None listed
Conditions
Brief summary
The safety and performance of the Apex Total Knee Replacement system manufactured by Omni Life Science and Global Orthopaedic Technology will be evaluated following primary total knee arthroplasty.
Interventions
This study is a post-market, prospective study to monitor and evaluate the intended performance and ongoing safety of the Apex Knee System manufactured by Omni Life Science and Global Orthopaedic Technology following a primary total knee arthroplasty.
It follows the investigators standard practice for a total knee arthroplasty. The surgical duration will be the same as for a routine total knee arthroplasty surgery. All participants will be clinically assessed using standard functional paramete
This study is a post-market, prospective study to monitor and evaluate the intended performance and ongoing safety of the Apex Knee System manufactured by Omni Life Science and Global Orthopaedic Technology following a primary total knee arthroplasty. It follows the investigators standard practice for a total knee arthroplasty. The surgical duration will be the same as for a routine total knee arthroplasty surgery. All participants will be clinically assessed using standard functional parameters measuring range of movement pre-operatively, three months post-operatively, 1 year, and 2 years.
Sponsors
Global Orthopaedic Technology
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Be over 18 years old 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. Agree to attend the research centre for the required post-operative 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 or likely poor compliance 3. Any medical condition including current infections that in the judgement of the investigator would prohibit 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 femur osteotomy 8. Extra-articular deformity 9. The individual does not speak, read, or comprehend the English language
Outcome results
None listed