Trapezio-metacarpal Arthroplasty: Comparison of ARPE Prosthesis With the Literature.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Key Pinch Strength
研究概览
简要总结
This study is designed to document the objective and subjective measurements after trapeziometacarpal athroplasty with ARPE prosthesis and to compare those to literature values of outcome after trapeziectomy and trapeziectomy with ligament reconstruction and tendon interposition (LRTI), as published in a recent meta-analysis.
详细描述
The primary objective is to compare functional outcome at 3 years after trapezio-metarcarpal arthroplasty with trapeziectomy and trapeziectomy with ligament reconstruction and tendon interposition. Literature values obtained by a recently published meta analysis will be used.
The secondary objectives are:
- to compare functional outcome at 1 and at 5 years after trapezio-metarcarpal arthroplasty with trapeziectomy and trapeziectomy with ligament reconstruction and tendon interposition
- to determine pre- and post-operative HR QOL
- Incidence of radiolucencies at each follow up time point. Literature values from the same meta analysis will be used,
Patients will be assessed at preoperatively, and at 1, 3 and 5 years postoperatively. Measured Outcomes: grip strength, tip pinch strength, key pinch strength, pain, occurrence of adverse events, hand function.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •patients with trapezio-metacarpal arthritis Eaton Stage of trapezio-metacarpal arthritis: Stage II - IV
- •patients willing to return for follow up evaluation.
排除标准
- •local or systemic infections
- •severe muscular, neurological or vascular deficiencies of the extremity involved
- •bone destruction or poor bone to affect implant stability
- •allergy to any of the components of the implant
结局指标
主要结局
Key Pinch Strength
时间窗: Pre-operative, 1, 3 and 5 years follow-up
Key pinch strength is an indicator of muscle health and measures the precision grip by using a pinch dynamometer. The device is placed between the radial side of the index finger and thumb and the force applied while the patients pinch as hard as possible is measured.
VAS Pain
时间窗: Pre-operative, 1, 3 and 5 years follow-up
Pain level is collected with VAS (Visual Analog Scale): the patients are asked to mark their current pain level on a horizontal line containing values ranging from 0 (no pain) to 100 (very severe pain).
Grip Strength
时间窗: Pre-operative, 1, 3 and 5 years follow-up
Grip strength is an indicator of muscle health in the hands and forearms and is measured with a hand-held dynamometer. The patients squeeze the dynamometer with all of their strength and the force applied is measured.
Tip Pinch Strength
时间窗: Pre-operative, 1, 3 and 5 years follow-up
Tip pinch strength is an indicator of muscle health and measures the precision grip by using a pinch dynamometer. The device is placed between the tip of the index finger and thumb and the force applied while the patients pinch as hard as possible is measured.
次要结局
- Motion - ROM Measurement - Radial Abduction(Pre-operative, 1, 3 and 5 years follow-up)
- EQ-5D - VAS Score(Pre-operative, 1, 3 and 5 years follow-up)
- Number of Implants With Visible Radiolucency Line Around the Implanted Prosthesis(1, 3 and 5 years follow-up)
- Hand Function: DASH Questionnaire - Sport(Pre-operative, 1, 3 and 5 years follow-up)
- Motion - ROM Measurement - Palmar Abduction(Pre-operative, 1, 3 and 5 years follow-up)
- EQ-5D - Health Status Score(Pre-operative, 1, 3 and 5 years follow-up)
- Hand Function: DASH Questionnaire - Disability(Pre-operative, 1, 3 and 5 years follow-up)
- Hand Function: DASH Questionnaire - Work(Pre-operative, 1, 3 and 5 years follow-up)