Clinical trial NCT06799377: Complications Related To Activity After Pediatric Both Bone Fractures: Exploring the Effects of Activity on Fracture Displacement
Official title: Complications Related to Activity After Both Bone Fractures: Why do we Restrict Activity?
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Forearm Fractures (Both Bone Forearm Fractures, Isolated Ulnar Shaft, Isolated Radial Shaft)
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2025-01-29
Enrollment: 100
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Clinical Trial with two group that receive different activity restrictions
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Re-Displacement
timeFrame: From Cast Placement to Cast Removal, aproximately 6-8 weeks.
Secondary outcomes:
measure: Complications
timeFrame: From casting to cast removal, approximately 6-8 weeks.
measure: Activity Level as measured by patient-completed validated activity surveys (PAQ)
timeFrame: Time of clinic presentation to cast removal, approximately 6-8 weeks.
measure: Activity Level as measured by patient-worn activity trackers
timeFrame: Time of clinic presentation to cast removal, approximately 6-8 weeks
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt Children's Hospital Orthopedics Clinic
state: Tennessee
Study officials:
References:
citation: 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.
citation: 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.
citation: 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
citation: 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.
citation: 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.