IP-coated Revision Hip Implants (NCT06737809) | Clinical Trial Compass
RecruitingNot Applicable
IP-coated Revision Hip Implants
Germany, Poland268 participantsStarted 2025-06-25
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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 standard at the clinical investigation site
* 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
Exclusion Criteria:
* Simultaneous participation in another interventional 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 hypersensitivi…