Topical Vancomycin for Infection Prophylaxis in TJA

• Status: Not yet recruiting
• Trial end date: 2025-06-15
• Target enrollment: 0
• Participant gender: All

Summary

11% of the general population undergo total hip arthroplasty (THA) in their lifetime and 7% undergo total knee arthroplasty (TKA), with these rates expected to rise up to 50% by 2026. Periprosthetic joint infection (PJI) remains one of the most common complications, accounting for 30% of THA/TKA revision surgeries. Topical delivery of antibiotic powder may reduce the incidence of PJI but its potential drawbacks include wound healing complications, reduced osteoblast activity, third body wear, and antibiotic resistance. In THA and TKA, topical administration of vancomycin powder for the primary prevention of PJI has been studied in observational studies, but conclusions are limited due to the low incidence of PJI and high number of patients required to detect a significant difference. Investigators therefore propose a randomized controlled trial (RCT) investigating the impact of topical vancomycin compared to standard care on PJI rates following THA and TKA.

Aim: To determine whether topical vancomycin is a safe and effective intervention for the primary prevention of PJI after THA and TKA.

Study Design: This is a pilot multi-centre RCT to evaluate the study design and assess feasibility prior to implementation across Canada. Investigators aim to recruit 50 THA and 50 TKA patients.

Inclusion Criteria THA or TKA Patients aged 18 years or older Patients must complete 1 year follow-up Exclusion Criteria Patients undergoing surgery for inflammatory arthritis, post-traumatic arthritis, or avascular necrosis History or septic arthritis based on history or synovial aspirate Prior major operation on the affected joint Current immunosuppressive medications Vancomycin allergy or history of a vancomycin-related complication Recruitment: surgeons introduce study to the patients, research staff will conduct recruitment.

Intervention: Patients will be randomized preoperatively and remain blinded to their treatment arm. Patients allocated to the control group will have all standard care infection prophylaxis interventions. Patients allocated to the vancomycin group will undergo all the standard care measures in addition to 1g of powdered vancomycin applied to the wound.

Follow-up: Patients will complete follow-up at 2 weeks, 6 weeks, 3 months, 6 months, and 1 year visits.

Primary outcome: PJI in the same joint. Secondary outcome: PJI in THA and TKA subgroups:

Reoperation on the same joint Superficial and non-infectious wound complications All complications

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alberta Hip and Knee Clinic
• Collaborator: University of Calgary
• Treatments: Vancomycin

Criteria

Inclusion Criteria:

• Adult patients aged 18 years or older, who are undergoing elective primary THA or TKA for osteoarthritis

• Patients must be able and willing to complete one year of follow-up postoperatively

Exclusion Criteria:

• Patients undergoing surgery for inflammatory arthritis, post-traumatic arthritis, or avascular necrosis

• History or septic arthritis based on history or synovial aspirate

• Prior major operation on the affected joint including osteotomy, open reduction internal fixation, or major open ligamentous repair, but excluding arthroscopic procedures such as ACL reconstruction or meniscus or labral debridement/repair

• Current immunosuppressive medications

• Vancomycin allergy or history of a vancomycin-related complication such as ototoxicity or nephrotoxicity