NCT01529099已完成4 期
A Prospective, Non-comparative, Single Centre Study to Determine the Performance & Survivorship of the SIGMA HP® PARTIAL KNEE SYSTEM.
DePuy International3 个研究点 分布在 2 个国家目标入组 64 人开始时间: 2009年1月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 3
- 主要终点
- Survivorship (revision)
研究概览
简要总结
This is a postmarketing study to assess the overall performance and survivorship of the SIGMA HP® PARTIAL KNEE SYSTEM.
详细描述
The purpose of this study is to collect more information about the Sigma HP® Partial Knee System made by DePuy International. The aim of this study is to measure how this particular type of knee replacement performs over a two year 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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects, aged at least 21 years.
- •Subjects who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.
- •Subjects, who, in the opinion of the Clinical Investigator, are able to understand this clinical investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.
- •Subject has non-inflammatory degenerative joint disease (NIDJD), including: osteoarthritis, posttraumatic arthritis, avascular necrosis and chondrocalcinosis.
- •Subject has a functional stable knee.
- •Subject, in the opinion of the Investigator, is suitable for either a single or bicompartmental knee replacement.
- •Subject meets the following selected radiographic parameters:
- •X-ray evaluation confirms the presence of NIDJD
- •Disease location: 1 to 2 compartments, maximum. Disease can be present in the patellofemoral compartment, the medial tibiofemoral compartment, lateral tibiofemoral compartments alone or in any two compartments.
- •Disease severity: Kellgren and Lawrence44 Grade II or greater for all compartments replaced.
排除标准
- •Subjects who, in the opinion of the Clinical Investigator, have an existing condition that would compromise their participation and follow-up in this clinical investigation.
- •Women who are pregnant.
- •Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.
- •Subjects who have participated in a clinical investigation with an investigational product in the last 3 months.
- •Subjects who are currently involved in any injury litigation claims.
- •Multiple joint involvement that will compromise rehabilitation (for example: advanced hip, ankle or spine disease).
- •Known to be a prisoner, mentally incompetent, an alcohol / drug abuser, involved in medical-legal case or worker's compensation
- •Previous knee arthroplasty (any type) in any one of the three compartments of the knee.
- •Requires more than a lateral soft tissue release or an anterior cruciate ligament reconstruction.
- •Uncorrectable anatomical tibio-femoral angle.
- •Bone deficiency requiring structural bone grafts to support the implants.
- •Previous patellectomy.
- •For Subjects indicated for a patellofemoral arthroplasty, Subject has uncorrected patella baja (Caton-Deschamps ratio less than or equal to 0.6).
- •Tri-compartmental disease process (patella-femoral, medial tibio-femoral and lateral tibio-femoral).
- •Active bacterial infection that may spread to other areas of the body (e.g., osteomyelitis, pyogenic infection of knee joint, urinary tract infection, etc.).
- •Significant neurological or musculoskeletal deformity or a disease that may affect gait or weight bearing, (e.g., muscular dystrophy, multiple sclerosis, amputation).
- •Known allergy to implant materials.
研究组 & 干预措施
Sigma HP Partial Knee
Experimental
Partial knee replacement
干预措施: SIGMA HP PARTIAL KNEE (Device)
结局指标
主要结局
Survivorship (revision)
时间窗: 2 years
Kaplan Meier Survival analysis at 2 years (based on revision of the femoral or tibial components)
次要结局
未报告次要终点
研究者
研究点 (3)
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