NCT01284972已完成不适用
Short to Mid Term Follow-up of Patient Implanted With the HINTEGRA® Total Ankle Prosthesis
Integra LifeSciences Services6 个研究点 分布在 6 个国家目标入组 225 人开始时间: 2009年2月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 225
- 试验地点
- 6
- 主要终点
- rate of device related complications at the follow up after 2 years of implantation
研究概览
简要总结
The Hintegra® Total Ankle Prosthesis is a non constrained, three-component prosthesis that consists of a flat tibial component, an anatomically-shaped talar component, and a high-density polyethylene inlay. The Hintegra ankle was specifically developed as an attempt to address the needs of minimal bone resection, extended bone support, proper ligament balancing, and minimal contact stressed within and around the prosthesis.
The objective of this study is to evaluate the safety and efficacy of the HINTEGRA® Total Ankle prosthesis at short and mid term follow up.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
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
- •Patient implanted with an Hintegra® Total Ankle Prosthesis (only prosthesis designed with pegs) in primary ankle surgery since a minimum of 2 years
- •Age ≥ 18 years
- •Have willingness to give his/her data transfer authorisation
排除标准
- •History of prior mental illness or patient demonstrates that their mental capacity may interfere with their ability to follow the study protocol
结局指标
主要结局
rate of device related complications at the follow up after 2 years of implantation
时间窗: more than 2 years after the implantation
次要结局
- AOFAS Ankle-Hindfoot Scale score (American Orthopaedic Foot and Ankle Society).(more than 2 years after the implantation)
研究者
研究点 (6)
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