N/A
N=58
Management of Distal Radius Fractures in Children Younger Than 11 Years Old.
Bone Fractures · Radius Fractures · Closed Fractures
Bottom Line
View on ClinicalTrials.gov: NCT02670629 ↗Enrolled (actual)
58
Serious AEs
3.5%
Results posted
Nov 2019
Primary outcome: Primary: Radial Shortening in Degrees - Residual Radiographic Deformities in Terms of the Radial Tilt, Radial Shortening and Radial Variation, Obtained in Both Groups. — 8.96; 8.998 degrees
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Partial reduction with overriding position (Procedure); Closed anatomic reduction (Procedure)
- Age
- Pediatric · 2+ yrs
- Sex
- All
- Sponsor
- Carlos A Acosta-Olivo
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Radial Shortening in Degrees - Residual Radiographic Deformities in Terms of the Radial Tilt, Radial Shortening and Radial Variation, Obtained in Both Groups. |
8.96; 8.998 | — |
| PRIMARY Patients With Residual Radiographic Deformities Obtained in Both Groups. |
4; 1 | — |
| 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. |
3.4; 1.2 | — |
| SECONDARY Residual Functional Deficits Assessed by the UEFI (Upper Extremity Functional Index)in Patients With Distal Radius Fractures Treated Without an Anatomical Reduction. |
1.78; 0.755 | 0.003 sig |
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.
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
Data sourced from ClinicalTrials.gov (NCT02670629). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.