背景:梯形掌骨(TMC)骨关节炎(OA)是拇指捏过程中疼痛和无力导致残疾的常见原因。对于无反应病例的最佳手术治疗尚无共识。治疗与成本相关,根据手术程序,手术后可能需要长达1年的时间才能恢复。尚未进行比较球窝TMC假体与带韧带重建的梯形切除术的随机对照试验。
方法:随机,失明,平行组优势临床试验,比较梯形切除术与长肌外展肌(APL)关节成形术和Maaía®假体假体置换。患者,18岁及以上,符合试验资格标准的临床诊断为单侧或双侧TMCOA将被邀请参加.诊断将由经验丰富的手外科医生根据症状做出,临床病史,体检,和补充成像测试。提供知情同意书的总共106名患者将被随机分配到APL关节成形术和使用Maia®假体进行假体置换的治疗中。参与者将完成不同的问卷,包括EuroQuol5D-5L(EQ-5D-5L),快速DASH,和基线时的患者额定腕部评估(PRWE),在6周,以及手术治疗后3、6、12、24、36、48和60个月。参加者将接受体检,运动范围评估,实力衡量每一次任命。试验的主要结果变量是从基线到12个月的视觉模拟量表(VAS)的变化。每年进行5年的长期随访分析,以评估慢性变化和假体生存率。这些费用将使用直接和间接医疗费用从提供者和社会的角度计算出来。
结论:这是第一个随机研究,调查了梯形切除术和韧带重建关节成形术和Maea假体的有效性和成本效用。我们希望这项试验的发现能够为TMCOA的手术方法带来新的见解。
背景:ClinicalTrials.govNCT04562753。2020年6月15日注册。
BACKGROUND: 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.
METHODS: 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.
CONCLUSIONS: 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.
BACKGROUND: ClinicalTrials.gov NCT04562753. Registered on June 15, 2020.