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

Radius Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02670629
• Other study ID #: OR14-011
• Status: Completed
• Phase: N/A
• Start date: January 2013
• Est. completion date: December 2015

Study information

• Verified date: December 2019
• Source: Universidad Autonoma de Nuevo Leon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Bone Fractures
• Closed Fractures
• Fractures, Bone
• Fractures, Closed
• Radius Fractures

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Carlos A Acosta-Olivo

References & 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. — View 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. — View 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. — View 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. — View Citation

Hove LM, Brudvik C. Displaced paediatric fractures of the distal radius. Arch Orthop Trauma Surg. 2008 Jan;128(1):55-60. Epub 2007 Oct 17. — View 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. Review. — View Citation

Wilkins KE. Principles of fracture remodeling in children. Injury. 2005 Feb;36 Suppl 1:A3-11. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	10 weeks
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.	10 weeks
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.	10 weeks
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.	10 weeks
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.	10 weeks