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

Knee Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04446676
• Other study ID #: Gruca Teaching Hospital
• Status: Recruiting
• Phase: N/A
• Start date: November 17, 2020
• Est. completion date: January 2027

Study information

• Verified date: March 2022
• Source: Prof A Gruca Teaching Hospital
• Contact: Pawel Bartosz
• Phone: +48 793629685
• Email: pbartosz[@]vp.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 2027
• Est. primary completion date: July 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Infection

Intervention

Device:
• stabilization with stem
In both groups revision endoprosthesis of knee will be implanted with stem or sleeve stabilization.
• stabilization with sleeve
In both groups revision endoprosthesis of knee will be implanted with stem or sleeve stabilization.

Locations

Country	Name	City	State
Poland	Gruca Teaching Hospital, Centre of Postgraduate Medical Centre	Otwock	Mazowieckie

Sponsors (1)

Lead Sponsor	Collaborator
Prof A Gruca Teaching Hospital

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Knee Society Score	Clinical evaluation of patients after knee revision	1 year
Other	The Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC)	Clinical evaluation of patients after knee revision	1 year
Other	Visual Analogue Score	Clinical evaluation of patients after knee revision	1 year
Other	Alignment	Radiological alignment of knee after operation in degrees	6 weeks
Other	C-reactive protein	After operation and at period controls (mg/l)	1 year
Other	Erythrocyte sedimentation rate	After operation and at period controls (mm/h)	1 year
Primary	Reinfection	Rate of reinfection in both groups	2 years
Secondary	Loosening radiological signs	Radiological evaluation of implant loosening with Modern Knee Society Radiographic Evaluation System	2 years