NCT05659329已完成不适用
A Retrospective Multicenter Study to Review the Use of Simplex High Viscosity Bone Cement in Primary Total Knee Arthroplasty
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 主要终点
- Number of Participants With Successful Application of Bone Cement
研究概览
简要总结
This study is a retrospective multicenter study to review the use of Simplex High Viscosity Bone Cement in Primary Total Knee Arthroplasty
详细描述
This study is a retrospective investigation of subjects who have received primary Triathlon Total Knee Arthroplasty inserted with Simplex High Viscosity (HV) Cement to evaluate the success rate defined as absence of revision for aseptic loosening of components at two years postoperative.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •The Patient is age 18 or over at time of study device implantation
- •Patients who have undergone primary Triathlon Total Knee Arthroplasty in which Simplex HV/Simplex HV Gentamicin was indicated for fixation and used on label
- •Patients who have been followed for at least 24 months postoperatively
排除标准
- •Patients who have undergone revision surgery
- •Patients who have undergone bilateral Knee Arthroplasty
- •Patients contraindicated for either the devices implanted, or the cement used, according to medical history review and instructions for use
- •Patient has a cementless tibial baseplate.
- •Patient has an active or suspected latent infection in or about the affected knee joint
- •Patient has muscle loss or neuromuscular impairment in the affected limb that would create an unjustifiable risk
- •Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. > 30 days)
- •Patient has a known hypersensitivity to any of the cements constituents or in patients with severe renal failure
- •Patient is a prisoner
结局指标
主要结局
Number of Participants With Successful Application of Bone Cement
时间窗: 24 months
A successful application is defined as absence of revision of Triathlon Total Knee components cemented with Simplex high viscosity bone cement (Simplex HV) within outcome measure timeframe.
次要结局
- Knee Society Score (KSS) Pain Motion Score: Range of Motion(pre-op, 2 years, 5 years (optional))
- KSS Function Score: Walking(pre-operative, 2 years, 5 years (optional))
- Oxford Knee Score (OKS) Results(pre-op, 2 years, 5 years (optional))
- KSS Pain Motion Score: Stability(pre-operative, 2 years, 5 years (optional))
- KSS Pain Motion Score: Pain(Pre-operative, 2 years, 5 years (optional))
- KSS Function Score: Walking Aids(Pre-operative, 2 years, 5 years (optional))
- KSS Function Score: Stairs(Pre-operative, 2 years, 5 years (optional))
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