de la Caffinière J Y
Service de Chirurgie Orthopédique et Traumatologique, Hôpital Delafontaine, Saint-Denis.
Rev Chir Orthop Reparatrice Appar Mot. 1997;83(4):343-53.
This clinical study aimed specifically to evaluate the role of flexibility in aseptic consolidation of unstable tibial fractures on compact bones. The device employed was made of intramedular nails placed separately and locked together using an original proximal system.
125 unstable compact bone fractures of the tibial shaft were treated by this method for almost 6 years. 110 cases were included in this study. 30 per cent of the fractures were open. The topographical breakdown of fracture sites on the diaphysis was 6 times, in the upper third (Sector I), 23 times in Sector II and 66 times in the lower third (Sector III). In 13 cases, there were sequential fractures of which the upper site was in Sector I. 57 cases were simple sites (A), 27 were sites with edges greater than 50 per 100 of the diaphyseal circumference (B), and 26 per 100 of comminuted sites (C). The distance measured in the fracture sites after osteosynthesis were 66 times within 3 mm, 24 cases from 4 to 10 mm, 12 cases from 11 to 15 mm, and 8 cases over 16 mm.
110 cases were followed for more than 6 months. Consolidation was established on standard clinical and radiological criteria. The value of parameters affecting consolidation and the time period recorded were validated by a precise statistical evaluation using Stat. View II software, and Fisher and Yates tables.
Complications due to implants were rare and minor. There were only 4 cases of nonunion resulting from secondary desaxation of two pins apparatus. 16 cases of nonunion (14.5 per 100) were recorded but 3 were forseeable nonunions, because of a traumatic bone loss. 8 cases were Sector I fractures of which 7 were Sector I unsequental fractures. 7 cases had a gap of 10 to 15 mm, and 5 of 16 to 20 mm. Thus 42.1 per 100 of cases in Sector I were not consolidated compared to only 6.1 per 100 of cases in Sector III. Primary consolidation of the 94 cases was achieved in an average of 11.08 +/- 3.19 weeks (minimum 6 weeks, maximum 20 weeks). Time for consolidation did not appear to be affected by anatomical type, opened fracture (degree 1 or 2) nor number of nails used. But, there were significant differences according to topography and postoperative gap at the fracture site. Sector II fractures took 15 days less than Sector I fracture: average 10.5 as compared to 12.6 weeks. The cases with a gap of 0 to 3 mm consolidated at an average of 10.6 weeks, those with 4 to 10 mm: 11.39 weeks, with a gap of 11 to 15 mm: 14.4 weeks, and the cases superior to 16 mm: 14.8 weeks.
Compared to the interlocking nail, this procedure gave an average shortening of consolidation delay of 1 month for closed and degree 1 and 2 open fractures. This rapidity of consolidation can only be explained by the flexibility parameter. Thus it is only the flexibility of the device which can explain that even with a gap of 11 to 15 mm left within the fracture site, consolidation occurred 1 time out of 2 and 9 times out of 10 when the gap was 4 to 10 mm. Finally, this mechanical parameter can explain that consolidation is by far the shortest for low fractures although these are reputed to be the least osteogenic.
本临床研究旨在专门评估柔韧性在不稳定胫骨骨折密质骨无菌性愈合中的作用。所采用的装置由分别置入的髓内钉组成，并使用一种原始的近端系统锁定在一起。
采用该方法治疗125例胫骨干不稳定密质骨骨折近6年。本研究纳入110例。30%的骨折为开放性骨折。骨干骨折部位的解剖分布为：上三分之一（I区）6次，II区23次，下三分之一（III区）66次。13例为连续性骨折，其中上位骨折部位在I区。57例为简单骨折部位（A），27例为骨折边缘大于骨干周径50%的部位（B），26例为粉碎性骨折部位（C）。骨合成后骨折部位测量的距离在3mm以内的有66例，4至10mm的有24例，11至15mm的有12例，超过16mm的有8例。
对110例患者进行了6个月以上的随访。根据标准的临床和放射学标准确定骨折愈合情况。使用Stat.View II软件以及费舍尔和耶茨表，通过精确的统计评估对影响骨折愈合的参数值和记录的时间段进行了验证。
植入物引起的并发症罕见且轻微。仅4例骨不连是由于双钉装置继发脱钉所致。记录到16例骨不连（每100例中有14.5例），但3例为可预见的骨不连，原因是创伤性骨丢失。8例为I区骨折，其中7例为I区非连续性骨折。7例骨折间隙为10至15mm, 16例中有5例间隙为16至20mm。因此，I区每100例中有4
