Actively Recruiting
SHort Interval Full Two-stage Implant Exchange for Hip or Knee Prosthetic Joint Infection with Early Prosthesis Reimplantation
Led by University Hospital, Montpellier · Updated on 2024-08-06
100
Participants Needed
2
Research Sites
65 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new approach to treat hip or knee prosthetic joint infections (PJI) by testing the feasibility of a two-stage complete implant exchange with early prosthesis reimplantation between 16 and 30 days after implant removal. This prospective bicentric study includes 50 patients and compares them to a retrospective group of 50 patients who underwent the classical two-stage implant exchange with longer intervals. The goal is to find a safer and more efficient timing for reimplantation that may reduce immobilization and improve joint function. Participants in the prospective group will undergo a standardized surgical procedure where the prosthesis is reimplanted within 16 to 30 days after removal, combined with 12 weeks of antibiotic therapy according to French guidelines. The retrospective group consists of patients treated with the traditional two-stage method involving a longer delay before reimplantation, typically over six weeks. Both groups will be monitored and compared to evaluate outcomes related to infection control and joint functionality. Throughout the study, participants will receive seven clinical evaluations from the time of inclusion until 15 months after prosthesis removal. Researchers will assess feasibility by measuring the rate of patients following the protocol without major deviations at 3 months. Additional outcomes include clinical cure rates, reinfection rates, length of hospital stay, joint function at 6 and 15 months, quality of life assessments, and antibiotic tolerance. The total study duration is 42 months, allowing comprehensive follow-up and analysis of early reimplantation benefits and risks.
CONDITIONS
Brief Title
SHort Interval Full Two-stage Implant Exchange
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient over 18 years old
- Confirmed definite osteoarticular infection in a hip or knee prosthesis according to EBJIS definitions (2021)
- Indication for two-stage surgery due to inability for conservative or one-stage treatment
- Effective contraception during the study period for fertile women of childbearing age
- For retrospective group, patients managed before 31/12/2021 with definite osteoarticular infection and at least 15 months follow-up after antibiotics end
You will not qualify if you...
- Indication for conservative treatment, one-stage surgery, or long interval two-stage surgery
- Reimplantation requiring a different surgical approach than initial scar closure
- Other surgeries planned within 30 days of implant removal
- Participation in another interventional treatment study or exclusion period due to such participation
- Not affiliated with a social security plan or beneficiary
- Failure to obtain written informed consent
- Legal protection measures (guardianship, curatorship)
- Under judicial safeguard
- Pregnant or breastfeeding women
- Refusal to participate (retrospective group)
- Bacteriological samples positive for fungi
- Infection not confirmed after sample analysis
- Withdrawal of consent
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 16 to 30 days
Participants undergo implant removal followed by early prosthesis reimplantation within 16 to 30 days, with standardized surgical procedures.
1 surgery visit and immediate post-operative care
Duration - 12 weeks
Participants receive 12 weeks of adapted antibiotic therapy following prosthesis reimplantation according to French recommendations.
Regular visits for antibiotic therapy monitoring
Duration - Up to 15 months after prosthesis removal
Participants attend clinical evaluations to monitor recovery, infection status, joint functionality, and quality of life up to 15 months after prosthesis removal.
7 clinical evaluation visits from inclusion to month 15
Trial Site Locations
Total: 2 locations
1
CHU de Montpellier - Hôpital Saint-Eloi
Montpellier, France, 34090
Actively Recruiting
2
CH de Sète - Hôpitaux du bassin de Thau
Sète, France, 34200
Actively Recruiting
Research Team
N
Nathalie PANSU, MD
V
Vincent LE MOING, MD PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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