A Prospective, Randomized Study Comparing Cemented and Cementless Fixed Bearing Unicondylar Medial Knee Replacement
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Knee Society Score
研究概览
简要总结
The primary study objective is to evaluate a cementless partial knee system that has a modular 3-D printed porous metal tibial component and a cemented partial knee system. The hypothesis is that at minimum 2-year follow-up, fixed bearing medial partial knee replacements using cementless and cemented fixation will demonstrate no differences in clinical outcome.
详细描述
This is a prospective, randomized, unblinded clinical trial of 100 patients will be enrolled by invitation of the principal investigator. Inclusion criteria include patients 18-85 years old, patients receiving a medial fixed bearing partial knee replacement and patients deemed suitable for both cemented and cementless fixation after review of the preoperative radiographs. Minimum two-year outcome will be analyzed, and long-term follow-up will continue to 5 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age18-85 years old
- •medial fixed bearing partial knee replacement
- •bone suitable for both cemented and cementless fixation after review of the preoperative radiographs.
排除标准
- •Non-English speakers
- •current smokers
- •grossly porotic bone
- •advanced other compartment arthritis at the time of surgery necessitating a total knee arthroplasty (TKA)
- •previous high tibial osteotomy with prior hardware
- •patients who are randomized but are deemed unsuitable to receive the assigned implant by the surgeon due to bone quality or bone cuts
结局指标
主要结局
Knee Society Score
时间窗: 2 years postoperative
Clinical score for knee status and function. (0-100 scale, with 0 being the worst score and 100 being the best score.)
次要结局
未报告次要终点
研究者
Kevin B. Fricka, MD
Principal Investigator
Anderson Orthopaedic Research Institute