Ignite Creation Date:
2024-05-06 @ 3:26 AM
Last Modification Date:
2024-10-26 @ 11:33 AM
Study NCT ID:
NCT02288117
Status:
UNKNOWN
Last Update Posted:
2020-12-19
First Post:
2014-11-06
Brief Title:
Prospective Clinical 5-year Follow-up of the LINK SP-CL Hip Prosthesis Stem
Sponsor:
Waldemar Link GmbH Co KG
Organization:
Waldemar Link GmbH Co KG
Study Overview
Official Title:
Prospective Clinical 5-year Follow-up of the LINK SP-CL Hip Prosthesis Stem
Status:
UNKNOWN
Status Verified Date:
2020-12
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this PMCF is to collect clinical and radiographic outcome information on Total Hip Arthroplasty THA performed with LINK SP-CL Hip Prosthesis Stem under routine conditions
The results collected will be used to clinically confirm the performance and safety of the LINK SP-CL Hip Prosthesis Stem in terms of the manufacturers obligation to perform a PMCF Furthermore the results can be used for future regulatory processes if needed
The results collected will be used to clinically confirm the performance and safety of the LINK SP-CL Hip Prosthesis Stem in terms of the manufacturers obligation to perform a PMCF Furthermore the results can be used for future regulatory processes if needed
Detailed Description:
Post Market Clinical Follow-ups PMCF through observational studies are an important tool to detect infrequent complications or problems events specific to defined patient populations and long term performance issues under routine conditions 23 Against this background a prospective multi-center outcome study of the LINK SP-CL is planned
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