M. Kuhl, St. Cloud Orthopedics, Sartell, MN, USA.
C. Beimel, Stryker Trauma GmbH, Kiel, Germany.
Clin Orthop Relat Res. 2020 Sep;478(9):2132-2144. doi: 10.1097/CORR.0000000000001306.
Computer-assisted surgery (CAS) techniques have been shown to improve implant placement and reduce the radiation time during cephalomedullary nailing in cadaveric and pilot clinical studies of intertrochanteric hip fractures. However, clinical comparisons of CAS and conventional techniques are lacking. It is unclear whether CAS offers clear advantages in terms of radiation time, operative time, and accuracy of lag-screw placement in patients undergoing surgery for intertrochanteric hip fractures and whether any potential difference in accuracy is associated with a change in the risk of lag-screw cut-out postoperatively.
QUESTIONS/PURPOSES: In patients undergoing cephalomedullary nailing for intertrochanteric hip fractures compared with the conventional technique, we asked: (1) Is the CAS technique associated with a decrease in tip-apex distance (TAD), with less variation and fewer outliers at the standard (25 mm) and lower (15 mm) TAD thresholds? (2) Is the CAS technique associated with a decrease in radiation and operative time? (3) If the CAS technique results in a decrease in TAD, is this decrease associated with a decrease in lag screw cut-out postoperatively?
Between Oct 2007 and June 2015, 964 stable and unstable intertrochanteric hip fractures were treated surgically at our institution. Of these, 23% (225 of 964) were isolated, acute intertrochanteric hip fractures managed by a single surgeon. Ninety-five percent (213 of 225) of hip fractures were surgically treated with the same cephalomedullary nail based on the general indications of displaced fractures, poor bone quality, and medical complexity. This same surgeon used a sliding hip screw device in the remaining 5% (12 of 225) of hip fractures for the treatment of nondisplaced and minimally displaced fractures in younger patients with fewer medical comorbidities and good bone quality. Between October 2007 and August 2011, all procedures were performed with conventional lag screw placement (n = 110), and between September 2011 and June 2015, all procedures were performed with CAS (n = 103) for lag screw placement. Postoperative radiographs were missing or unavailable for TAD analysis for 3% (3 of 110) of the conventional technique group and 6% (6 of 103) of the CAS group, so these patients were excluded. The remaining 97% (107 of 110) of conventional procedures and 94% (97 of 103) of CAS procedures were included in the TAD, radiation time, and operative time analysis. For the evaluation of cut-out postoperatively, 24% (26 of 107) of conventional patients and 25% (24 of 97) of CAS patients were excluded due to mortality and/or loss to follow-up at a minimum of 1 year. The remaining 76% (81 of 107) of conventional patients and 75% (73 of 97) of CAS patients were included in the cut-out analysis. A retrospective chart review was performed to obtain the data and then compare TAD, radiation time, operative time, and cut-out between the two cohorts.
The median TAD for the CAS procedures was lower than the median TAD for the conventional procedures (median 13 mm versus median 16 mm, median difference 3 mm; p < 0.001 power for difference = 85%). In addition, the TAD variation was also less for the CAS procedures compared with the conventional procedures (interquartile range [IQR] 4 mm versus IQR 9 mm, IQR difference 5 mm; p < 0.001, power for difference = 98%). A TAD greater than 25 mm was found in 1% (1 of 97) of the CAS procedures and 12% (13 of 107) of the conventional procedures. A difference between the proportions could be detected indicating a lesser chance of a TAD > 25 mm in the CAS cohort (odds ratio = 0.075 [95% confidence interval 0.010 to 0.587]; p = 0.002, power for difference 90%). A TAD > 15 mm was found in 23% (22 of 97) of the CAS procedures and 56% (60 of 107) of the conventional procedures, also indicating a lesser chance of a TAD > 15 mm in the CAS cohort (OR = 0.230 [95% CI 0.125 to 0.423], relative risk for TAD > 15 mm = 0.404 [95% CI 0.270 to 0.606]; p < 0.001, power for difference > 99%). The median radiation time for the CAS cohort was lower than the median radiation time for the conventional cohort (median 1.4 minutes versus median 1.7 minutes, median difference 0.3 minutes; p = 0.002, power for difference = 81%). No difference in median total operating time was found for the CAS procedures compared with the conventional procedures (median 36 minutes versus median 38 minutes, median difference 2 minutes; p = 0.227, power for difference = 18%, power for equivalency = 93%). There was no difference in cut-out noted with the use of the CAS compared with the conventional technique with the numbers available. Based on the current results, the upper 95% probability for a cutout complication ranges from 0% to 5% in the CAS cohort versus 0% to 9% in the conventional cohort (difference of upper 95% CI = 4%).
CAS use is associated with a decrease in median TAD with less variation and fewer outliers during cephalomedullary nailing. Compared with the conventional technique, fewer outliers were noted with the CAS at the standard TAD threshold of 25 mm and a lower TAD threshold of 15 mm. Additional research is needed to determine the association of TAD variation and outliers on cut-out and to determine if there is any clinical value to the decrease in TAD variation and outliers noted here. The patient and surgical team are exposed to less radiation with the CAS compared with the conventional technique, but this difference is small and it is unclear if this benefit justifies CAS use. Incorporating CAS into the cephalomedullary nailing procedure is not associated with a change in operative time, so there are no costs or risks associated with increased operative time. More procedures would be needed to provide adequate power to better analyze the risk of lag screw cut-out, allowing a more complete understanding of the value of this technology compared with its cost.
