Age Dependency of Biological Reaction on Wear Particles

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.

Study Overview

• Status: Unknown
• Conditions: Total Hip Arthroplasty; Wear
• Intervention / Treatment: Other: incubation

• Study Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• no informed consent

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
<40; patients younger than 40 years	Other: incubation; standardized wear particles are co-incubated with isolated patient cells (monocytes)
40-60; patients younger than 60 years and not older than 40 years	Other: incubation; standardized wear particles are co-incubated with isolated patient cells (monocytes)
60-80; patients younger than 80 years and not older than 80 years	Other: incubation; standardized wear particles are co-incubated with isolated patient cells (monocytes)
>80; patients older than 80 years	Other: incubation; standardized wear particles are co-incubated with isolated patient cells (monocytes)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
biological reaction	TNF-alpha concentration one hour after incubation of patient cells with wear particles in-vitro	one hour

Collaborators and Investigators

• Sponsor: University of Jena

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2017
• Primary Completion (Anticipated): August 1, 2019
• Study Completion (Anticipated): August 1, 2020

Study Registration Dates

• First Submitted: May 22, 2017
• First Submitted That Met QC Criteria: May 22, 2017
• First Posted (Actual): May 24, 2017

Study Record Updates

• Last Update Posted (Actual): May 24, 2017
• Last Update Submitted That Met QC Criteria: May 22, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: AgeWear

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No