NCT Number: NCT06799377
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.
Interested in participating?
Request Info8 year–18 year
All sexes
Interventional
Not applicable
Nashville, Tennessee, 37232, United States
Location status: Recruiting
James Bathon, B.S.
CONTACT
James F Bathon, B.S.
SUB_INVESTIGATOR
Nathaniel Lempert, M.D.
CONTACT
Nathaniel Lempert, M.D.
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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"
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."
Time frame: 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.
Time frame: 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.
Time frame: Time of clinic presentation to cast removal, approximately 6-8 weeks.
Activity levels based on patient-completed validated activity surveys (PAQ)
Time frame: Time of clinic presentation to cast removal, approximately 6-8 weeks
Activity levels based on patient-worn activity trackers
Contact information is provided by the study sponsor or research team.
James F Bathon, B.S.
CONTACT
Nathaniel Lempert, M.D.
CONTACT
Vanderbilt University Medical Center
Other
Complications Related to Activity After Both Bone Fractures: Why do we Restrict Activity?
Acronym: CRABB-Y
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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