Massachusetts General Hospital, Department of Orthopaedic Surgery, 55 Fruit Street, YAW-2-2C, Boston, Massachusetts 02114, USA.
BMC Musculoskelet Disord. 2010 Dec 14;11:282. doi: 10.1186/1471-2474-11-282.
Malunion is the most common complication of distal radius fracture. It has previously been demonstrated that there is a correlation between the quality of anatomical correction and overall wrist function. However, surgical correction can be difficult because of the often complex anatomy associated with this condition. Computer assisted surgical planning, combined with patient-specific surgical guides, has the potential to improve pre-operative understanding of patient anatomy as well as intra-operative accuracy. For patients with malunion of the distal radius fracture, this technology could significantly improve clinical outcomes that largely depend on the quality of restoration of normal anatomy. Therefore, the objective of this study is to compare patient outcomes after corrective osteotomy for distal radius malunion with and without preoperative computer-assisted planning and peri-operative patient-specific surgical guides.
METHODS/DESIGN: This study is a multi-center randomized controlled trial of conventional planning versus computer-assisted planning for surgical correction of distal radius malunion. Adult patients with extra-articular malunion of the distal radius will be invited to enroll in our study. After providing informed consent, subjects will be randomized to two groups: one group will receive corrective surgery with conventional preoperative planning, while the other will receive corrective surgery with computer-assisted pre-operative planning and peri-operative patient specific surgical guides. In the computer-assisted planning group, a CT scan of the affected forearm as well as the normal, contralateral forearm will be obtained. The images will be used to construct a 3D anatomical model of the defect and patient-specific surgical guides will be manufactured. Outcome will be measured by DASH and PRWE scores, grip strength, radiographic measurements, and patient satisfaction at 3, 6, and 12 months postoperatively.
Computer-assisted surgical planning, combined with patient-specific surgical guides, is a powerful new technology that has the potential to improve the accuracy and consistency of orthopaedic surgery. To date, the role of this technology in upper extremity surgery has not been adequately investigated, and it is unclear whether its use provides any significant clinical benefit over traditional preoperative imaging protocols. Our study will represent the first randomized controlled trial investigating the use of computer assisted surgery in corrective osteotomy for distal radius malunions.
NCT01193010.
畸形愈合是桡骨远端骨折最常见的并发症。先前的研究表明，解剖矫正质量与腕关节整体功能之间存在相关性。然而，由于这种情况通常涉及复杂的解剖结构，因此手术矫正可能具有挑战性。计算机辅助手术规划与患者特定的手术导板相结合，有可能提高对患者解剖结构的术前理解以及术中的准确性。对于桡骨远端骨折畸形愈合的患者，该技术可以显著改善主要依赖于正常解剖结构恢复质量的临床结果。因此，本研究的目的是比较桡骨远端畸形愈合矫正截骨术患者采用术前计算机辅助规划与围手术期患者特定手术导板的治疗效果。
方法/设计：这是一项桡骨远端畸形愈合矫正截骨术常规规划与计算机辅助规划的多中心随机对照试验。将邀请患有桡骨远端关节外畸形愈合的成年患者参加我们的研究。在提供知情同意后，患者将被随机分为两组：一组接受常规术前规划的矫正手术，另一组接受计算机辅助术前规划和围手术期患者特定手术导板的矫正手术。在计算机辅助规划组中，将获得受影响前臂和正常对侧前臂的 CT 扫描。这些图像将用于构建缺陷的 3D 解剖模型，并制造患者特定的手术导板。术后 3、6 和 12 个月将通过 DASH 和 PRWE 评分、握力、影像学测量和患者满意度来评估结果。
计算机辅助手术规划与患者特定的手术导板相结合是一种强大的新技术，具有提高骨科手术准确性和一致性的潜力。迄今为止，该技术在上肢手术中的作用尚未得到充分研究，其使用是否比传统的术前成像方案提供任何显著的临床益处尚不清楚。我们的研究将是首例调查计算机辅助手术在桡骨远端畸形愈合矫正截骨术中应用的随机对照试验。
NCT01193010。
