Clinical Trial: Cohort of Prosthetic Joint Infections

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Prospective Cohort of Patients With Prosthetic Joint Infection

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.


Detailed Summary:

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.

Sponsor: Groupe Hospitalier Diaconesses Croix Saint-Simon

Current Primary Outcome: Number of patients with hip and knee prosthetic joint reinfection (relapse and new infection) and multi-variable analysis of reinfection risk factors [ Time Frame: 4 years ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]
  • Assessment of mechanical failure rate six years after prosthesis revision with one or two stage exchange arthroplasty [ Time Frame: 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. [ Time Frame: 2 years ]
  • Assessment of reinfection rate of shoulder PJI two years after prosthesis revision with one or two stage exchange arthroplasty. [ Time Frame: 2 years ]


Original Secondary Outcome: Same as current

Information By: Groupe Hospitalier Diaconesses Croix Saint-Simon

Dates:
Date Received: May 27, 2016
Date Started: September 2015
Date Completion: September 2025
Last Updated: June 10, 2016
Last Verified: June 2016