Age Dependency of Biological Reaction on Wear Particles

• Conditions: Wear; Total Hip Arthroplasty
• Interventions: Other: incubation

• Registration Number: NCT03164733
• Lead Sponsor: University of Jena

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

Not available

Study Timeline

• Status Verified: 2017-05
• Study First Submitted: 2017-05-22
• Study First Submitted QC: 2017-05-22
• Last Update Submitted: 2017-05-22
• Study First Posted: 2017-05-24
• Last Update Posted: 2017-05-24
• Study Start: 2017-08
• Primary Completion: 2019-08
• Study Completion: 2020-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• having received a total hip arthroplasty 4 weeks before blood sample for this study

Exclusion Criteria

• no informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
40-60	incubation	patients younger than 60 years and not older than 40 years
60-80	incubation	patients younger than 80 years and not older than 80 years
<40	incubation	patients younger than 40 years
>80	incubation	patients older than 80 years

Primary Outcome Measures

Name	Time	Method
biological reaction	one hour	TNF-alpha concentration one hour after incubation of patient cells with wear particles in-vitro