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。
研究者
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
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