The Utility of a Non-Invasive Distractor During Arthroscopy of the Knee Joint
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 14
- 主要终点
- Lateral Knee Joint Distraction Distance measured in millimeters (mm) during arthroscopy using a reference probe
研究概览
简要总结
Patients will be prospectively recruited for knee joint distraction who are undergoing knee arthroscopy. Patient demographics, operative factors, and rates of medical comorbidities will be collected and evaluated. Intraoperative arthroscopic images will be evaluated by the attending Orthopaedic surgeon with standard and testing mechanism and a measuring device will be used to measure the distance between the femur and tibia in the medial and lateral compartments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- 是
入选标准
- •Adults ≥ 18 years of age who have capacity to provide informed consent. Eligible participants will include existing patients of Dr. DiStefano who are scheduled to undergo knee arthroscopic surgery to address meniscal pathology. Study risks, benefits and description will be provided and informed consent will be obtained.
排除标准
- •Patients with prior history of neurovascular deficiency or history of prior injury
- •Patients with a prior history of knee surgery
- •Patients with diagnosed knee ligament laxity or knee instability.
- •Patients that are not cleared for knee arthroscopy
研究组 & 干预措施
Lateral Non-Invasive Knee Distraction
lateral aspect of knee with distraction device
干预措施: Non-Invasive Knee Joint Distraction (Device)
Medial Manual Knee Distraction
medial aspect of knee with only manual distraction. no device.
干预措施: Manual Joint Distraction (Procedure)
Lateral Manual Knee Distraction
lateral aspect of knee with only manual distraction. no device.
干预措施: Manual Joint Distraction (Procedure)
Medial Non-Invasive Knee Distraction
medial aspect of knee with distraction device
干预措施: Non-Invasive Knee Joint Distraction (Device)
结局指标
主要结局
Lateral Knee Joint Distraction Distance measured in millimeters (mm) during arthroscopy using a reference probe
时间窗: intraoperative
with manual distraction vs non-invasive distractor
Medial Knee Joint Distraction Distance measured in millimeters (mm) during arthroscopy using a reference probe
时间窗: intraoperative
with manual distraction vs non-invasive distractor
次要结局
- Pre and Post operative pain scores(preoperative and within 1 year after knee arthroscopy)