The Medacta International GMK Sphere Post-Marketing Surveillance Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 500
- 试验地点
- 4
- 主要终点
- Assessment of the clinical outcome following total knee replacement using the Knee Society Score.
研究概览
简要总结
This is a Post-Marketing Surveillance of GMK Sphere knee prosthesis.
详细描述
The clinical performance of the GMK® Sphere, manufactured by Medacta International, will be evaluated by a multicentre, prospective clinical surveillance study.
The Elective Orthopaedic Centre (EOC), in Epsom, Surrey, will be the study coordinating centre. Four further centres will participate in the clinical study, for five total centres. Each participating centre will recruit approximately 100 patients. Patient recruitment will cease when a cohort of 500 GMK® Sphere knee replacements have been implanted.
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
- 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 must be between the age of 18 and 80 at the time of consent
- •Listed for total knee replacement surgery.
- •Patients who are willing 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 condylar structures or loss of integrity of the medial or lateral ligament
- •Any patient who cannot or will not provide informed consent for participation in the study
- •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
研究组 & 干预措施
GMK Sphere Knee Replacement
Patients who comply with the protocol and received GMK Sphere component.
干预措施: GMK Sphere Knee Replacement (Device)
结局指标
主要结局
Assessment of the clinical outcome following total knee replacement using the Knee Society Score.
时间窗: 6 months
次要结局
- Assessment of implant survivorship as a measure of safety and tolerability.(6 weeks, 6 months, 3, 5, 7 and 10 years.)
- The EuroQol score as a measure of patient' quality of life.(pre-op, 6 months, 3, 5,7 and 10 years)
- The OXFORD score as a measure of implant functionality.(pre-op, 6 months and annually for 10 years)
- Assessment of the clinical outcome following total knee replacement using the Knee Society Score(pre-op, at 6 months, at 3, 5, 7 and 10 years.)
- Radiographic analysis(pre-op, 6 months, 3, 5,7 and 10 years.)