Department of Orthopaedics, Radboud University Medical Center, Radboud Institute for Health Sciences, Nijmegen, the Netherlands.
Department of Surgery, Radboud University Medical Center, Radboud Institute for Health Sciences, Nijmegen, the Netherlands.
Clin Orthop Relat Res. 2023 Jul 1;481(7):1373-1384. doi: 10.1097/CORR.0000000000002535. Epub 2023 Jan 6.
The most frequently occurring adverse events in individuals with a transfemoral amputation treated with a bone-anchored prosthesis are soft tissue infections and stoma-related complications. These soft tissue complications are believed to be influenced by surgical technique and implant design, but little is known about the effect of changes to treatment on these events.
QUESTIONS/PURPOSES: (1) What is the result of surgical technique and implant modifications on the incidence of soft tissue infections and stoma-related complications in transfemoral bone-anchored prosthesis users, depending on whether they had a conventional stoma and a cobalt-chrome-molybdenum (CoCrMo) osseointegration implant (treatment period 2009 to 2013) or a shallower stoma and titanium osseointegration implant (2015 to 2018)? (2) What is the incidence of serious complications, such as bone or implant infection, aseptic loosening, intramedullary stem breakage, and periprosthetic fracture?
Between 2009 and 2013, we performed osseointegration implant surgery using a conventional surgical technique and a CoCrMo implant in 42 individuals who had a lower extremity amputation experiencing socket-related problems that resulted in limited prosthesis use. We considered all individuals treated with two-stage surgery with a standard press-fit transfemoral osseointegration implant as potentially eligible for inclusion. Based on this, 100% (42) were eligible, and 5% (two of 42) were excluded because they did not provide informed consent, leaving 95% (40 of 42) for analysis. Between 2015 and 2018, we treated 79 individuals with similar indications with osseointegration implant surgery, now also treating individuals with dysvascular amputations. We used an adapted surgical technique resulting in a shallower stoma combined with a titanium implant. Using the same eligibility criteria as for the first group, 51% (40 of 79) were eligible; 49% (39 of 79) were excluded because they were treated with transtibial amputation, a patient-specific implant, or single-stage surgery and 1% (one of 79) were lost before the 2-year follow-up interval, leaving 49% (39 of 79) for analysis. The period of 2013 to 2015 was a transitional period and was excluded from analysis in this study to keep groups reasonably comparable and to compare a historical approach with the present approach. Hence, we presented a comparative study of two study groups (defined by surgical technique and implant design) with standardized 2-year follow-up. The risk factors for adverse events were similar between groups, although individuals treated with the shallow stoma surgical technique and titanium implant potentially possessed an increased risk because of the inclusion of individuals with dysvascular amputation and the discontinuation of prolonged postoperative antibiotic prophylaxis. Outcomes studied were soft tissue infections and stoma-related complications (hypergranulation or keloid formation as well as stoma redundant tissue) and bone or implant infection, aseptic loosening, implant stem breakage, periprosthetic fracture, and death.
Patients treated with the shallow stoma surgical technique and titanium implant experienced fewer soft tissue infections (13 versus 76 events, absolute risk 0.17 [95% CI 0.09 to 0.30] versus 0.93 [95% CI 0.60 to 1.45]; p < 0.01), which were treated with less invasive measures, and fewer stoma redundant tissue events (0 versus five events, absolute risk 0 versus 0.06 [95% CI 0.03 to 0.14]) than patients treated with the conventional stoma surgical technique and CoCrMo implant. This was contrasted by an increased incidence of surgical site infections occurring between surgical stages 1 and 2, when no stoma was yet created, after the implementation of treatment changes (conventional surgery and CoCrMo implant versus shallow stoma surgery and titanium implant: one versus 11 events, absolute risk 0.01 [95% CI 0.00 to 0.08] versus 0.14 [95% CI 0.08 to 0.25]; p = 0.02). Patients treated with the shallow stoma surgical technique and titanium implant did not experience serious complications, although bone infections occurred (six events in 8% [three of 40] of patients) in the conventional surgery and CoCrMo implant group, all of which were successfully treated with implant retention.
