NCT02262065

Brief Summary

Assessment of cytokine polymorphisms in 100 patients with aseptic complications to arthroplasty as compared to 100 symptom-free arthroplasty patients. In selected patients additional in-vitro cytokine release assay with peripheral blood mononuclear cells (PBMC) stimulated with different wear particles.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
195

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

December 23, 2013

Completed
10 months until next milestone

First Posted

Study publicly available on registry

October 10, 2014

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 22, 2019

Completed
Last Updated

February 27, 2019

Status Verified

February 1, 2019

Enrollment Period

5.5 years

First QC Date

December 23, 2013

Last Update Submit

February 26, 2019

Conditions

AllergyImplants

Keywords

implantallergyparticlecytokine

Outcome Measures

Primary Outcomes (1)

  • Polymorphism frequency

    Frequency of 4 different cytokine polymorphisms will be assessed in the 2 study groups.

    2 years

Secondary Outcomes (1)

  • Cytokine production

    1 year

Study Arms (2)

Patients

Patients with suspected arthroplasty intolerance

Controls

Patients with well tolerated arthroplasties

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with arthroplasty: A) without symptoms B) with aseptic complications

You may qualify if:

  • arthroplasty
  • over 18 years
  • no infection

You may not qualify if:

  • inability to consent
  • malposition
  • infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ludwig-Maximilians-University Munich, Dept. of Dermatology

Munich, Bavaria, 80337, Germany

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood samples of 20 patients (subgroup analysis)

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

  • Peter Thomas, Prof. Dr.

    Ludwig-Maximilians - University of Munich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

December 23, 2013

First Posted

October 10, 2014

Study Start

July 1, 2012

Primary Completion

January 1, 2018

Study Completion

February 22, 2019

Last Updated

February 27, 2019

Record last verified: 2019-02

Locations

DE(1)