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

Recruiting now · Not applicable

Conditions studied: Knee Infection

In brief

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.

Key facts

Study ID

NCT04446676

Run by

Prof A Gruca Teaching Hospital

People needed

200

Starts

2020-11-17

Expected to finish

2027-01-01

Last updated by the study team

2022-03-15

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Gruca Teaching Hospital, Centre of Postgraduate Medical Centre — Otwock, Masovian Voivodeship, Poland (enrolling)

Full record on ClinicalTrials.gov

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