IP-coated Revision Hip Implants
HIPrevision
HIPrevision - A Randomized Multicenter Clinical Investigation of Antimicrobial IP-Coated Revision Hip Prostheses
2 other identifiers
interventional
268
2 countries
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2025
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 19, 2024
CompletedFirst Posted
Study publicly available on registry
December 17, 2024
CompletedStudy Start
First participant enrolled
June 25, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2028
January 12, 2026
January 1, 2026
1.9 years
November 19, 2024
January 9, 2026
Conditions
Keywords
Outcome Measures
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.
12 months
Secondary Outcomes (9)
Change of functional outcome over follow-up period (Harris Hip Score (HHS))
2 years post operative
Changes in quality of life
2 years post operative
Implant survival
2 years post operative
Radiographic assessment
2 years post operative
Occurrence of safety issues with the new device
2 years post operative
- +4 more secondary outcomes
Study Arms (2)
IP coated hip arthroplasty implants
EXPERIMENTALParticipants receive an infection prevention (IP) coated hip implant
Standard hip arthroplasty implants
ACTIVE COMPARATORParticipants receive a standard (uncoated) hip implant
Interventions
Revision total hip arthroplasty (THA) due to periprosthetic joint infection
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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:
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Aesculap AGlead
Study Sites (2)
Charité - Universitätsmedizin Berlin
Berlin, 10117, Germany
Gruca Orthopedic and Trauma Teaching Hospital, Samodzielny Publiczny Szpital Kliniczny im. prof. Adama Grucy CMKP
Otwock, 05-400, Poland
Related Publications (1)
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.
PMID: 41699680DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sebastian Meller, Dr.
Charite University, Berlin, Germany
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 19, 2024
First Posted
December 17, 2024
Study Start
June 25, 2025
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
June 1, 2028
Last Updated
January 12, 2026
Record last verified: 2026-01