Comparing two methods of knee stabilization after infection treatment
Impact of the Type of Stabilization in the Two-stage Knee Reimplantation on Reinfection - Prospective, Randomized Study.
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Prof A Gruca Teaching Hospital Academic / other |
| Locations | 1 site (Otwock, Masovian Voivodeship) |
| Trial ID | NCT04446676 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals who have undergone primary knee replacement and are now facing a second-stage reimplantation due to knee infection.
Not a fit: Patients with significant intraoperative bone defects, autoimmune diseases, or other specified health conditions may not benefit from this study.
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 performed: While the approach of comparing stabilization methods is not widely tested, similar studies in orthopedic infection management have shown promising results.
Eligibility criteria
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 this trial is running
Otwock, Masovian Voivodeship
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.