跳至主要内容
临床试验/JPRN-UMIN000021279
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

发起方
Zimmer Biomet G. K.

相似试验