Adrian Miriam, Wachtlin Daniel, Kronfeld Kai, Sommerfeldt Dirk, Wessel Lucas M
Clinic for Pediatric Surgery, University Hospital Mannheim, Faculty of Heidelberg, Mannheim, Germany.
Interdisciplinary Centre for Clinical Trials Mainz (IZKS Mainz), University Medical Centre, Johannes Gutenberg University, Mainz, Germany.
Trials. 2015 Sep 30;16:437. doi: 10.1186/s13063-015-0912-x.
Angulated 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/DESIGN: This 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.
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.
DRKS00004874 , 30 October 2013.
儿童前臂远端成角骨折是非常常见的损伤。目前，对于这些儿童是应采用石膏保守治疗；复位后使用石膏治疗；还是在麻醉下进行复位、穿针及石膏固定，尚无标准指南。小型前瞻性和回顾性研究表明，前臂远端骨骺具有较高的重塑能力，能够可靠地纠正对线不良。本试验的目的是回答手术治疗和保守治疗的结果是否相当这一问题。
方法/设计：这是一项前瞻性、跨国、多中心、随机、观察者盲法、积极对照的平行组试验，观察期为24个月。本试验的主要目的是评估重塑治疗患者的长期功能结局是否劣于接受闭合复位和克氏针固定的患者。该试验应纳入742例急性骨折患者。患者将被纳入德国、瑞士和奥地利的30个医疗中心。所有5至11岁因前臂远端成角骨折就诊于急诊科的患者，在获得知情同意后将进行在线随机分组。主要终点是24个月后的Cooney评分。次要终点是12/24个月时的放射学移位程度。
成角骨折的治疗是一个激烈争论的问题。为避免对线不良，建议在全身麻醉下进行一期手法复位和穿针。尚无大型研究证明手法复位和穿针优于单纯固定。如果重塑似乎是一种安全的替代方法，那么可以避免在全身麻醉下进行手法复位、克氏针固定和拔针，从而节省大量费用。
DRKS00004874，2013年10月30日。
