A Clinical Investigation to evaluate the Apex KneeTM Pegged Tibial Baseplate Porous Coated components in primary Total Knee Arthroplasty using Roentgen Stereophotogrammetric Analysis (RSA) in patients with knee osteoarthritis

Corin Australia Pty Limited0 个研究点目标入组 30 人开始时间: 2022年3月30日最近更新: 2023年5月22日

试验速览

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•1. Be over the age of 18 years, upper age limit is 80
•2. Be capable of understanding the study requirements and of providing informed consent
•3. Be eligible for a primary total knee replacement based on history, physical
•examination and radiological evaluation.
•4. Degenerative native knee-joint pathology
•5. Adequate bone stock for uncemented tibial fixation
•6. Agree to attend the research centre for the required post-operative assessments and radiological evaluation.

•1. Women who are pregnant or breast feeding or plan to become pregnant during the
•course of the study.
•2. Not willing or unable to return for required follow-up visits or clear demonstration of
•likely poor compliance.
•3. Any medical condition including current infections that in the judgement of the
•investigator would prohibit the patient from participating in the study
•4. Psychiatric or mental disorders, alcohol abuse or other substance abuse, which in
•the opinion of the investigator would inhibit compliance with routine surgical followup.
•5. The individual has a neuromuscular or neurosensory deficiency that limits the ability
•to evaluate the safety and effectiveness of the device.
•6. Previous patellectomy
•7. The individual does not speak, read or comprehend the English language.

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