Level III, therapeutic study.
计算机辅助手术 (CAS) 技术已被证明可以改善髓内钉固定在尸体和 pilot 临床试验中的股骨转子间骨折中的植入物位置,并减少辐射时间。然而,缺乏 CAS 和传统技术的临床比较。尚不清楚 CAS 是否在辐射时间、手术时间和拉力螺钉放置的准确性方面具有明显优势,对于接受股骨转子间骨折手术的患者,任何潜在的准确性差异是否与术后拉力螺钉切出的风险增加有关。
问题/目的:与传统技术相比,我们在接受股骨转子间骨折髓内钉固定的患者中提出了以下问题:(1) CAS 技术是否与尖端 - 顶点距离 (TAD) 降低有关,在标准 (25mm) 和较低 (15mm) TAD 阈值下,变化和离群值更少?(2) CAS 技术是否与辐射和手术时间减少有关?(3) 如果 CAS 技术导致 TAD 降低,这种降低是否与术后拉力螺钉切出减少有关?
2007 年 10 月至 2015 年 6 月,我院共治疗 964 例稳定和不稳定的股骨转子间骨折,其中 23%(225/964)为孤立性、急性股骨转子间骨折,由一位外科医生单独治疗。95%(213/225)的髋部骨折采用相同的股骨近端髓内钉治疗,根据移位骨折、骨质量差和医疗复杂性的一般适应证。对于年龄较小、合并症较少、骨质量较好的非移位和轻度移位骨折患者,剩余的 5%(12/225)髋部骨折采用滑动髋螺钉装置治疗。2007 年 10 月至 2011 年 8 月,所有手术均采用传统拉力螺钉放置(n=110),2011 年 9 月至 2015 年 6 月,所有手术均采用 CAS(n=103)进行拉力螺钉放置。由于术后 TAD 分析的放射学图像缺失或不可用,常规技术组中有 3%(3/110)和 CAS 组中有 6%(6/103)的患者被排除在外,因此这些患者被排除在外。其余 97%(107/110)的常规手术和 94%(97/103)的 CAS 手术均纳入 TAD、辐射时间和手术时间分析。对于术后切出的评估,由于死亡率和/或至少 1 年的随访丢失,常规组的 24%(26/107)和 CAS 组的 25%(24/97)患者被排除在外。其余 76%(81/107)的常规患者和 75%(73/97)的 CAS 患者被纳入切出分析。通过回顾性图表审查获取数据,然后比较两组 TAD、辐射时间、手术时间和切出率。
CAS 手术的中位数 TAD 低于常规手术的中位数 TAD(中位数 13mm 与中位数 16mm,中位数差异 3mm;p<0.001 差异=85%)。此外,与常规手术相比,CAS 手术的 TAD 变化也较小(四分位距 [IQR] 4mm 与 IQR 9mm,IQR 差异 5mm;p<0.001,差异=98%)。在 CAS 手术中,有 1%(1/97)的 TAD 大于 25mm,在常规手术中有 12%(13/107)的 TAD 大于 25mm。可以检测到两者之间的比例差异,表明在 CAS 队列中 TAD 大于 25mm 的可能性较小(比值比=0.075 [95%置信区间 0.010 至 0.587];p=0.002,差异=90%)。在 CAS 手术中有 23%(22/97)的 TAD 大于 15mm,在常规手术中有 56%(60/107)的 TAD 大于 15mm,这也表明在 CAS 队列中 TAD 大于 15mm 的可能性较小(比值比=0.230 [95%置信区间 0.125 至 0.423],TAD 大于 15mm 的相对风险=0.404 [95%置信区间 0.270 至 0.606];p<0.001,差异=99%)。CAS 组的中位数辐射时间低于常规组(中位数 1.4 分钟与中位数 1.7 分钟,中位数差异 0.3 分钟;p=0.002,差异=81%)。与常规手术相比,CAS 手术的总手术时间中位数无差异(中位数 36 分钟与中位数 38 分钟,中位数差异 2 分钟;p=0.227,差异=18%,等效性=93%)。在可用的病例中,与常规技术相比,使用 CAS 并没有发现切出并发症的差异。根据目前的结果,在 CAS 队列中,切出并发症的上限 95%概率范围为 0%至 5%,而在常规队列中为 0%至 9%(差异上限 95%CI=4%)。
CAS 的使用与髓内钉固定时 TAD 中位数降低有关,变异和离群值减少。与传统技术相比,CAS 在标准 TAD 阈值 25mm 和较低的 TAD 阈值 15mm 时,离群值较少。需要进一步研究 TAD 变异和离群值与切出的关系,以确定这里注意到的 TAD 变异和离群值是否具有临床价值。与传统技术相比,CAS 使患者和手术团队接受的辐射量减少,但这种差异很小,目前尚不清楚这种益处是否证明了 CAS 的使用是合理的。将 CAS 纳入股骨近端髓内钉固定术并不会增加手术时间,因此不会增加手术时间带来的成本或风险。需要更多的手术来提供足够的效能,以更好地分析拉力螺钉切出的风险,从而更全面地了解这项技术相对于其成本的价值。
III 级,治疗性研究。