A Clinical Investigation to evaluate safety and performance of APEX KNEE Vitamin E, Cold Gamma Irradiated, Mechanically Annealed XLPE (ECiMa) Patella and Tibial Insert components in primary Total Knee Arthroplasty in patients with knee osteoarthritis
- Conditions
- Total Knee ArthroplastyOsteoarthritisMusculoskeletal - OsteoarthritisSurgery - Other surgery
- Registration Number
- ACTRN12622000504718
- Lead Sponsor
- Corin Australia Pty Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 300
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:
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 follow-up.
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. Previous proximal tibial or distal femoral osteotomy.
8. Extra-articular deformity
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method