A Prospective Radiostereometric Analysis (RSA) Study of Implant Stability and Clinical Evaluation of Simplex High Viscosity Bone Cement in Primary Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Implant Migration measured with Radiostereometric Analysis (RSA)
研究概览
简要总结
In this study the investigators propose to monitor subjects who have received Triathlon total knee components inserted with HV cement. The primary outcome will be fixation of the tibial implant component as assessed with RSA and to determine the functionality of patients after surgery using self-reported questionnaires. This is a historical control study, comparing the study cohort to a previous group with Triathlon implants and the long-standing Simplex T cement. The secondary outcomes are inducible displacements of the implants as well as a qualitative evaluation of the cement handling characteristics performed by the operating room staff.
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
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic arthritis of the knee indicating primary total knee arthroplasty
- •Between the ages of 21 and 80 inclusive
- •Patients willing and able to comply with follow-up requirements and self-evaluations
- •Ability to give informed consent
排除标准
- •Active or prior infection
- •Medical condition precluding major surgery
- •Severe osteoporosis or osteopenia
- •Neuromuscular impairment
- •Significant co-morbidity affecting ability to ambulate
结局指标
主要结局
Implant Migration measured with Radiostereometric Analysis (RSA)
时间窗: 2 years
Total implant migration will be measured in mm using RSA
次要结局
- Qualitative handling characteristics captured through semi-structured interviews(intra-operative)
研究者
Michael Dunbar
Principal Investigator
Nova Scotia Health Authority