IP-coated Revision Hip Implants
ConditionPeri-Prosthetic Joint Infection
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAesculap AG
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
IP Plasmafit® Revision cup (and stem) system
DeviceRevision total hip arthroplasty (THA) due to periprosthetic joint infection
Treatment groups
268 Participants
are divided into 2 treatment groupsGroup A: IP coated hip arthroplasty implantsExperimental treatment 1 intervention
Group B: Standard hip arthroplasty implantsActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Occurrence 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 monthsSecondary outcomes
1
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 operative2
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 operative3
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 operative4
Radiographic assessment
radiographic measurements to assess implant migration, signs of loosening and changes in the fixation area over time
Time frame
2 years post operativeSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov