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

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.

Study Overview

• Status: Recruiting
• Conditions: Knee Infection
• Intervention / Treatment: Device: stabilization with stem; Device: stabilization with sleeve

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 Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Paweł Bartosz; Phone Number: +48 793629685; Email: pbartosz@vp.pl

Study Locations

• Poland
  • Mazowieckie
    • Otwock, Mazowieckie, Poland, 05-400
      • Recruiting
      • Gruca Teaching Hospital, Centre of Postgraduate Medical Centre
      • Contact: Paweł Bartosz; Phone Number: +48 793629685; Email: pbartosz@vp.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Stem stabilization; Group of patients with stem endoprosthesis stabilization	Device: stabilization with stem; In both groups revision endoprosthesis of knee will be implanted with stem or sleeve stabilization.
Active Comparator: Sleeve stabilization; Group of patients with sleeve endoprosthesis stabilization	Device: stabilization with sleeve; In both groups revision endoprosthesis of knee will be implanted with stem or sleeve stabilization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reinfection	Rate of reinfection in both groups	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Loosening radiological signs	Radiological evaluation of implant loosening with Modern Knee Society Radiographic Evaluation System	2 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee Society Score	Clinical evaluation of patients after knee revision	1 year
The Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC)	Clinical evaluation of patients after knee revision	1 year
Visual Analogue Score	Clinical evaluation of patients after knee revision	1 year
Alignment	Radiological alignment of knee after operation in degrees	6 weeks
C-reactive protein	After operation and at period controls (mg/l)	1 year
Erythrocyte sedimentation rate	After operation and at period controls (mm/h)	1 year

Collaborators and Investigators

• Sponsor: Prof A Gruca Teaching Hospital
• Investigators: Principal Investigator: Paweł Bartosz, Prof. A. Gruca Teaching Hospital in Otwock

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2020
• Primary Completion (Anticipated): July 1, 2026
• Study Completion (Anticipated): January 1, 2027

Study Registration Dates

• First Submitted: June 21, 2020
• First Submitted That Met QC Criteria: June 23, 2020
• First Posted (Actual): June 25, 2020

Study Record Updates

• Last Update Posted (Actual): March 15, 2022
• Last Update Submitted That Met QC Criteria: March 14, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: infection; knee arthroplasty; two-stage; sleeve; stem
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Recurrence; Reinfection
• Other Study ID Numbers: Gruca Teaching Hospital

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Study protocol and Informed consent form will be shared
• IPD Sharing Time Frame: 1 year
• IPD Sharing Supporting Information Type: Study Protocol; Informed Consent Form (ICF)

Drug and device information, study documents

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