Adaptations to surgical technique and newer implant designs, as well as learning curve and experience, have resulted in a reduced incidence and severity of soft tissue infections and stoma redundant tissue, contrasted by an increase in surgical site infections before stoma creation. Serious complications such as deep implant infection were infrequent in this 2-year follow-up period. We believe the benefits of these treatment modifications outweigh the disadvantages and currently advise surgeons to create a shallower stoma with a stable soft tissue envelope, combined with a titanium implant.
Level III, therapeutic study.
接受骨锚定假体治疗的股骨截肢患者最常发生的不良事件是软组织感染和造口相关并发症。这些软组织并发症被认为受手术技术和植入物设计的影响，但对于治疗变化对这些事件的影响知之甚少。
问题/目的：（1）在接受股骨骨锚定假体的患者中，手术技术和植入物改良对软组织感染和造口相关并发症的发生率有何影响，这些患者是否有传统造口和钴铬钼（CoCrMo）骨整合植入物（治疗期为 2009 年至 2013 年）或较浅的造口和钛骨整合植入物（2015 年至 2018 年）？（2）严重并发症（如骨或植入物感染、无菌性松动、髓内干断裂和假体周围骨折）的发生率是多少？
2009 年至 2013 年，我们对 42 名因义肢使用相关问题导致有限义肢使用的下肢截肢患者进行了骨整合植入物手术，采用传统手术技术和 CoCrMo 植入物。我们认为所有接受二期标准压配合股骨骨整合植入物手术的患者都有潜在的纳入资格。基于此，100%（42 人）符合条件，5%（42 人中有 2 人）因未提供知情同意而被排除在外，95%（40 人中有 40 人）进行了分析。2015 年至 2018 年，我们对 79 名具有类似适应症的患者进行了骨整合植入物手术治疗，现在也治疗血管功能不良截肢患者。我们采用改良手术技术，导致造口较浅，并结合钛植入物。使用与第一组相同的资格标准，51%（79 人中有 40 人）符合条件；49%（79 人中有 39 人）因接受胫骨截肢、个体化植入物或一期手术而被排除，1%（79 人中有 1 人）在 2 年随访间隔前丢失，因此 49%（79 人中有 39 人）进行了分析。2013 年至 2015 年是过渡期，为保持组间可比性并比较历史方法与当前方法，本研究未对其进行分析。因此，我们对两组（定义为手术技术和植入物设计）进行了对比研究，两组均进行了标准化的 2 年随访。尽管接受浅造口手术技术和钛植入物治疗的患者可能因包括血管功能不良截肢患者和停止长期术后抗生素预防而存在更高的风险，但两组之间的不良事件风险因素相似。研究的结果是软组织感染和造口相关并发症（过度生长或瘢痕形成以及造口多余组织）和骨或植入物感染、无菌性松动、植入物干断裂、假体周围骨折和死亡。
接受浅造口手术技术和钛植入物治疗的患者发生软组织感染（13 例与 76 例事件，绝对风险 0.17 [95%CI 0.09 至 0.30]与 0.93 [95%CI 0.60 至 1.45]；p < 0.01）的次数较少，且治疗方式也较不侵入性，发生造口多余组织事件（0 例与 5 例事件，绝对风险 0 与 0.06 [95%CI 0.03 至 0.14]）的次数也较少，而接受传统造口手术技术和 CoCrMo 植入物治疗的患者则较多。与此形成对比的是，在实施治疗变化后（传统手术和 CoCrMo 植入物与浅造口手术和钛植入物），在手术阶段 1 和 2 之间发生手术部位感染的发生率增加，此时尚未创建造口，发生率为 1 例与 11 例事件，绝对风险 0.01 [95%CI 0.00 至 0.08]与 0.14 [95%CI 0.08 至 0.25]；p = 0.02）。接受浅造口手术技术和钛植入物治疗的患者未发生严重并发症，但在传统手术和 CoCrMo 植入物组中发生了 6 例（40 例患者中有 8%）骨感染，所有感染均通过保留植入物成功治疗。
手术技术和新型植入物设计的改进，以及学习曲线和经验，导致软组织感染和造口多余组织的发生率和严重程度降低，而在创建造口之前手术部位感染的发生率增加。在这 2 年的随访期间，严重并发症（如深部植入物感染）并不常见。我们认为这些治疗改变的好处超过了其缺点，目前建议外科医生创建一个较浅的、有稳定软组织包绕的造口，并结合钛植入物。
III 级，治疗性研究。
