: 10 weeks ]
    Patients were evaluated using a modified UEFI scale fot the appropriate age in order to assess functional deficits in the fractured limb.
Current Other Pre-specified Outcome Measures
 (submitted: October 23, 2019)
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. [ Time Frame: 10 weeks ]
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.
Original Other Pre-specified Outcome Measures
 (submitted: January 27, 2016)
Aesthetic results measured by clinical radial alignment in degrees in patients with distal radius fractures treated without an anatomical reduction [ Time Frame: 10 weeks ]
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.
 
Descriptive Information
Brief Title  ICMJE Management of Distal Radius Fractures in Children Younger Than 11 Years Old.
Official Title  ICMJE Management of Distal Radius Fractures in Children Younger Than 11 Years Old. Comparison Between Two Groups
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Bone Fractures
  • Radius Fractures
  • Closed Fractures
Intervention  ICMJE
  • Procedure: 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.
  • Procedure: 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.
Study Arms  ICMJE
  • Active Comparator: 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.

    Intervention: Procedure: Closed anatomic reduction
  • Experimental: 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.

    Intervention: Procedure: Partial reduction with overriding position
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 23, 2019)
58
Original Actual Enrollment  ICMJE
 (submitted: January 27, 2016)
60
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 11 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02670629
Other Study ID Numbers  ICMJE OR14-011
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Carlos A Acosta-Olivo, Universidad Autonoma de Nuevo Leon
Study Sponsor  ICMJE Carlos A Acosta-Olivo
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Oscar Fernando Mendoza Lemus, MD, PhD Hospital Universitario José E Gonzalez
PRS Account Universidad Autonoma de Nuevo Leon
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP