Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06627673
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-03
Brief Title:
MultiCenter IDE Study of the PEEK-OPTIMA Femoral Component vs a CoCr Alloy TKA Femoral Component of Similar Design
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None