NCT06737809

IP-coated Revision Hip Implants

HIPrevision - A Randomized Multicenter Clinical Investigation of Antimicrobial IP-Coated Revision Hip Prostheses

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 268 (estimated)
• Sponsor: Aesculap AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DEVICE	IP Plasmafit® Revision cup (and stem) system	Revision total hip arthroplasty (THA) due to periprosthetic joint infection

Timeline

• Start date: 2025-06-25
• Primary completion: 2027-06-01
• Completion: 2028-06-01
• First posted: 2024-12-17
• Last updated: 2026-01-12

Locations

2 sites across 2 countries: Germany, Poland