Update on Vertebral Augmentation for Thoracolumbar Fragility Fractures

Thoracolumbar fragility fractures are the most common osteoporotic fracture worldwide and are thought to occur in 30% to 50% of individuals older than 50 years.[1] While many osteoporotic vertebral fractures are asymptomatic, they have the potential to cause significant pain and functional disability in cases of delayed healing or nonunion. Historically, nonsurgical treatment has been the mainstay of care for stable-appearing thoracolumbar vertebral fractures; however there is a paucity of evidence supporting its effectiveness.[2,3] Vertebral augmentation, also known as vertebroplasty or kyphoplasty, involves injecting polymethylmethacrylate cement into fractured vertebrae via a percutaneous approach. While the efficacy of the procedure was disputed following its development in the 1990s, a robust body of literature now supports its ability to reduce pain and improve function in patients with osteoporotic vertebral fractures.[2,4–8]

Nonsurgical treatment has historically been the mainstay of the initial treatment of osteoporotic vertebral fractures and often includes analgesics, activity modification and bracing. Despite their widespread use, evidence supporting the effectiveness of orthoses in improving outcomes after vertebral fractures is lacking.[9] A 2009 randomized prospective study of treatment with thoracolumbosacral orthoses (TLSO) by Bailey et al demonstrated no significant differences in pain scores or functional outcomes when compared with unbraced patients.[10] Similar findings were described by Kim et al in a 2014 prospective study comparing rigid versus soft orthoses versus no bracing for osteoporotic vertebral fractures. No differences in pain reduction were demonstrated in patients treated with bracing versus those who were not.[11] While the majority of patients with symptomatic vertebral compression fractures go on to heal regardless of treatment modality, approximately 10% to 20% of patients fail to improve without procedural intervention.[3,12] Several authors have studied risk factors for treatment failure with conservative management.[13] Age, presence of middle column injury, hyperintensity on T2-weighted imaging, and location within the thoracolumbar junction have all been cited as risk factors for nonunion and persistent pain.[14,15]

The use of opioids for treatment of fracture-related pain is of concern due to the potential for dependence as well their side effect profile (ie, constipation, nausea, delirium). The side effects of opioid use are particularly problematic in patients with osteoporotic fractures given their advanced age and frailty. Multiple studies have demonstrated a significant reduction or elimination of opioid use in patients undergoing vertebral augmentation for osteoporotic thoracolumbar fractures.[16–18] The largest of these studies utilized the MarketScan database to analyze opioid prescription data in 8,845 patients.[17] In this population, approximately 75% of patients were using opioids before the procedure. Within this group, 49% of patients discontinued opioid use following vertebral augmentation while an additional 8.5% of the cohort reduced their opioid intake. Data on opioid use in patients treated nonsurgically were not included in the study.

Like other fragility fractures, osteoporotic vertebral fractures are associated with increased mortality risk.[19–21] A recent study analyzed 492 cases of patients older than 65 years with vertebral compression fractures, finding an overall mortality rate of 13.4% at 1 year and 40.6% at 5 years.[20] Although some authors have reported conflicting results, patients undergoing vertebral augmentation seem to have lower mortality when compared with patients treated nonoperatively.[18,22–24] A 2015 cohort analysis of more than 1.2 million cases of vertebral fracture within the national Medicare claims database demonstrated that patients undergoing kyphoplasty had 55% mortality risk reduction when compared to patients treated nonoperatively.[22] Hinde et al performed a meta-analysis of 16 studies that included more than 2 million patients with osteoporotic vertebral fractures. The authors found a 22% mortality risk reduction at up to 10 years in patients undergoing vertebral augmentation.[23]

Restoration and maintenance of vertebral body height after vertebral augmentation with polymethylmethacrylate remains a challenge. In most clinical settings, patients undergo vertebral augmentation weeks to months after their fracture has occurred, by which time initial fibrous healing has taken place. Fracture reduction via traditional balloon kyphoplasty is limited by the risk of balloon rupture as well as the need to remove the balloon prior to cement delivery. To address this problem, “third generation” vertebral augmentation techniques have been developed that involve placing permanent structural implants within the fractured vertebrae via a transpedicular approach.[25] Currently available implants are composed of either titanium or polyetheretherketone. In certain systems, these implants are secured by injecting polymethylmethacrylate cement after expansion, whereas in other systems the implants are self-stabilizing. In a recent meta-analysis that pooled results from 1320 treated fractures, third-generation systems provided superior restoration of vertebral height and reduction of kyphosis with equivalent improvement in pain scores and functional outcomes when compared with traditional techniques for vertebral augmentation.[26] Long-term studies are needed to determine whether this improved restoration of sagittal alignment confers superior clinical benefit.

Osteoporotic vertebral fractures are a common diagnosis treated by spine surgeons worldwide. While many of these fractures will heal uneventfully, certain patients experience severe ongoing pain related to delayed healing, nonunion, and/or sagittal deformity. Modern studies of vertebral augmentation support its use as a safe and effective treatment option for this growing patient population. Vertebral augmentation technology continues to evolve with a focus on improving sagittal realignment capability in order to deliver superior long-term clinical outcomes.

References

1. Ballane G, Cauley JA, Luckey MM, Fuleihan FE. Worldwide prevalence and incidence of osteoporotic vertebral fractures. Osteoporos Int. 2017;28(5):1531-1542.

2. Rzewuska M, Ferreira M, Mclachlan AJ, et al. The efficacy of conservative treatment of osteoporotic compression fractures on acute pain relief: a systematic review with meta-analysis. Eur Spine J. 2015;24(4):702-714.

