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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-18
SponsorVanderbilt University Medical Center

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Isolated Distal Radius Metaphyseal Fx (with or without ulna styloid)

Distal Third (<4 cm from physis) Radius and Ulna fracture (i.e. without obvious physeal involvement)

Insolated Radial Shaft Fracture (diaphyseal)

Radial and Ulna Shaft Fracture (diaphyseal)

Disqualifiers

Initial presentation >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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Restricted Activity Reccomendations

    Behavioral

    Patients in this respective group will be given restricted activity recommendations over the casting period. They will be told "Your child has a forearm/wrist fracture. It is unknown if remaining active while in a cast affects the risk of complications after this type of fracture. Your child has been randomized to the "restricted activity" group. We ask that you limit sprinting, jumping, and organized sports during the time of cast immobilization. As a rule of thumb, we recommend "feet on the floor" activities while playing and avoiding playgrounds and gym class if possible. While it is not realistic to restrict a young child entirely, do your best to avoid strenuous or intense exercise until cleared by your physician or nurse practitioner"

  • Full Activity/Limited Activity Reccomendations

    Behavioral

    Patients in this respective group will be allowed to engage in most activities. They will be read "Your child has a forearm/wrist fracture. It is unknown if remaining active while in a cast affects the risk of complications after this type of fracture. Your child has been randomized to the "activity as tolerated" group. Your child may participate in all desired activities except contact sports. Your child does not need to increase his/her activity level but should participate in activities as they feel comfortable doing so. Sprinting, jumping, and organized sports are acceptable as long as your child is not experiencing pain. Your child may use playgrounds and participate in gym class as desired. Do your best to avoid restricting your child from activities unless they are experiencing pain or you have concerns about their safety."

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Restricted Activity GroupActive comparator 1 intervention
Group B: Activity (Limited) GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Re-Displacement

Re-displacement will be defined as a change in angulation of greater than 10 degrees.

Time frame
From Cast Placement to Cast Removal, aproximately 6-8 weeks.

Secondary outcomes

1

Complications

The rate of complications including skin irritation/breakdown, the need for re-casting, and the need for operative management.

Time frame
From casting to cast removal, approximately 6-8 weeks.
2

Activity Level as measured by patient-completed validated activity surveys (PAQ)

Activity levels based on patient-completed validated activity surveys (PAQ)

Time frame
Time of clinic presentation to cast removal, approximately 6-8 weeks.
3

Activity Level as measured by patient-worn activity trackers

Activity levels based on patient-worn activity trackers

Time frame
Time of clinic presentation to cast removal, approximately 6-8 weeks

Other outcomes

Sponsors and contacts

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