NCT03038464

Brief Summary

The two-stage protocol is gold standard in terms of infection control treating prosthetic joint infections of total hip and total knee arthroplasty. The antibiotic pause for diagnostic reasons before reconstruction (stage two) is discussed concerning persistence of infection and development of resistant bacterial strains. Serological markers and synovial analysis are common use to exclude persistence of infection. The investigators therefore asked 1) is the serological testing of c-reactive protein and leukocytes a valuable tool to predict a persistence of infection and 2) what is the role of synovial aspiration of PMMA Spacers on hip and knee joints.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

November 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 31, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

April 25, 2017

Status Verified

January 1, 2017

Enrollment Period

2.4 years

First QC Date

January 30, 2017

Last Update Submit

April 24, 2017

Conditions

Diagnosis Prosthetic Joint Infection

Outcome Measures

Primary Outcomes (1)

  • Reinfection rate

    Reinfection rate after reimplantation of joint prosthesis

    2 years

Interventions

Synovial biopsyDIAGNOSTIC_TEST

Biopsy of jint prior reimplantation of new joint prosthesis

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with periprostheitc joint infection

You may qualify if:

  • Patients with periprostheitc joint infection

You may not qualify if:

  • Reinfection in history

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinikum rechts der Isar

Munich, Bavaria, 81675, Germany

RECRUITING

Central Study Contacts

norbert harrasser

CONTACT

15232716657norbert.harrasser@gmx.net

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 30, 2017

First Posted

January 31, 2017

Study Start

November 1, 2016

Primary Completion

April 1, 2019

Study Completion

May 1, 2019

Last Updated

April 25, 2017

Record last verified: 2017-01

Locations

DE(1)