Preventing infections after knee replacement surgery with vancomycin
Prospective, Randomized, Double Blinded Trial Comparing Clinical, Radiological and Laboratory Outcomes in Prevention of Infection After Total Knee Arthroplasty With or Without Vancomycin.
NA · Centre of Postgraduate Medical Education · NCT05461651
This study is testing if using vancomycin during knee replacement surgery can help prevent infections after the operation.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 1800 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Centre of Postgraduate Medical Education (other) |
| Locations | 1 site (Otwock, Masovian Voivodeship) |
| Trial ID | NCT05461651 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a prospective, randomized, double-blinded investigation aimed at comparing the outcomes of infection prevention in patients undergoing total knee arthroplasty (TKA) with and without the use of vancomycin. The study will assess clinical, radiological, and laboratory outcomes to determine if adding vancomycin to the joint before wound closure can effectively reduce the incidence of postoperative infections. Participants will be monitored for infection rates following their surgery to evaluate the efficacy of the intervention.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with gonarthrosis who are undergoing total knee arthroplasty.
Not a fit: Patients who may not benefit from this study include those under 40 years of age, those with multiligament injuries, or those with other significant musculoskeletal disorders.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of infections following knee replacement surgeries, leading to better recovery outcomes for patients.
How similar studies have performed: While the use of vancomycin in surgical settings has been explored, this specific approach in total knee arthroplasty is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Gosnartrosis Exclusion Criteria: * no informed consent to participate in the study age under 40 multilligament injury or single plane knee instability another musculoskeletal disorders in lower limb ASA score \> II
Where this trial is running
Otwock, Masovian Voivodeship
- Department of Orthopaedics and Traumatology, Postgraduate Center for Medical Education, Professor A. Gruca Teaching Hospital — Otwock, Masovian Voivodeship, Poland (RECRUITING)
Study contacts
- Study coordinator: Rafal Kaminski, MD PhD
- Email: rkaminski@spskgruca.pl
- Phone: 48 227754031
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.
Conditions: Infection, TKA, Vancomycin