Forearm Fractures (Both Bone Forearm Fractures, Isolated Ulnar Shaft, Isolated Radial Shaft)
Conditions
Brief summary
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.
Interventions
BEHAVIORALRestricted Activity Reccomendations
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
BEHAVIORALFull Activity/Limited Activity Reccomendations
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.
Sponsors
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized Clinical Trial with two group that receive different activity restrictions
Eligibility
Sex/Gender
ALL
Age
8 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Re-Displacement | From Cast Placement to Cast Removal, aproximately 6-8 weeks. | Re-displacement will be defined as a change in angulation of greater than 10 degrees. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complications | From casting to cast removal, approximately 6-8 weeks. | The rate of complications including skin irritation/breakdown, the need for re-casting, and the need for operative management. |
| Activity Level as measured by patient-completed validated activity surveys (PAQ) | Time of clinic presentation to cast removal, approximately 6-8 weeks. | Activity levels based on patient-completed validated activity surveys (PAQ) |
| Activity Level as measured by patient-worn activity trackers | Time of clinic presentation to cast removal, approximately 6-8 weeks | Activity levels based on patient-worn activity trackers |
Countries
United States
Contacts
Primary ContactNathaniel Lempert, M.D.
Backup ContactJames F Bathon, B.S.
Outcome results
None listed