Journal of Korean Neurosurgical Society

The Korean Neurosurgical Society (대한신경외과학회)
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Safety and Efficacy of Bone Cement (Spinofill®) for Verte-broplasty in Patients with Osteoporotic Compression Fracture : A Preliminary Prospective Study

  • Park, Han Byeol (Department of Neurosurgery, Gil Medical Center, Gachon University College of Medicine) ;
  • Son, Seong (Department of Neurosurgery, Gil Medical Center, Gachon University College of Medicine) ;
  • Jung, Jong Myung (Department of Neurosurgery, Gil Medical Center, Gachon University College of Medicine) ;
  • Lee, Sang Gu (Department of Neurosurgery, Gil Medical Center, Gachon University College of Medicine) ;
  • Yoo, Byung Rhae (Department of Neurosurgery, Gil Medical Center, Gachon University College of Medicine)
  • Received : 2022.02.08
  • Accepted : 2022.04.08
  • Published : 2022.09.01
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Abstract

Objective : Although several commercialized bone cements are used during percutaneous vertebroplasty (PVP) for patients with osteoporotic vertebral compression fracture (OVCF), there are no reports using domestic products from South Korea. In this study, we investigated the safety and efficacy of Spinofill® (Injecta Inc., Gunpo, Korea), a new polymethyl methacrylate product. Methods : A prospective, single-center, and single-arm clinical trial of 30 participants who underwent PVP using Spinofill® for painful thoracolumbar OVCF was performed with 6-months follow-up. Clinical and surgical outcomes included the Visual analog scale (VAS), Korean-Oswestry disability index (K-ODI), and Odom's criteria, complication rate, and recurrence rate. Radiological outcomes were evaluated by measuring the findings of postoperative computed tomography and simple radiograph. Results : The pain of VAS (from 8.95±1.05 to 4.65±2.06, p<0.001) and the life quality based on K-ODI (from 33.95±5.84 to 25.65±4.79, p<0.001) improved significantly, and successful patient satisfaction were achieved in 20 patients (66.7%) 1 day after surgery. These immediate improvements were maintained or more improved during the follow-up. There was no surgery- or product-related complications, but OVCF recurred in two patients (6.7%). Favorable cement interdigitation was reported in 24 patients (80.0%), and extra-vertebral cement leakage was reported in 13 patients (43.0%). The mean vertebral height ratio (from 60.49%±21.97% to 80.07%±13.16%, p<0.001) and segmental kyphotic angle (from 11.46°±8.50° to 7.79°±6.08°, p=0.002) improved one day after surgery. However, these short-term radiological findings somewhat regressed at the end. Conclusion : The overall outcomes of PVP using Spinofill® were as favorable as those of other conventionally used products.

Keywords

Acknowledgement

This research was supported by a grant from the Gachon University Gil Medical Center (grant No. FRD2020-15) and the National Research Foundation of Korea (NRF) grant funded by the Korea government (MSIT) (No. 2021M3I2A1077405).

References

  1. Bae JS, Park JH, Kim KJ, Kim HS, Jang IT : Analysis of risk factors for secondary new vertebral compression fracture following percutaneous vertebroplasty in patients with osteoporosis. World Neurosurg 99 : 387-394, 2017 https://doi.org/10.1016/j.wneu.2016.12.038
  2. Balkarli H, Kilic M, Balkarli A, Erdogan M : An evaluation of the functional and radiological results of percutaneous vertebroplasty versus conservative treatment for acute symptomatic osteoporotic spinal fractures. Injury 47 : 865-871, 2016 https://doi.org/10.1016/j.injury.2016.01.041
  3. Borgstrom F, Zethraeus N, Johnell O, Lidgren L, Ponzer S, Svensson O, et al. : Costs and quality of life associated with osteoporosis-related fractures in Sweden. Osteoporos Int 17 : 637-650, 2006 https://doi.org/10.1007/s00198-005-0015-8
  4. Buchbinder R, Osborne RH, Ebeling PR, Wark JD, Mitchell P, Wriedt CJ, et al. : Efficacy and safety of vertebroplasty for treatment of painful osteoporotic vertebral fractures: a randomised controlled trial [ACTRN012605000079640]. BMC Musculoskelet Disord 9 : 156, 2008
  5. Compston J, Cooper A, Cooper C, Gittoes N, Gregson C, Harvey N, et al. : UK clinical guideline for the prevention and treatment of osteoporosis. Arch Osteoporos 12 : 43, 2017
  6. Deramond H, Depriester C, Toussaint P : Vertebroplasty and percutaneous interventional radiology in bone metastases: techniques, indications, contra-indications. Bull Cancer Radiother 83 : 277-282, 1996 https://doi.org/10.1016/S0924-4212(97)86071-9
  7. Firanescu C, Lohle PN, de Vries J, Klazen CA, Juttmann JR, Clark W, et al. : A randomised sham controlled trial of vertebroplasty for painful acute osteoporotic vertebral fractures (VERTOS IV). Trials 12 : 93, 2011
  8. Firanescu CE, de Vries J, Lodder P, Venmans A, Schoemaker MC, Smeets AJ, et al. : Vertebroplasty versus sham procedure for painful acute osteoporotic vertebral compression fractures (VERTOS IV): randomised sham controlled clinical trial. BMJ 361 : k1551, 2018
  9. Gangi A, Kastler BA, Dietemann JL : Percutaneous vertebroplasty guided by a combination of CT and fluoroscopy. AJNR Am J Neuroradiol 15 : 83-86, 1994
  10. Guo JB, Zhu Y, Chen BL, Xie B, Zhang WY, Yang YJ, et al. : Surgical versus non-surgical treatment for vertebral compression fracture with osteopenia: a systematic review and meta-analysis. PLoS One 10 : e0127145, 2015
  11. INJECTA : SPINOFILL. Available at : http://www.injecta-hq.com/product/pro04.asp?scrID=0000000144&pageNum=2&subNum=4&ssubNum=1
  12. Jensen ME, Evans AJ, Mathis JM, Kallmes DF, Cloft HJ, Dion JE : Percutaneous polymethylmethacrylate vertebroplasty in the treatment of osteoporotic vertebral body compression fractures: technical aspects. AJNR Am J Neuroradiol 18 : 1897-1904, 1997
  13. Johnell O, Kanis JA : An estimate of the worldwide prevalence and disability associated with osteoporotic fractures. Osteoporos Int 17 : 1726-1733, 2006 https://doi.org/10.1007/s00198-006-0172-4
  14. Kaufmann TJ, Trout AT, Kallmes DF : The effects of cement volume on clinical outcomes of percutaneous vertebroplasty. AJNR Am J Neuroradiol 27 : 1933-1937, 2006
  15. Kim DY, Lee SH, Lee HY, Lee HJ, Chang SB, Chung SK, et al. : Validation of the Korean version of the oswestry disability index. Spine (Phila Pa 1976) 30 : E123-E127, 2005 https://doi.org/10.1097/01.brs.0000157172.00635.3a
  16. Klazen CA, Verhaar HJ, Lampmann LE, Juttmann JR, Blonk MC, Jansen FH, et al. : VERTOS II: percutaneous vertebroplasty versus conservative therapy in patients with painful osteoporotic vertebral compression fractures; rationale, objectives and design of a multicenter randomized controlled trial. Trials 8 : 33, 2007
  17. Klezl Z, Majeed H, Bommireddy R, John J : Early results after vertebral body stenting for fractures of the anterior column of the thoracolumbar spine. Injury 42 : 1038-1042, 2011 https://doi.org/10.1016/j.injury.2011.04.006
