Actively Recruiting
IP-coated Revision Hip Implants
Led by Aesculap AG · Updated on 2026-01-12
268
Participants Needed
2
Research Sites
153 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
IP-coated Revision Hip Implants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients older than 18 years
- Patients indicated for unilateral cementless acetabular and hip stem revision due to chronic periprosthetic infection, using single-stage or two-stage surgery
- Patients assessed as therapy compliant and able to attend follow-up visits
- Patients with ASA physical status I to III
- Patients who have signed written informed consent
You will not qualify if you...
- Participation in another interventional clinical trial involving drugs or medical devices
- Implant components unsuitable for patient anatomy or bone defect
- Need for plate osteosynthesis at the implantation site
- Previous implantation of a silver-coated device
- Immunodeficiency or current immunosuppressive therapy
- Ongoing cancer treatment such as chemotherapy or radiation
- Severe soft tissue defects requiring flap procedures
- Periprosthetic joint infections with fungal infection
- Current antibiotic suppression therapy
- Body mass index over 40 kg/m2
- Pregnancy, breastfeeding, or inadequate contraception in women of childbearing potential
- Known or reported allergies to silver or titanium
- Patients in custodial settings or dependent relationships with sponsor or investigators
- Contraindications due to joint function diseases, severe osteoporosis or osteomalacia
- Poor bone quality, malformations, or diseases affecting implant stability
- Non-regenerative bone conditions lacking proximal femoral support and failed defect union when XXL prosthesis heads are needed
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Charité - Universitätsmedizin Berlin
Berlin, Germany, 10117
Actively Recruiting
2
Gruca Orthopedic and Trauma Teaching Hospital, Samodzielny Publiczny Szpital Kliniczny im. prof. Adama Grucy CMKP
Otwock, Poland, 05-400
Actively Recruiting
Research Team
L
Lutz Dreyer, Dr.
CONTACT
B
Britta Wachter, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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