Clinical Outcomes of Antibiotic-Impregnated Cement Spacers in the Treatment of Infected Total Hip Arthroplasty: A Pilot Randomized Clinical Trial

Background: Two-stage revision arthroplasty remains the gold standard for managing periprosthetic joint infection (PJI) following total hip arthroplasty (THA) and involves temporary implantation of an antibiotic-loaded cement spacer. Objective: This pilot randomized clinical trial aimed to compare silicone mold–based articulating spacers with commercially prefabricated spacers regarding infection eradication and functional outcomes in patients with infected THA. Methods: Fourteen patients diagnosed with infected THA were randomly assigned to receive either a prefabricated spacer (control group) or a silicone mold–based spacer (intervention group). Clinical outcomes were assessed using the Hip Osteoarthritis Outcome Score (HOOS) before spacer implantation and six weeks after the first-stage revision. Functional improvement was evaluated using gain score analysis. Statistical analyses were performed using SPSS, with p < ۰.۰۵ considered statistically significant. Results: Infection eradication was achieved in all patients in both groups. In both groups, after surgery, there were significant differences in HOOS (p < ۰.۰۰۱) compared with before surgery. Mean HOOS improved significantly after surgery in the control group (from ۴۹.۶۰ ± ۹.۷۹ to ۷۱.۶۰ ± ۴.۷۲) and in the intervention group (from ۴۸.۵۲ ± ۸.۶۴ to ۶۹.۶۷ ± ۳.۷۷). Gain score analysis showed no statistically significant difference between groups (p = ۰.۷۷). Conclusion: Silicone mold–based spacers demonstrated clinical and infection-control outcomes comparable to those of prefabricated spacers. Given their lower cost and ease of fabrication, silicone mold–based spacers may serve as a practical and cost-effective alternative, particularly in resource-limited settings.

کلیدواژه ها:

Total hip arthroplasty ، Two-stage revision ، Hip spacer ، Silicon mold