34. A novel bone cement screw system combined with vertebroplasty for the treatment of Kummell disease with bone deficiency at vertebral anterior border: minimum three-year follow-up study

Abstract

BACKGROUND CONTEXT When vertebroplasty is used to treat Kummell disease with bone deficiency at vertebral anterior border, bone cement displacement often occurs intraoperative or postoperative. We designed and used a new bone cement screw system to avoid this serious complication. PURPOSE The purpose of this study is to evaluate the safety and effectiveness of this novel operation method through more than 3 years of follow-up. STUDY DESIGN/SETTING Retrospective cohort study. PATIENT SAMPLE A total of 27 patients suffering from single-segment Kummell disease. OUTCOME MEASURES The clinical efficacy was evaluated using Odom's criteria and statistical analysis based on the results of imaging parameters, VAS, ODI and SF-36. METHODS From January 2012 to August 2016, 27 patients suffering from single-segment Kummell disease with bone deficiency at vertebral anterior border were treated by vertebroplasty combined with novel bone cement screw. Bone cement is released into the diseased vertebrae through screw to fully fill the intravertebral vacuum cleft. Screw fixation of bone cement can avoid intraoperative or postoperative displacement. All patients were operated by unilateral technique, only one screw was implanted for each patient. The clinical efficacy was evaluated using Odom's criteria and statistical analysis based on the results of vertebral body index (VBI), vertebral body angle (VBA), bisegmental Cobb angle (BCA), visual analog scale (VAS), Oswestry Disability Index (ODI), and the MOS 36-item Short Form Health Survey (SF-36). RESULTS The operation was completed successfully in 27 cases. The average operation time was 49.63±10.82 min, and the average volume of cement injected was 4.70±0.87 ml. The patients’ preoperative VBI, VBA, BCA, VAS and ODI scores were 43.11±5.94, 21.04±2.55, 45.00±6.26, 7.59±0.84, and 79.85±7.58, respectively. The postoperative measurements were 78.70±2.55, 12.70±2.11, 26.11±4.73, 3.22±0.93 and 50.04±9.28. At the last follow-up, the measurements were 78.04±2.30, 13.15±2.38, 27.07±4.87, 2.04±0.65, and 22.85±5.06, respectively. There was significant difference between the preoperative and postoperative data, as well as the preoperative and the last follow-up data (P CONCLUSIONS This 3-year follow-up study shows that the novel bone cement screw system combined with vertebroplasty has a good short and medium-term therapeutic effect on patients with Kummell disease and bone deficiency at vertebral anterior border, while its long-term efficacy is subject to further studies. FDA DEVICE/DRUG STATUS This abstract does not discuss or include any applicable devices or drugs.