Antimicrobial peptides occur naturally in our intrinsic immune system. PLG0206 is a novel, engineered, 24-amino acid peptide which has broad-spectrum antimicrobial activity, including in biofilm and against multi-drug resistant pathogens (1,2). This is the first clinical study to evaluate the safety and tolerability of PLG0206 when administered via an irrigation solution in patients with periprosthetic joint infections (PJI) following total knee arthroplasty (TKA) during debridement, antibiotics, and implant retention (DAIR). Secondary objectives were to evaluate pharmacokinetics (PK), biomarkers and initial clinical efficacy at one year post-DAIR procedure. This prospective, multicenter, open-label, interventional study assessed two dose levels of PLG0206. Fourteen patients underwent revision for PJI after TKA. At the end of debridement, they received a single intra-articular irrigation of PLG0206 into the wound cavity lasting 15 minutes at concentrations of 3 mg/mL (n=7) or 10 mg/mL (n=7). Patients received post-operative care and intravenous/oral antimicrobial therapy as per their institutional guidelines. Patients were monitored for safety and signs of relapse or persistent infection for 12 months post study drug administration and PK and blood biomarkers were assessed.Aim
Method
Total hip arthroplasty (THA) in the young patient has been associated with higher rates of revision and perioperative complications. For clinicians and patients alike, there remains a desire to better characterize the durability of THA in young patients. We reviewed secondary data from our institutional database for all patients who underwent primary THA from January 2000 to May 2015. Patients were identified using ICD-9 procedure code 81.51. Our primary interest was the survival of implants in patients 30 years of age or younger (n=167) while using a contemporaneous cohort of patients age 60 and older as a control (n=1359). Failure was defined as revision THA for any reason. Cox regression with robust standard errors was used to calculate hazard ratios. A population-averaged Poisson regression analysis was used to compare complication rates. The rate of all-cause revision THA was 2.4 times greater (95% CI 1.10 – 5.37, p=0.028) in young patients (7%, 12/167) undergoing primary or conversion to THA compared to their elderly counterparts (3.7%, 50/1,359). Survival at 10 years was 89% (95% CI 82 – 94) in the young cohort and 96% (94 – 97) in the elderly cohort. The primary reasons for revision in young that patients compared to their elderly counterparts included metal-on-metal implants (IRR 8.12, 95% CI 2.04 – 32.38, p=0.003). These data demonstrate that patients 30 years of age and younger substantially benefit from THA but should be warned of higher risk of subsequent revision.
