跳至主要内容
临床试验/NL-OMON46471
NL-OMON46471
尚未招募
不适用

Early Functional Outcome and Patient Satisfaction In Guided motion vs Conventional Total Knee Arthroplasty - Guided Motion vs Conventional TKA

Orthopedium0 个研究点目标入组 192 人待定

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
degenerative knee joint
发起方
Orthopedium
入组人数
192
状态
尚未招募
最后更新
2年前

概览

简要总结

暂无简介。

注册库
who.int
开始日期
待定
结束日期
待定
最后更新
2年前
研究类型
Interventional

研究者

发起方
Orthopedium

入排标准

入选标准

  • 1\. Subject requires primary total knee arthroplasty due to degenerative joint disease
  • 2\. Subject is 18\-80 years of age and skeletally mature
  • 3\. Subject agrees to consent to and to follow the study visit schedule (as defined in the study protocol and informed consent form), by signing the EC approved informed consent form
  • 4\. Subject plans to be available through 2 years postoperative follow\-up
  • 5\. Subject is capable of understanding the Dutch language
  • 6\. Subject is able to consent to participate by signing the informed consent form

排除标准

  • 1\. subject has severe pronation of the ipsilateral foot or any other lower extremity or hip condition causing abnormal ambulation
  • 2\. patient has undergone a previous osteotomy or fracture fix
  • 3\. subject has active infection or sepsis (treated or untreated)
  • 4\. subject has presence of malignant tumor, metastatic, or neoplastic disease
  • 5\. subject has conditions that may interfere with the TKA survival or outcome (i.e., Paget\*s or Charcot\*s disease, vascular insufficiency, severe muscular atrophy, uncontrolled diabetes, severe renal insufficiency or neuromuscular disease)
  • 6\. subject has inadequate bone stock to support the device
  • 7\. subject has an emotional or neurological condition that would pre\-empt their ability or willingness to participate in the study

结局指标

主要结局

未指定

相似试验