Viewing Study NCT03164733


Ignite Creation Date: 2025-12-25 @ 2:45 AM
Ignite Modification Date: 2025-12-30 @ 9:20 PM
Study NCT ID: NCT03164733
Status: UNKNOWN
Last Update Posted: 2017-05-24
First Post: 2017-05-22
Is Gene Therapy: True
Has Adverse Events: False

Brief Title: Age Dependency of Biological Reaction on Wear Particles
Sponsor: University of Jena
Organization:

Study Overview

Official Title: Age Dependency of Biological Reaction on Wear Particles
Status: UNKNOWN
Status Verified Date: 2017-05
Last Known Status: NOT_YET_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: Wear is the main reason for revision operations after joint arthroplasty. While the survival of modern implants is often longer than the expected life span in old patients, young patients (\<60 years) have to expect at least one wear induced revision operation. The reason is the throughout all registries consistantly significantly reduced implant survival rates in young patients. In the swedish arthrplasty registry the 15 year survival for patients older than 75 years is 95 % and for those younger than 50 years is 75 %. This corresponds to a 5fold increased revision rate (5 % vs. 25 %) 15 years after implantation. This significant difference cannot be explained by the higher activity of younger patients alone. Patient specific factors, that modulate the biological reaction on wear particles, are therefore highly probable. These could explain the significant age dependency of implant survival.

The main hypothesis of this study is therefore, that the biological reaction on wear particles depends on the patients age.
Detailed Description: None

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: