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三维打印定制一体化半骨盆假体用于髋臼原发性恶性肿瘤患者的并发症有哪些,以及这些患者的功能情况如何?

What are the Complications of Three-dimensionally Printed, Custom-made, Integrative Hemipelvic Endoprostheses in Patients with Primary Malignancies Involving the Acetabulum, and What is the Function of These Patients?

作者信息

Wang Jie, Min Li, Lu Minxun, Zhang Yuqi, Wang Yitian, Luo Yi, Zhou Yong, Duan Hong, Tu Chongqi

机构信息

J. Wang, L. Min, M. Lu, Y. Zhang, Y. Wang, Y. Luo, Y. Zhou, H. Duan, C. Tu, Department of Orthopedics, West China Hospital, Sichuan University, Chengdu, People's Republic of China.

J. Wang, L. Min, M. Lu, Y, Zhang, Y. Luo, Y. Zhou, C. Tu, Bone and Joint 3D-Printing and Biomechanical Laboratory, Department of Orthopedics, West China Hospital, Sichuan University, Chengdu, People's Republic of China.

出版信息

Clin Orthop Relat Res. 2020 Nov;478(11):2487-2501. doi: 10.1097/CORR.0000000000001297.

Abstract

BACKGROUND

Functional reconstruction after resection of pelvic malignancies involving the acetabulum remains challenging. Numerous reconstruction methods have been proposed, but they are generally associated with mechanical and nonmechanical complications. To improve the function of patients with primary malignancies of the acetabulum after internal hemipelvectomy and reduce the complication rate after this procedure, we designed a series of three-dimensionally (3D) printed, custom-made, integrative hemipelvic endoprostheses with a porous structure and wanted to present the early results of using this construct to determine whether it could be considered a reasonable reconstruction option.

QUESTIONS/PURPOSES: We performed this study to (1) evaluate, in a small group of patients, whether the new endoprosthesis restores short-term lower-limb function; (2) identify short-term complications associated with the use of this endoprosthesis; and (3) assess osseointegration between the host bone and the 3D-printed integrative hemipelvic endoprosthesis with a porous structure.

METHODS

Between October 2016 and May 2017, our center treated 26 patients with malignancies involving the acetabulum. Thirteen of these patients received hemipelvic replacement with a 3D-printed, custom-made, integrative endoprosthesis, six received hemipelvic replacement with a modular endoprosthesis, four received radiotherapy, and three received external hemipelvectomy. Resection and reconstruction with a 3D-printed, custom-made, integrative endoprosthesis were indicated if the resection margin was the same as that achieved in hemipelvectomy, if reconstruction would preserve reasonable function after resection, if the patient had a good physical status and life expectancy longer than 6 months, and if the patient was willing to accept the potential risk of a 3D-printed, custom-made, endoprosthesis. The exclusion criteria were an inability to achieve a satisfactory surgical margin with limb salvage, inability to preserve the function of the limb because of tumor involvement of the sacral nerve or sciatic nerve, and unresectable and/or widely metastatic disease on presentation. Pain and function were evaluated with the 10-cm VAS score (range 0 to 10; a lower score is desirable), the 1993 version of the Musculoskeletal Tumor Society (MSTS-93) score (range 0 to 30; a higher score is desirable), and the Harris hip score ([HHS]; range 0 to 100; a higher score is desirable) were evaluated preoperatively and at a median of 27 months after reconstruction (range 24 to 31 months). The functional scores and complications were recorded after reviewing the patients' records. Osseointegration was assessed with digital tomosynthesis by two senior surgeons. We observed the trabecular structures connected to the implant surface to assess whether there was good osseointegration.

RESULTS

The median preoperative VAS score, MSTS-93 score, and HHS were 5 (range 2 to 8), 14 (range 3 to 18), and 64 (range 20 to 76) points, respectively. At the latest follow-up interval, the median VAS score, MSTS-93 score, and HHS were 2 (range 0 to 6), 23 (range 15 to 27), and 82 (range 44 to 93) points, respectively. No deep infection, dislocation, endoprosthetic breakage, aseptic loosening, or local recurrence occurred. Two patients experienced delayed wound healing; the wounds healed after débridement. Using digital tomography, we found that all implants were well-osseointegrated at the final follow-up examination.

