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

NCT06799377 | Recruiting DMC

• 1 other identifier: 241179
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Complications

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

• Activity Level as measured by 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

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

Study Arms (2)

Restricted Activity Group

ACTIVE COMPARATOR

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

Activity (Limited) Group

ACTIVE COMPARATOR

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

Interventions

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"

Restricted Activity Group

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."

Activity (Limited) Group

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt Children's Hospital Orthopedics Clinic

Nashville, Tennessee, 37232, United States

RECRUITING

Related Publications (5)

• 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.

  PMID: 32160501 BACKGROUND

• 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.

  PMID: 26057068 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 30276723 BACKGROUND

• 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.

  PMID: 36913227 BACKGROUND

Central Study Contacts

Nathaniel Lempert, M.D.

CONTACT

419-344-3993; nathaniel.lempert@vumc.org

James F Bathon, B.S.

CONTACT

914-471-3665

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatric Orthopaedics

Model Details: Randomized Clinical Trial with two group that receive different activity restrictions

Study Record Dates

• First Submitted: January 16, 2025
• First Posted: January 29, 2025
• Study Start: January 16, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: July 10, 2025

Record last verified: 2025-07

Locations

US (1)