Weil Nikki L, Termaat M Frank, Rubinstein Sidney M, El Moumni Mostafa, Zuidema Wietse P, Derksen Robert Jan, Krijnen Pieta, van Bodegom-Vos Leti, Wendt Klaus W, van Kuijk Cornelis, Rosendaal Frits R, Breederveld Roelf S, Goslings J Carel, Schipper Inger B, van Tulder Maurits W
Department of Surgery/Trauma Surgery, Leiden University Medical Centre, P.O. Box 9600, 2300 RC, Leiden, the Netherlands.
Department of Health Sciences, VU University Amsterdam, de Boelelaan 1085, 1081 HV, Amsterdam, the Netherlands.
Trials. 2015 Feb 27;16:66. doi: 10.1186/s13063-015-0600-x.
Extremity fractures such as wrist and ankle fractures are a common and costly healthcare problem. The management of these fractures depends on fracture type and loss of congruity of the joint, resulting in cast immobilization or operative treatment. Loss of congruity or displacement leading to uneven joint loading, osteoarthritis and an increased probability of a poor functional outcome should be identified within the first 2 weeks post-trauma, based upon radiographs to determine optimal treatment. After this period, routine radiographs are scheduled for monitoring the bone-healing process. Current protocols describe imaging at 1, 2, 6 and 12 weeks post-trauma. However, it is questionable whether routine radiography following the initial follow-up ( 2-weeks post-trauma) is cost effective. The aim of this study is to determine whether a modification of the radiographic follow-up protocol can be conducted with no worse outcome and less cost than the current standard of care for patients with a wrist or ankle fracture.
METHODS/DESIGN: In a multicenter randomized controlled trial, 697 patients aged 18 years or older will be included: 385 wrist fracture- and 312 ankle fracture patients. Patients will be randomized into two groups: Group 1 receives usual care, consisting of radiographs 1, 2, 6 and 12 weeks post-trauma; Group 2 receives radiographs beyond the initial follow-up only when clinically indicated. The primary outcome is the overall extremity-specific function. For wrist fractures, this includes the Disabilities of the Arm, Shoulder and Hand Score; for the ankle fractures, this includes the Olerud and Molander ankle score. Secondary outcomes include: healthcare cost, the specific function measured with the Patient Rated Wrist and Hand Evaluation for wrist fractures and American Academy of Orthopaedic Surgeons foot and ankle questionnaire for ankle fractures, pain-intensity, health-related quality of life, self-perceived recovery, and complications. Both groups will be monitored at 1, 2, and 6 weeks and 3, 6, and 12 months.
This study will provide data on (cost) effectiveness of routine radiography in the follow-up of wrist and ankle fractures, and could pave the way for a change in (inter)national protocols.
Netherlands Trial Register NTR4610 , registration date 22 June 2014.
手腕和脚踝骨折等四肢骨折是一个常见且代价高昂的医疗保健问题。这些骨折的治疗取决于骨折类型和关节的一致性丧失情况，从而导致采用石膏固定或手术治疗。创伤后2周内，应根据X线片确定最佳治疗方案，以识别导致关节负荷不均、骨关节炎以及功能预后不良可能性增加的一致性丧失或移位情况。在此期间之后，安排常规X线片检查以监测骨愈合过程。当前方案规定在创伤后1、2、6和12周进行影像学检查。然而，初始随访（创伤后2周）后的常规X线摄影是否具有成本效益仍值得怀疑。本研究的目的是确定对于手腕或脚踝骨折患者，是否可以修改X线随访方案，且结果不劣于当前标准治疗，同时成本更低。
方法/设计：在一项多中心随机对照试验中，将纳入697名18岁及以上的患者：385名手腕骨折患者和312名脚踝骨折患者。患者将被随机分为两组：第1组接受常规治疗，包括在创伤后1、2、6和12周进行X线检查；第2组仅在临床指征提示时在初始随访之后进行X线检查。主要结局是四肢特定的总体功能。对于手腕骨折，这包括手臂、肩部和手部残疾评分；对于脚踝骨折，这包括奥勒鲁德和莫兰德脚踝评分。次要结局包括：医疗成本、手腕骨折采用患者自评手腕和手部评估以及脚踝骨折采用美国矫形外科医师学会足踝问卷测量的特定功能、疼痛强度、健康相关生活质量、自我感知恢复情况以及并发症。两组将在1、2和6周以及3、6和12个月时进行监测。
本研究将提供关于手腕和脚踝骨折随访中常规X线摄影（成本）效益的数据，并可能为（国际）方案的改变铺平道路。
荷兰试验注册NTR4610，注册日期2014年6月22日。
