Burden Eleanor G, Batten Timothy John, Thomas William, Evans Jonathan P, Smith Christopher
Royal Devon University Healthcare NHS Foundation Trust, Exeter, UK.
Gloucestershire Hospitals NHS Foundation Trust, Gloucester, UK.
Shoulder Elbow. 2025 Apr;17(2):200-208. doi: 10.1177/17585732241244722. Epub 2024 Apr 17.
This feasibility trial aims to assess the practicality of, and obtain preliminary data to inform, a definitive randomised controlled trial (RCT) of total elbow arthroplasty (TEA) versus distal humeral hemiarthroplasty (HA) in patients over the age of 65 years with unreconstructible distal humeral fractures (DHF). 17 patients met the inclusion criteria during the 18-month recruitment period from December 2020 until June 2022, and 15 (88%) consented to be randomised (recruitment rate: 0.7/month). Two patients withdrew from the study prior to surgery leaving 13 patients for analysis (retention rate: 87%). Seven patients were randomised to TEA and six patients to HA. 100% of patients were available for 12-month follow-up. A 10-point difference in favour of HA in DASH (44.5 vs. 54.2) and OES (31.6 vs. 21.3) was seen during 6-week follow-up, while no difference in patient-reported outcome measures was seen at 3- or 12-month follow-up. This study demonstrates feasibility of undertaking an RCT of TEA versus HA in patients over the age of 65 with unreconstructible DHF. Preliminary data corroborate with the ongoing clinical equipoise and support the requirement for a larger adequately powered RCT. This trial is registered in the US Clinical Trials Registry (https://clinicaltrials.gov/study/NCT04646798?cond=distal%20humeral%20fracture&rank=6) Clinical Trial ID: NCT04646798.
这项可行性试验旨在评估在65岁以上不可重建的肱骨远端骨折（DHF）患者中进行全肘关节置换术（TEA）与肱骨远端半关节置换术（HA）的确定性随机对照试验（RCT）的实用性，并获取初步数据以提供参考。在2020年12月至2022年6月的18个月招募期内，17例患者符合纳入标准，其中15例（88%）同意随机分组（招募率：0.7例/月）。两名患者在手术前退出研究，剩余13例患者进行分析（保留率：87%）。7例患者被随机分配至TEA组，6例患者被随机分配至HA组。100%的患者可进行12个月的随访。在6周随访时，DASH评分（44.5对54.2）和OES评分（31.6对21.3）显示HA组有10分的优势，而在3个月或12个月随访时，患者报告的结局指标未见差异。本研究证明了在65岁以上不可重建DHF患者中进行TEA与HA的RCT的可行性。初步数据与目前的临床平衡相符，并支持进行一项更大规模、有足够效力的RCT的必要性。本试验已在美国临床试验注册中心注册（https://clinicaltrials.gov/study/NCT04646798?cond=distal%20humeral%20fracture&rank=6），临床试验编号：NCT04646798。
