Trauma Unit, Department of Surgery, Academic Medical Center, Amsterdam, The Netherlands.
BMC Musculoskelet Disord. 2011 Jul 6;12:151. doi: 10.1186/1471-2474-12-151.
Posttraumatic osteoarthritis can develop after an intra-articular extremity fracture, leading to pain and loss of function. According to international guidelines, anatomical reduction and fixation are the basis for an optimal functional result. In order to achieve this during fracture surgery, an optimal view on the position of the bone fragments and fixation material is a necessity. The currently used 2D-fluoroscopy does not provide sufficient insight, in particular in cases with complex anatomy or subtle injury, and even an 18-26% suboptimal fracture reduction is reported for the ankle and foot. More intra-operative information is therefore needed.Recently the 3D-RX-system was developed, which provides conventional 2D-fluoroscopic images as well as a 3D-reconstruction of bony structures. This modality provides more information, which consequently leads to extra corrections in 18-30% of the fracture operations. However, the effect of the extra corrections on the quality of the anatomical fracture reduction and fixation as well as on patient relevant outcomes has never been investigated.The objective of this study protocol is to investigate the effectiveness of the intra-operative use of the 3D-RX-system as compared to the conventional 2D-fluoroscopy in patients with traumatic intra-articular fractures of the wrist, ankle and calcaneus. The effectiveness will be assessed in two different areas: 1) the quality of fracture reduction and fixation, based on the current golden standard, Computed Tomography. 2) The patient-relevant outcomes like functional outcome range of motion and pain. In addition, the diagnostic accuracy of the 3D-RX-scan will be determined in a clinical setting and a cost-effectiveness as well as a cost-utility analysis will be performed.
METHODS/DESIGN: In this protocol for an international multicenter randomized clinical trial, adult patients (age > 17 years) with a traumatic intra-articular fracture of the wrist, ankle or calcaneus eligible for surgery will be subjected to additional intra-operative 3D-RX. In half of the patients the surgeon will be blinded to these results, in the other half the surgeon may use the 3D-RX results to further optimize fracture reduction. In both randomization groups a CT-scan will be performed postoperatively. Based on these CT-scans the quality of fracture reduction and fixation will be determined. During the follow-up visits after hospital discharge at 6 and 12 weeks and 1 year postoperatively the patient relevant outcomes will be determined by joint specific, health economic and quality of life questionnaires. In addition a follow up study will be performed to determine the patient relevant outcomes and prevalence of posttraumatic osteoarthritis at 2 and 5 years postoperatively.
The results of the study will provide more information on the effectiveness of the intra-operative use of 3D-imaging during surgical treatment of intra-articular fractures of the wrist, ankle and calcaneus. A randomized design in which patients will be allocated to a treatment arm during surgery will be used because of its high methodological quality and the ability to detect incongruences in the reduction and/or fixation that occur intra-operatively in the blinded arm of the 3D-RX. An alternative, pragmatic design could be to randomize before the start of the surgery, then two surgical strategies would be compared. This resembles clinical practice better, but introduces more bias and does not allow the assessment of incongruences that would have been detected by 3D-RX in the blinded arm.
Dutch Trial Register NTR 1902.
关节内肢体骨折后可发生创伤后骨关节炎，导致疼痛和功能丧失。根据国际指南，解剖复位和固定是获得最佳功能结果的基础。为了在骨折手术中实现这一目标，需要对骨碎片和固定材料的位置有最佳的视图。目前使用的二维透视术不能提供足够的见解，特别是在解剖结构复杂或损伤轻微的情况下，甚至有报道称踝关节和足部的骨折复位不理想率为 18%-26%。因此，需要更多的术中信息。
最近开发了 3D-RX 系统，该系统提供常规的二维透视图像以及骨结构的三维重建。这种方式提供了更多的信息，因此导致 18%-30%的骨折手术需要额外的矫正。然而，额外矫正对解剖复位和固定质量以及患者相关结果的影响从未被研究过。
本研究方案的目的是研究术中使用 3D-RX 系统与常规二维透视在腕关节、踝关节和跟骨创伤性关节内骨折患者中的效果。将在两个不同领域评估效果：1）基于当前金标准计算机断层扫描（CT）评估骨折复位和固定的质量。2）患者相关的结果，如功能活动范围和疼痛。此外，将在临床环境中确定 3D-RX 扫描的诊断准确性，并进行成本效益和成本效用分析。
方法/设计：在这项国际多中心随机临床试验方案中，符合手术条件的腕关节、踝关节或跟骨创伤性关节内骨折的成年患者（年龄>17 岁）将接受额外的术中 3D-RX。在一半的患者中，外科医生将对这些结果不知情，而在另一半患者中，外科医生可以使用 3D-RX 结果进一步优化骨折复位。在两组随机分组中，术后均进行 CT 扫描。根据这些 CT 扫描，确定骨折复位和固定的质量。在出院后的随访中，分别在术后 6 周、12 周和 1 年，通过关节特异性、健康经济学和生活质量问卷来确定患者相关的结果。此外，还将进行一项随访研究，以确定术后 2 年和 5 年的患者相关结果和创伤后骨关节炎的发生率。
该研究的结果将提供更多关于术中使用三维成像在腕关节、踝关节和跟骨关节内骨折手术治疗中的有效性的信息。由于其具有较高的方法学质量，并且能够检测到术中在 3D-RX 盲法臂中发生的复位和/或固定的不一致性，因此使用了一种随机设计，在手术过程中为患者分配治疗臂。另一种更实用的设计是在手术开始前随机分组，然后比较两种手术策略。这更接近临床实践，但会引入更多的偏倚，并且无法评估 3D-RX 在盲法臂中检测到的不一致性。
荷兰试验注册 NTR 1902。
