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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Forearm Fractures (Both Bone Forearm Fractures, Isolated Ulnar Shaft, Isolated Radial Shaft)
• Intervention / Treatment: Behavioral: Restricted Activity Reccomendations; Behavioral: Full Activity/Limited Activity Reccomendations

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nathaniel Lempert, M.D.; Phone Number: 419-344-3993; Email: nathaniel.lempert@vumc.org
• Study Contact Backup: Name: James F Bathon, B.S.; Phone Number: 914-471-3665

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Recruiting
      • Vanderbilt Children's Hospital Orthopedics Clinic
      • Contact: Nathaniel Lempert, M.D.; Phone Number: 419-344-3993; Email: nathaniel.lempert@vumc.org
      • Contact: James Bathon, B.S.; Phone Number: 9144713665; Email: james.f.bathon@vanderbilt.edu
      • Principal Investigator: Nathaniel Lempert, M.D.
      • Sub-Investigator: James F Bathon, B.S.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Restricted Activity Group; 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"	Behavioral: Restricted 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"
Active Comparator: Activity (Limited) Group; 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."	Behavioral: Full 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."

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Re-Displacement	Re-displacement will be defined as a change in angulation of greater than 10 degrees.	From Cast Placement to Cast Removal, aproximately 6-8 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications	The rate of complications including skin irritation/breakdown, the need for re-casting, and the need for operative management.	From casting to cast removal, approximately 6-8 weeks.
Activity Level as measured by patient-completed validated activity surveys (PAQ)	Activity levels based on patient-completed validated activity surveys (PAQ)	Time of clinic presentation to cast removal, approximately 6-8 weeks.
Activity Level as measured by patient-worn activity trackers	Activity levels based on patient-worn activity trackers	Time of clinic presentation to cast removal, approximately 6-8 weeks

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center

Publications and helpful links

General Publications

• Sengab A, Krijnen P, Schipper IB. Displaced distal radius fractures in children, cast alone vs additional K-wire fixation: a meta-analysis. Eur J Trauma Emerg Surg. 2019 Dec;45(6):1003-1011. doi: 10.1007/s00068-018-1011-y. Epub 2018 Oct 1.
• Alagoz E, Gulec MA. Factors affecting re-displacement in pediatric forearm fractures and the role of cast indices. Jt Dis Relat Surg. 2020;31(1):95-101. doi: 10.5606/ehc.2020.71523.
• Ting BL, Kalish LA, Waters PM, Bae DS. Reducing Cost and Radiation Exposure During the Treatment of Pediatric Greenstick Fractures of the Forearm. J Pediatr Orthop. 2016 Dec;36(8):816-820. doi: 10.1097/BPO.0000000000000560.
• Sara Peiffer, Samuel J. Dressler, William L. Hennrikus; Outcomes of Displaced Forearm Fractures in Children Treated With Closed Reduction and Casting and a Loop and Sling Attached to the Cast Proximal to the Fracture Site. Pediatrics March 2021; 147 (3_MeetingAbstract): 798. 10.1542/peds.147.3MA8.798a
• Knopp BW, Harris M. Pediatric Forearm Fracture Characteristics as Prognostic Indicators of Healing. Cureus. 2023 Feb 7;15(2):e34741. doi: 10.7759/cureus.34741. eCollection 2023 Feb.

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: January 16, 2025
• First Submitted That Met QC Criteria: January 22, 2025
• First Posted (Actual): January 29, 2025

Study Record Updates

• Last Update Posted (Actual): July 10, 2025
• Last Update Submitted That Met QC Criteria: July 9, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: 241179

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: We do not plan to submit to International Committee of Medical Journal Editors (ICMJE)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No