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 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

暂无简介。

•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

•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

发起方

Orthopedium