A Comparative Study Evaluating the Diagnostic Accuracy of Wrist Arthroscopy Using the NanoScope Compared to Conventional Arthroscopic Instrumentation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Surgeon-Rated Midcarpal Visualization With Arthrex Nanoscope
研究概览
简要总结
The purpose of this study is to evaluate the diagnostic efficacy of Arthrex NanoScope compared to conventional arthroscopic instruments. Patients with wrist pathology who are indicated for an arthroscopic procedure will be enrolled pre-operatively after a thorough discussion of the study aims, risks, and benefits. At the time of surgery, under standard conditions, using standard wrist arthroscopy portals, a diagnostic arthroscopy will be performed with the Arthrex Nanoscope. The diagnostic arthroscopy will be performed in a stepwise manner for consistency with notation of pathology and intended intervention. The diagnostic arthroscopy will then be performed with the standard arthroscopic equipment, again noting pathology and final intervention. Post-operatively, diagnostic accuracy, incidence of change in intervention, and surgeon rated ease of use and confidence will be determined.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Age > 18 years.
- •Wrist pathology based on clinical examination/imaging studies undergoing wrist arthroscopy for further evaluation/treatment.
- •Willingness to participate in the study
排除标准
- •Age < 18 years.
研究组 & 干预措施
Experimental Cohort
Patients with clinically diagnosed wrist pathology undergoing wrist arthroscopy
干预措施: Diagnostic Arthroscopy using the Arthrex NanoScope (Diagnostic Test)
Experimental Cohort
Patients with clinically diagnosed wrist pathology undergoing wrist arthroscopy
干预措施: Diagnostic Arthroscopy using standard arthroscopic instruments (Diagnostic Test)
结局指标
主要结局
Surgeon-Rated Midcarpal Visualization With Arthrex Nanoscope
时间窗: Day 1
Midcarpal visualization rated on a 5-point scale: (1) - bad; (2) - poor; (3) - fair; (4) - good; (5) - excellent.
Surgeon-Rated Radiocarpal Visualization With Arthrex Nanoscope
时间窗: Day 1
Radiocarpal visualization rated on a 5-point scale: (1) - bad; (2) - poor; (3) - fair; (4) - good; (5) - excellent.
Surgeon-Rated Radiocarpal Visualization With Conventional Instrument
时间窗: Day 1
Radiocarpal visualization rated on a 5-point scale: (1) - bad; (2) - poor; (3) - fair; (4) - good; (5) - excellent.
Surgeon-Rated Midcarpal Visualization With Conventional Instrument
时间窗: Day 1
Midcarpal visualization rated on a 5-point scale: (1) - bad; (2) - poor; (3) - fair; (4) - good; (5) - excellent.
次要结局
- Surgeon-rated Ease of Use of Arthrex NanoScope(Day 1)
- Surgeon-rated Ease of Use of Conventional Instrument(Day 1)
- Surgeon-rated Confidence in Arthrex NanoScope Diagnosis(Day 1)
- Surgeon-rated Confidence in Conventional Instrument Diagnosis(Day 1)