Medical Services ► Clinical Trials ► ORT23139 (2021-4883_DRIFT)

Distal Radius Interventions for Fracture Treatment (DRIFT)

Study Details

Reduction and Nonreduction Treatment of Displaced Pediatric Distal Radius Fractures (Peds-DRIFT Trial - Distal Radius Interventions for Fracture Treatment)

Conditions: Fracture Distal Radius

Study ID:

ORT23139 (2021-4883_DRIFT)

Study Description

This protocol describes a multicenter, prospective randomized superiority trial comparing functional outcomes between children treated with sedated reduction versus no formal reduction.

Eligibility Requirements

Inclusion Criteria

Provision of signed and dated informed consent form by parent or legal guardian
Stated willingness to comply with all study procedures and availability for the duration of the study
Male or female, aged 4-10 years
Diagnosis of 100% dorsally displaced radius metaphyseal fracture with any or no ulna involvement
Fracture is less than 5cm from the distal radial growth plate
Willing to adhere to the immobilization regimen
Fracture is acute (occurred less than 10 days prior to consent and assignment of treatment arm AND with ability to be taken to operating room (OR) or reduced in the emergency department (ED)

Exclusion Criteria

Physeal involvement of fracture
Presence of open fracture, pathologic fracture, neuromuscular disease, or metabolic disease
Fracture cannot be treated with acute reduction due to being older than 10 days
Patient and parents are unable to adhere to procedures or complete follow-up due to insufficient comprehension of consent form or surveys or developmental delay.