JPRN-UMIN000021279已完成未知
Randomized controlled study comparing Vanguard with KneeAlign2 navigational system versus Vanguard conventional - Vanguard with/without KneeAlign 2
Zimmer Biomet G. K.0 个研究点目标入组 100 人开始时间: 2016年3月2日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 100
研究概览
简要总结
There were no complications reported. The absolute differences of the femoral prosthesis, tibial prosthesis, and hip-knee-ankle angle from a neutral mechanical axis were less in the navigation group compared with those in the conventional group. Alignment outliers of the tibial prosthesis and hip-knee-ankle angle were less in the navigation group (9% and 27%, respectively) compared with those in the conventional group (31% and 49%; p = 0.01 and p =0.04, respectively).
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 ot applicable(—)
- 性别
- All
入选标准
- 未提供
排除标准
- •- Knee degenerative diseases other than Knee Osteoarthritis (such as necrosis / Rheumatoid Arthritis) - Severe OA deformation (FTA:> 185 degrees / < 175 degrees) - Active Infection (or within 6 weeks after infection) - Sepsis - Osteomyelitis - Any type of implant is inserted in the affected side of lower extremity - Hip disease on the affected side - Uncooperative patient or patient with neurologic disorders who are incapable of following directions - diagnosed Osteoporosis or Osteomalacia - Metabolic disorders which may impair bone formation - Distant foci of infections which may spread to the implant site - Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram - Vascular insufficiency, muscular atrophy or neuromuscular disease.
研究者
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