NCT04446676 Impact of the Type of Stabilization in the Two-stage Knee Reimplantation on Reinfection - Prospective, Randomized Study.
| NCT ID | NCT04446676 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Prof A Gruca Teaching Hospital |
| Condition | Knee Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2020-11-17 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2020-11-17 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Paweł Bartosz
PRINCIPAL INVESTIGATOR
Prof. A. Gruca Teaching Hospital in Otwock
Frequently Asked Questions
Who can join the NCT04446676 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Knee Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04446676 currently recruiting?
Yes, NCT04446676 is actively recruiting participants. Contact the research team at pbartosz@vp.pl for enrollment information.
Where is the NCT04446676 trial being conducted?
This trial is being conducted at Otwock, Poland.
Who is sponsoring the NCT04446676 clinical trial?
NCT04446676 is sponsored by Prof A Gruca Teaching Hospital. The principal investigator is Paweł Bartosz at Prof. A. Gruca Teaching Hospital in Otwock. The trial plans to enroll 200 participants.