Age Dependency of Biological Reaction on Wear Particles

Total Hip Arthroplasty Clinical Trial

Official title:

Age Dependency of Biological Reaction on Wear Particles

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03164733
• Other study ID #: AgeWear
• Status: Not yet recruiting
• Phase: N/A
• First received: May 22, 2017
• Last updated: May 22, 2017
• Start date: August 2017
• Est. completion date: August 2020

Study information

• Verified date: May 2017
• Source: University of Jena
• Contact: Georg Matziolis, MD PhD
• Phone: +49 36691 81011
• Email: g.matziolis[@]krankenhaus-eisenberg.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: August 2020
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• no informed consent

Related Conditions & MeSH terms

• Total Hip Arthroplasty
• Wear

Intervention

Other:
• incubation
standardized wear particles are co-incubated with isolated patient cells (monocytes)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Jena

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	biological reaction	TNF-alpha concentration one hour after incubation of patient cells with wear particles in-vitro	one hour