Peri-Prosthetic Joint InfectionHIPrevisionNCT06737809
IP-coated Revision Hip Implants
A study testing IP Plasmafit® Revision cup (and stem) system in people with Peri-Prosthetic Joint Infection, run by Aesculap AG at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peri-Prosthetic Joint Infection
- What is being tested?
- IP Plasmafit® Revision cup (and stem) system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 268 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 25 Jun 2025to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Germany1 site, 1 recruiting
- Recruiting
Charité - Universitätsmedizin Berlin
Berlin, 10117
Sebastian Meller, Dr.
Poland1 site, 1 recruiting
- Recruiting
Gruca Orthopedic and Trauma Teaching Hospital, Samodzielny Publiczny Szpital Kliniczny im. prof. Adama Grucy CMKP
Otwock, 05-400
Jerzy Białecki, Prof. Dr.
About this study
Official title: HIPrevision - A Randomized Multicenter Clinical Investigation of Antimicrobial IP-Coated Revision Hip Prostheses
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.
Read the 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.
- Conditions
- Peri-Prosthetic Joint Infection
- Being tested
- IP Plasmafit® Revision cup (and stem) system
- Keywords
- arthroplasty, replacement, hip, anti-infective agent, silver, periprosthetic joint infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IP Plasmafit® Revision cup (and stem) systemDevice
Revision total hip arthroplasty (THA) due to periprosthetic joint infection
| Study group | Role | What they receive |
|---|---|---|
| IP coated hip arthroplasty implants | Experimental | Participants receive an infection prevention (IP) coated hip implant Receives: Device: IP Plasmafit® Revision cup (and stem) system |
| Standard hip arthroplasty implants | Active comparator | Participants receive a standard (uncoated) hip implant Receives: Device: IP Plasmafit® Revision cup (and stem) system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (9)
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)
Measured: 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
Measured: 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.
Measured: 2 years post operative
Radiographic assessment
radiographic measurements to assess implant migration, signs of loosening and changes in the fixation area over time
Measured: 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
Measured: 2 years post operative
Level of silver ion concentration
Laboratory analysis will be performed to monitor silver ion concentration in biospecimen.
Measured: 12 months
Changes in blood biomarkers for liver function
Participants will be monitored for their level of liver enzymes (ALT, AST, GGT)
Measured: 12 months
Changes in blood biomarker for kidney function
Participants will be monitored for their level of kidney marker (eGFR).
Measured: 12 months
Changes in blood biomarker for inflammation
Participants will be monitored for their level of inflammation marker CRP.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start25 Jun 2025
- Primary completionJun 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peri-Prosthetic Joint InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 268 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aesculap AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sebastian Meller, Dr., Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06737809
- Sponsor's protocol ID
- AAG-G-H-2023
- Other IDs
- CIV-24-05-047447
- Acronym
- HIPrevision
- Status last verified
- Jan 2026
- First submitted
- 19 Nov 2024
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Alt V, Walter N, Baixauli F, Bialecki J, Dreyer L, Goronzy J, Hardt S, Herold D, Kendoff D, Maenz S, Rak D, Rudert M, Sionek A, Stiehler M, Meller S. HIPrevision - a multicenter prospective randomized control superiority trial of antimicrobial IP-coated revision hip prostheses versus non-IP-coated comparators for the revision of periprosthetic hip joint infections. Trials. 2026 Feb 17;27(1):174. doi: 10.1186/s13063-026-09541-6.
PubMed 41699680
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HIPrevision - A Randomized Multicenter Clinical Investigation of Antimicrobial IP-Coated Revision Hip Prostheses
- ClinicalTrials.gov ID
- NCT06737809
- Acronym / sponsor ID
- HIPrevision / AAG-G-H-2023
- Conditions
- Peri-Prosthetic Joint Infection
- Keywords
- arthroplasty, replacement, hip, anti-infective agent, silver, periprosthetic joint infection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 268 participants (estimated)
- Lead sponsor
- Aesculap AGIndustry (pharma, biotech, devices)
- Study start
- 25 Jun 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 17 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IP coated hip arthroplasty implants | Experimental | Device: IP Plasmafit® Revision cup (and stem) systemParticipants receive an infection prevention (IP) coated hip implant |
| Standard hip arthroplasty implants | Active comparator | Device: IP Plasmafit® Revision cup (and stem) systemParticipants receive a standard (uncoated) hip implant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IP Plasmafit® Revision cup (and stem) systemRevision total hip arthroplasty (THA) due to periprosthetic joint infection | Device | IP coated hip arthroplasty implants, Standard hip arthroplasty implants |
Primary outcome
Occurrence of periprosthetic joint infections
Time frame: 12 months
Participants are monitored for 12 months after revision surgery. Every case of periprosthetic joint infection according to the definition of the EBJIS classification counts.
9 secondary outcomes
Change of functional outcome over follow-up period (Harris Hip Score (HHS))
Time frame: 2 years post operative
Changes in quality of life
Time frame: 2 years post operative
Implant survival
Time frame: 2 years post operative
Radiographic assessment
Time frame: 2 years post operative
Occurrence of safety issues with the new device
Time frame: 2 years post operative
Level of silver ion concentration
Time frame: 12 months
Changes in blood biomarkers for liver function
Time frame: 12 months
Changes in blood biomarker for kidney function
Time frame: 12 months
Changes in blood biomarker for inflammation
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Derived from this study: PubMed 41699680Alt V, Walter N, Baixauli F, Bialecki J, Dreyer L, Goronzy J, Hardt S, Herold D, Kendoff D, Maenz S, Rak D, Rudert M, Sionek A, Stiehler M, Meller S. HIPrevision - a multicenter prospective randomized control superiority trial of antimicrobial IP-coated revision hip prostheses versus non-IP-coated comparators for the revision of periprosthetic hip joint infections. Trials. 2026 Feb 17;27(1):174. doi: 10.1186/s13063-026-09541-6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sebastian Meller, Dr. principal investigator
Charite University, Berlin, Germany
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IP Plasmafit® Revision cup (and stem) system in people with Peri-Prosthetic Joint Infection, run by Aesculap AG at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lutz Dreyer, Dr. (+49 7461 95 ext. 0, hiprevision_study@bbraun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of periprosthetic joint infections (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06737809, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.