Hulsmans Martijn H J, van Heijl Mark, Houwert R Marijn, Hammacher Eric R, Meylaerts Sven A G, Verhofstad Michiel H J, Dijkgraaf Marcel G W, Verleisdonk Egbert J M M
Department of Surgery, Diakonessenhuis Utrecht, PO Box 80250, 3508 TG, Utrecht, The Netherlands.
Utrecht Traumacenter, Utrecht, The Netherlands.
Clin Orthop Relat Res. 2017 Feb;475(2):532-539. doi: 10.1007/s11999-016-5113-8. Epub 2016 Nov 9.
Studies comparing plate with intramedullary nail fixation of displaced midshaft clavicle fractures show faster recovery in the plate group and implant-related complications in both groups after short-term followup (6 or 12 months). Knowledge of disability, complications, and removal rates beyond the first postoperative year will help surgeons in making a decision regarding optimal implant choice. However, comparative studies with followup beyond the first year or two are scarce.
QUESTIONS/PURPOSES: We asked: (1) Does plate fixation or intramedullary nail fixation for displaced midshaft clavicle fractures result in less disability? (2) Which type of fixation, plate or intramedullary, is more frequently associated with implant-related irritation and implant removal? (3) Is plate or intramedullary fixation associated with postoperative complications beyond the first postoperative year?
Between January 2011 and August 2012, patients with displaced midshaft clavicle fractures were enrolled and randomized to plate or intramedullary nail fixation. A total of 58 patients with plate and 62 patients with intramedullary nails initially were enrolled. Minimum followup was 30 months (mean, 39 months; range, 30-51 months). Two patients (3%) with plate fixation and two patients (3%) with intramedullary nails were lost to followup. The QuickDASH was obtained at final followup and compared between patients who had plate fixation and those who had intramedullary nail fixation. Postoperative complications measured include infection, implant-related irritation, implant failure, nonunion, and refracture after implant removal. Indications for implant removal included implant-related irritation, implant failure, nonunion, patient's wish, or surgeon's preference.
Between patients with plate versus intramedullary nail fixation, there were no differences in QuickDASH scores (plate, 1.8 ± 3.6; intramedullary nail, 1.8 ± 7.2; mean difference, -0.7; 95% CI, -2.2 to 2.04; p = 0.95). The proportion of patients having implant-related irritation was not different (39 of 56 [70%] versus 41 of 62 [66%]; relative risk, 1.05; 95% CI, 0.82-1.35; p = 0.683). Intramedullary fixation was associated with a higher likelihood of implant removal (51 of 62 [82%] versus 28 of 56 [50%]; relative risk, 1.65; 95% CI, 1.24-2.19; p < 0.001). Among the removed implants more plates than intramedullary nails were removed after the 1-year followup (12 of 28 [43%] versus six of 51 [12%]; p = 0.002). There were no infections, implant breakage, nonunions, or refractures between the 1-year and final followup in either group.
After a mean followup of 39 months, disability scores were excellent. Major complications did not occur after the 1-year followup. A frequent and bothersome problem after both surgical treatments is implant-related irritation, resulting in high rates of implant removal, after 1 year. Future research could focus on analyzing risk factors for implant irritation or removal.
Level II, therapeutic study.
比较钢板与髓内钉固定移位型锁骨中段骨折的研究表明，在短期随访（6或12个月）后，钢板固定组恢复更快，且两组均出现与植入物相关的并发症。了解术后第一年之后的残疾情况、并发症及取出率，将有助于外科医生决定最佳的植入物选择。然而，随访超过一两年的比较研究较少。
问题/目的：我们探讨：（1）对于移位型锁骨中段骨折，钢板固定或髓内钉固定是否会导致更少的残疾？（2）哪种固定方式，钢板还是髓内固定，更常与植入物相关的刺激和植入物取出有关？（3）钢板或髓内固定与术后第一年之后的并发症是否有关？
2011年1月至2012年8月，纳入移位型锁骨中段骨折患者并随机分为钢板固定组或髓内钉固定组。最初共纳入58例钢板固定患者和62例髓内钉固定患者。最小随访时间为30个月（平均39个月；范围30 - 51个月）。2例（3%）钢板固定患者和2例（3%）髓内钉固定患者失访。在最终随访时获取QuickDASH评分，并对钢板固定患者和髓内钉固定患者进行比较。测量的术后并发症包括感染、植入物相关刺激、植入物失败、骨不连以及植入物取出后的再骨折。植入物取出的指征包括植入物相关刺激、植入物失败、骨不连、患者意愿或外科医生的偏好。
钢板固定组与髓内钉固定组患者的QuickDASH评分无差异（钢板组，1.8±3.6；髓内钉组，1.8±7.2；平均差异， - 0.7；95%可信区间， - 2.2至2.04；p = 0.95）。发生植入物相关刺激的患者比例无差异（56例中的39例[70%]对62例中的41例[66%]；相对风险，1.05；95%可信区间，0.82 - 1.35；p = 0.683）。髓内固定与更高的植入物取出可能性相关（62例中的51例[82%]对56例中的28例[50%]；相对风险，1.65；95%可信区间，1.24 - 2.19；p < 0.001）。在取出的植入物中，1年随访后取出的钢板比髓内钉更多（28例中的12例[43%]对51例中的6例[12%]；p = 0.002）。两组在1年随访至最终随访期间均未发生感染、植入物断裂、骨不连或再骨折。
平均随访39个月后，残疾评分良好。1年随访后未发生主要并发症。两种手术治疗后常见且令人困扰的问题是植入物相关刺激，导致1年后植入物取出率较高。未来的研究可聚焦于分析植入物刺激或取出的危险因素。
二级，治疗性研究。
