NCT01957228

Brief Summary

On joint orthopaedic hardware infections are one of the most frequently encountered complications in orthopaedic surgery. However 6% of the cultures remain sterile, etiological diagnosis cannot be established despite obvious signs of infection. As part of this research project, we have developed a new strategy diagnosis including directly the use of PCR to reduce the number of negative results. This should have a major therapeutic impact in terms of timeliness and specificity of antibiotic. Primary: Evaluate the effectiveness of the new diagnostic strategy on etiological identification of prosthesis infections. Hypothesis: Minimum 6 percent increase in the number of patients with an etiological diagnosis of infection on prosthesis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
980

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2013

Longer than P75 for not_applicable

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

First Submitted

Initial submission to the registry

September 30, 2013

Completed
7 days until next milestone

Study Start

First participant enrolled

October 7, 2013

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 8, 2013

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 26, 2022

Completed
Last Updated

April 21, 2023

Status Verified

April 1, 2023

Enrollment Period

6 years

First QC Date

September 30, 2013

Last Update Submit

April 20, 2023

Conditions

Prosthetic Joint Infections

Outcome Measures

Primary Outcomes (1)

  • Bone biopsies multisite

    Increase of at least 6% of patients with an etiologic diagnosis of prosthesis infection established.

    4 years

Study Arms (1)

bone biopsies

EXPERIMENTAL
Procedure: bone biopsies

Interventions

bone biopsiesPROCEDURE
bone biopsies

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient is more than 18 years old.
  • Patient with a prescription of a microbiologic diagnostic of Prosthetic joint infection
  • Patient who do not declined to have his medical records reviewed for research
  • Patient with health insurance

You may not qualify if:

  • Patient minor (\<18 years).
  • Pregnant or lactating woman.
  • Major under guardianship Patient.
  • Patient deprived of liberty or under court order

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

Location

Study Officials

  • LOIC MONDOLONI

    Assistance Publique Hopitaux De Marseille

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2013

First Posted

October 8, 2013

Study Start

October 7, 2013

Primary Completion

September 30, 2019

Study Completion

October 26, 2022

Last Updated

April 21, 2023

Record last verified: 2023-04

Locations

FR(1)