Cohort of Prosthetic Joint Infections

NCT02801253 | Recruiting DMC

• 1 other identifier: ID RCB: 2014-A01100-47
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

Management of prosthetic joint infections (PJI) is a challenging task. These infections include different clinical and microbiological settings calling upon various treatment strategies according to infection type (acute or chronic), bone quality, the involved micro-organism and the patient's general condition and willing. Treatment of PJI combines surgery and prolonged antibiotic therapy. In some patients with a high operative risk prolonged suppressive antibiotic therapy can be used. Lack of large prospective studies motivated the conception of this cohort with a long term follow up, regardless to PJI management procedures.

Conditions

Prosthetic Joint Infection

Outcome Measures

Primary Outcomes (1)

• Number of patients with hip and knee prosthetic joint reinfection (relapse and new infection) and multi-variable analysis of reinfection risk factors

  2 years

Secondary Outcomes (4)

• Assessment of joint function at one, two, four and 6 years after prosthesis revision with one or two stage exchange arthroplasty.

  1, 2, 4, 6 years

• Assessment of mechanical failure rate six years after prosthesis revision with one or two stage exchange arthroplasty

  6 years

• Assessment of treatment failure rate in patients with hip and knee PJI 2 years after prolonged suppressive antibiotic therapy in non-operated patients.

  2 years

• Assessment of reinfection rate of shoulder PJI two years after prosthesis revision with one or two stage exchange arthroplasty.

  2 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients managed in the investigators referral center of bone and joint infection, who meet protocol selection criteria will be included in the study. The investigators expect to recruit 400 patients.

You may qualify if:

• Patient aged over 18 years old with hip, knee and or shoulder joint prosthesis who consented to participate in the study with:
• According to musculoskeletal infection society definition: PJI is present when one of the major criteria exists or four out of six minor criteria.
• Major Criteria:
• Two positive periprosthetic cultures with phenotypically identical organisms, OR
• A sinus tract communicating with the joint, OR
• Minor Criteria:
• Elevated serum C-reactive protein (CRP) AND erythrocyte sedimentation rate (ESR)
• Elevated synovial fluid white blood cell (WBC)
• Elevated synovial fluid polymorphonuclear neutrophil percentage (PMN%)
• The presence of pus in the joint without known cause
• Positive histological analysis of periprosthetic tissue
• A single positive culture
• Or a PJI which meets the following three criteria:
• Medical story suggesting prosthetic joint infection.
• The presence of pain either with or without swelling for more than 3 months unrelated to a mechanical cause.

You may not qualify if:

• Patient who does not meet eligibility criteria.
• Patient lawfully deprived of his liberty.
• Patient not insured under social security scheme.

Sponsors & Collaborators

• Groupe Hospitalier Diaconesses Croix Saint-Simon: lead

Study Sites (1)

Groupe Hospitalier Diaconesses Croix Saint Simon

Paris, Île-de-France Region, 75020, France

RECRUITING

Study Officials

• VALERIE ZELLER, Doctorate

  Groupe Hospitalier Diaconesses Croix Saint-Simon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

YOUNES KERROUMI, Doctorate

CONTACT

(+33) 1 64 44 33 84; ykerroumi@hopital-dcss.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: infectious diseases specialist

Study Record Dates

• First Submitted: May 27, 2016
• First Posted: June 15, 2016
• Study Start: September 11, 2015
• Primary Completion: September 1, 2025
• Study Completion (Estimated): September 1, 2029
• Last Updated: March 29, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)