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

Not Applicable

Recruiting

• Conditions: Knee Infection
• Interventions: Device: stabilization with stem; Device: stabilization with sleeve

• Registration Number: NCT04446676
• Lead Sponsor: Prof A Gruca Teaching Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2020-06-21
• Study First Submitted QC: 2020-06-23
• Study First Posted: 2020-06-25
• Study Start: 2020-11-17
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-14
• Last Update Posted: 2022-03-15
• Primary Completion: 2026-07
• Study Completion: 2027-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• second-stage of knee reimplantation
• primary knee replacement in primary knee osteoarthritis
• fulfillment of International Consensus Meeting 2018 infection criteria

Exclusion Criteria

• intraoperative bone defects Anderson Orthopedic Research Institute score >II
• autoimmune disease
• diabetes
• peripheral vascular disease
• congenital or acquired immunodeficiencies
• lack of pathogens after first-stage
• multi-bacterial infection
• multidirectional instability
• lack of patient consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stem stabilization	stabilization with stem	Group of patients with stem endoprosthesis stabilization
Sleeve stabilization	stabilization with sleeve	Group of patients with sleeve endoprosthesis stabilization

Primary Outcome Measures

Name	Time	Method
Reinfection	2 years	Rate of reinfection in both groups

Secondary Outcome Measures

Name	Time	Method
Loosening radiological signs	2 years	Radiological evaluation of implant loosening with Modern Knee Society Radiographic Evaluation System

Trial Locations

Locations (1)

Gruca Teaching Hospital, Centre of Postgraduate Medical Centre; 🇵🇱 Otwock, Mazowieckie, Poland