Ignite Creation Date:
2024-10-25 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06615739
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-18
Brief Title:
Comprehensive SRS Regenerex Tissue Attachment
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Post-market Clinical Follow-up Study to Provide Safety Performance and Clinical Benefits Data of the Comprehensive Segmental Revision System SRS Regenerex Tissue Attachment Augments - a Retrospective Enrollment and Prospective Follow-up Consecutive Series Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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 objective of this retrospective and prospective consecutive series data collection is to confirm safety performance and clinical benefits of the Comprehensive SRS Regenerex Tissue Attachment Augments when used for limb salvage arthroplasty
Detailed Description:
Consecutive subjects implanted with Comprehensive SRS Regenerex Tissue Attachment Augments according to the approved indications with the longest-term follow-up possible willl be identified and invited to participate in the study
The primary objective is the assessment of safety by analyzing implant survivorship This will be established by recording the incidence and frequency of revisions complications and adverse events Relation of the events to the implant andor procedure should be specified
The study will include one site There will be a maximum of 103 patients enrolled in the study
The primary objective is the assessment of safety by analyzing implant survivorship This will be established by recording the incidence and frequency of revisions complications and adverse events Relation of the events to the implant andor procedure should be specified
The study will include one site There will be a maximum of 103 patients enrolled in the study
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