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Suspended
NCT06799377
Complications Related To Activity After Pediatric Both Bone Fractures: Exploring the Effects of Activity on Fracture Displacement
Conditions: Forearm Fractures (Both Bone Forearm Fractures, Isolated Ulnar Shaft, Isolated Radial Shaft)
Sex: All
Ages: 8 Years – 18 Years
Healthy volunteers: No
Phase: NA
Enrollment: 100
Sponsor: Vanderbilt University Medical Center
Location: Vanderbilt Children's Hospital Orthopedics Clinic Nashville Tennessee
Summary
The goal of this randomized clinical study is to understand the effect of activity on the re-displacement of pediatric forearm fractures in patients ages 8-18 years old excluding those with known metabolic bone disease or obvious refracture. The main questions the study aims to answer are:
Does increased activity lead to increased re-displacement rates during the treatment of pediatric forearm fractures? Are there complications associated with increased levels of activity during the treatment of pediatric forearm fractures (skin irritation, need for re-casting, operation)? Do activity restrictions provided for pediatric forearm fractures influence patient activity levels?
Participants will be randomized into activity-restricted vs activity-limited (no contact sports). Some patients will be provided an ActiGraph Activity tracker to monitor patient activity. Every patient will complete a validated activity survey (PAQ) to assess activity at each follow-up appointment. Activity data and any complications will be recorded from time of initial presentation to cast removal.
Eligibility Criteria
Inclusion Criteria:
* Isolated Distal Radius Metaphyseal Fx (with or without ulna styloid)
* Distal Third (\7 days from the time of injury
* Pathologic fracture
* Any patient with metabolic bone disease (ex. Osteoporosis, skeletal dysplasias)
* Any patient with known bone fragility condition (ex. Osteogenesis imperfecta)
* If operative treatment is required at initial presentation
Source: ClinicalTrials.gov (NCT06799377). StuddyBuddy aggregates publicly available trial information.