Randomized Study Evaluating Cost of Arthrex Nano Arthroscopy Products in Arthroscopic Knee ACL Surgery Versus Conventional Arthroscopy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 42
- 主要终点
- Compare patient satisfaction for Anterior Cruciate Ligament (ACL) surgery when using either Arthrex Nanoscope 2.0 or conventional arthroscopy.
研究概览
简要总结
The study is a pilot study designed to generate preliminary data regarding the cost of ACL surgery 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
- Treatment
- 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 is 18 - 60 years of age.
- •Subject body mass index (BMI) is 40 or lower (BMI ≤ 40).
- •Subject signed informed consent and is willing and able to comply with all study requirements and follow-up visits.
- •Confirmed ACL injury by MRI and physical exam as per standard of care.
- •Subjects not excluded for having meniscal pathology that requires resection or repair.
- •Subjects not excluded for having lateral-extra-articular tenodesis
排除标准
- •Revision ACL case.
- •Current bilateral knee injury.
- •Insufficient quantity or quality of bone.
- •Blood supply limitations and previous infections which may retard healing.
- •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 related to the ACL reconstruction, 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.
研究组 & 干预措施
ACL surgery using Arthrex NanoScope
The rod-lens arthroscope has been the standard of care in the operating room for more than 40 years. Arthrex's all-in-one disposable, 2 mm, chip-on-tip camera system now allows surgeons to miniaturize their treatment solutions.
干预措施: ACL surgery using Arthrex NanoScope (Device)
ACL surgery using conventional arthroscopy
Conventional arthroscopy using standard of care equipment
干预措施: ACL surgery using conventional arthroscopy (Procedure)
结局指标
主要结局
Compare patient satisfaction for Anterior Cruciate Ligament (ACL) surgery when using either Arthrex Nanoscope 2.0 or conventional arthroscopy.
时间窗: From enrollment to 2 years
1\. Patient Reported Outcomes Knee Injury and Osteoarthritis Outcome Score (KOOS)
Compare patient satisfaction for Anterior Cruciate Ligament (ACL) surgery when using either Arthrex Nanoscope 2.0 or conventional arthroscopy.
时间窗: From enrollment to 2years
3\. Patient Reported Outcomes Single Assessment Numeric Evaluation (SANE)
次要结局
- Operating Room (OR) metrics that may be correlated with staff satisfaction and operating team satisfaction.(immediately postoperatively)
- Operating Room (OR) metrics that may be correlated with staff satisfaction and operating team satisfaction.(1 month postoperatively)