Complications liées à l'activité après les deux fractures osseuses pédiatriques: explorer les effets de l'activité sur le déplacement des fractures (CRABB-Y)
Complications liées à l'activité après les deux fractures osseuses: pourquoi restreignions-nous l'activité?
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.
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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-
Tennessee
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Nashville, Tennessee, États-Unis, 37232
- Vanderbilt Children's Hospital Orthopedics Clinic
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: 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" |
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" |
|
Comparateur actif: 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." |
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." |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Re-Displacement
Délai: 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. |
From Cast Placement to Cast Removal, aproximately 6-8 weeks.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Complications
Délai: 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. |
From casting to cast removal, approximately 6-8 weeks.
|
|
Activity Level as measured by patient-completed validated activity surveys (PAQ)
Délai: Time of clinic presentation to cast removal, approximately 6-8 weeks.
|
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
Délai: Time of clinic presentation to cast removal, approximately 6-8 weeks
|
Activity levels based on patient-worn activity trackers |
Time of clinic presentation to cast removal, approximately 6-8 weeks
|
Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- 241179
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
We do not plan to submit to International Committee of Medical Journal Editors (ICMJE)
Informations sur les médicaments et les dispositifs, documents d'étude
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