Ter Meulen Dirk P, Selles Caroline A, Kret Esther J, Kruiswijk Anouk A, Slichter Malou E, Colaris Joost W, Vochteloo Anne, Willems Hanna C, Kraan Gerald A, Goslings J Carel, Kleinlugtenbelt Ydo V, Willigenburg Nienke W, Schep Niels W L, Poolman Rudolf W
OLVG, Orthopedic Surgery Department, Amsterdam, the Netherlands.
Maasstad Hospital, Trauma Surgery Department, Rotterdam, the Netherlands.
JB JS Open Access. 2025 Sep 8;10(3). doi: 10.2106/JBJS.OA.25.00060. eCollection 2025 Jul-Sep.
Evidence supporting surgery in elderly patients with distal radius fractures is limited, but displaced fractures may benefit from surgery. This study aimed to determine whether casting is noninferior to surgery for patients aged 65 years or older with substantially displaced intra-articular (AO type C) distal radius fractures.
This multicenter randomized controlled noninferiority trial included 138 patients (mean age 76 years, SD 6.0) in 19 Dutch hospitals. 138 patients were randomized with a mean age of 76 years (SD 6.0). After 12 months, 126 patients (91%) completed the trial. All patients had a nonacceptable fracture position according to the guideline after reduction. Patients were randomized between casting and open reduction internal fixation (ORIF). The primary outcome was the Patient Rated Wrist Evaluation (PRWE) at the 1-year follow-up. Secondary outcomes included the Disability of the Arm, Shoulder, and Hand questionnaire; quality of life (measured by the EQ-5D-3L); range of motion; grip strength; and complications. Primary analyses were linear mixed models with an intention-to-treat approach.
The mean PRWE score at 1-year follow-up for the casting group was 20.4 (95% CI, 15.3-25.6) and in the surgical group was 14.5 (95% CI, 9.9-19.0). The primary intention-to-treat crude analysis was inconclusive regarding noninferiority, with a between-group difference of 6.0 points (95% CI, -2.1 to 14.1) in favor of surgery. However, noninferiority was demonstrated after correction for baseline covariates and in both as-treated analyses. The surgical group had better grip strength but significantly more reoperations (i.e., hardware removal). Subgroup analysis showed greater benefits of surgery in physiologically younger patients, while more frail patients had no advantage.
The primary analysis did not demonstrate noninferiority of casting compared with surgery at 1-year follow-up in patients aged 65 years or older with substantially displaced intra-articular distal radius fractures. The benefit of surgery was consistent across multiple outcomes, most notably in the short term and for physiologically younger patients.
RCT. Level I evidence. See Instructions for Authors for a complete description of levels of evidence.
支持老年桡骨远端骨折患者手术治疗的证据有限，但移位骨折可能从手术中获益。本研究旨在确定对于65岁及以上的严重移位关节内（AO C型）桡骨远端骨折患者，石膏固定是否不劣于手术治疗。
这项多中心随机对照非劣效性试验纳入了荷兰19家医院的138例患者（平均年龄76岁，标准差6.0）。138例患者被随机分组，平均年龄76岁（标准差6.0）。12个月后，126例患者（91%）完成了试验。根据复位后的指南，所有患者的骨折位置均不可接受。患者被随机分为石膏固定组和切开复位内固定（ORIF）组。主要结局是1年随访时的患者腕关节评估（PRWE）。次要结局包括手臂、肩部和手部残疾问卷；生活质量（采用EQ-5D-3L测量）；活动范围；握力；以及并发症。主要分析采用意向性分析的线性混合模型。
石膏固定组1年随访时的平均PRWE评分为20.4（95%CI，15.3 - 25.6），手术组为14.5（95%CI，9.9 - 19.0）。意向性分析的初步粗分析在非劣效性方面尚无定论，组间差异为6.0分（95%CI，-2.1至14.1），手术组占优。然而，在校正基线协变量后以及在两种实际治疗分析中均显示出非劣效性。手术组握力更好，但再次手术（即取出内固定物）显著更多。亚组分析显示，手术对生理上较年轻的患者益处更大，而身体更虚弱的患者则无优势。
在65岁及以上严重移位关节内桡骨远端骨折患者的1年随访中，初步分析未显示石膏固定不劣于手术治疗。手术的益处体现在多个结局中，最显著的是在短期内以及对生理上较年轻的患者。
随机对照试验。I级证据。有关证据水平的完整描述，请参阅作者须知。
