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Immobilization Without Reduction vs. Reduction Under General Anesthesia in Metaphyseal Fractures of the Distal Radius

Radius Fracture Distal Clinical Trial

Official title:
Cast Immobilization Without Reduction vs. Reduction Under General Anesthesia in Metaphyseal Fractures of the Distal Radius.

Clinical Trial Summary

Distal radius metaphyseal fractures are the most frequent in the pediatric population. The current treatment for angulated or shortened fractures is effective. Still, it exposes children to anesthetic risks supported by the pain generated by the reduction. Due to the excellent remodeling capacity of bone at an early age, it is questionable whether an anatomical reduction is necessary. The clinical experiment's objective is to compare the functional result of immobilization without reducing angulated or displaced metaphyseal fractures of the distal radius against fractures brought to reduction under general anesthesia. Means difference in function subdomain of the upper limb of the PROMIS® scale is the primary outcome. The secondary results are wrist mobility, radius alignment, wrist articular relationships, and surgical complications.

Clinical Trial Description

The participant will be recruited in one center. If participants and their parents accept to participate in this study, treatments will be randomly allocated using the Big Stick Design technique with a maximum tolerated imbalance of 2. The sequence will be generated by a research assistant who is completely independent of the study, does not know the purpose of the study and the interventions. Each of the random numbers will be stored in an opaque envelope sealed externally with the order in which they should be opened. Patient registration and follow-up information will be stored in REDCap®. Clinical and radiographic outcomes will be evaluated. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05008029
Study type Interventional
Source Instituto de Ortopedia Infantil Roosevelt
Contact Maria F Garcia, MD
Phone 3534000
Email m-garciar@javeriana.edu.co
Status Recruiting
Phase N/A
Start date June 15, 2021
Completion date March 15, 2023
View Details
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