  18. Lou S, Shi X, Zhang X, Lyu H, Li Z, Wang Y : Percutaneous vertebroplasty versus non-operative treatment for osteoporotic vertebral compression fractures: a meta-analysis of randomized controlled trials. Osteoporos Int 30 : 2369-2380, 2019 https://doi.org/10.1007/s00198-019-05101-8
  19. Ma X, Xing D, Ma J, Wang J, Chen Y, Xu W, et al. : Risk factors for new vertebral compression fractures after percutaneous vertebroplasty: qualitative evidence synthesized from a systematic review. Spine (Phila Pa 1976) 38 : E713-E722, 2013 https://doi.org/10.1097/BRS.0b013e31828cf15b
  20. Martincic D, Brojan M, Kosel F, Stern D, Vrtovec T, Antolic V, et al. : Minimum cement volume for vertebroplasty. Int Orthop 39 : 727-733, 2015 https://doi.org/10.1007/s00264-014-2620-7
  21. Molloy S, Mathis JM, Belkoff SM : The effect of vertebral body percentage fill on mechanical behavior during percutaneous vertebroplasty. Spine (Phila Pa 1976) 28 : 1549-1554, 2003
  22. Nieuwenhuijse MJ, Muijs SP, van Erkel AR, Dijkstra SP : A clinical comparative study on low versus medium viscosity polymethylmetacrylate bone cement in percutaneous vertebroplasty: viscosity associated with cement leakage. Spine (Phila Pa 1976) 35 : E1037-E1044, 2010 https://doi.org/10.1097/BRS.0b013e3181ddd262
  23. Odom GL, Finney W, Woodhall B : Cervical disk lesions. J Am Med Assoc 166 : 23-28, 1958 https://doi.org/10.1001/jama.1958.02990010025006
  24. Qaseem A, Forciea MA, McLean RM, Denberg TD, Barry MJ, Cooke M, et al. : Treatment of low bone density or osteoporosis to prevent fractures in men and women: a clinical practice guideline update from the American college of physicians. Ann Intern Med 166 : 818-839, 2017 https://doi.org/10.7326/M15-1361
  25. Son S, Lee SG, Kim WK, Park CW, Yoo CJ : Early vertebroplasty versus delayed vertebroplasty for acute osteoporotic compression fracture : are the results of the two surgical strategies the same? J Korean Neurosurg Soc 56 : 211-217, 2014 https://doi.org/10.3340/jkns.2014.56.3.211
  26. Voormolen MH, Mali WP, Lohle PN, Fransen H, Lampmann LE, van der Graaf Y, et al. : Percutaneous vertebroplasty compared with optimal pain medication treatment: short-term clinical outcome of patients with subacute or chronic painful osteoporotic vertebral compression fractures. The VERTOS study. AJNR Am J Neuroradiol 28 : 555-560, 2007
  27. Wang M, Zhang L, Fu Z, Wang H, Wu Y : Selections of bone cement viscosity and volume in percutaneous vertebroplasty: a retrospective cohort study. World Neurosurg 150 : e218-e227, 2021 https://doi.org/10.1016/j.wneu.2021.02.133
  28. Watts NB, Camacho PM, Lewiecki EM, Petak SM; AACE/ACE Postmenopausal Osteoporosis Guidelines Task Force : American Association of Clinical Endocrinologists/American College of Endocrinology clinical practice guidelines for the diagnosis and treatment of postmenopausal osteoporosis-2020 update. Endocr Pract 27 : 379-380, 2021 https://doi.org/10.1016/j.eprac.2021.02.001
  29. Yang EZ, Xu JG, Huang GZ, Xiao WZ, Liu XK, Zeng BF, et al. : Percutaneous vertebroplasty versus conservative treatment in aged patients with acute osteoporotic vertebral compression fractures: a prospective randomized controlled clinical study. Spine (Phila Pa 1976) 41 : 653-660, 2016 https://doi.org/10.1097/BRS.0000000000001298
  30. Zhan Y, Jiang J, Liao H, Tan H, Yang K : Risk factors for cement leakage after vertebroplasty or kyphoplasty: a meta-analysis of published evidence. World Neurosurg 101 : 633-642, 2017 https://doi.org/10.1016/j.wneu.2017.01.124
  31. Zhang L, Wang Q, Wang L, Shen J, Zhang Q, Sun C : Bone cement distribution in the vertebral body affects chances of recompression after percutaneous vertebroplasty treatment in elderly patients with osteoporotic vertebral compression fractures. Clin Interv Aging 12 : 431-436, 2017 https://doi.org/10.2147/CIA.S113240
  32. Prevention and management of osteoporosis. World Health Organ Tech Rep Ser 921 : 1-164, backcover, 2003