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Age Dependency of Biological Reaction on Wear Particles

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03164733
Recruitment Status : Unknown
Verified May 2017 by Georg Matziolis, Jena University Hospital.
Recruitment status was:  Not yet recruiting
First Posted : May 24, 2017
Last Update Posted : May 24, 2017
Sponsor:
Information provided by (Responsible Party):
Georg Matziolis, Jena University Hospital

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.


Condition or disease Intervention/treatment
Total Hip Arthroplasty Wear Other: incubation

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Age Dependency of Biological Reaction on Wear Particles
Estimated Study Start Date : August 2017
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2020

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)




Primary Outcome Measures :
  1. biological reaction [ Time Frame: one hour ]
    TNF-alpha concentration one hour after incubation of patient cells with wear particles in-vitro


Biospecimen Retention:   Samples With DNA
Blood samples of patients that have received a total hip arthroplasty


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
80 patients having received a total hip arthroplasty 4 weeks before blood sample for this study
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • no informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03164733


Contacts
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Contact: Georg Matziolis, MD PhD +49 36691 81011 g.matziolis@krankenhaus-eisenberg.de

Sponsors and Collaborators
University of Jena
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Responsible Party: Georg Matziolis, head of the orthopaedic department, Jena University Hospital
ClinicalTrials.gov Identifier: NCT03164733    
Other Study ID Numbers: AgeWear
First Posted: May 24, 2017    Key Record Dates
Last Update Posted: May 24, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No