RecruitingNot ApplicableNCT04446676

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


Sponsor

Prof A Gruca Teaching Hospital

Enrollment

200 participants

Start Date

Nov 17, 2020

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 90 Years

Inclusion Criteria3

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

Exclusion Criteria9

  • 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

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEstabilization with stem

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

DEVICEstabilization with sleeve

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


Locations(1)

Gruca Teaching Hospital, Centre of Postgraduate Medical Centre

Otwock, Masovian Voivodeship, Poland

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04446676


Related Trials