Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06627699
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-03
Brief Title:
Prospective In-Vivo Post-Market Safety and Efficacy Surveillance Registry of the MAXX Orthopedics Freedom Total Knee System
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Prospective In-Vivo Post-Market Safety and Efficacy Surveillance Registry of the MAXX Orthopedics Freedom Total Knee System
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:
In an effort to satisfy regulatory requirements for post-market surveillance of product safety and efficacy a representative sample of patients will be recruited for prospective monitoring
Detailed Description:
In an effort to satisfy regulatory requirements for post-market surveillance of product safety and efficacy a representative sample of patients will be recruited for prospective monitoring
To maintain equal site distribution per device patient recruitment will include up to a total of twenty 20 registry sites and thirty 30 primary TKA candidates per site surgeon for a total of 600 registry patients A total of no more than 200 patients across all sites will be recruited per level of constraint eg 200 CR 200PS 200UC for this registry with a 10-month accrual target from study initiation per site 3 patients consented month
To maintain equal site distribution per device patient recruitment will include up to a total of twenty 20 registry sites and thirty 30 primary TKA candidates per site surgeon for a total of 600 registry patients A total of no more than 200 patients across all sites will be recruited per level of constraint eg 200 CR 200PS 200UC for this registry with a 10-month accrual target from study initiation per site 3 patients consented month
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