NCT05003414进行中（未招募）不适用
A Prospective, Multicentre, International, Post-marketing, Longitudinal, Observational Cohort Study to Monitor the Performances of GMK Sphere Cementless Knee Prosthesis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 5
- 主要终点
- Survival rate
研究概览
简要总结
This is a Post-Marketing Surveillance study of GMK Sphere cementless knee prosthesis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A disabled or severely disabled joint as a result of arthritis, traumatic arthritis, rheumatoid arthritis, poly-arthritis or avascular necrosis
- •Patients between the age of 18 and 80 at the time of consent
- •Listed for total knee replacement surgery.
- •Patients who are willing and able to give informed written consent
排除标准
- •Progressive local or systemic infection
- •Muscular loss, neuromuscular disease or vascular deficiency of the affected limb, making the operation unjustifiable
- •Severe instability secondary to advance destruction of condralar structures or loss of integrity of the medial or lateral ligament
- •Those whose prospects for a recovery to independent mobility would be compromised by known coexistent, medical problems
- •Patient whose BMI exceeds 40
- •Any case not described in the inclusion criteria
结局指标
主要结局
Survival rate
时间窗: 10 years
Kaplan Meier method
次要结局
- Clinical outcome: Knee Society score(Preop and 1, 2, 5, 10 years postop)
- Patient-reported outcome: Forgotten Joint Score(1, 2, 5, 10 years postop)
- Radiographic performance of the implants looking for radiolucencies, migration, loosening, subsidence(Immediately postop + 1, 2, 5, 10 years postop)
- Intraoperative and postoperative Adverse events(Intraop + Immediately postop + 1, 2, 5, 10 years postop)
研究者
研究点 (5)
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