Intra-articular antibiotic infusions versus intravenous antibiotic administration for infected knee arthroplasty: a study protocol for a randomized multicenter clinical trial
Abstract
Background: Periprosthetic joint infection (PJI) poses a formidable challenge following total joint arthroplasty (TJA). Whether using Debridement, Antibiotics, and Implant Retention (DAIR) for acute cases or one/two-stage revision for chronic scenarios, postoperative antibiotics administered intravenously is standard. However, this delivery method inevitably risks hepatic and renal function impairment, lacking a sufficiently minimal biofilm eradication concentration. Intra-articular infusion as a novel antibiotic delivery method can circumvent systemic circulation, reduce the risk of hepatic and renal function impairment, and provide a sufficiently high antibiotic concentration at the prosthetic infection site. Yet, the efficacy of these methods has never been evaluated in a randomized controlled trial. The study aims to investigate infection control rates within 2 years post intra-articular antibiotic infusion versus intravenous antibiotic administration in a randomized design.
Methods: This pragmatic, multicenter, two-armed, parallel group, open, randomized non-inferiority trial (non-inferiority margin-15%) involves 11 high-volume tertiary referral centers (1:1 allocation). One hundred forty-two eligible PJI patients following total knee arthroplasty, undergoing one-stage revision, were randomly assigned to intra-articular or intravenous antibiotics. Blinding is not possible due to the nature of the intervention. However, data collectors and statistical analysts remain…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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