Comparing two methods of knee stabilization after infection treatment
Official title: Impact of the Type of Stabilization in the Two-stage Knee Reimplantation on Reinfection - Prospective, Randomized Study.
Run by Prof A Gruca Teaching Hospital · NCT04446676 · Data updated 2026-11-12
This study tests whether using a stem or sleeve method for knee stabilization helps people who have had an infection in their knee feel better and stay infection-free after surgery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 90 Years |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Prof A Gruca Teaching Hospital Academic / other |
| Locations | 1 site (Otwock, Masovian Voivodeship) |
| Status | Recruiting |
| Started | November 17, 2020 |
| Main results expected | July 2026 |
| Study ends | January 2027 |
| Registry record updated | March 15, 2022 |
| Trial ID | NCT04446676 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals who have undergone primary knee replacement and are now facing a second-stage reimplantation due to knee infection.
✕Probably not a fit
Patients with significant intraoperative bone defects, autoimmune diseases, or other specified health conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the impact of two different stabilization methods, stem versus sleeve, in patients undergoing two-stage knee reimplantation due to periprosthetic joint infection. Participants will first receive debridement and spacer implantation, followed by a six-week antibiotic treatment. After ensuring no signs of reinfection, they will be randomized to receive either a stem or sleeve stabilization during the second stage of the procedure. The study aims to evaluate the reinfection rates and overall knee function over a two-year period.
Why it matters
Potential benefit: If successful, this study could lead to improved outcomes and lower reinfection rates for patients undergoing knee reimplantation.
How similar studies have gone: While the approach of comparing stabilization methods is not widely tested, similar studies in orthopedic infection management have shown promising results.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Gruca Teaching Hospital, Centre of Postgraduate Medical Centre
Otwock, Masovian Voivodeship, Poland Recruiting
Study contacts
- Principal investigator: Paweł Bartosz — Prof. A. Gruca Teaching Hospital in Otwock
- Study coordinator: Paweł Bartosz
- Email: pbartosz@vp.pl
- Phone: +48 793629685
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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-
Comparing two types of spacers for treating knee joint infections
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.