Trapeziometacarpal (TMC) osteoarthritis (OA) is a common cause of pain and weakness during thumb pinch leading to disability. There is no consensus about the best surgical treatment in unresponsive cases. The treatment is associated with costs and the recovery may take up to 1 year after surgery depending on the procedure. No randomized controlled trials have been conducted comparing ball and socket TMC prosthesis to trapeziectomy with ligament reconstruction. A randomized, blinded, parallel-group superiority clinical trial comparing trapeziectomy with abductor pollicis longus (APL) arthroplasty and prosthetic replacement with Maïa® prosthesis. Patients, 18 years old and older, with a clinical diagnosis of unilateral or bilateral TMC OA who fulfill the trial’s eligibility criteria will be invited to participate. The diagnosis will be made by experienced hand surgeons based on symptoms, clinical history, physical examination, and complementary imaging tests. A total of 106 patients who provide informed consent will be randomly assigned to treatment with APL arthroplasty and prosthetic replacement with Maïa® prosthesis. The participants will complete different questionnaires including EuroQuol 5D-5L (EQ-5D-5L), the Quick DASH, and the Patient Rated Wrist Evaluation (PRWE) at baseline, at 6 weeks, and 3, 6, 12, 24, 36, 48, and 60 months after surgical treatment. The participants will undergo physical examination, range of motion assessment, and strength measure every appointment. The trial’s primary outcome variable is the change in the visual analog scale (VAS) from baseline to 12 months. A long-term follow-up analysis will be performed every year for 5 years to assess chronic changes and prosthesis survival rate. The costs will be calculated from the provider’s and society perspective using direct and indirect medical costs. This is the first randomized study that investigates the effectiveness and cost-utility of trapeziectomy and ligament reconstruction arthroplasty and Maïa prosthesis. We expect the findings from this trial to lead to new insights into the surgical approach to TMC OA. ClinicalTrials.gov NCT04562753. Registered on June 15, 2020.

中文翻译：

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球窝斜方掌骨假体与斜方切除术和韧带重建相比的成本效益和成本效用：随机对照临床试验的研究方案

斜方掌骨 (TMC) 骨关节炎 (OA) 是拇指挤压时疼痛和无力并导致残疾的常见原因。对于无反应病例的最佳手术治疗尚未达成共识。治疗费用较高，根据手术方式，术后恢复可能需要长达 1 年的时间。尚未进行比较球窝 TMC 假体与韧带重建梯形切除术的随机对照试验。一项随机、双盲、平行组优效性临床试验，比较了斜方肌切除术与拇长展肌 (APL) 关节置换术以及 Maïa® 假体置换术。临床诊断为单侧或双侧 TMC OA 且符合试验资格标准的 18 岁及以上患者将被邀请参加。诊断将由经验丰富的手外科医生根据症状、临床病史、体格检查和补充影像学检查做出。总共 106 名提供知情同意书的患者将被随机分配接受 APL 关节置换术和使用 Maïa® 假体置换的治疗。参与者将在基线、第 6 周以及第 3、6、12、24、36 周完成不同的问卷，包括 EuroQuol 5D-5L (EQ-5D-5L)、Quick DASH 和患者评分手腕评估 (PRWE)。手术治疗后48个月和60个月。参与者每次预约都将接受体检、运动范围评估和力量测量。该试验的主要结果变量是视觉模拟评分 (VAS) 从基线到 12 个月的变化。每年都会进行一次为期5年的长期跟踪分析，以评估慢性变化和假体存活率。费用将从提供者和社会的角度使用直接和间接医疗费用来计算。这是第一项调查梯形切除术和韧带重建关节成形术和 Maïa 假体的有效性和成本效益的随机研究。我们预计该试验的结果将为 TMC OA 的手术方法带来新的见解。 ClinicalTrials.gov NCT04562753。注册日期：2020年6月15日。