Complications Related To Activity After Pediatric Both Bone Fractures: Exploring the Effects of Activity on Fracture Displacement (CRABB-Y)

Vanderbilt University Medical Center

Status: Enrolling

Conditions: Forearm Fractures (Both Bone Forearm Fractures, Isolated Ulnar Shaft, Isolated Radial Shaft)

Treatments: Behavioral: Full Activity/Limited Activity Reccomendations; Behavioral: Restricted Activity Reccomendations

Study type: Interventional

Funder types: Other

Identifiers

NCT06799377

241179

Details and patient eligibility

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 8 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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)

Exclusion criteria

• 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)
• If operative treatment is required at initial presentation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Restricted Activity Group

Active Comparator group

Description:

This group of patients will be given restricted activity recommendations. 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"

Treatment:

Behavioral: Restricted Activity Reccomendations

Activity (Limited) Group

Active Comparator group

Description:

This group of patients will be given limited activity recommendations. 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 "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:

Behavioral: Full Activity/Limited Activity Reccomendations