Clinical Trial to Estimate the Efficacy, Safety and Cost-utility of the Trapezium-Metacarpal (TMC) Prosthesis Compared to Suspensionplasty.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- Change in Pain, pre- to post-operatively, as measured by a standard visual analogue score (VAS) diagram to grade perceived pain
研究概览
简要总结
The main objective of the study is to evaluate the efficacy, safety and cost-utility of the Trapezium-Metacarpal (TMC) prosthesis against Suspensionplasty with Abductor Pollicis Longus (APL) for the treatment of patients with first carpometacarpal (CMC) joint osteoarthritis (OA). Patients will be allocated to one of these two groups:
- Maïa® TMC prosthesis (Groupe Lépine TM).
- APL Supensionplasty
We will collect patient data using the questionnaires administeredat baseline and after the treatment. The primary outcome will be pain measured by visual analogue scale (VAS) and secondary outcomes will include health-related quality of life measured by EuroQuol 5D questionnaire,
详细描述
First Carpometacarpal joint osteoarthritis (CMC-OA) is a common problem, being the second location of degenerative osteoarthritis in the hand. The pain, weakness, and swelling cause considerable interference in the activities of daily living, especially in activities that involve repetitive fist-clamp movements.
The conservative treatment available (pain killers, physiotherapy and splints) do not always manage to achieve complete remission of the symptoms or prevent its recurrence. There are several surgical techniques to treat osteoarthritis of the first CMC. The most common surgical treatments used are prosthetic joint replacement and trapeziectomy. The later can be done as an isolated procedure or associated with tendon interposition, ligament reconstruction or both. The preference for indication for one treatment or another is based on personal experience rather than on the available studies, which are highly heterogeneous.
In addition, the direct and indirect costs (those associated with productivity losses as a result of sick leave from the perspective of society) associated with the use of a CMC prosthesis remain unknown, with the shorter recovery time being one of the reasons for its implantation.
The main objective of the study is to determine whether the trapeziometacarpal prosthesis is more effective, safe and cost-effective than suspension suspensionplasty. The secondary objective is to evaluate the functional outcome and estimate the indirect costs and the incremental cost-effectiveness and cost-utility (efficiency) ratios of the trapeziometacarpal prosthesis with respect to suspensionplasty as a treatment for osteoarthritis of the basal thumb joint.
The primary outcome will be measured using the Visual Analogue Scale (VAS). Secondary outcomes will include Quick-DASH and health-related quality of life measured using the European Quality of Life-5 Dimensions Questionnaire (EQ-5D) and. In addition, we will collect direct and indirect costs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals aged 18 or older.
- •Diagnosis of First CMC OA.
- •Non-responses to conservative treatment.
- •Eaton Stage 2-3
- •Physical and cognitive aptitudes to understand and give written informed consent.
排除标准
- •Comorbidity with other medical conditions which would affect the hand (Carpal Tunnel Syndrome, De Quervain Tenosynovitis, Trigger Finger)
- •Rheumatoid Arthritis
- •Previous surgery in the same hand.
- •Rejection to participate
结局指标
主要结局
Change in Pain, pre- to post-operatively, as measured by a standard visual analogue score (VAS) diagram to grade perceived pain
时间窗: Baseline, 3 weeks after surgery, 6 weeks after surgery, 3 months after surgery, 6 months, 1 year after surgery, 2 years after surgery
The standard VAS diagram is a scale from 0 to 10 where 0 indicates No Pain (smiling face), and 10 indicates Worst possible, unbearable, excruciating pain (crying face).
次要结局
- 3 Change in Patient-Reported Function as measured by the short form Disabilities of the Arm, Shoulder, and Hand (QuickDASH) questionnaire, within and between procedure cohorts(Baseline, 3 weeks after surgery, 6 weeks after surgery, 3 months after surgery, 6 months, 1 year after surgery, 2 years after surgery)
- Direct and Indirect Costs(Baseline, 3 weeks after surgery, 6 weeks after surgery, 3 months after surgery, 6 months, 1 year after surgery, 2 years after surgery)
- Health-related quality of life questionnaire Euro-Quol 5D (EQ-5D)(Baseline, 3 weeks after surgery, 6 weeks after surgery, 3 months after surgery, 6 months, 1 year after surgery, 2 years after surgery)
- Change in pre-operative pinch and grip strength as measured by kilograms of pressure.(Baseline, 3 weeks after surgery, 6 weeks after surgery, 3 months after surgery, 6 months, 1 year after surgery, 2 years after surgery)