Division of Orthopedic Surgery, Oslo University Hospital, Oslo, Norway.
Institute of Clinical Medicine, University of Oslo, Oslo, Norway.
J Orthop Trauma. 2020 Nov;34(11):612-619. doi: 10.1097/BOT.0000000000001802.
To compare a modern ring fixator [Taylor Spatial Frame (TSF)] and reamed intramedullary nailing (IMN) for the treatment of closed tibial shaft fractures.
Randomized controlled trial.
Two university hospitals.
Patients between 18 and 70 years of age surgically treated for an acute tibial shaft fracture.
TSF (n = 31) versus a reamed intramedullary nail (n = 32). The patients were followed up for 2 years.
The physical component summary of Short Form 36 (SF-36) at 2 years was the primary outcome measure. Secondary outcomes included the other components of the SF-36, pain assessed by a visual analogue scale (VAS), complications, and resource consumption.
The mean age was 43 years (SD 14.0), and 42 (67%) were men. The physical component summary at 2 years was 52.4 (SD 6.3) in the TSF group and 53.3 (SD 8.0) in the IMN group (P = 0.35). There were modest differences in the other SF-36 scores during the follow-up period. Up to and including 12 months, the TSF group had less knee pain [at 12 months: VAS 0.5 (SD 1.2) vs. VAS 2.4 (SD 2.2; P < 0.001)], but this was not statistically significant at 24 months [VAS 0.7 (SD 1.4) vs. VAS 1.5 (SD 2.0; P = 0.11)]. Superficial skin infections were more frequent in the TSF group [22 (71%) vs. 4 (13%); P < 0.001]. The number of other complications was similar between the groups.
Both TSF and IMN provided good clinical results. TSF had more pin-track infections but less knee pain the first year.
Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.
比较现代环式固定器（Taylor Spatial Frame，TSF）与扩髓髓内钉（reamed intramedullary nailing，IMN）治疗闭合性胫骨骨干骨折的效果。
随机对照试验。
两所大学医院。
年龄 18-70 岁、接受急性胫骨骨干骨折手术治疗的患者。
TSF（n=31）组与扩髓髓内钉（n=32）组。患者随访 2 年。
2 年时的 36 项简短健康调查问卷（Short Form 36，SF-36）的生理成分综合评分是主要观察指标。次要观察指标包括 SF-36 的其他成分、视觉模拟评分（visual analogue scale，VAS）评估的疼痛、并发症和资源消耗。
平均年龄 43 岁（标准差 14.0），42 例（67%）为男性。TSF 组的 2 年时生理成分综合评分为 52.4（标准差 6.3）分，IMN 组为 53.3（标准差 8.0）分（P=0.35）。在随访期间，SF-36 的其他评分存在适度差异。在至 12 个月期间，TSF 组的膝关节疼痛较轻[12 个月时：VAS 0.5（标准差 1.2）分比 VAS 2.4（标准差 2.2；P＜0.001）]，但在 24 个月时无统计学差异[VAS 0.7（标准差 1.4）分比 VAS 1.5（标准差 2.0；P=0.11）]。TSF 组的浅表皮肤感染更为常见[22 例（71%）比 4 例（13%）；P＜0.001]。两组的其他并发症数量相似。
TSF 和 IMN 均能获得良好的临床效果。TSF 组的针道感染较多，但第 1 年的膝关节疼痛较轻。
治疗学Ⅰ级。欲了解完整的证据等级说明，请参见作者须知。
