Accepted for/Published in: JMIR Research Protocols
Date Submitted: Oct 29, 2021
Date Accepted: Feb 6, 2022
Date Submitted to PubMed: Apr 18, 2022
Casting Without Reduction Versus Closed Reduction with or Without Fixation in the Treatment of Distal Radius Fractures in Children: Study Protocol for a Randomized Non-Inferiority Trial
ABSTRACT
Background:
Acute treatment for distal radius fractures, the most frequent in pediatric population, represents a challenge to the orthopedic surgeon. Deciding upon surgical restoration of the alignment or cast immobilization without reducing the fracture is a complex concern given bone’s remodeling potential in children. In addition, the lack of evidence-based safe boundaries of shortening and angulation, that will not jeopardize upper extremity functionality in the future further complicates this decision.
Objective:
Authors hypothesize that functional outcomes, assessed with the PROMIS Pediatric Physical Function v2.0, are not worse in children treated with cast immobilization in situ compared with closed reduction with or without percutaneous fixation. Ulnar variance and fracture alignment in the sagittal and coronal planes, range of motion, pressure ulcers, pain control, radius osteotomy due to deformity, pseudoarthrosis cure, and remanipulation will also be compared as secondary outcomes.
Methods:
This is the protocol of a randomized non-inferiority trial comparing upper extremity functionality in children aged 5 to 10 years, after sustaining a distal radius fracture, treated with either cast immobilization in situ or closed reduction with or without fixation in a single orthopedic hospital. Functional follow-up is projected at six months, while clinical and radiographic follow-up will occur at two weeks, 3 and 9 months.
Results:
Recruitment commenced in July 2021. As of January 2022, 23 children have been randomized. Authors expect an average of five patients monthly; therefore, recruitment and analysis should be complete by October 2024.
Conclusions:
An experimental design that addresses upper extremity functionality after cast immobilization in situ in children who have sustained a distal fracture of the radius may yield compelling information that could aid the clinician upon deciding the most suitable orthopedic treatment. Clinical Trial: Clinicaltrials.gov NCT05008029
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