Pilot Study Using Radiostereometric Analysis (RSA) to Evaluate the Fixation of the Tibial Components in the DePuy M.B.T. Revision Knee System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Implant Migration
研究概览
简要总结
Motivated by the growing number of revision total knee arthroplasty (TKAs) and the interest among surgeons to quantify the effectiveness of specific implant designs, the goal of the current project is to use Radiostereometric Analysis (RSA) to provide conclusive and clinically relevant results on fixation of the tibial component with the DePuy M.B.T. Revision TKA system using Metaphyseal Sleeves.
Does the tibial component of the M.B.T. Revision Knee System achieve adequate fixation to the underlying bone (proximal tibia) as measured by migration? • Null Hypothesis: The maximum total point motion (MTPM) value of migration of the M.B.T. Revision Knee System component between postoperative years one and two does not exceed 0.2 mm indicating adequate long-term fixation at the bone-implant interface.
• Alternative Hypothesis: The MTPM value of migration of the M.B.T. Revision Knee System component between postoperative years one and two does exceed 0.2 mm indicating inadequate long-term fixation at the bone-implant interface.
b) In what proportion of patients is adequate fixation achieved?
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Revision TKA is indicated and it is the opinion of the investigator that the PFC Sigma M.B.T. Tibial component with metaphyseal sleeves and a stem is a suitable treatment
- •Contained bone defects in the proximal tibia that allow for contiguous contact between metaphyseal sleeves and cortical bone
- •Use of tibial stem
- •Ability to give informed consent
排除标准
- •Revision TKA due to infection
- •Patellar revision only
- •Polyethylene liner exchange only
- •Revision requiring hinged TKA
- •Uncontained defects in the proximal tibia that preclude contiguous contact between metaphyseal sleeves and cortical bone
结局指标
主要结局
Implant Migration
时间窗: 2 years
次要结局
- BMD(2 years)
研究者
Michael Dunbar
Orthopedic Surgeon
Nova Scotia Health Authority