A Prospective, Non-Comparative Multi-centre Study to Evaluate the Safety and Performance of the DePuy Minimally Invasive (Preservation) Unicompartmental Knee and Instrumentation.
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 247
- 试验地点
- 2
- 主要终点
- To demonstrate the suitability of the developed instrumentation to safely and accurately implant the Preservation Unicompartmental Knee using radiographic and intra-operative assessment
研究概览
简要总结
The primary purpose of this investigation is to evaluate the surgical performance of the DePuy Minimally Invasive (Preservation) Unicompartmental Knee and Instrumentation in a Multi-centre setting.
The secondary objective of this investigation is to evaluate the long-term survivorship of the DePuy Minimally Invasive (Preservation) Unicompartmental Knee.
详细描述
Primary endpoint - to demonstrate the suitability of the developed instrumentation to safely and accurately implant the preservation Unicompartmental Knee using postoperative radiographic limb and component alignment data.
Secondary endpoints - to demonstrate the survivorship and performance of the Preservation Unicompartmental Knee using the American Knee Society clinical and radiological assessment, Oxford Knee Score and survivorship analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects, who are 40 to 75 years of age inclusive.
- •Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom written consent has been obtained.
- •Subjects who, in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.
- •Subjects who exhibit loss of articular cartilage which is predominantly confined to a single compartment. The remaining compartments must be intact and able to bear normal loads.
- •Subjects who in the opinion of the Clinical Investigator are considered to be suitable for treatment with the investigation device, according to the indications specified in the package insert leaflet.
排除标准
- •Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study.
- •Subjects with a known history of poor compliance to medical treatment.
- •Women who are pregnant.
- •Subjects who are known drug or alcohol abusers or with psychological disorders that could effect follow-up care or treatment outcomes.
- •Subjects who have participated in a clinical study with an investigational product in the last month.
- •Subjects who are currently involved in any injury litigation claims.
- •Revision of an existing unicompartmental implant.
- •Subjects who have gross ligament laxity / instability.
- •Subjects who have an inflammatory joint disease
- •Subjects in whom there is evidence of previous joint sepsis
- •Subjects who have a pre-operative flexion contracture of 15° or greater
- •Subjects who have a pre-operative flexion of less than 90°
- •Subjects who have a pre-operative limb deformity of greater than 15° varus or valgus
- •Subjects who have morbid obesity i.e. BMI > 40%
结局指标
主要结局
To demonstrate the suitability of the developed instrumentation to safely and accurately implant the Preservation Unicompartmental Knee using radiographic and intra-operative assessment
时间窗: 0 days
Intraoperative
次要结局
- To demonstrate the survivorship and performance of the Preservation Unicompartmental Knee using the American Knee Society clinical and radiographic assessment, Oxford Knee Score and survivorship analysis.(6 months, 1, 3, 5, 10 and 15 years)