CONCLUSIONS

A 3D-printed, custom-made, integrative hemipelvic endoprosthesis provides acceptable early outcomes in patients undergoing pelvic reconstruction. Osseointegration is possible, and we anticipate this will lead to biologic stability with a longer follow-up interval. The custom-made integrative design ensured precise implantation. Although a few patients in this study had only a short follow-up duration, the functional results were reasonable. We have observed no major complications so far, but this was a very small series and we caution that these are large reconstructions that will certainly result in complications for some patients. Our method uses a precise preoperative simulation and endoprosthesis design to aid the surgeon in performing challenging operations. If our early results are confirmed with more patients and longer follow-up and are replicated at other centers, this may be a reconstruction option for patients with periacetabular malignancies.

LEVEL OF EVIDENCE

Level IV, therapeutic study.

摘要

背景

髋臼周围骨盆恶性肿瘤切除术后的功能重建仍然具有挑战性。已经提出了许多重建方法,但它们通常与机械和非机械并发症相关。为了改善髋臼原发性恶性肿瘤患者在半骨盆切除术后的功能,并降低该手术后的并发症发生率,我们设计了一系列具有多孔结构的三维(3D)打印定制一体化半骨盆假体,并希望展示使用这种假体的早期结果,以确定它是否可被视为一种合理的重建选择。

问题/目的:我们进行这项研究是为了(1)在一小群患者中评估新假体是否能恢复短期下肢功能;(2)确定使用这种假体相关的短期并发症;(3)评估宿主骨与具有多孔结构的3D打印一体化半骨盆假体之间的骨整合情况。

方法

2016年10月至2017年5月期间,我们中心治疗了26例髋臼周围恶性肿瘤患者。其中13例患者接受了3D打印定制一体化假体的半骨盆置换,6例接受了模块化假体的半骨盆置换,4例接受了放疗,3例接受了外侧半骨盆切除术。如果切除边缘与半骨盆切除术中达到的边缘相同,如果重建能在切除术后保留合理功能,如果患者身体状况良好且预期寿命超过6个月,并且如果患者愿意接受3D打印定制假体的潜在风险,则采用3D打印定制一体化假体进行切除和重建。排除标准包括保肢手术无法获得满意的手术切缘、由于骶神经或坐骨神经受肿瘤侵犯而无法保留肢体功能以及就诊时不可切除和/或广泛转移的疾病。术前以及重建后中位27个月(范围24至31个月)采用10厘米视觉模拟评分(VAS评分,范围0至10;分数越低越好)、1993年版肌肉骨骼肿瘤学会(MSTS - 93)评分(范围0至30;分数越高越好)以及Harris髋关节评分([HHS],范围0至100;分数越高越好)评估疼痛和功能。在查阅患者病历后记录功能评分和并发症情况。由两名资深外科医生通过数字断层合成评估骨整合情况。我们观察与植入物表面相连的小梁结构,以评估是否存在良好的骨整合。

结果

术前VAS评分、MSTS - 93评分和HHS评分的中位数分别为5分(范围2至8)、14分(范围3至18)和64分(范围20至76)。在最近的随访期,VAS评分、MSTS - 93评分和HHS评分的中位数分别为2分(范围0至6)、23分(范围15至27)和82分(范围44至93)。未发生深部感染、脱位、假体断裂、无菌性松动或局部复发。两名患者出现伤口愈合延迟;清创后伤口愈合。通过数字断层扫描,我们发现在最后一次随访检查时所有植入物均实现了良好的骨整合。

结论

3D打印定制一体化半骨盆假体为接受骨盆重建的患者提供了可接受的早期结果。骨整合是可能的,我们预计随着更长的随访期这将带来生物学稳定性。定制一体化设计确保了精确植入。尽管本研究中的一些患者随访时间较短,但功能结果是合理的。到目前为止,我们尚未观察到重大并发症,但这是一个非常小的系列研究,我们提醒这是大型重建手术,肯定会有一些患者出现并发症。我们的方法采用精确的术前模拟和假体设计来辅助外科医生进行具有挑战性的手术。如果我们的早期结果能在更多患者中得到证实且随访时间更长,并在其他中心得到重复验证,那么这可能是髋臼周围恶性肿瘤患者的一种重建选择。

证据水平

IV级,治疗性研究。

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