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

Официальное название

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

Обзор

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.

Вмешательства

• Поведенческое 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 fl
• Поведенческое 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 th

Первичные конечные точки

• Re-Displacement [Срок оценки: From Cast Placement to Cast Removal, aproximately 6-8 weeks.]

Вторичные конечные точки (3)

• Complications [Срок оценки: From casting to cast removal, approximately 6-8 weeks.]
• Activity Level as measured by patient-completed validated activity surveys (PAQ) [Срок оценки: Time of clinic presentation to cast removal, approximately 6-8 weeks.]
• Activity Level as measured by patient-worn activity trackers [Срок оценки: Time of clinic presentation to cast removal, approximately 6-8 weeks]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Vanderbilt Children's Hospital Orthopedics Clinic — Nashville

Публикации

• 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
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT06799377 · 241179

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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