Early prosthesis reimplantation for hip or knee joint infections

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective bicentric feasibility study evaluates the safety and efficiency of a two-stage full implant exchange with early prosthesis reimplantation between 16 and 30 days after implant removal for patients with hip or knee prosthetic joint infections (PJI). The study will include 50 patients who will undergo this procedure and will be compared to a retrospective group of 50 patients managed with the classical two-stage exchange method. The aim is to determine if earlier reimplantation, combined with a 12-week antibiotic therapy, can reduce immobilization time and improve joint functionality. Follow-up will consist of seven clinical evaluations over 15 months post-implant removal.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Prospective group:

* Patient over 18 years old
* Patient managed for a definite osteoarticular infection in a hip or knee prosthesis according to EBJIS definitions (2021) Clinical definition : fistula communicating with the prosthesis, prosthesis exposed / Or biological ≥ 2 samples positive for the same microorganism / And/ or 3000 leukocytes or \> 80% of PNN on the synovial fluid / Or histological: visible microorganism, \> or = 5 PNN on 5 HPN
* Patient with an indication for 2-stage surgery:

A Impossibility of conservative treatment : infection occurring more than 4 weeks after prosthesis implantation, fistula, documented resistant germ, loosened prosthesis / B Unsuitable 1-stage change: recurrence after 1-stage management, precarious bone capital, documented resistant microorganism, infection without prior microbiological documentation, fistula, surgeon's assessment in disfavor

\- Effective contraception during the research period for fertile women of childbearing age

Retrospective group :

* Patient managed before 31/12/2021 for a definite osteoarticular infection in a hip or knee prosthesis according to EBJIS definitions (2021) Clinical definition : fistula communicating with the prosthesis, prosthesis exposed Or biological ≥ 2 samples positive for the same microorganism And/ or 3000 leukocytes or \> 80% of PNN on the synovial fluid Or histological: visible microorganism, \> or = 5 PNN on 5 HPN
* Patient managed by 2 "long" stage surgery with reimplantation time \> 6 weeks with an evolutionary follow-up of at least 15 months after the end of antibiotics

Exclusion Criteria:

Prospective group :

* Indication for conservative treatment, 1-stage or 2 long stage surgery
* Reimplantation by another surgical approach requiring complete skin closure of the initial scar
* Other surgeries scheduled within 30 days of removal
* Participation in another interventional treatment study and/or in an exclusion period due to participation in another protocol
* Subject not affiliated with a social security plan or beneficiary of such a plan
* Failure to obtain written informed consent
* Patient with a legal protection measure (guardianship, curatorship)
* Patient under justice safeguard
* Pregnant or breastfeeding woman

Retrospective group :

\- Refusal to participate

Study exit criteria

* Bacteriological samples positive for fungi
* Infection not retained after analysis of samples (no sufficient clinical or biological criteria according to EBJIS definition)
* Withdrawal of consent

Where it's running

• CHU de Montpellier - Hôpital Saint-Eloi
  Montpellier, France Recruiting
• CH de Sète - Hôpitaux du bassin de Thau
  Sète, France Recruiting

Study contacts

• Principal investigator: Nathalie PANSU, MD — Infectious Diseases department, Montpellier university hospital
• Study coordinator: Nathalie PANSU, MD
• Email: n-pansu@chu-montpellier.fr
• Phone: +33467339510

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.