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

نویسندگان

1 Assistant Professor, Department of Orthopedic Surgery, School of Medicine, North Khorasan University of Medical Sciences

2 Associated Professor, Department of Orthopedic Surgery, School of Medicine, North Khorasan University of Medical Sciences, Bojnurd, Iran

3 Assistant Professor, Department of Medical Physics and Radiology, School of Allied Medical Sciences, North Khorasan University of Medical Sciences, Bojnurd, Iran

doi
10.30483/rjm.2026.254685.1455
چکیده

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 < 0.05 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 < 0.001) compared with before surgery. Mean HOOS improved significantly after surgery in the control group (from 49.60 ± 9.79 to 71.60 ± 4.72) and in the intervention group (from 48.52 ± 8.64 to 69.67 ± 3.77). Gain score analysis showed no statistically significant difference between groups (p = 0.77). 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.