Actively Recruiting

Phase Not Applicable
Age: 8Years - 18Years
All Genders
NCT06799377

Complications Related To Activity After Pediatric Both Bone Fractures: Exploring the Effects of Activity on Fracture Displacement

Led by Vanderbilt University Medical Center · Updated on 2025-07-10

100

Participants Needed

1

Research Sites

80 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Complications Related To Activity After Pediatric Both Bone Fractures: Exploring the Effects of Activity on Fracture Displacement

Who Can Participate

Age: 8Years - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged 8 to 18 years with isolated distal radius metaphyseal fracture (with or without ulna styloid)
  • Distal third (less than 4 cm from growth plate) radius and ulna fracture without obvious growth plate involvement
  • Isolated radial shaft fracture (diaphyseal)
  • Radial and ulna shaft fractures (diaphyseal)
Not Eligible

You will not qualify if you...

  • Initial presentation more than 7 days after injury
  • Pathologic fractures
  • Any metabolic bone disease such as osteoporosis or skeletal dysplasias
  • Known bone fragility conditions like osteogenesis imperfecta
  • Need for surgery at initial presentation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Vanderbilt Children's Hospital Orthopedics Clinic

Nashville, Tennessee, United States, 37232

Actively Recruiting

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Research Team

N

Nathaniel Lempert, M.D.

CONTACT

J

James F Bathon, B.S.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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