IP-coated Revision Hip Implants
ConditionPeri-Prosthetic Joint Infection
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAesculap AG
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- IP Plasmafit® Revision cup (and stem) system
Treatment groups
268 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov