IP-coated Revision Hip Implants (HIPrevision)

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.

Study Overview

• Status: Recruiting
• Conditions: Peri-Prosthetic Joint Infection
• Intervention / Treatment: Device: IP Plasmafit® Revision cup (and stem) system

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 Type: Interventional
• Enrollment (Estimated): 268
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lutz Dreyer, Dr.; Phone Number: +49 7461 95; Email: hiprevision_study@bbraun.com
• Study Contact Backup: Name: Britta Wachter, Dr.; Phone Number: +49 746195; Email: hiprevision_study@bbraun.com

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Recruiting
    • Charite - Universitatsmedizin Berlin
    • Contact: Sebastian Meller, Dr.
• Poland
  • Otwock, Poland, 05-400
    • Recruiting
    • Gruca Orthopedic and Trauma Teaching Hospital, Samodzielny Publiczny Szpital Kliniczny im. prof. Adama Grucy CMKP
    • Contact: Jerzy Białecki, Prof. Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

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 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:
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IP coated hip arthroplasty implants; Participants receive an infection prevention (IP) coated hip implant	Device: IP Plasmafit® Revision cup (and stem) system; Revision total hip arthroplasty (THA) due to periprosthetic joint infection
Active Comparator: Standard hip arthroplasty implants; Participants receive a standard (uncoated) hip implant	Device: IP Plasmafit® Revision cup (and stem) system; Revision total hip arthroplasty (THA) due to periprosthetic joint infection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic assessment	radiographic measurements to assess implant migration, signs of loosening and changes in the fixation area over time	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	2 years post operative
Level of silver ion concentration	Laboratory analysis will be performed to monitor silver ion concentration in biospecimen.	12 months
Changes in blood biomarkers for liver function	Participants will be monitored for their level of liver enzymes (ALT, AST, GGT)	12 months
Changes in blood biomarker for kidney function	Participants will be monitored for their level of kidney marker (eGFR).	12 months
Changes in blood biomarker for inflammation	Participants will be monitored for their level of inflammation marker CRP.	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)	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	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.	2 years post operative

Collaborators and Investigators

• Sponsor: Aesculap AG
• Investigators: Principal Investigator: Sebastian Meller, Dr., Charite University, Berlin, Germany

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: November 19, 2024
• First Submitted That Met QC Criteria: December 12, 2024
• First Posted (Actual): December 17, 2024

Study Record Updates

• Last Update Posted (Estimated): January 12, 2026
• Last Update Submitted That Met QC Criteria: January 9, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: arthroplasty; silver; periprosthetic joint infection; hip; replacement; anti-infective agent
• Additional Relevant MeSH Terms: Investigative Techniques; Therapeutics; Diagnostic Techniques and Procedures; Diagnosis; Drug Therapy; Diagnostic Imaging; Microscopy; Microscopy, Electron, Transmission; Microscopy, Electron; Drug Delivery Systems; Microscopy, Electron, Scanning Transmission
• Other Study ID Numbers: AAG-G-H-2023; CIV-24-05-047447 (Other Identifier: EUDAMED)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No