背景:手术部位感染(SSI)是骨科植入后的常见并发症。我们开发了一种用于钛植入物的碘涂层,以减少植入物相关的感染,并进行了一项前瞻性临床研究,以评估碘支持植入物的疗效和潜在缺点。
方法:2008年7月至2017年7月,653例患者(男性377例,女性27例;平均年龄,48.6)术后感染或受损状态的患者使用负载碘的钛植入物进行治疗。平均随访期为41.7个月。在477名患者中,碘支持的植入物用于预防感染,176名患者,治疗活动性感染(一期手术,89例患者;两阶段手术,87名患者)。在四肢和骨盆,主要诊断包括:161个肿瘤,92畸形/缩短,47假关节,42处骨折,32感染TKA,25骨关节炎,21化脓性关节炎,20个感染的THA,和6骨髓炎。在脊柱病例中,有136例肿瘤,化脓性脊柱炎36例,变性35例。确定了植入物失败的五种模式,并将其分类如下:软组织失败(类型1),无菌性松动(2型),结构失效(类型3),感染(4型),和肿瘤进展(5型)。
结果:我们系列的总体失败率为26.3%(172/653)。有101个机械故障,其中1型故障22例,2型故障20例,3型故障59例。非机械原因占71个故障,包括45个4型和26个5型故障。感染的总发生率为6.8%。植入后的平均感染时间为9.1个月。预防病例的总感染率为3.7%,治疗病例的总感染率为15.3%。一期置换(14.6%)和二期置换(16.0%)无差异。脊柱外科SSI治疗11例,使用碘涂层仪器的再感染率为0%。
结论:与以前的报道相比,碘支持的植入物的五种失败模式令人满意。特别是,因为与其他方法相比,用于受损宿主的碘涂层植入物的感染率较低,术后感染更容易控制。对于需要一期翻修手术的脊柱感染,它可以被认为是非常有效的。
方法:试验注册前瞻性,观察研究。
BACKGROUND: Surgical site infection (SSI) is a common complication following orthopedic implantation. We developed an iodine coating for titanium implants to reduce implant-related infections and conducted a prospective clinical study to evaluate the efficacy and potential drawbacks of iodine-supported implants.
METHODS: Between July 2008 and July 2017, 653 patients (377 male and 27 female patients; mean age, 48.6) with postoperative infection or a compromised status were treated using iodine-loaded titanium implants. The mean follow-up period was 41.7 months. In 477 patients, iodine-supported implants were used to prevent infection and in 176 patients, to treat active infection (one-stage surgery, 89 patients; two-stage surgery, 87 patients). In the limbs and pelvis, the primary diagnoses included the following: 161 tumors, 92 deformities/shortening, 47 pseudarthrosis, 42 fractures, 32 infected TKA, 25 osteoarthritis, 21 pyogenic arthritis, 20 infected THA, and 6 osteomyelitis. In the spinal cases, there were 136 cases of tumors, 36 cases of pyogenic spondylitis, and 35 cases of degeneration. Five modes of implant failure were identified and classified as follows: soft tissue failure (type 1), aseptic loosening (type 2), structural failure (type 3), infection (type 4), and tumor progression (type 5).
RESULTS: The overall failure rate in our series was 26.3% (172/653). There were 101 mechanical failures, including 22 type 1, 20 type 2, and 59 type 3 failures. Non-mechanical causes accounted for 71 failures, including 45 type 4 and 26 type 5 failures. The overall incidence of infections was 6.8%. The mean time to the onset of infection after implantation was 9.1 months. The overall infection rate was 3.7% in the prevention cases and 15.3% in the treatment cases. There was no difference between one-stage replacement (14.6%) and two-stage replacement (16.0%). There were 11 cases of treatment for SSI of spine surgery, and the re-infection rate was 0% using iodine-coated instruments.
CONCLUSIONS: The five modes of failure of the iodine-supported implant were satisfactory compared with previous reports. In particular, because the infection rate of iodine-coated implants used for compromised hosts is low compared with other methods, postoperative infection is more easily controlled. It can be considered highly effective for spinal infections that require one-stage revision surgery.
METHODS: Trial registration Prospective, Observation study.