Razavi Journal of Medicine

Razavi Journal of Medicine

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

Document Type : Original Article

Authors
Ismaeil Garivani 1
Reza Ganji 2
Mohamad Amin Younessi Heravi 3
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
10.30483/rjm.2026.254685.1455
Abstract
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.
Keywords
Total hip arthroplasty
Two-stage revision
Hip spacer
Silicon mold

 

Acknowledgements: The authors sincerely thank all participants in this study and the Orthopedic Department of North Khorasan University of Medical Sciences for their valuable support and cooperation throughout this project.

 

Availability of data and materials: The data that support the findings of this study are available from the corresponding author upon reasonable request.

 

Conflicts of interests: The authors declare no conflict of interest.

 

Consent for publication: Not applicable.

 

Ethics approval and consent to participate: This pilot double-blinded randomized clinical trial was approved by the Ethics Committee of North Khorasan University of Medical Sciences, Bojnurd, Iran (IR.NKUMS.REC.1403.097) and registered in the Iranian Registry of Clinical Trials (IRCT code: IRCT20191111045400N5). The study was conducted in accordance with the ethical principles outlined in the Declaration of Helsinki. Written informed consent to publication (including images, personal and clinical details of the participant) was obtained from the patient.

 

Financial disclosure: This study was supported by a grant from North Khorasan University of Medical Sciences (Grant number: NKUMS4030080).

 

Author contributions: All authors contributed to the Study design, Methodology, data collection, analysis, and interpretation. All authors approved the final manuscript and agree to be accountable for all aspects of the work.

 

Open Access Policy: This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited. To view a copy of this licence, visit https://creativecommons.org/licenses/by/4.0/

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Razavi Journal of Medicine
Volume 14, Issue 2
Spring 2026
Pages 1-11