Post-Market Evaluation of the MISHA® Knee System for Symptom Relief in Subjects With Medial Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 6
- 主要终点
- Freedom from device- and procedure-related Subsequent Surgical Interventions
研究概览
简要总结
Prospective evaluation of the safety and effectiveness of the MISHA Knee System.
The study will collect data on the procedural and long-term adverse events, WOMAC pain and function scores, KSS satisfaction, subsequent surgical interventions, BMI levels, range of motion, UCLA activity level of the subjects, and perform radiographic/x-ray evaluations at clinical visits through 5 years post-procedure.
The primary analysis of this study is freedom from device- and procedure-related SSIs at five (5) years post-implantation.
This study will also assess device performance in subjects with intact and retained devices and subjects with devices removed prior to study termination and freedom from conversion to arthroplasty through 5 years.
Study subjects will be followed over a five-year post-implant period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects aged 25 to 65 years at time of index procedure
- •Body Mass Index (BMI) of < 35
- •Activity exacerbated knee pain isolated to the medial compartment and not global in nature
- •WOMAC pain ≥ 40
- •Failed non-operative OA treatment
排除标准
- •Large medial osteophyte(s) or considerable extruded meniscus that may interfere with the placement or function of the device
- •Poor bone quality (e.g., bony erosion, osteopenia, osteoporosis)
- •Ligamentous instability
- •Active or recent knee infection
- •Inflammatory joint disease, including sequalae of viral infections
- •Suspected or documented allergy or hypersensitivity to cobalt, chromium, nickel or other metals
- •History of keloid, hypertrophic or contracture scaring
- •Propensity for restrictive scar formation or adhesions with prior procedures
研究组 & 干预措施
MISHA Knee System
干预措施: MISHA Knee System (Device)
结局指标
主要结局
Freedom from device- and procedure-related Subsequent Surgical Interventions
时间窗: 5 years post-implantation
次要结局
- WOMAC Pain(5 years)
- WOMAC Function(5 years)