JPRN-jRCTs032180377已完成未知
Randomized Controlled Study Comparing iASSIST Knee System Versus Conventional Instrumentation - iASSIST study
Ohdera Toshihiro0 个研究点目标入组 93 人开始时间: 2019年3月19日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 93
研究概览
简要总结
Although good implant placement was obtained using iASSIST, all the investigators were surgeons familiar with subject device. In the future, the studies which investigate the alignment error due to patient characteristics and the tendency of implant alignment according to the level of proficiency of the surgeon will be conducted by researchers. We expect that even less experienced surgeons can take advantage of the features of this device to provide more accurate Total Knee Arthroplasty.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Knee (either unilateral or bilateral) osteoarthritis (varus deformity only)
- •Male or female
- •At least 20 years of age
- •Patients willing to return for follow-up evaluations.
排除标准
- •Absolute contraindications include:
- •Knee degenerative diseases other than knee osteoarthritis (such as necrosis/rheumatoid arthritis)
- •Too severe OA deformation (FTA: > 190 degrees/< 175 degrees)
- •Active infection (or within 6 weeks after infection)
- •Osteomyelitis
- •Any type of implant is inserted in the affected side of lower extremity
- •Hip and/or foot disease on the affected side
- •Additional contraindications include:
- •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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