Actively Recruiting

Phase Not Applicable
Age: 8Years - 18Years
All Genders
ID06799377

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

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

100

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying how activity levels affect the risk of re-displacement and complications in children aged 8 to 18 years with forearm fractures. The study aims to find out whether increased activity during cast treatment leads to more re-displacements or other issues like skin irritation, re-casting, or surgery. It also examines if activity restrictions influence how active children really are during recovery. Participants are randomly assigned to one of two groups: a restricted activity group advised to avoid strenuous play and sports, focusing on "feet on the floor" activities; or a limited activity group allowed to engage in most activities except contact sports, with guidance to avoid pain or safety risks. Some children will wear activity trackers, and all will complete activity surveys at follow-up visits. The study period covers from casting to cast removal, about 6 to 8 weeks. Throughout the study, children will have regular follow-up appointments where researchers will collect data on activity levels via surveys and trackers, and monitor for complications or re-displacement of the fracture. The main measure is whether the fracture moves again during treatment. Secondary measures include activity levels and any complications. The total participation duration is approximately 6 to 8 weeks from initial presentation to cast removal.

CONDITIONS

Brief 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...

  • Isolated distal radius metaphyseal fracture (with or without ulna styloid)
  • Distal third radius and ulna fracture less than 4 cm from growth plate, without obvious growth plate involvement
  • Isolated radial shaft fracture (diaphyseal)
  • Radial and ulna shaft fracture (diaphyseal)
Not Eligible

You will not qualify if you...

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

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit (in-person)

Treatment

Duration - Approximately 6 to 8 weeks (duration of cast immobilization)

Participants follow activity recommendations during the casting period to study the effects of activity on fracture displacement and complications.

Regular clinic visits during casting period for monitoring

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.

J

James F Bathon, B.S.

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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Published Research Related To This Trial