Using antibiotic-loaded bone cement to prevent infections after knee surgery
Antibiotic Loaded Bone Cement in Prevention of Periprosthetic Joint Infections in Primary Total Knee Arthroplasty: A Register-based Multicenter Randomized Controlled Non-inferiority Trial (Acronym: ALBA Trial)
This study is testing if using antibiotic-loaded bone cement during knee surgery can help prevent infections for patients getting a new knee.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 9172 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Norwegian Arthroplasty Register Government |
| Locations | 1 site (Bergen) |
| Trial ID | NCT04135170 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of antibiotic-loaded bone cement (ALBC) compared to plain bone cement in preventing periprosthetic joint infections (PJI) in patients undergoing primary total knee arthroplasty (TKA). It is a double-blinded, multicenter, register-based randomized controlled trial designed to recruit over 9,000 patients. The study aims to determine if ALBC can reduce the risk of infection without increasing the risk of complications such as aseptic loosening or systemic toxicity. The trial will be conducted in Norwegian hospitals, focusing on a pragmatic approach to assess real-world outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are patients undergoing full-cemented primary total knee arthroplasty, regardless of the underlying diagnosis.
Not a fit: Patients with a history of knee infection, those requiring specialized knee implants, or those allergic to the antibiotics used in the cement may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of infections following knee surgeries, improving patient outcomes and recovery times.
How similar studies have performed: While the use of antibiotic-loaded bone cement is routine in some European countries, this specific approach in the US context is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * all patients undergoing full-cemented primary TKA irrespective of the diagnosis leading to TKA Exclusion Criteria: * any history of infection in the knee, a need for fully stabilized or hinged TKA, a history of allergy to the antibiotics used in the cement, inability or not willing to consent for inclusion in NAR or the trial, and participation in other studies that might have pharmacological interaction with this trial.
Where this trial is running
Bergen
- Department of Orthopeadic Surgery, Haukeland University Hospital — Bergen, Norway (Recruiting)
Study contacts
- Study coordinator: Tesfaye H Leta, PhD
- Email: tesfaye.hordofa.leta@helse-bergen.no
- Phone: +4791691925
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.