ACTRN12622000504718
Recruiting
N/A
A Clinical Investigation to evaluate safety and performance of APEX KNEE ECiMa Patella and Tibial Insert components in primary Total Knee Arthroplasty in patients with knee osteoarthritis
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Corin Australia Pty Limited
- Enrollment
- 300
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Inclusion Criteria:
- •1\. Minimum 18 years of age, maximum age limit 80
- •2\. Be capable of understanding the study requirements and of
- •providing informed consent
- •3\. Be eligible for a primary total knee replacement with APEX Knee
- •based on history, physical examination and radiological
- •evaluation.
- •4\. Agree to attend the research centre for the required postoperative
- •assessments and radiological evaluation.
Exclusion Criteria
- •Exclusion Criteria:
- •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
Outcomes
Primary Outcomes
Not specified
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