| NCT ID | NCT06737809 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Aesculap AG |
| Condition | Peri-Prosthetic Joint Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 268 participants |
| Start Date | 2025-06-25 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 268 participants in total. It began in 2025-06-25 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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 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
Contact & Investigator
Sebastian Meller, Dr.
PRINCIPAL INVESTIGATOR
Charite University, Berlin, Germany
Frequently Asked Questions
Who can join the NCT06737809 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Peri-Prosthetic Joint Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06737809 currently recruiting?
Yes, NCT06737809 is actively recruiting participants. Contact the research team at hiprevision_study@bbraun.com for enrollment information.
Where is the NCT06737809 trial being conducted?
This trial is being conducted at Berlin, Germany, Otwock, Poland.
Who is sponsoring the NCT06737809 clinical trial?
NCT06737809 is sponsored by Aesculap AG. The principal investigator is Sebastian Meller, Dr. at Charite University, Berlin, Germany. The trial plans to enroll 268 participants.