Management of Distal Radius Fractures in Children Younger Than 11 Years Old.
NCT ID: NCT02670629
Last Updated: 2019-12-18
Study Results
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View full resultsBasic Information
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COMPLETED
NA
58 participants
INTERVENTIONAL
2013-01-31
2015-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Multiple Fractures
* Previous Fractures in either distal radius
* Metabolic Disease
* Open Fractures
2 Years
11 Years
ALL
No
Sponsors
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Carlos A Acosta-Olivo
OTHER
Responsible Party
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Carlos A Acosta-Olivo
Professor - Orthopedics and Trauma Surgery
Principal Investigators
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Oscar Fernando Mendoza Lemus, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario José E Gonzalez
References
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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.
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.
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.
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.
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.
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.
Wilkins KE. Principles of fracture remodeling in children. Injury. 2005 Feb;36 Suppl 1:A3-11. doi: 10.1016/j.injury.2004.12.007.
Study Documents
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Document Type: Individual Participant Data Set
View DocumentOther Identifiers
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OR14-011
Identifier Type: -
Identifier Source: org_study_id