Clinical trial NCT04446676: Impact of the Type of Stabilization in the Two-stage Knee Reimplantation on Reinfection - Prospective, Randomized Study.
Official title: Impact of the Type of Stabilization in the Two-stage Knee Reimplantation on Reinfection - Prospective, Randomized Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Knee Infection
Keywords: knee arthroplasty
infection
two-stage
sleeve
stem
Lead sponsor: Prof A Gruca Teaching Hospital
Sponsor class: OTHER
First posted: 2020-06-25
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups with endoprosthesis stabilisation with stem or sleeve.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Reinfection
timeFrame: 2 years
Secondary outcomes:
measure: Loosening radiological signs
timeFrame: 2 years
Other outcomes:
measure: Knee Society Score
timeFrame: 1 year
measure: The Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC)
timeFrame: 1 year
measure: Visual Analogue Score
timeFrame: 1 year
measure: Alignment
timeFrame: 6 weeks
measure: C-reactive protein
timeFrame: 1 year
measure: Erythrocyte sedimentation rate
timeFrame: 1 year
Locations:
city: Otwock
country: Poland
facility: Gruca Teaching Hospital, Centre of Postgraduate Medical Centre
state: Mazowieckie
Study officials:
affiliation: Prof. A. Gruca Teaching Hospital in Otwock
name: Paweł Bartosz
role: PRINCIPAL_INVESTIGATOR
References: