Actively Recruiting

Phase Not Applicable
Age: 18Years - 90Years
All Genders
Healthy Volunteers
NCT04446676

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

Led by Prof A Gruca Teaching Hospital · Updated on 2022-03-15

200

Participants Needed

1

Research Sites

319 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 90Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Second stage of knee reimplantation
  • Primary knee replacement performed for primary knee osteoarthritis
  • Fulfillment of International Consensus Meeting 2018 infection criteria
Not Eligible

You will not qualify if you...

  • Intraoperative bone defects with Anderson Orthopedic Research Institute score greater than II
  • Autoimmune disease
  • Diabetes
  • Peripheral vascular disease
  • Congenital or acquired immunodeficiencies
  • Lack of pathogens identified after the first stage
  • Multi-bacterial infection
  • Multidirectional instability
  • Lack of patient consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Gruca Teaching Hospital, Centre of Postgraduate Medical Centre

Otwock, Masovian Voivodeship, Poland, 05-400

Actively Recruiting

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Research Team

P

Paweł Bartosz

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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