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New treatment option for Peri-Prosthetic Joint Infection
Official title IP-coated Revision Hip Implants
ClinicalTrials.gov ID: NCT06737809
What this study is testing
- What it's testing
- The primary aim of the clinical investigation is to demonstrate the efficacy of a silver-based antimicrobial coating on hip implants in the reduction of periprosthetic infections in revision hip arthroplasty due to periprosthetic infection.
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
- Patients \> 18 years
- Patients indicated for unilateral cementless acetabular and hip stem revision due to chronic periprosthetic infection (according to EBJIS...
- According to the assessment of the clinical investigator, the subject is therapy compliant and able to attend the follow-up visits
- ASA physical status I - III
- Patient's signed written informed consent is available
You likely can't join if
- Simultaneous participation in another treatment clinical trial (drugs or medical devices studies)
- The investigational implant components (femoral and/or acetabular) are not suitable for the patient anatomy or bone defect
- Patients who require plate osteosynthesis at the implantation site
- Patients with an already implanted silver-coated device
- Patients with immunodeficiency, i.e. patients currently receiving immunosuppressive therapy or patients with severe immunodeficiency requiring drug...
- Patients currently undergoing cancer treatment, e.g. chemotherapy or radiation therapy
See the full eligibility criteria
- Patients \> 18 years
- Patients indicated for unilateral cementless acetabular and hip stem revision due to chronic periprosthetic infection (according to EBJIS definition): single-stage or two-stage surgical procedure according to clinical...
- According to the assessment of the clinical investigator, the subject is therapy compliant and able to attend the follow-up visits
- ASA physical status I - III
- Patient's signed written informed consent is available
- Simultaneous participation in another treatment clinical trial (drugs or medical devices studies)
- The investigational implant components (femoral and/or acetabular) are not suitable for the patient anatomy or bone defect
- Patients who require plate osteosynthesis at the implantation site
- Patients with an already implanted silver-coated device
- Patients with immunodeficiency, i.e. patients currently receiving immunosuppressive therapy or patients with severe immunodeficiency requiring drug therapy
- Patients currently undergoing cancer treatment, e.g. chemotherapy or radiation therapy
- Severe soft tissue defects that require local or free flap procedure
- Periprosthetic joint infections with evidence of fungal infection
- Antibiotic suppression therapy
- BMI \> 40 kg/m2
- Pregnancy, breast-feeding, or women of childbearing potential and not taking adequate contraceptive precautions
- Known or patient reported hypersensitivity to silver or titanium
- Patients held in a custodial setting
- Patients in a relationship of dependence on the sponsor, the clinic or the investigator
- Patients with contraindication for the investigational and comparator devices:
- in case of secondary diseases influencing the function of the joint implant
- in case of severe osteoporosis or osteomalacia
- in case of poor bone quality and osseous malformations, diseases in the area of the implant fixation, which may primarily or subsequently affect the stability of the joint replacement anchorage
- in case of non-regenerative bone conditions with lack of proximal femoral bone support and failure of defect union when use of prosthesis heads with neck length XXL is indicated
The study team makes the final eligibility decision.
Where it's taking place
- Berlin, Germany
- Otwock, Poland
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 Berlin, Germany; Otwock, Poland. 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.