Trial reportTrials2015
A comparison of intervention and conservative treatment for angulated fractures of the distal forearm in children (AFIC): study protocol for a randomized controlled trial.
Trial report in Trials, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
13 citing papers in PubMed, 2 syntheses or guidelines pooled it, 19 citations in OpenAlex.
- Interventions for treating wrist fractures in children.The Cochrane database of systematic reviews · 2018Pooled it
- Is percutaneous pinning needed for the treatment of displaced distal radius metaphyseal fractures in children?: A systematic review.Medicine · 2018Pooled it
- Article
- Secondary Displacement of Forearm Fractures in Children: When to Anticipate Remodeling and When to Intervene?Children (Basel, Switzerland) · 2026Article
- Article
- Fractures of the proximal radius in children: management and results of 100 consecutive cases.Archives of orthopaedic and trauma surgery · 2022Article
- Is there a reason to challenge our current practice in children's forearm fractures?Acta orthopaedica · 2021Article
- The Concentration of Selected Inflammatory Cytokines (IL-6, IL-8, CXCL5, IL-33) and Damage-Associated Molecular Patterns (HMGB-1, HSP-70) Released in an Early Response to Distal Forearm Fracture and the Performed Closed Reduction With Kirschner Wire Fixation in Children.Frontiers in endocrinology · 2021Article
- Extraphyseal distal radius fracture in children: is the cast always needed? A retrospective analysis comparing Epibloc system and K-wire pinning.European journal of orthopaedic surgery & traumatology : orthopedie traumatologie · 2020Article
- Prevention of secondary displacement and reoperation of distal metaphyseal forearm fractures in children.Journal of clinical orthopaedics and trauma · 2020Article
- Is there a standard treatment for displaced pediatric diametaphyseal forearm fractures?: A STROBE-compliant retrospective study.Medicine · 2019Article
- Palmar approach with Kirschner-wire fixation in the treatment of children's distal radius extension type fracture.Chinese journal of traumatology = Zhonghua chuang shang za zhi · 2018Article
- Elastic stable intramedullary fixation using epibloc versus crossed kirschner wires fixation for distal forearm fractures in children: A retrospective analysis.African journal of paediatric surgery : AJPSArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 5 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAngulated fractures of the distal forearm are very frequent lesions in childhood. Currently, there are no standard guidelines on whether these children should be treated conservatively with a cast; with reduction and a cast; or with reduction, pinning and a cast under anesthesia. Minor prospective and retrospective studies have shown that the distal physis of the forearm possesses high remodeling capacity leading to reliable correction of malalignment. The aim of this trial is to answer the question about whether operative and conservative treatment show equivocal results. METHODS/
designThis is a prospective, multinational, multicenter, randomized, observer-blinded, actively controlled, parallel group trial, with 24 months of observation. The primary objective of this trial is to assess whether or not the long-term functional outcome in remodeling patients is inferior to patients receiving closed reduction and K-wire pinning. The trial should include 742 patients with acute fracture. The patients will be included in 30 medical centers in Germany, Switzerland and Austria. All patients 5 to 11 years of age presenting at the emergency department with an angulated distal fracture of the forearm will be randomized online after informed consent. The primary endpoint is the Cooney Score after 24 months. The secondary endpoint is the grade of radiological displacement at 12/24 months. DISCUSSION: Therapy of angulated fractures is a matter of intensive debate. Primary manipulation and pinning under general anesthesia is recommended in order to avoid malalignment. No major study has proven the advantage of manipulation and pinning over immobilization alone. Should remodeling appear to be a safe alternative, manipulation under general anesthesia, K-wire pinning and removal of pins could be avoided, thus sparing significant costs.
trial registrationDRKS00004874 , 30 October 2013.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.