NCT04446676

Impact of the Type of Stabilization in the Two-stage Knee Reimplantation on Reinfection - Prospective, Randomized Study.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Prof A Gruca Teaching Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

Summary

Participants after first-stage of knee infection reimplantation will be assign to one of two groups: with stem vs. with sleeve. Investigators will check participants on clinical, laboratory and reinfection signs. The main hypothesis is that better mechanical stability of endoprosthesis with sleeves will support infection treatment.

Detailed description

All participants will be treated because of periprosthetic joint infection of the knee, after primary arthroplasty. All participants will be treated with two-stage protocol. In first stage debridement and spacer implantation will be performed. After 6-week antibiotics, when will be absent clinical or laboratory signs of reinfection, second stage will be performed. All participants upon fulfillment all inclusion and exclusion criteria will sign informed consent. With computer software patients will be randomized to one of two groups: with stem vs. with sleeve. After operation all patients will get target antibiotics for 3 weeks. Pre-operation and after on periodic controls will checked the Knee Society Score, The Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC), Visual Analogue Scale. After 2-year observation evaluation of reinfection rate will be performed in both groups.

Conditions

• Knee Infection

Interventions

Type	Name	Description
DEVICE	stabilization with stem	In both groups revision endoprosthesis of knee will be implanted with stem or sleeve stabilization.
DEVICE	stabilization with sleeve	In both groups revision endoprosthesis of knee will be implanted with stem or sleeve stabilization.

Timeline

• Start date: 2020-11-17
• Primary completion: 2026-07-01
• Completion: 2027-01-01
• First posted: 2020-06-25
• Last updated: 2022-03-15

Locations

1 site across 1 country: Poland