Revision hip implants with IP silver antimicrobial coating

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults indicated for unilateral cementless acetabular and femoral stem revision due to chronic periprosthetic joint infection will receive either standard CE-marked revision components or the same components with an IP (infection-prevention) silver coating, using the site's usual single-stage or two-stage surgical approach. The primary aim is to determine whether the silver coating reduces subsequent periprosthetic infection and the need for further revision surgery. Participants will be followed at predefined postoperative visits to record infection events, implant survival, pain, and functional outcomes. The coated components are intended to provide the same mechanical restoration and pain relief as uncoated implants while adding local antimicrobial protection.

Why it matters

Who can join: the full rules

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

Where it's running

• Charité - Universitätsmedizin Berlin
  Berlin, Germany Recruiting
• Gruca Orthopedic and Trauma Teaching Hospital, Samodzielny Publiczny Szpital Kliniczny im. prof. Adama Grucy CMKP
  Otwock, Poland Recruiting

Study contacts

• Principal investigator: Sebastian Meller, Dr. — Charite University, Berlin, Germany
• Study coordinator: Lutz Dreyer, Dr.
• Email: hiprevision_study@bbraun.com
• Phone: +49 7461 95

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.