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

Primary Purpose

Bone Fractures, Radius Fractures, Closed Fractures

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Partial reduction with overriding position
Closed anatomic reduction
Sponsored by
Carlos A Acosta-Olivo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bone Fractures focused on measuring Pediatric orthopedics

Eligibility Criteria

2 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Anatomic Closed Reduction + Short Cast

    Partial reduction overriding position

    Arm 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.

    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.

    Outcomes

    Primary Outcome Measures

    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.
    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.

    Secondary Outcome Measures

    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.
    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.

    Full Information

    First Posted
    January 22, 2016
    Last Updated
    December 10, 2019
    Sponsor
    Carlos A Acosta-Olivo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02670629
    Brief Title
    Management of Distal Radius Fractures in Children Younger Than 11 Years Old.
    Official Title
    Management of Distal Radius Fractures in Children Younger Than 11 Years Old. Comparison Between Two Groups
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2013 (undefined)
    Primary Completion Date
    December 2015 (Actual)
    Study Completion Date
    December 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Carlos A Acosta-Olivo

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bone Fractures, Radius Fractures, Closed Fractures
    Keywords
    Pediatric orthopedics

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    58 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Anatomic Closed Reduction + Short Cast
    Arm Type
    Active Comparator
    Arm 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.
    Arm Title
    Partial reduction overriding position
    Arm Type
    Experimental
    Arm Description
    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 Type
    Procedure
    Intervention Name(s)
    Partial reduction with overriding position
    Intervention Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Closed anatomic reduction
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Radial Shortening in Degrees - Residual Radiographic Deformities in Terms of the Radial Tilt, Radial Shortening and Radial Variation, Obtained in Both Groups.
    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
    Title
    Patients With Residual Radiographic Deformities Obtained in Both Groups.
    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
    Secondary Outcome Measure Information:
    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.
    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
    Title
    Residual Functional Deficits Assessed by the UEFI (Upper Extremity Functional Index)in Patients With Distal Radius Fractures Treated Without an Anatomical Reduction.
    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
    Other Pre-specified Outcome Measures:
    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.
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Years
    Maximum Age & Unit of Time
    11 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Oscar Fernando Mendoza Lemus, MD, PhD
    Organizational Affiliation
    Hospital Universitario José E Gonzalez
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    12621255
    Citation
    Cannata G, De Maio F, Mancini F, Ippolito E. Physeal fractures of the distal radius and ulna: long-term prognosis. J Orthop Trauma. 2003 Mar;17(3):172-9; discussion 179-80. doi: 10.1097/00005131-200303000-00002.
    Results Reference
    background
    PubMed Identifier
    22298057
    Citation
    Crawford SN, Lee LS, Izuka BH. Closed treatment of overriding distal radial fractures without reduction in children. J Bone Joint Surg Am. 2012 Feb 1;94(3):246-52. doi: 10.2106/JBJS.K.00163.
    Results Reference
    result
    PubMed Identifier
    532582
    Citation
    Friberg KS. Remodelling after distal forearm fractures in children. II. The final orientation of the distal and proximal epiphyseal plates of the radius. Acta Orthop Scand. 1979 Dec;50(6 Pt 2):731-9. doi: 10.3109/17453677908991303.
    Results Reference
    result
    PubMed Identifier
    9743754
    Citation
    Green JS, Williams SC, Finlay D, Harper WM. Distal forearm fractures in children:the role of radiographs during follow up. Injury. 1998 May;29(4):309-12. doi: 10.1016/s0020-1383(97)00208-8.
    Results Reference
    result
    PubMed Identifier
    17940779
    Citation
    Hove LM, Brudvik C. Displaced paediatric fractures of the distal radius. Arch Orthop Trauma Surg. 2008 Jan;128(1):55-60. doi: 10.1007/s00402-007-0473-x. Epub 2007 Oct 17.
    Results Reference
    result
    PubMed Identifier
    19916008
    Citation
    Pretell Mazzini J, Rodriguez Martin J. Paediatric forearm and distal radius fractures: risk factors and re-displacement--role of casting indices. Int Orthop. 2010 Mar;34(3):407-12. doi: 10.1007/s00264-009-0904-0.
    Results Reference
    result
    PubMed Identifier
    15652934
    Citation
    Wilkins KE. Principles of fracture remodeling in children. Injury. 2005 Feb;36 Suppl 1:A3-11. doi: 10.1016/j.injury.2004.12.007.
    Results Reference
    result
    Available IPD and Supporting Information:
    Available IPD/Information Type
    Individual Participant Data Set
    Available IPD/Information URL
    https://drive.google.com/open?id=0Bwd7ib0yn_zqMnBVZnY2NFFJTzA
    Available IPD/Information Identifier
    Fx radio distal
    Available IPD/Information Comments
    Excel document with all the information regarding the patients included in this research protocol

    Learn more about this trial

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

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