Early prosthesis reimplantation for hip or knee joint infections
SHort Interval Full Two-stage Implant Exchange
This study is testing if putting a new hip or knee joint back in sooner after an infection can help patients recover faster and use their joint better compared to the usual waiting time.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Montpellier Academic / other |
| Locations | 2 sites (Montpellier and 1 other locations) |
| Trial ID | NCT05642013 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with a confirmed hip or knee prosthetic joint infection requiring a two-stage surgical intervention.
Not a fit: Patients with infections that can be managed conservatively or those not suitable for two-stage surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to shorter recovery times and improved joint functionality for patients with prosthetic joint infections.
How similar studies have performed: While two-stage implant exchange is a common practice, this specific approach of early reimplantation is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Montpellier and 1 other locations
- 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
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.