Feasibility Analysis of the Bone Cement‐Gelatine Sponge Composite Intravertebral Prefilling Technique for Reducing Bone Cement Leakage in Stage I and II Kümmell's Disease: A Prospective Randomized Controlled Trial

OBJECTIVE: Bone cement leakage is a major complication of percutaneous vertebroplasty (PVP) while treating Kümmell's disease and it is a focus of close attention during the surgical procedure. The study aimed to investigate whether pre‐injecting a composite of bone cement and gelatine sponge (the “bone cement‐gelatine sponge composite”) before injecting bone cement during PVP aids in lowering the leakage rate in stage I and II Kümmell's disease. METHODS: This prospective analysis evaluated 74 patients with stage I and II Kümmell's disease who underwent PVP treatment at our hospital from December 2019 to December 2021. The participants were divided randomly into groups based on whether the bone cement‐gelatine sponge composite was used during the surgery. The two groups were the bone cement‐gelatine sponge composite group (GS group, comprising 37 patients) and the no bone cement‐gelatine sponge composite group (N‐GS group, comprising 37 patients). The independent samples t‐test and chi‐square test were employed to compare general information, operative time, cement injection volume, intraoperative bleeding, and bone cement leakage between the two groups. Additionally, the visual analogue scale (VAS) score, Oswestry disability index (ODI), anterior vertebral height ratio (AVHR), and the kyphotic Cobb angle were compared between the two groups at the preoperative, 2 days postoperative, and 6 months postoperative stages using repeated measures analysis of variance. RESULTS: All patients were followed up for more than 6 months, with an average of (11.19 ± 2.21) months. No significant differences were observed in terms of the operative time, cement injection volume, and intraoperative bleeding between the two groups (P > 0.05). The incidence of bone cement leakage in the N‐GS group (32.43%) was significantly higher than that in the GS group (5.41%), and the difference was statistically significant (P < 0.05). The VAS score and ODI of the two groups at postoperative 2 days and 6 months improved significantly (P < 0.05). The AVHR and kyphotic Cobb angle were corrected to a certain extent (P < 0.05); however, no significant difference was observed between the two groups (P > 0.05). CONCLUSION: The bone cement‐gelatine sponge composite intravertebral prefilling technique can lower bone cement leakage in stage I and II Kümmell's disease and can also relieve pain and improve vertebral body height.