MultiCenter Prospective Parallel Registry Controlled Investigational Device Exemption Clinical Study to Determine Non-Inferiority of the PEEK-OPTIMA™ Femoral Component Versus a CoCr Alloy Femoral Component of Similar Design for TKA
Maxx Orthopedics Inc
Summary
The purpose of this investigational device exemption (IDE) study is to monitor the performance (safety and efficacy) of the Maxx Orthopedics, Freedom Total Knee® System, with a femoral component of similar design, manufactured from polyether-ether-ketone (PEEK).
Description
The purpose of this investigational device exemption (IDE) study is to monitor the performance (safety and efficacy) of the Maxx Orthopedics, Freedom Total Knee® System, with a femoral component of similar design, manufactured from polyether-ether-ketone (PEEK). PEEK is a high-performance, engineering thermoplastic characterized by an unusual combination of properties. These properties range from high temperature performance to mechanical strength and excellent chemical resistance. The PEEK-OPTIMA® femoral component, is an investigational device and is the subject of this study approved for…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Male and female subjects 18 years of age or older. * Subjects with a primary diagnosis of end-stage symptomatic unilateral primary knee osteoarthritis. * Subjects with a pre-operative Knee Society Score (KSS) Knee score of \>25 and \<75. * Subjects who, in the opinion of the Investigator, can understand this clinical investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups. * Subjects who can give voluntary, written informed consent to participate in this clinical investigation…
Interventions
- DeviceTotal Knee Arthroplasty
Primary Total Knee Arthroplasty with a PEEK femoral component
Locations (2)
- AscentisLeawood, Kansas
- South Texas Bone and JointSan Antonio, Texas