BridgeMD
New treatment option for Prosthetic-joint Infection
Official title SHort Interval Full Two-stage Implant Exchange
ClinicalTrials.gov ID: NCT05642013
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Patient with an indication for 2-stage surgery: A Impossibility of conservative treatment : infection occurring more than 4 weeks after prosthesis...
- Patient managed before 31/12/2021 for a definite osteoarticular infection in a hip or knee prosthesis according to EBJIS definitions (2021) Clinical...
You likely can't join if
- 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 treatment 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
See the full eligibility 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...
- 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 /...
- 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...
- 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
- 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 treatment 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
The study team makes the final eligibility decision.
Where it's taking place
- Montpellier, France
- Sète, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Montpellier, France; Sète, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.