Actively Recruiting
SHort Interval Full Two-stage Implant Exchange
Led by University Hospital, Montpellier · Updated on 2024-08-06
100
Participants Needed
2
Research Sites
234 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a prospective bicentric feasibility study, which aims to evaluate the feasibility of a two-stage full implant exchange with early prosthesis reimplantation between 16 and 30 days after implants removal for hip or knee prosthetic joint infection. This study concern 50 patients, prospectively included and compared to the last 50 patients with hip or knee PJI managed with classical two-stage implant exchange. The duration of the study is 42 months.
CONDITIONS
Official Title
SHort Interval Full Two-stage Implant Exchange
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient over 18 years old
- Definite osteoarticular infection in a hip or knee prosthesis according to EBJIS 2021 definitions
- Indication for two-stage surgery due to inability for conservative treatment or unsuitability for one-stage change
- Effective contraception during the study for fertile women of childbearing age
- For retrospective group: treated before 31/12/2021 with definite infection and two-stage surgery with reimplantation time over 6 weeks and at least 15 months follow-up after antibiotics
You will not qualify if you...
- Indication for conservative treatment, one-stage or long two-stage surgery
- Reimplantation requiring a different surgical approach with complete skin closure of the initial scar
- Other surgeries planned within 30 days after implant removal
- Participation in another interventional treatment study or in exclusion period from another protocol
- Not affiliated with a social security plan
- Failure to provide written informed consent
- Under legal protection measures or justice safeguard
- Pregnant or breastfeeding women
- For retrospective group: refusal to participate
- Positive bacteriological samples for fungi
- Infection not confirmed by clinical or biological criteria
- Withdrawal of consent
AI-Screening
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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
CONTACT
V
Vincent LE MOING, MD PhD
CONTACT
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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