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
Study Type
Enrollment (Anticipated)
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
<40
patients younger than 40 years
|
standardized wear particles are co-incubated with isolated patient cells (monocytes)
|
|
40-60
patients younger than 60 years and not older than 40 years
|
standardized wear particles are co-incubated with isolated patient cells (monocytes)
|
|
60-80
patients younger than 80 years and not older than 80 years
|
standardized wear particles are co-incubated with isolated patient cells (monocytes)
|
|
>80
patients older than 80 years
|
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
Time Frame: one hour
|
TNF-alpha concentration one hour after incubation of patient cells with wear particles in-vitro
|
one hour
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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