Department of Orthopaedic Surgery, Akershus University Hospital, Lørenskog, Norway.
University of Oslo, Oslo, Norway.
J Bone Joint Surg Am. 2019 Feb 20;101(4):311-321. doi: 10.2106/JBJS.18.00014.
The aim of the study was to compare the functional outcomes following fixation with a volar locking plate (VLP) with those outcomes after augmented external fixation (EF) of displaced, intra-articular distal radial fractures in patients 18 to 70 years of age.
Following inclusion, randomization, and surgery, clinical examination and outcome assessments were conducted at 6 weeks, 12 weeks, 6 months, 1 year, and 2 years. The primary outcome was the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) score, and secondary outcomes included wrist range of motion, grip strength, and pain assessed with a visual analog scale (VAS).
Over a span of 3 years, 166 patients were included in the study. The mean age was 55.0 years (standard deviation [SD] = 11.5 years), with the ages distributed evenly in each treatment group by block randomization (84 patients in the VLP group and 82 in the EF group). The patients in the VLP group had a significantly better mean QuickDASH score, range of motion, and grip strength at 6 weeks, 12 weeks, 6 months, and 1 year. There were no significant differences between the groups at 2 years. On the basis of the minimal clinically important difference, the difference in the QuickDASH score was clinically relevant only at 6 weeks and arguably at 3 months (9.2 and 8.5 points, respectively). Therefore, the statistically significant improvement in the functional outcome of VLP compared with that of EF cannot be safely said to have clinical relevance beyond 12 weeks. The overall complication rate was comparable between the 2 groups. The rate of follow-up at 2 years was 97.0%.
VLP fixation resulted in faster recovery of function compared with EF, but no functional advantage was demonstrated at 2 years.
Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.
本研究旨在比较 18 至 70 岁的患者中，关节内桡骨远端骨折的经掌侧锁定钢板（VLP）固定与增强型外固定（EF）后的功能结果。
纳入、随机分组和手术后，分别在 6 周、12 周、6 个月、1 年和 2 年进行临床检查和结果评估。主要结局指标是快速残疾的手臂、肩和手（QuickDASH）评分，次要结局指标包括腕关节活动范围、握力和视觉模拟量表（VAS）评估的疼痛。
在 3 年的时间跨度内，共有 166 名患者纳入研究。平均年龄为 55.0 岁（标准差[SD] = 11.5 岁），每组患者年龄分布均匀，采用分组随机分组（VLP 组 84 例，EF 组 82 例）。VLP 组患者在 6 周、12 周、6 个月和 1 年时的平均 QuickDASH 评分、活动范围和握力均显著更好。两组在 2 年时无显著差异。基于最小临床重要差异，QuickDASH 评分的差异仅在 6 周和 3 个月时具有临床意义（分别为 9.2 和 8.5 分）。因此，与 EF 相比，VLP 功能结果的统计学显著改善不能被安全地认为在 12 周后具有临床意义。两组总体并发症发生率相当。2 年的随访率为 97.0%。
VLP 固定比 EF 固定更快地恢复功能，但在 2 年时没有表现出功能优势。
治疗水平 I. 有关证据水平的完整说明，请参见作者说明。
