Trials / Not Yet Recruiting
Not Yet RecruitingNCT06627673
MultiCenter IDE Study of the PEEK-OPTIMA™ Femoral Component vs a CoCr Alloy TKA Femoral Component of Similar Design
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
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- Sponsor
- Maxx Orthopedics Inc · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Detailed 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 IDE by the Federal Food and Drug Administration (FDA). Maxx Orthopedics, Freedom Total Knee System is used with instrumentation to assist with surgery of the knee. The Maxx Orthopedics, Freedom Total Knee System implants are approved by the FDA for use in the United States and is not investigational. All patients will receive the Freedom Total Knee System with the PEEK femoral component. Patient / study participents' records will be reviewed for identification of any and all complications, post-operative care, component safety and efficacy, and if re-operation is needed.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Total Knee Arthroplasty | Primary Total Knee Arthroplasty with a PEEK femoral component |
Timeline
- Start date
- 2025-01-01
- Primary completion
- 2028-01-01
- Completion
- 2028-03-01
- First posted
- 2024-10-04
- Last updated
- 2024-10-04
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06627673. Inclusion in this directory is not an endorsement.