NCT06603740尚未招募不适用
Randomized Study Evaluating Cost of Arthrex Nano Arthroscopy Products in Arthroscopic Knee Meniscectomy Versus Conventional Arthroscopy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Cost Comparison (TDBC)
研究概览
简要总结
The study is a pilot study designed to generate preliminary data regarding the cost of partial meniscectomy using NanoScope versus conventional arthroscopy in a traditional operating room (OR) setting
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject requires simple partial posterior or mid-body meniscectomy.
- •Subject is 18 - 60 years of age.
- •Subject body mass index (BMI) is 35 or lower (BMI ≤ 35).
- •Subject signed informed consent and is willing and able to comply with all study requirements and follow-up visits.
- •Confirmed meniscal injury by physical exam as per standard of care.
- •Normal mechanical alignment; < 5° varus and < 7° valgus, of the affected knee by clinical assessment or X-Rays as per standard of care
排除标准
- •Subject requires complex repair or anterior meniscectomy.
- •Subject has a concomitant chondral lesion of the ipsilateral knee in addition to meniscal tear.
- •Current bilateral knee injury.
- •Insufficient quantity or quality of bone.
- •Blood supply limitations and previous infections which may retard healing.
- •Congenital ligamentous hypermobility defined by Beighton score 4 or
- •Locked knee or haemarthrosis.
- •Subjects that are skeletally immature.
- •Advanced Osteoarthritis; Kellgren Lawrence ≥ 2
- •Fracture of the lower extremities within 6 months prior to screening.
- •Previous surgery on the affected knee within 12 months prior to screening.
- •Sensitivity to silicone, polyester, nylon, FD&C Blue No. 2 dye and beeswax.
- •Other concomitant disease that would interfere with study outcomes.
- •Subject is included in a vulnerable population (child, prisoner, etc).
- •Conditions that tend to limit the patient's ability or willingness to restrict activities, follow directions, or perform online subject assessments during the healing period.
- •Subject is requesting or receiving Worker's compensation related to the knee injury. -
结局指标
主要结局
Cost Comparison (TDBC)
时间窗: Operative Visit
Cost comparison using the time-drive activity-based costing (TDABC) study design between NanoScope versus conventional arthroscopy for partial meniscectomy in a traditional OR setting.
次要结局
- International Knee Documentation Committee (IKDC) Score(Pre Operative, 2 weeks and 6 weeks post op)
- Visual Analogue Scale (VAS)(Pre Operative, 2 weeks and 6 weeks post op)
研究者
研究点 (2)
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