Casting Without Reduction Versus Closed Reduction With or Without Fixation in the Treatment of Distal Radius Fractures in Children: Protocol for a Randomized Noninferiority Trial

BACKGROUND: Acute treatment for distal radius fractures, the most frequent fractures in the pediatric population, represents a challenge to the orthopedic surgeon. Deciding on surgical restoration of the alignment or cast immobilization without reducing the fracture is a complex concern given the remodeling potential of bones 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: The authors aim to measure functional outcomes, assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Physical Function v2.0 instrument. The authors hypothesize that outcomes will not be worse in children treated with cast immobilization in situ compared with those treated with closed reduction with or without percutaneous fixation. The authors also aim to compare the following as secondary outcomes: 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. METHODS: This is the protocol of a randomized noninferiority 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 6 months, while clinical and radiographic follow-up will occur at 2 weeks, 3 months, and 9 months. RESULTS: Recruitment commenced in July 2021. As of January 2022, 23 children have been randomized. Authors expect an average of 5 patients to be recruited monthly; therefore, recruitment and analysis should be complete by October 2024. CONCLUSIONS: This 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 in deciding on the most suitable orthopedic treatment. TRIAL REGISTRATION: ClinicalTrials.gov NCT05008029; https://clinicaltrials.gov/ct2/show/NCT05008029 INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/34576