3. Petitt JC, Desai A, Kashkoush A, et al. Failure of conservatively managed traumatic vertebral compression fractures: a systematic review. World Neurosurg. 2022;165:81–8.

4. Pron G, Hwang M, Smith R, et al. Cost-effectiveness studies of vertebral augmentation for osteoporotic vertebral fractures: a systematic review. Spine J. 2022;22:1356–1371.

5. Beall DP, Phillips TR. Vertebral augmentation: an overview. Skeletal Radiol. 2023;52:1911–1920.

6. Hoffmann J, Preston G, Whaley J, Khalil JG. Vertebral augmentation in spine surgery. J Am Acad Orthop Surg. 2023;31:477–489.

7. Klazen CAH, Lohle PNM, de Vries J, et al. Vertebroplasty versus conservative treatment in acute osteoporotic vertebral compression fractures (Vertos II): an open-label randomised trial. Lancet. 2010;376:1085–1092.

8. Clark W, Bird P, Gonski P, et al. Safety and efficacy of vertebroplasty for acute painful osteoporotic fractures (VAPOUR): a multicentre, randomised, double-blind, placebo-controlled trial. Lancet. 2016;388:1408–1416.

9. Rzewuska M, Ferreira M, McLachlan AJ, Machado GC, Maher CG. The efficacy of conservative treatment of osteoporotic compression fractures on acute pain relief: a systematic review with meta-analysis. Eur Spine J. 2015;24(4):702–714.

10. Bailey CS, Dvorak MF, Thomas KC, et al. Comparison of thoracolumbosacral orthosis and no orthosis for the treatment of thoracolumbar burst fractures: interim analysis of a multicenter randomized clinical equivalence trial. J Neurosurg Spine. 2009;11(3):295–303.

11. Kim H-J, Yi J-M, Cho H-G, et al. Comparative study of the treatment outcomes of osteoporotic compression fractures without neurologic injury using a rigid brace, a soft brace, and no brace: a prospective randomized controlled non-inferiority trial. J Bone Joint Surg Am. 2014;96:1959–1966.

12. Soultanis K, Thano A, Soucacos PN. Outcome of thoracolumbar compression fractures following non-operative treatment. Injury. 2021;52:3685–3690.

13. Muratore M, Ferrera A, Masse A, Bistolfi A. Osteoporotic vertebral fractures: predictive factors for conservative treatment failure. A systematic review. Eur Spine J. 2018;27:2565–2576.

14. Tsujio T, Nakamura H, Terai H, et al. Characteristic radiographic or magnetic resonance images of fresh osteoporotic vertebral fractures predicting potential risk for nonunion: a prospective multicenter study. Spine (Phila Pa 1976). 2011;36:1229–1235.

15. Inose H, Kato T, Ichimura S, et al. Risk factors of nonunion after acute osteoporotic vertebral fractures: a prospective multicenter cohort study. Spine (Phila Pa 1976). 2020;45:895–902.

16. Tolba R, Bolash RB, Shroll J, et al. Kyphoplasty increases vertebral height, decreases both pain score and opiate requirements while improving functional status. Pain Pract. 2014;14:E91-E97.

17. Ni W, Ricker C, Quinn M, et al. Trends in opioid use following balloon kyphoplasty or vertebroplasty for the treatment of vertebral compression fractures. Osteoporos Int. 2022;33:821–837.

18. Gerling MC, Eubanks JD, Patel R, Whang PG, Bohlman HH, Ahn NU. Cement augmentation of refractory osteoporotic vertebral compression fractures: survivorship analysis. Spine (Phila Pa 1976). 2011;36:E1266-E1269.

19. Bliuc D, Nguyen ND, Milch VE, Nguyen TV, Eisman JA, Center JR. Mortality risk associated with low-trauma osteoporotic fracture and subsequent fracture in men and women. JAMA. 2009;301:513–521.

20. Gutiérrez-González R, Royuela A, Zamarron A. Survival following vertebral compression fractures in population over 65 years old. Aging Clin Exp Res. 2023;35:1609–1617.

21. Gold LS, Suri P, O’Reilly MK, Kallmes DF, Heagerty PJ, Jarvik JG. Mortality among older adults with osteoporotic vertebral fracture. Osteoporos Int. 2023;34:1561–1575.

22. Edidin AA, Ong KL, Lau E, Kurtz SM. Morbidity and mortality after vertebral fractures: comparison of vertebral augmentation and nonoperative management in the medicare population. Spine (Phila Pa 1976). 2015;40:1228–1241.

23. Hinde K, Maingard J, Hirsch JA, Phan K, Asadi H, Chandra RV. Mortality outcomes of vertebral augmentation (vertebroplasty and/or balloon kyphoplasty) for osteoporotic vertebral compression fractures: a systematic review and meta-analysis. Radiology. 2020;295:96–103.

24. Cazzato RL, Bellone T, Scardapane M, et al. Vertebral augmentation reduces the 12-month mortality and morbidity in patients with osteoporotic vertebral compression fractures. Eur Radiol. 2021;31:8246–8255.

25. Manz D, Georgy M, Beall DP, Baroud G, Georgy BA, Muto M. Vertebral augmentation with spinal implants: third-generation vertebroplasty. Neuroradiology. 2020;62:1607–1615.

26. Dong C, Zhu Y, Zhou J, et al. Therapeutic efficacy of third-generation percutaneous vertebral augmentation system (PVAS) in osteoporotic vertebral compression fractures (OVCFs): a systematic review and meta-analysis. Biomed Res Int. 2022;2022:9637831.

Author: Brandon P. Hirsch, MD

From The CORE Institute in Phoenix, Arizona.