What Are the Long-term Results of MUTARS(®) Modular Endoprostheses for Reconstruction of Tumor Resection of the Distal Femur and Proximal Tibia?
What Are the Long-term Results of MUTARS(®) Modular Endoprostheses for Reconstruction of Tumor Resection of the Distal Femur and Proximal Tibia?
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DOI：
10.1007/s11999-015-4644-8
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发表时间：
2017-03
影响因子：
4.2
通讯作者：
Dijkstra PD
中科院分区：
文献类型：
--
作者：
Bus MP;van de Sande MA;Fiocco M;Schaap GR;Bramer JA;Dijkstra PD
模块化内置假体通常用于重建骨肿瘤切除后股骨远端和胫骨近端的缺损。由于骨肉瘤的保肢手术相对较新，自 20 世纪 80 年代以来使用越来越频繁，因此关注此类假肢治疗原发性肿瘤的长期效果的研究很少。 (1) 在使用 MUTARS® 模块化内置假体进行膝关节周围肿瘤重建时，有多少比例的患者会出现机械并发症，哪些因素可能与机械故障相关？ (2) 有哪些非机械性并发症？ (3) 5 年、10 年和 15 年的种植体失败率是多少？ (4) 使用该假肢多久能保肢一次？ 1995 年至 2010 年间，内置假体是我们中心青少年和成人膝关节切除术后重建的首选方法。在此期间，我们为 105 名患者进行了 114 次 MUTARS® 膝关节置换术；没有使用其他内置假体系统。 4 名患者（105 名患者中的 4 名 [4%]）失访，留下 101 名患者的 110 处重建进行审查。使用反向Kaplan-Meier方法计算中位随访时间，等于8.9年（95%置信区间[CI]，8.0-9.7）。手术时的平均年龄为 36 岁（范围：13-82 岁）。主要诊断为骨肉瘤（n = 56 [55%]）、骨平滑肌肉瘤（n = 10 [10%]）和软骨肉瘤（n = 9 [9%]）。在我们研究的早期阶段，我们常规使用非骨水泥、无涂层种植体进行初次重建。后来，羟基磷灰石 (HA) 涂层植入物成为标准。 89 例重建（110 例中的 89 例 [81%]）为远端股骨置换（78 例未骨水泥[89 例中的 78 例{88%}，其中 42 例为 HA 涂层[78 例中的 42 例{54%}]），21 例（110 例中的 21 例[19%]）为近端胫骨置换。在 26 次重建中（110 次中的 26 次 [24%]），此次重建是针对之前失败的重建进行的。我们使用竞争风险模型来估计种植体失败的累积发生率。 7 次重建中出现了软组织或不稳定的并发症（110 次重建中的 7 次 [6%]）。根据我们掌握的数据，对于非骨水泥远端股骨置换，我们无法检测到翻修（17 例中的 5 例 [29%]）和初次重建（61 例中的 8 例 [13%]）之间松动的差异（风险比 [HR]，1.72；95% CI，0.55-5.38；p = 0.354）。与未涂层的非骨水泥种植体（36 个中的 11 个 [31%]）相比，羟基磷灰石涂层的非骨水泥种植体的松动风险较低（42 个中的 2 个 [5%]）（HR，0.23；95% CI，0.05–1.06；p = 0.060）。 15 例重建中出现结构性并发症（110 例中的 15 例 [14%]）。 14 次重建中发生感染（110 次重建中的 14 次 [13%]）。 10 名患者出现局部复发（101 名患者中的 10 名 [10%]）。以机械原因失败为终点，5年、10年和15年种植体失败的累积发生率分别为16.9%（95% CI，9.6-24.2）、20.7%（95% CI，12.5-28.8%）和37.9%（95% CI，16.1-59.7）。我们能够挽救一些失败，因此在随访时，90 名患者（101 名患者中的 90 名 [89%]）原位接受了 MUTARS®。尽管尚未证明任何系统能够理想地恢复正常功能并证明植入物的长期保留，但 MUTARS® 模块化内置假体代表了肿瘤切除后膝关节置换的可靠的长期选择，这似乎与外科医生可用的其他模块化植入物相当。尽管患者数量相对较少，但我们可以证明，使用这种假体，非骨水泥 HA 涂层种植体有助于实现持久固定。 IV级，治疗研究。
Modular endoprostheses are commonly used to reconstruct defects of the distal femur and proximal tibia after bone tumor resection. Because limb salvage surgery for bone sarcomas is relatively new, becoming more frequently used since the 1980s, studies focusing on the long-term results of such prostheses in treatment of primary tumors are scarce. (1) What proportion of patients experience a mechanical complication with the MUTARS® modular endoprosthesis when used for tumor reconstruction around the knee, and what factors may be associated with mechanical failure? (2) What are the nonmechanical complications? (3) What are the implant failure rates at 5, 10, and 15 years? (4) How often is limb salvage achieved using this prosthesis? Between 1995 and 2010, endoprostheses were the preferred method of reconstruction after resection of the knee in adolescents and adults in our centers. During that period, we performed 114 MUTARS® knee replacements in 105 patients; no other endoprosthetic systems were used. Four patients (four of 105 [4%]) were lost to followup, leaving 110 reconstructions in 101 patients for review. The reverse Kaplan-Meier method was used to calculate median followup, which was equal to 8.9 years (95% confidence interval [CI], 8.0–9.7). Mean age at surgery was 36 years (range, 13–82 years). Predominant diagnoses were osteosarcoma (n = 56 [55%]), leiomyosarcoma of bone (n = 10 [10%]), and chondrosarcoma (n = 9 [9%]). In the early period of our study, we routinely used uncemented uncoated implants for primary reconstructions. Later, hydroxyapatite (HA)-coated implants were the standard. Eighty-nine reconstructions (89 of 110 [81%]) were distal femoral replacements (78 uncemented [78 of 89 {88%}, 42 of which were HA-coated [42 of 78 {54%}]) and 21 (21 of 110 [19%]) were proximal tibial replacements. In 26 reconstructions (26 of 110 [24%]), the reconstruction was performed for a failed previous reconstruction. We used a competing risk model to estimate the cumulative incidence of implant failure. Complications of soft tissue or instability occurred in seven reconstructions (seven of 110 [6%]). With the numbers we had, for uncemented distal femoral replacements, we could not detect a difference in loosening between revision (five of 17 [29%]) and primary reconstructions (eight of 61 [13%]) (hazard ratio [HR], 1.72; 95% CI, 0.55–5.38; p = 0.354). Hydroxyapatite-coated uncemented implants had a lower risk of loosening (two of 42 [5%]) than uncoated uncemented implants (11 of 36 [31%]) (HR, 0.23; 95% CI, 0.05–1.06; p = 0.060). Structural complications occurred in 15 reconstructions (15 of 110 [14%]). Infections occurred in 14 reconstructions (14 of 110 [13%]). Ten patients had a local recurrence (10 of 101 [10%]). With failure for mechanical reasons as the endpoint, the cumulative incidences of implant failure at 5, 10, and 15 years were 16.9% (95% CI, 9.6–24.2), 20.7% (95% CI, 12.5–28.8%), and 37.9% (95% CI, 16.1–59.7), respectively. We were able to salvage some of the failures so that at followup, 90 patients (90 of 101 [89%]) had a MUTARS® in situ. Although no system has yet proved ideal to restore normal function and demonstrate long-term retention of the implant, MUTARS® modular endoprostheses represent a reliable long-term option for knee replacement after tumor resection, which seems to be comparable to other modular implants available to surgeons. Although the number of patients is relatively small, we could demonstrate that with this prosthesis, an uncemented HA-coated implant is useful in achieving durable fixation. Level IV, therapeutic study.