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

NCT02670629 | Completed Results DMC

• 1 other identifier: OR14-011
• Study Type: interventional
• Target: 58
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Bone Fractures; Radius Fractures; Closed Fractures

Keywords

Pediatric orthopedics

Outcome Measures

Primary Outcomes (2)

• 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.

  10 weeks

• 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.

  10 weeks

Secondary Outcomes (2)

• 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 weeks

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

  10 weeks

Other Outcomes (1)

• 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 weeks

Study Arms (2)

Anatomic Closed Reduction + Short Cast

ACTIVE COMPARATOR

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.

Procedure: Closed anatomic reduction

Partial reduction overriding position

EXPERIMENTAL

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.

Procedure: Partial reduction with overriding position

Interventions

Partial reduction with overriding position PROCEDURE

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.

Partial reduction overriding position

Closed anatomic reduction PROCEDURE

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.

Anatomic Closed Reduction + Short Cast

Eligibility Criteria

• Age: 2 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Carlos A Acosta-Olivo: lead

Related Publications (7)

• 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.

  PMID: 12621255 BACKGROUND

• 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.

  PMID: 22298057 RESULT

• 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.

  PMID: 532582 RESULT

• 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.

  PMID: 9743754 RESULT

• 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.

  PMID: 17940779 RESULT

• 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.

  PMID: 19916008 RESULT

• Wilkins KE. Principles of fracture remodeling in children. Injury. 2005 Feb;36 Suppl 1:A3-11. doi: 10.1016/j.injury.2004.12.007.

  PMID: 15652934 RESULT

MeSH Terms

Conditions

Fractures, Bone; Radius Fractures; Fractures, Closed

Condition Hierarchy (Ancestors)

Wounds and Injuries; Forearm Injuries; Arm Injuries

Results Point of Contact

• Title: Dr. Adriana Hernández
• Organization: Servicio de Ortopedia y Traumatología . Hospital Universitario "José Eleuterio González"

adrianahl@gmail.com

8112901288

Study Officials

• Oscar Fernando Mendoza Lemus, MD, PhD

  Hospital Universitario José E Gonzalez

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor - Orthopedics and Trauma Surgery

Study Record Dates

• First Submitted: January 22, 2016
• First Posted: February 2, 2016
• Study Start: January 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 18, 2019
• Results First Posted: November 14, 2019

Record last verified: 2019-12