临床试验/NCT02343705

NCT02343705终止不适用

Evaluation of the Latella Knee Implant System for Medial Osteoarthritis Pain Reduction (Latella-2 Study)

Cotera, Inc.12 个研究点分布在 3 个国家目标入组 67 人开始时间: 2015年1月最近更新: 2017年4月28日

适应症

试验速览

阶段: 不适用
状态: 终止
发起方: Cotera, Inc.
入组人数: 67
试验地点: 12
主要终点: Primary Endpoint: Efficacy assessed by KOOS pain score at 6 months after treatment with the Latella Implant

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The objective of the Latella-2 study is to demonstrate the safety and efficacy of the Latella Knee Implant System for the reduction of medial osteoarthritis knee pain.

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: 30 Years 至 70 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•History of pain due to medial osteoarthritis
•Qualifying baseline pain scores
•Kellgren-Lawrence Grades 2-3

排除标准

•Osteoporosis
•Rheumatoid arthritis
•Joint instability
•Metal ion allergy
•Permanent implant in or around the knee joint
•Prior anterior cruciate ligament reconstruction

结局指标

主要结局

Primary Endpoint: Efficacy assessed by KOOS pain score at 6 months after treatment with the Latella Implant

时间窗: 6 Months

Primary Endpoint: Safety assessed by surgical re-intervention rate following implantation of the Latella device

时间窗: 6 Months

次要结局

Device and procedure complication rates(6, 12 and 24 months)
Changes in knee outcome measures (KOOS, IKDC, NRS)(6, 12 and 24 months)

研究者

发起方

Cotera, Inc.

申办方类型

Industry

责任方

Sponsor

研究点 (12)

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