A Prospective, Randomized, Controlled, Multi-Center Study to Evaluate the Safety and Effectiveness of the Episealer® Knee System Compared to Microfracture for the Treatment of Focal Femoral Knee Chondral or Osteochondral Lesions
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 13
- 试验地点
- 24
- 主要终点
- Incidence of subsidence or migration at 24 months
研究概览
简要总结
The study is a randomized, prospective, multicenter, controlled clinical trial of the Episealer Knee System. The Episealer Knee System is intended for subjects with up to two focal femoral knee chondral or osteochondral lesion that is causing pain and/or disability and requires surgical treatment.
详细描述
The primary objective of this study is to evaluate the safety and clinical effectiveness of the Episealer Knee System (Episealer Trochlea Solo, Episealer Femoral Twin, and Episealer Condyle Solo) compared to microfracture (with or without debridement) in a group of subjects that require repair of up to 2 focal femoral chondral or osteochondral lesions in the knee.
Clinical success will be analyzed via subject reported outcomes to measure function and pain improvements as compared to baseline, incidence of secondary surgical interventions for the treated knee, absence of subsidence or migration through radiographic assessment, and assessment of weight-bearing status.
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
- Single (Participant)
盲法说明
In this investigation, neither the investigator nor the subject can be blinded to the treatment group assignment due to the implant's distinctive form that can be detected on radiographs; however, the randomization assignment will not be disclosed to the subject until after surgery is performed.
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Incidence of subsidence or migration at 24 months
时间窗: 24 Months
This endpoint will examine the incidence of subsidence/migration at 24 months
Incidence of Secondary Surgical Intervention
时间窗: 24 Months
This endpoint will examine the incidence of Secondary Surgical Interventions (SSIs) at 24 months
Change in Visual Analog Scale (VAS) Pain Scores
时间窗: 24 Months
This endpoint will examine the change in VAS Pain scores at 24 months
Change in the Knee Injury & Osteoarthritis Outcome Score (KOOS) Subscores
时间窗: 24 Months
This endpoint will examine the change in KOOS subscores at 24 months
Weight bearing status
时间窗: 8 weeks
This endpoint will examine the weight bearing status at 8 weeks
次要结局
- Change in 12-Item Short Form Survey (SF-12) score at all follow-up time points(3-weeks, 8-weeks, 6-months, 12-months, and 24-months)
- Change in VAS Pain score at all follow-up time points(3-weeks, 8-weeks, 6-months, 12-months, and 24-months)
- Incidence of adverse events and device deficiencies at all follow-up time points(3-weeks, 8-weeks, 6-months, 12-months and 24-months)
- Incidence of radiographic findings at all follow-up time points(8 weeks, 12-months, and 24-months)
- Change in the KOOS Subscores at all follow-up time points(3-weeks, 8-weeks, 6-months, 12-months, and 24-months)