Age Dependency of Biological Reaction on Wear Particles

NCT03164733 | Unknown

• 1 other identifier: AgeWear
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Total Hip Arthroplasty; Wear

Outcome Measures

Primary Outcomes (1)

• biological reaction

  TNF-alpha concentration one hour after incubation of patient cells with wear particles in-vitro

  one hour

Study Arms (4)

<40

patients younger than 40 years

Other: incubation

40-60

patients younger than 60 years and not older than 40 years

Other: incubation

60-80

patients younger than 80 years and not older than 80 years

Other: incubation

>80

patients older than 80 years

Other: incubation

Interventions

incubation OTHER

standardized wear particles are co-incubated with isolated patient cells (monocytes)

40-60; 60-80; <40; >80

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• no informed consent

Sponsors & Collaborators

• University of Jena: lead

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples of patients that have received a total hip arthroplasty

MeSH Terms

Interventions

Infectious Disease Incubation Period

Intervention Hierarchy (Ancestors)

Disease Transmission, Infectious; Public Health; Environment and Public Health

Central Study Contacts

Georg Matziolis, MD PhD

CONTACT

+49 36691 81011; g.matziolis@krankenhaus-eisenberg.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: head of the orthopaedic department

Study Record Dates

• First Submitted: May 22, 2017
• First Posted: May 24, 2017
• Study Start: August 1, 2017
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2020
• Last Updated: May 24, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share