Thoma Achilleas, Levis Carolyn, Patel Pinkal, Murphy Jessica, Duku Eric
Division of Plastic Surgery, Department of Surgery, McMaster University, Hamilton, ON, Canada; Department of Health Research Methods, Evidence and Impact (HEI), McMaster University, Hamilton, ON, Canada; Michael G. DeGroote School of Medicine, McMaster University, Hamilton, ON, Canada; and Department of Psychiatry and Behavioral Neurosciences, McMaster University, Hamilton, ON, Canada.
Plast Reconstr Surg Glob Open. 2018 Mar 19;6(3):e1705. doi: 10.1097/GOX.0000000000001705. eCollection 2018 Mar.
There are numerous surgical techniques for the treatment of first carpometacarpal joint osteoarthritis, however, controversy exists as to whether outcomes differ between techniques. This feasibility study aimed to determine if a large-scale, health-related quality of life and functional outcomes study comparing 2 surgical techniques, complete trapeziectomy with ligament reconstruction and tendon interposition (T + LRTI) versus partial trapeziectomy and tendon interposition (PT + TI) arthroplasty, is possible.
Patients with advanced stage arthritis (Eaton stages II-IV) of the thumb were invited to undergo either T + LRTI or PT + TI at 1 of the 2 hand surgery practices. Feasibility outcomes included: (1) Process: recruitment rate; (2) Resources: eligibility rate, eligibility criteria, retention, and compliance rates (completion of health-related quality of life questionnaires, Disabilities of the Arm, Shoulder, and Hand, EuroQol-5D-3L, and SF-36, and functional measurements, grip, key pinch, and tip pinch strength, at 1-week preoperatively and 1, 3, 6, and 12 months postoperatively); (3) Management: determining the practices' commitment to the study; and (4) Scientific: calculation of the variances and treatment effect sizes (ES) of differences between procedures. Data from baseline measurements and 6-month follow-up were used for analysis.
Sixty patients were screened, of which 34 (57%) were eligible for surgery. Twenty-one (81%) of the 26 ineligible patients were excluded due to previous or additional planned surgical procedures on the same hand, particularly carpal tunnel release (n = 17). Twenty patients consented; 12 in the T + LRTI and 8 in the PT + TI group. The highest completion rate for the 3 questionnaires and the functional measurements, for both groups was at 6-month time point. Compliance rates for questionnaire completion at 6-months were calculated at 50% and 75% for the T + LRTI and PT + TI group, respectively. Functional measurement completion rate was 50% and 63% for T + LRTI and PT + TI groups, respectively. Treatment ES were group dependent, with Disabilities of the Arm, Shoulder, and Hand, EuroQol-5D-3L usual activities and anxiety/depression showing a large ES in the PT + TI group; the T + LRTI group showed large ES in EQ-5D state of health today.
Authors conclude that a large-scale study is feasible and dependent on: (1) increasing sample size to account for the high attrition rate; (2) liberalizing inclusion criteria to include patients with carpal tunnel syndrome; (3) allotting more time at follow-up visits to ensure completion of all measurements; and (4) increasing staff involvement (ie, develop rapport with patients and maintain stability with research assistants).
治疗第一腕掌关节骨关节炎有多种手术技术,然而,不同技术的治疗效果是否存在差异仍存在争议。本可行性研究旨在确定是否有可能开展一项大规模的、与健康相关的生活质量和功能结局研究,比较两种手术技术,即完全大多角骨切除术联合韧带重建及肌腱嵌入术(T + LRTI)与部分大多角骨切除术及肌腱嵌入术(PT + TI)关节成形术。
邀请拇指晚期关节炎(伊顿分期II-IV期)患者在两家手外科诊所中的一家接受T + LRTI或PT + TI手术。可行性结局包括:(1)过程:招募率;(2)资源:符合条件率、纳入标准、保留率和依从率(完成与健康相关的生活质量问卷、手臂、肩部和手部功能障碍问卷、欧洲五维健康量表-3L和简明健康调查问卷SF-36,以及功能测量,包括术前1周及术后1、3、6和12个月的握力、捏力和指尖捏力);(3)管理:确定诊所对研究的投入程度;(4)科学性:计算两种手术方法差异的方差和治疗效应量(ES)。使用基线测量数据和6个月随访数据进行分析。
共筛查60例患者,其中34例(57%)符合手术条件。26例不符合条件的患者中有21例(81%)因同一只手先前已进行或计划进行其他手术,尤其是腕管松解术(n = 17)而被排除。20例患者同意参与研究;T + LRTI组12例,PT + TI组8例。两组在6个月时间点时,3份问卷和功能测量的完成率最高。T + LRTI组和PT + TI组6个月时问卷完成的依从率分别为50%和75%。T + LRTI组和PT + TI组功能测量完成率分别为50%和63%。治疗效应量因组而异,手臂、肩部和手部功能障碍问卷、欧洲五维健康量表-3L的日常活动及焦虑/抑郁方面,PT + TI组显示出较大的效应量;T + LRTI组在欧洲五维健康量表的当前健康状况方面显示出较大的效应量。
作者得出结论,大规模研究是可行的,但取决于:(1)增加样本量以应对高损耗率;(2)放宽纳入标准以纳入腕管综合征患者;(3)在随访时安排更多时间以确保完成所有测量;(4)增加工作人员参与度(即与患者建立融洽关系并保持研究助理的稳定性)。