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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
268
Revision total hip arthroplasty (THA) due to periprosthetic joint infection
Charité - Universitätsmedizin Berlin
Berlin, Germany
RECRUITINGGruca Orthopedic and Trauma Teaching Hospital, Samodzielny Publiczny Szpital Kliniczny im. prof. Adama Grucy CMKP
Otwock, Poland
RECRUITINGOccurrence of periprosthetic joint infections
Participants are monitored for 12 months after revision surgery. Every case of periprosthetic joint infection according to the definition of the EBJIS classification counts.
Time frame: 12 months
Change of functional outcome over follow-up period (Harris Hip Score (HHS))
Harris-Hip-Score: The Harris Hip Score (HHS) is a clinical tool used to evaluate the function of the hip joint, particularly after hip surgery or in cases of hip disease. The HHS consists of 10 items divided into four categories: Pain (maximum 44 points) Function (maximum 47 points) Range of Motion (maximum 5 points) Deformity (maximum 4 points)
Time frame: 2 years post operative
Changes in quality of life
Measure Description: EQ-5D-5L The EQ-5D-5L is a standardized instrument used to measure health outcomes. Developed by the EuroQol Group (EQ), it assesses five dimensions (5D) of health: Mobility Self-care Usual activities Pain/discomfort Anxiety/depression Each dimension has five levels (5L) of severity: no problems, slight problems, moderate problems, severe problems, and extreme problems
Time frame: 2 years post operative
Implant survival
Measure Description: Kaplan-Meier implant survival Kaplan-Meier Analysis is a standard statistical method to describe the survival of human subjects or medical products over a defined time period. The revision-free survival rate is the performance indicator of the product under investigation and confirms the clinical outcome of the hip prosthesis. Information on survival of the implant will be collected until the last follow-up of the study patients took place.
Time frame: 2 years post operative
Radiographic assessment
radiographic measurements to assess implant migration, signs of loosening and changes in the fixation area over time
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Time frame: 2 years post operative
Occurrence of safety issues with the new device
Adverse events, device failures and component revision will be monitored throughout the study to assess the safety
Time frame: 2 years post operative
Level of silver ion concentration
Laboratory analysis will be performed to monitor silver ion concentration in biospecimen.
Time frame: 12 months
Changes in blood biomarkers for liver function
Participants will be monitored for their level of liver enzymes (ALT, AST, GGT)
Time frame: 12 months
Changes in blood biomarker for kidney function
Participants will be monitored for their level of kidney marker (eGFR).
Time frame: 12 months
Changes in blood biomarker for inflammation
Participants will be monitored for their level of inflammation marker CRP.
Time frame: 12 months