Evaluation of the Safety and Efficacy of Bone Cement in Experimental Pigs Using Vertebroplasty
10.12300/j.issn.1674-5817.2025.006
- VernacularTitle:椎体成形术用于实验猪体内骨水泥安全性及有效性评价
- Author:
Zhenhua LIN
1
;
Xiangyu CHU
1
;
Zhenxi WEI
1
;
Chuanjun DONG
1
;
Zenglin ZHAO
1
;
Xiaoxia SUN
1
;
Qingyu LI
1
;
Qi ZHANG
1
Author Information
1. Shandong Institute of Medical Device and Pharmaceutical Packaging Inspection, Jinan 250101, China
- Publication Type:Journal Article
- Keywords:
Vertebroplasty;
Bone cement;
Bone filling material;
Compressive strength;
Hard tissue pathology;
Osseointegration;
Pigs
- From:
Laboratory Animal and Comparative Medicine
2025;45(4):466-472
- CountryChina
- Language:Chinese
-
Abstract:
ObjectiveThe full name of vertebroplasty is percutaneous vertebroplasty (PVP). It is a clinical technique that injects bone cement into the diseased vertebral body to achieve strengthening of the vertebra. The research on the safety and efficacy of bone cement is the basis for clinical application. In this study, vertebroplasty is used to evaluate and compare the safety and efficacy of Tecres and radiopaque bone cement in experimental pigs, and to determine the puncture method suitable for pigs and the pre-clinical evaluation method for the safety and efficacy of bone cement. MethodsTwenty-four experimental pigs (with a body weight of 60-80 kg) were randomly divided into an experimental group (Group A) and a control group (Group B). Group A was the Tecres bone cement group, and Group B was the radiopaque bone cement group, with 12 pigs in each group. Under the monitoring of a C-arm X-ray machine, the materials were implanted into the 1st lumbar vertebra (L1) and 4th lumbar vertebra (L4) of the pigs via percutaneous puncture using the unilateral pedicle approach. The animals were euthanized at 4 weeks and 26 weeks after the operation, respectively. The L4 vertebrae were taken for compressive strength testing, and the L1 vertebrae were taken for hard tissue pathological examination to observe the inflammatory response, bone necrosis, and degree of osseointegration at the implantation site. ResultsThe test results of compressive strength between groups A and B showed no significant difference at 4 weeks and 26 weeks after bone cement implantation (P > 0.05). Observation under an optical microscope (×100) revealed that at 4 weeks postoperatively, both groups A and B showed that the bone cement was surrounded by proliferative fibrous tissue, with lymphocyte infiltration around it. The bone cement was combined with bone tissue, the trabecular arrangement was disordered, and osteoblasts and a small amount of osteoid were formed. At 26 weeks postoperatively, bone cement was visible in both groups A and B. The new bone tissue was mineralized, the trabeculae were fused, the trabecular structure was regular and dense with good continuity, and no obvious inflammatory reaction was observed. ConclusionIn experimental pig vertebrae, there were no significant differences observed in the compressive strength, inflammation response, bone destruction, and integration with the bone between Tecres and non-radiopaque bone cement. Both exhibited good biocompatibility and osteogenic properties. It indicates that using vertebroplasty to evaluate the safety and efficacy of bone cement in pigs is scientifically sound.
