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NCT Number: NCT02801253

Cohort of Prosthetic Joint Infections

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Groupe Hospitalier Diaconesses Croix Saint Simon

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

Location status: Recruiting

Location contact

Valérie ZELLER, Doctorate

CONTACT

[email protected]

(+33)1 44 64 17 80

Younes KERROUMI, Doctorate

CONTACT

[email protected]

(+33)1 44 64 33 84

About this study

Large prospective cohort study in a French referral center for bone and joint infections.

Population

  • all patients who consented to participate in the study with PJI treated with:
  • debridement-synovectomy for acute infection
  • with one-stage, two-stage exchange arthroplasty for chronic infection
  • other procedures (complete removal of the prosthesis) and antibiotic therapy
  • patients (non-operated or operated) receiving prolonged suppressive antibiotic therapy

Outcome:

  • Follow-up at least 2 years
  • Events monitored: reinfection including relapse and new infection, joint revision for mechanical failure, PJI related or non-related death Study duration: 10 years. Recruitment period: 4 years. Maximal duration of data collection: 6 years. Investigator center: monocenter study. Mean patient inclusion per year: 100 patients per year.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Germ identification in a single sample of fluid aspiration or tissue culture.
  • Or microbial growth in prosthesis sonication fluid culture greater than 50CFU/ml.

Exclusion criteria

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

Treatment and study plan

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

    Time frame: 2 years

Secondary outcomes

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

    Time frame: 1, 2, 4, 6 years

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

    Time frame: 6 years

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

    Time frame: 2 years

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

    Time frame: 2 years

Study contacts

Contact information is provided by the study sponsor or research team.

YOUNES KERROUMI, Doctorate

CONTACT

[email protected]

(+33) 1 64 44 33 84

Sponsors and collaborators

Lead sponsor

Groupe Hospitalier Diaconesses Croix Saint-Simon

Other

Registry information

Official study title

Prospective Cohort of Patients With Prosthetic Joint Infection

Acronym: COPINS

Important dates

Study start
2015
Primary completion
2025
Study completion
2029
First posted
Jun 15, 2016
Registry last updated
Mar 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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