Clinical trial NCT06737809: IP-coated Revision Hip Implants
Official title: HIPrevision - A Randomized Multicenter Clinical Investigation of Antimicrobial IP-Coated Revision Hip Prostheses
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Peri-Prosthetic Joint Infection
Keywords: arthroplasty
replacement
hip
anti-infective agent
silver
periprosthetic joint infection
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
First posted: 2024-12-17
Enrollment: 268
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: The clinical investigation will include patients indicated for revision hip arthroplasty due to chronic periprosthetic infection. Subjects will either receive standard CE-marked revision hip implants or the newly developed IP (Infection prevention)- coated revision hip implants. The primary clinical benefit of the IP hip implant components remains the functional restoration of the hip joint and pain relief, as successfully shown for the uncoated predecessor devices, but additionally the IP coating is regarded ancillary to the intended purpose of the implant. Periprosthetic infections are one of the major complications in revision hip arthroplasty, leading to implant re-revision. A clinical investigation to evaluate additional measures to reduce this complication rate in revision total hip arthroplasty therefore has high clinical relevance.

Eligibility criteria: Inclusion Criteria:

* 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 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 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

Primary outcomes:
measure: Occurrence of periprosthetic joint infections
timeFrame: 12 months
Secondary outcomes:
measure: Change of functional outcome over follow-up period (Harris Hip Score (HHS))
timeFrame: 2 years post operative
measure: Changes in quality of life
timeFrame: 2 years post operative
measure: Implant survival
timeFrame: 2 years post operative
measure: Radiographic assessment
timeFrame: 2 years post operative
measure: Occurrence of safety issues with the new device
timeFrame: 2 years post operative
measure: Level of silver ion concentration
timeFrame: 12 months
measure: Changes in blood biomarkers for liver function
timeFrame: 12 months
measure: Changes in blood biomarker for kidney function
timeFrame: 12 months
measure: Changes in blood biomarker for inflammation
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References: