Henley M B, Chapman J R, Agel J, Harvey E J, Whorton A M, Swiontkowski M F
Department of Orthopaedic Surgery, Harborview Medical Center, University of Washington, Seattle 98104, USA.
J Orthop Trauma. 1998 Jan;12(1):1-7. doi: 10.1097/00005131-199801000-00001.
To compare unreamed intramedullary nailing (IMN) with external fixation (EF) in patients with Type II, IIIA, and IIIB open fractures of the tibial shaft.
An inception cohort of consecutive patients with Type II, IIIA, and IIIB tibial fractures incurred between January 1988 and March 1993 were systematically allocated into one of two treatment groups. Patients were treated and followed with a prospectively designed protocol.
All patients were skeletally mature and had incurred a fracture of the tibial diaphysis within twenty-four hours of presentation to the tertiary care hospital, a Level I Trauma Center. One hundred seventy-four fractures in 168 patients were stabilized with either IMN (104) or half-pin EF (70). There were 132 men and thirty-six women, with an average age of thirty-three years (range, 14 to 77 years).
Except for the selection of the fixation device, open fracture care was similar in the two treatment groups. All patients underwent emergent irrigation and debridement with concomitant skeletal stabilization. Cephalosporin antibiotics were administered perioperatively for twenty-four to forty-eight hours. No wounds were closed primarily. Delayed primary closure, skin grafting, and/or myoplasty were performed between three and ten days after injury.
The main outcome measures were final fracture alignment, presence of infection or inflammation, hardware failure, time to union, and the number of operative procedures.
The IMN group had significantly fewer incidences of malalignment than did the EF group [8 vs. 31 percent; p = 0.00005; confidence interval (CI) = 0.18, 0.76] and had significantly fewer subsequent procedures (mean of 1.7 vs. mean of 2.7 per fracture; p = 0.001; CI = 0.45, 1.59). IMN resulted in fewer infections/ inflammatory problems than did EF at the injury site (13 vs. 21 percent; p = 0.73; CI = -0.63, 0.45) and significantly fewer at surgical interfaces (i.e., pin sites, nail and interlocking screw insertion sites; 2 vs. 50 percent; p = 0.000; CI = 0.39, 0.60). No significant difference was found in the healing rates for the two implant groups. The more severe Gustilo injury types had longer healing times regardless of the type of fixation.
Results suggest that unreamed interlocking intramedullary nails are more efficacious than half-pin external fixators, in particular with regard to maintenance of limb alignment. However, the severity of soft tissue injury rather than the choice of implant appears to be the predominant factor influencing rapidity of bone healing and rate of injury site infection.
比较非扩髓髓内钉(IMN)与外固定架(EF)治疗胫骨干Ⅱ型、ⅢA 型和ⅢB 型开放性骨折患者的疗效。
对1988年1月至1993年3月间连续发生的Ⅱ型、ⅢA 型和ⅢB 型胫骨骨折患者的初始队列进行系统分组,分为两个治疗组之一。患者按照前瞻性设计的方案进行治疗和随访。
所有患者骨骼发育成熟,在三级护理医院(一级创伤中心)就诊后24小时内发生胫骨干骨折。168例患者的174处骨折采用IMN(104例)或半针EF(70例)固定。男性132例,女性36例,平均年龄33岁(范围14至77岁)。
除固定装置的选择外,两个治疗组的开放性骨折处理相似。所有患者均接受急诊冲洗和清创并同时进行骨骼固定。围手术期给予头孢菌素抗生素24至48小时。伤口均未一期闭合。在受伤后3至10天进行延迟一期缝合、植皮和/或肌成形术。
主要观察指标为最终骨折对线情况、感染或炎症的存在、内固定失败、愈合时间以及手术次数。
IMN组骨折对线不良的发生率显著低于EF组[8%对31%;p = 0.00005;置信区间(CI)= 0.18,0.76],后续手术次数也显著较少(每处骨折平均1.7次对2.7次;p = 0.001;CI = 0.45,1.59)。IMN导致损伤部位的感染/炎症问题少于EF(13%对21%;p = 0.73;CI = -0.63,0.45),手术界面(即针道、髓内钉和交锁螺钉置入部位)的感染/炎症问题显著更少(2%对50%;p = 0.000;CI = 0.39, 0.60)。两个植入物组的愈合率无显著差异。无论固定类型如何,更严重的 Gustilo 损伤类型愈合时间更长。
结果表明,非扩髓交锁髓内钉比半针外固定架更有效,特别是在维持肢体对线方面。然而,软组织损伤的严重程度而非植入物的选择似乎是影响骨愈合速度和损伤部位感染率的主要因素。