Abstract
Introduction: Life expectancy in Indonesia will increase along with economic and health advancements. Osteoarthritis is a degenerative disease that can affect joints in various parts of the human body, including the hip joint, one of the most frequently affected areas. Significant pain can lead to impaired mobility and dependence on support devices or assistance from others. Objective: To assess and compare the safety and biocompatibility of domestically produced vitamin E-stabilized UHMWPE (GUR® 1050-E) against commercial UHMWPE as acetabular liner material in the Total Hip Arthroplasty system. Methods: In vivo experimental study with a comparison of 2 groups. Laboratory of the Faculty of Veterinary Medicine, Airlangga University, 1 August–12 September 2025 (observation period 6 weeks). A total of 12 male rabbits aged 3–6 months (1500–2000 g) were divided into 2 groups (each n=6): domestically produced UHMWPE + vitamin E and commercial UHMWPE (control). After 7 days of acclimatization, sterile 6 × 5 mm UHMWPE implants were implanted into the right femur near the periosteum under ketamine–xylazine anesthesia. Outcomes included Draize Test and Body Condition Score (weeks 0, 3, 6), serum IL-6 and TNF-α levels by ELISA (weeks 0 and 6), and histopathology of the tissue around the implant (H&E) with Modified ISO 10993-6 assessment after euthanasia. Statistical analysis used SPSS 25.0. Results: All Draize scores at weeks 0, 3, and 6 were 0 in both groups without erythema or edema, and there were no significant differences across time points or between groups (p=1.000). IL-6 and TNF-α levels decreased significantly intragroup from week 0 to week 6 in both groups. The decrease in IL-6 in the UHMWPE + vitamin E group was greater than in the control group (Δ IL-6: 221.03 ± 200.91 vs. 21.26 ± 12.44; p=0.035), while the change in TNF-α between groups was not significantly different (p=0.073). The BCS was relatively stable without significant differences between groups. Local tissue response scores based on Modified ISO 10993-6 did not differ significantly between groups (p=0.945). Conclusion: Domestically produced vitamin E-stabilized UHMWPE has equivalent biocompatibility to commercial UHMWPE with no evidence of additional adverse effects.