Maharjan Rajiv, Shrestha Bikram Prasad, Chaudhary Pashupati, Rijal Raju, Shah Kalawar Rosan Prasad
Department of Orthopedics, BP Koirala Institute of Health Sciences, Dharan - 56700, Koshi, Nepal.
J Clin Orthop Trauma. 2021 Jan;12(1):148-160. doi: 10.1016/j.jcot.2020.07.006. Epub 2020 Aug 1.
Trauma related disabilities disproportionately affects low and middle income countries due to lack of resources, skills and optimal implants. Despite adequate animal studies, biomechanical studies, cohort studies and comparison studies we are not aware of any randomized trial to compare the functional outcome of SIGN (Surgical Implant Generation Network, US) solid nailing with a hollow nailing for tibial shaft fracture.
Sixty patients (≥16 years) of closed and Gustilo grade I traumatic fractures of the leg were randomized into SIGN solid nailing or hollow nailing group. Cases with compromised soft tissue and grossly deformed medullary canal were excluded. Functional outcome and need for resurgery were the primary outcomes while the secondary outcomes were duration of surgery, intraoperative blood loss, overall pain (VAS), radiological union (RUST), surgery related complications (infection, malalignment, shortening, nonunion) and pain/range of motion (ROM) of knee/ankle. All SIGN surgery related data were entered and retrieved online from www.signsurgery.org.
The demographical parameters were symmetrically distributed between the groups (p > 0.05). 2 cases in SIGN nailing and 4 cases in hollow nailing needed open reduction. The functional outcome, as assessed by blinded physiotherapist using Johner and Wruh criteria, was excellent in 18 (62.06%), good in 6 (20.68%), fair in 3 (10.34%) and poor in 2 (6.89%) for SIGN nail whereas it was 16 (57.14%), 8 (28.57%), 3 (10.71%) and 1 (3.57%) respectively for hollow nail. There was 1 case of implant failure and 1 case of infection. Intraoperative blood loss (397 ± 94.47 ml versus 350 ± 75.43 ml, p = 0.037) and duration of surgery (94.8 ± 14.57 min versus 82.0 ± 12.36 min, p = 0.001) were significantly more in hollow nailing group. At final follow up, overall pain on weight bearing (VAS score) and radiological union (RUST score) were 2.1 and 11.7 for SIGN nailing while they were 2.7 and 11.3 respectively for hollow nailing.(p = 0.41 and 0.45 respectively) The malrotation (p = 1.000), shortening (p = 1.000), varus-valgus angulation (p = 0.511), AP angulation (p = 0.706), ROM ankle (p = 0.239) and ROM knee (p = 0.086) were similar.
Solid SIGN nailing gives comparable functional outcome as conventional hollow nailing for tibia shaft fracture. For developing world with limited resources, SIGN nail is useful which is supplied freely and is designed to be used without image intensifier and fracture table.
由于缺乏资源、技术和理想的植入物，创伤相关残疾对低收入和中等收入国家的影响尤为严重。尽管有充分的动物研究、生物力学研究、队列研究和比较研究，但我们尚未发现有任何随机试验来比较SIGN（美国外科植入物生成网络）实心髓内钉与空心髓内钉治疗胫骨干骨折的功能结局。
60例（≥16岁）闭合性和Gustilo I级腿部创伤性骨折患者被随机分为SIGN实心髓内钉组或空心髓内钉组。排除软组织受损和髓腔严重变形的病例。功能结局和再次手术需求为主要结局，而次要结局包括手术时间、术中失血量、总体疼痛（视觉模拟评分法）、影像学骨愈合（放射学联合评分法）、手术相关并发症（感染、畸形、短缩、骨不连）以及膝关节/踝关节的疼痛/活动范围。所有与SIGN手术相关的数据均从www.signsurgery.org在线录入和检索。
两组间人口统计学参数分布对称（p>0.05）。SIGN髓内钉组有2例、空心髓内钉组有4例需要切开复位。采用Johner和Wruh标准，由盲法物理治疗师评估的功能结局，SIGN髓内钉组优18例（62.06%）、良6例（20.68%）、可3例（10.34%）、差2例（6.89%）；空心髓内钉组分别为16例（57.14%）、8例（28.57%）、3例（10.71%）和1例（3.57%）。有1例植入物失败和1例感染。空心髓内钉组术中失血量（397±94.47ml对350±75.43ml，p=0.037）和手术时间（94.8±14.57分钟对82.0±12.36分钟，p=0.001）明显更多。末次随访时，SIGN髓内钉组负重时总体疼痛（视觉模拟评分）和影像学骨愈合（放射学联合评分）分别为2.1和11.7，空心髓内钉组分别为2.7和11.3（p分别为0.41和0.45）。旋转畸形（p=1.000）、短缩（p=1.000）、内外翻成角（p=0.511）、前后成角（p=0.706）、踝关节活动范围（p=0.239）和膝关节活动范围（p=0.086）相似。
SIGN实心髓内钉治疗胫骨干骨折的功能结局与传统空心髓内钉相当。对于资源有限的发展中国家，SIGN髓内钉很有用，它免费供应且设计为无需影像增强器和骨折手术台即可使用。
