A Prospective, Multi-Center Study to Evaluate the ConforMIS iUni® G2 Unicompartmental Knee Resurfacing Device
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 120
- 试验地点
- 8
- 主要终点
- Knee Society Score
研究概览
简要总结
Study is prospective and multi-center. Study will include 100 to 200 patients across up to 20 sites.The study sites will be located in the United States.The study objective is to evaluate the safety and performance of the ConforMIS iUni® Unicompartmental Knee Resurfacing Device in patients with single compartment osteoarthritis.
详细描述
The iUni G2 Unicompartmental Resurfacing Device (iUni) is an FDA cleared and CE Marked implant designed for patients with damage isolated to either the medial or lateral tibiofemoral compartment of the knee. The study subjects will be followed for 10 years post implant. The study objective is to evaluate the safety and performance of the ConforMIS iUni® Unicompartmental Knee Resurfacing Device in patients with single compartment osteoarthritis. The iUni is a patient-specific unicompartmental resurfacing device designed from the patient's unique anatomy using proprietary software which interprets data from the patient's CT scan. The patient matched implant design is then coupled with unique patient-matched disposable instrumentation designed using the same CT data and software. The follow-up visit schedule will include visits at 6 weeks, 6 months (optional), 1 year, 2 years, 5 years and 10 years post implant.The remaining follow-up data collected at years 3, 4, 6, 7, 8, and 9 may be collected via phone call/email and does not require a subject visit to the site.The study sites will be located in the United States.
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
- •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
- •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
- •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
Knee Society Score
时间窗: 2 years
to assess knee pain and function
WOMAC Osteoarthritis Index
时间窗: 2 years
to assess knee pain and function
次要结局
- Knee Society Score and WOMAC at years 5 and 10 post-implantation(10 years)
- Length of tourniquet time in minutes(6 weeks)
- Length of hospital stay in hours(6 weeks)
- Annual revision rates at years 1 through 10 post-implantation(10 years)
- Incidence of major procedure-related and device-related complications(10 years)