RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Complications Related to Activity After Both Bone Fractures: Why do we Restrict Activity?

Quick Facts

Study Start:2025-01-16
Study Completion:2025-06-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06799377

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:8 Years to 18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Isolated Distal Radius Metaphyseal Fx (with or without ulna styloid)
  2. * Distal Third (\<4 cm from physis) Radius and Ulna fracture (i.e. without obvious physeal involvement)
  3. * Insolated Radial Shaft Fracture (diaphyseal)
  4. * Radial and Ulna Shaft Fracture (diaphyseal)
  1. * Initial presentation \>7 days from the time of injury
  2. * Pathologic fracture
  3. * Any patient with metabolic bone disease (ex. Osteoporosis, skeletal dysplasias)
  4. * Any patient with known bone fragility condition (ex. Osteogenesis imperfecta)
  5. * If operative treatment is required at initial presentation

Contacts and Locations

Study Contact

Nathaniel Lempert, M.D.
CONTACT
419-344-3993
nathaniel.lempert@vumc.org
James F Bathon, B.S.
CONTACT
914-471-3665

Study Locations (Sites)

Vanderbilt Children's Hospital Orthopedics Clinic
Nashville, Tennessee, 37232
United States

Collaborators and Investigators

Sponsor: Vanderbilt University Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-16
Study Completion Date2025-06-01

Study Record Updates

Study Start Date2025-01-16
Study Completion Date2025-06-01

Terms related to this study

Additional Relevant MeSH Terms

  • Forearm Fractures (Both Bone Forearm Fractures, Isolated Ulnar Shaft, Isolated Radial Shaft)