Section of Plastic Surgery, Department of Surgery, University of Michigan Medical School, Ann Arbor.
Michigan Medicine Comprehensive Hand Center, University of Michigan, Ann Arbor.
JAMA Netw Open. 2021 Jun 1;4(6):e2112710. doi: 10.1001/jamanetworkopen.2021.12710.
Distal radius fractures (DRFs) are common injuries among older adults and can result in substantial disability. Current evidence regarding long-term outcomes in older adults is scarce.
To compare outcomes across treatment groups at 24 months among adults with DRFs who participated in the WRIST trial.
DESIGN, SETTING, AND PARTICIPANTS: The Wrist and Radius Injury Surgical Trial (WRIST) randomized, international, multicenter trial was conducted from April 1, 2012, through December 31, 2016. Participants were adults aged 60 years or older with isolated, unstable DRFs at 24 health systems in the US, Canada, and Singapore. Data analysis was performed from March 2019 to March 2021.
Participants were randomized to open reduction and volar locking plate system (VLPS), external fixation with or without supplementary pinning (EFP), and percutaneous pinning (CRPP). The remaining participants chose closed reduction and casting.
The primary outcome was the 24-month Michigan Hand Outcomes Questionnaire (MHQ) summary score. Secondary outcomes were scores on the MHQ subdomains hand strength and wrist motion.
A total of 304 adults were recruited for the study, and 187 were randomized to undergo surgery, 65 to VLPS, 64 to EFP, and 58 to CRPP; 117 participants opted for closed reduction and casting. Assessments were completed at 24 months for 182 participants (160 women [87.9%]; mean [SD] age, 70.1 [8.5] years). Mean MHQ summary scores at 24 months were 88 (95% CI, 83-92) for VLPS, 83 (95% CI, 78-88) for EFP, 85 (95% CI, 79-90) for CRPP, and 85 (95% CI, 79-90) for casting, with no clinically meaningful difference across groups after adjusting for covariates (χ23 = 1.44; P = .70). Pain scores also did not differ across groups at 24 months (χ23 = 2.64; P = .45). MHQ summary scores changed from 82 (95% CI, 80-85) to 85 (95% CI, 83-88) (P = .12) between 12 and 24 months across groups. The rate of malunion was higher in the casting group (26 participants [59.1%]) than in the other groups (4 participants [8.0%] for VLPS, 8 participants [17.0%] for EFP, and 4 participants [9.8%] for CRPP; χ23 = 43.6; P < .001), but malunion was not associated with the 24-month outcome difference across groups.
The study did not find clinically meaningful patient-reported outcome differences 24 months after injury across treatment groups, with little change between 12 and 24 months. These findings suggest that long-term outcomes need not necessarily be considered in deciding between treatment options. Patient needs and recovery goals that fit to relative risks and benefits of each treatment type will be more valuable in treatment decision-making.
ClinicalTrials.gov Identifier: NCT01589692.
桡骨远端骨折(DRF)在老年人中很常见,可导致严重残疾。目前关于老年人长期结果的证据很少。
比较 WRIST 试验中桡骨远端骨折成人在 24 个月时各治疗组的结果。
设计、地点和参与者:腕关节和桡骨损伤手术试验(WRIST)是一项国际性的、多中心的随机试验,于 2012 年 4 月 1 日至 2016 年 12 月 31 日在 24 个美国、加拿大和新加坡的卫生系统中进行。参与者为年龄在 60 岁或以上、24 健康系统中有孤立性、不稳定 DRF 的成年人。数据分析于 2019 年 3 月至 2021 年 3 月进行。
参与者被随机分为切开复位掌侧锁定钢板系统(VLPS)、带或不带附加销钉的外固定(EFP)和经皮销钉(CRPP)组,其余参与者选择闭合复位和石膏固定。
主要结果是 24 个月密歇根手部结果问卷(MHQ)综合评分。次要结果是 MHQ 子域手强度和腕部运动的评分。
共有 304 名成年人参加了这项研究,其中 187 名被随机分配接受手术治疗,65 名接受 VLPS,64 名接受 EFP,58 名接受 CRPP,117 名选择闭合复位和石膏固定。182 名参与者在 24 个月时完成了评估(160 名女性[87.9%];平均[SD]年龄,70.1[8.5]岁)。VLPS、EFP、CRPP 和石膏固定的 24 个月 MHQ 综合评分分别为 88(95%CI,83-92)、83(95%CI,78-88)、85(95%CI,79-90)和 85(95%CI,79-90),在调整协变量后,各组之间没有临床意义上的差异(χ23=1.44;P=0.70)。24 个月时各组疼痛评分也无差异(χ23=2.64;P=0.45)。MHQ 综合评分从 12 个月时的 82(95%CI,80-85)到 24 个月时的 85(95%CI,83-88)(P=0.12),各组之间有所变化。石膏固定组的畸形愈合率较高(26 名参与者[59.1%]),明显高于其他组(VLPS 组 4 名参与者[8.0%],EFP 组 8 名参与者[17.0%],CRPP 组 4 名参与者[9.8%];χ23=43.6;P<0.001),但畸形愈合与各组 24 个月的结果差异无关。
研究未发现受伤后 24 个月各治疗组患者报告的结果有临床意义上的差异,12 至 24 个月之间的差异很小。这些发现表明,在决定治疗方案时不必考虑长期结果。患者的需求和符合每种治疗类型相对风险和益处的康复目标将在治疗决策中更有价值。
ClinicalTrials.gov 标识符:NCT01589692。