Randomized trial of surgery vs. non-surgical management for pelvic fragility fractures

IF 2.2 3区医学 Q3 CRITICAL CARE MEDICINE

Injury-International Journal of the Care of the Injured Pub Date : 2025-05-31 DOI:10.1016/j.injury.2025.112462

Steven F. Shannon , John David Black , Richard S. Yoon , Ryan Michels , Michael Hadeed , Gillian Soles , Edward Westrick , Kristoff Reid , Daniel Cher , Robyn Capobianco , Douglas Dirschl

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引用次数: 0

Abstract

Objectives

Non-surgical management (NSM) of posterior pelvic fragility fractures (PFF) can lead to prolonged disability, morbidity, and death. Surgical management (SM) also has risks but has been reported to rapidly restore mobility. This study sought to compare improvement in mobility between NSM and SM in a prospective cohort of patients with PFF.

Methods

Design: Prospective, randomized controlled trial of SM vs NSM

Setting

Academic and community trauma centers

Patient Selection Criteria

PFF patients without significant cognitive impairment who are bedbound

Outcome measures and comparisons

The primary endpoint was time to regain two points on a modified functional mobility scale (MFMS). Secondary endpoints included PROMIS physical function and pain interference, Oswestry Disability Index (ODI), and numeric rating scale (NRS) pain score. A 12-month CT scan was performed in the SM group only.

Results

Enrollment was challenging despite modifying the study to include an observational cohort. 28 subjects were enrolled (age 78±9.8); 16 underwent SM and 12 received NSM. The primary endpoint occurred at a median of 10 days in the SM group and 16 days in the NSM group (p = .1). 100 % of SM and 83 % of NSM subjects achieved the primary endpoint by 6 weeks. Five subjects who received SM could be considered NSM failures; including these failed subjects in the NSM group widened the difference in primary endpoint success rates (100 % in SM vs. 48 % in NSM, p < 0001). Some trends in secondary outcome measures favored SM, but they did not reach statistical significance. There were no device- or procedure-related serious adverse events.

Conclusion

Despite enrollment challenges, consistent trends were observed to suggest that SM may be superior to NSM in patients with painful PFF. Key challenges in enrollment in geriatric fracture trials comparing NSM to SM were identified. It is conceivable that studies such as this may represent the most robust investigations possible in comparing SM to NSM in PFF.

Level of Evidence

II.

查看原文本刊更多论文

骨盆脆性骨折的手术与非手术治疗的随机试验

目的骨盆后脆性骨折（PFF）的非手术治疗（NSM）可导致长期残疾、发病率和死亡。手术治疗（SM）也有风险，但有报道称可以迅速恢复活动能力。本研究旨在比较在PFF患者的前瞻性队列中，NSM和SM对活动能力的改善。设计：SM与nsm2的前瞻性随机对照试验设置：学术和社区创伤中心患者选择标准：无明显认知障碍且卧床的apff患者结局测量和比较：主要终点是在改良功能活动量表（MFMS）上恢复2分的时间。次要终点包括PROMIS身体功能和疼痛干扰、Oswestry残疾指数（ODI）和数字评定量表（NRS）疼痛评分。仅SM组进行了12个月的CT扫描。结果：尽管对研究进行了修改，纳入了观察性队列，但队列研究仍具有挑战性。纳入28例受试者（年龄78±9.8岁）；16例行SM， 12例行NSM。主要终点发生在SM组的中位时间为10天，NSM组的中位时间为16天（p = 0.1）。100%的SM和83%的NSM患者在6周内达到了主要终点。5名接受SM的被试可视为NSM失败；将这些失败的受试者纳入NSM组扩大了主要终点成功率的差异(SM为100%，NSM为48%，p <；0001)。次要结果测量的一些趋势倾向于SM，但它们没有达到统计学意义。没有器械或手术相关的严重不良事件。结论：尽管存在入组挑战，但一致的趋势表明，在疼痛性PFF患者中，SM可能优于NSM。在老年骨折试验中比较NSM和SM的关键挑战被确定。可以想象，这样的研究可能代表了在PFF中比较SM和NSM的最有力的调查。证据水平

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Injury-International Journal of the Care of the Injured 医学-急救医学

CiteScore

4.00

自引率

8.00%

发文量

699

审稿时长

96 days

期刊介绍： Injury was founded in 1969 and is an international journal dealing with all aspects of trauma care and accident surgery. Our primary aim is to facilitate the exchange of ideas, techniques and information among all members of the trauma team.