NCT01820676终止不适用
A Prospective, Multi-Center Study to Evaluate the ConforMIS iUni® G2+ Unicompartmental Knee Resurfacing Device
Restor3D1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2013年7月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- 2011 Knee Society Score
研究概览
简要总结
This study is designed to monitor long term clinical outcomes of the iUni G2+ unicompartmental knee replacement
详细描述
The study subjects will be followed for 10 years post implant. The follow-up visit schedule will include visits at 6 weeks, 6 months, 1 year, 2 years, 5 years and 10 years post implant.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical condition included in the approved Indications For Use
- •Unicompartmental osteoarthritis of the medial or lateral tibiofemoral compartment
- •Willingness to participate in the clinical study, to give informed consent, and to attend all follow-up visits
- •> 18 years of age
排除标准
- •Simultaneous bilateral procedure required
- •BMI > 35
- •Treatment for cancer within the past 5 years, with the exception of skin cancer
- •Poorly controlled diabetes
- •Neuromuscular conditions which prevent patient from participating in study activities
- •Active local or systemic infection
- •Immunocompromised
- •Fibromyalgia or other general body pain related condition
- •Advanced tricompartmental osteoarthritis
- •Symptomatic patellofemoral disease
- •Rheumatoid arthritis or other forms of inflammatory joint disease (excluding Gout unless it is in the treated knee or limiting overall function)
- •Loss of bone or musculature, osteoporosis, osteonecrosis, neuromuscular or vascular compromise in the area of the joint to be operated to an extent that the procedure is unjustified. Osteoporosis is defined by more than -2.5 standard deviations from the T score as measured on a Dual Energy X-Ray Absortiometry Scan (DEXA) within 2 years of surgery.
- •Advanced loss of osteochondral structure on the affected femoral condyle
- •Compromised ACL, PCL or collateral ligament
- •Severe (>15º) fixed valgus or varus deformity
- •Extension deficit > 15 º
- •Prior history of failed implant surgery of the joint to be treated
- •Unwilling or unable to comply with study requirements
- •Participation in another clinical study which would confound results
结局指标
主要结局
2011 Knee Society Score
时间窗: 1 Year
KOOS Score
时间窗: 1 Year
Oxford Knee Score
时间窗: 1 Year
次要结局
未报告次要终点
研究者
研究点 (1)
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