Investigational Device Exemption for the Scandinavian Total Ankle Replacement (STAR) - Bilateral Arm
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 5
- 主要终点
- Safety endpoints to be measured are: • Device failure or device removal/revision • Radiographically confirmed loosening and migration • Complications
研究概览
简要总结
The purpose of this study is to evaluate the safety of the S.T.A.R. device for patients with bilateral disease.
详细描述
The specific objectives are to show that the safety data of the S.T.A.R. ankle arthroplasty is similar for treatment of single ankle disease (as defined in the pivotal study) and bilateral ankle disease. The bilateral disease may be identified at the time of enrollment or may have progressed after enrollment and treatment of the first ankle in the pivotal study.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Moderate or severe pain, loss of mobility and function of the ankle
- •Primary arthrosis, post traumatic arthrosis or rheumatoid arthrosis
- •At least six months of conservative treatment for severe ankle conditions
- •Bilateral ankle disease that have not been enrolled in the pivotal study or single ankle disease and enrolled in the pivotal study but have subsequently developed ankle disease in the contralateral ankle and require surgical intervention
- •Willing and able to give informed consent
排除标准
- •Patients who have not reached skeletal maturity
- •Active or prior deep infection in the ankle joint or adjacent bones
- •Prior arthrodesis at the involved site
- •History of prior mental illness or patient demonstrates that their mental capacity may interfere with their ability to follow the study protocol
- •Obesity (weight greater than 250 lbs)
- •History of current or prior drug abuse or alcoholism
- •Any physical condition precluding major surgery
- •Prior surgery and/or injury that has adversely affected the ankle bone stock
- •Severe osteoporotic or osteopenic condition or other conditions that may lead to inadequate implant fixation in the bone
- •Insufficient ligament support
研究组 & 干预措施
3
The S.T.A.R. ankle system is the study device. The device has three parts: two metal bearing surfaces (cobalt-chromium alloy) plates with bars that fit into the bone and one plastic (polyethylene) spacer that moves between the metal plates like a ball bearing. The materials in the S.T.A.R. device are the same materials used in total hip and knee implants. Both ankles of every subject will be treated with the STAR ankle.
干预措施: Scandinavian Total Ankle Replacement (STAR) (Device)
结局指标
主要结局
Safety endpoints to be measured are: • Device failure or device removal/revision • Radiographically confirmed loosening and migration • Complications
时间窗: 12 months
次要结局
未报告次要终点