IP-coated Revision Hip Implants
Recruiting now · Not applicable
Conditions studied: Peri-Prosthetic Joint Infection
In brief
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.
Key facts
- Study ID
- NCT06737809
- Run by
- Aesculap AG
- People needed
- 268
- Starts
- 2025-06-25
- Expected to finish
- 2028-06-01
- Last updated by the study team
- 2026-01-12
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 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
Where it is running
- Charité - Universitätsmedizin Berlin — Berlin, Germany (enrolling)
- Gruca Orthopedic and Trauma Teaching Hospital, Samodzielny Publiczny Szpital Kliniczny im. prof. Adama Grucy CMKP — Otwock, Poland (enrolling)
Full record on ClinicalTrials.gov
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