Cohort of patients with prosthetic joint infections
Prospective Cohort of Patients With Prosthetic Joint Infection
This study is tracking adults with prosthetic joint infections to see how different treatments affect their recovery and long-term health over two years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 800 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Groupe Hospitalier Diaconesses Croix Saint-Simon Academic / other |
| Locations | 1 site (Paris, Île-de-France Region) |
| Trial ID | NCT02801253 on ClinicalTrials.gov |
What this trial studies
This observational cohort study aims to manage and monitor patients with prosthetic joint infections (PJI) at a French referral center. It includes patients over 18 years old who have undergone various treatment strategies for PJI, such as debridement-synovectomy or exchange arthroplasty, and those receiving prolonged suppressive antibiotic therapy. The study will follow participants for at least two years to assess outcomes like reinfection rates, joint revisions, and mortality related to PJI. The study spans a total duration of 10 years, with a recruitment period of 4 years and a maximum data collection period of 6 years.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with hip, knee, or shoulder joint prostheses diagnosed with prosthetic joint infections.
Not a fit: Patients without a confirmed diagnosis of prosthetic joint infection or those under 18 years old may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the management and treatment strategies for patients suffering from prosthetic joint infections.
How similar studies have performed: While there is a lack of large prospective studies in this area, the approach of long-term follow-up in managing PJI is promising and could provide valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Paris, Île-de-France Region
- Groupe Hospitalier Diaconesses Croix Saint Simon — Paris, Île-de-France Region, France (Recruiting)
Study contacts
- Principal investigator: VALERIE ZELLER, Doctorate — Groupe Hospitalier Diaconesses Croix Saint-Simon
- Study coordinator: YOUNES KERROUMI, Doctorate
- Email: ykerroumi@hopital-dcss.org
- Phone: (+33) 1 64 44 33 84
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.