Management strategies for osteoporotic vertebral compression fractures: a prospective multicentric study

INTRODUCTION

Osteoporosis is a systemic skeletal disorder characterized by reduced bone mass and microarchitectural deterioration, leading to increased fracture risk.¹ Vertebral compression fractures (VCFs) are the most common osteoporotic fractures, accounting for significant morbidity worldwide.² The global prevalence of osteoporosis is rising due to increased life expectancy, making OVCFs a significant public health concern.³ These fractures often result in chronic pain, spinal deformity, and impaired quality of life.⁴ Management strategies for OVCFs include conservative therapy (analgesics, bracing, physiotherapy) and minimally invasive procedures such as vertebroplasty and kyphoplasty.⁵ While conservative management is traditionally first-line, interventional procedures have gained popularity due to rapid pain relief and functional recovery.⁶ Vertebroplasty involves injection of bone cement into the fractured vertebra, providing stabilization.⁷ Kyphoplasty, a modification of vertebroplasty, includes balloon inflation to restore vertebral height before cement injection.⁸ Despite advances, there is ongoing debate regarding the superiority of these approaches.⁹ Few prospective multicentric studies have compared these modalities in the Indian population. This study aims to evaluate the effectiveness of different management strategies in OVCFs across multiple centres.

METHODS

This prospective multicentric observational study was conducted at three tertiary care centres in Odisha, namely Veer Surendra Sai Institute of medical sciences and research (VIMSAR), Burla, Fakira Mohan medical college, Balasore, and government medical college, Sundargarh, between December 2023 and December 2025. The study included patients aged 50 years and above who were diagnosed with osteoporotic vertebral compression fractures (OVCFs) based on clinical assessment and radiological confirmation. Patients presenting with acute or subacute osteoporotic vertebral fractures of less than six weeks duration were considered eligible for inclusion. Patients with traumatic vertebral fractures, malignancy-related fractures, neurological deficits, or a history of previous spinal surgery were excluded from the study.

A total of 220 eligible patients were enrolled consecutively after obtaining written informed consent. Following detailed clinical and radiological evaluation, treatment decisions were made by the treating orthopaedic surgeons according to fracture characteristics, patient preference, medical fitness, and institutional protocols. Based on the treatment modality received, patients were categorized into three groups: group A comprised 80 patients managed conservatively, group B included 70 patients who underwent vertebroplasty, and group C consisted of 70 patients treated with kyphoplasty.

Conservative treatment included analgesic medications, anti-osteoporotic therapy, spinal bracing, and supervised physiotherapy. Patients undergoing vertebroplasty were treated under fluoroscopic guidance using percutaneous injection of polymethylmethacrylate bone cement into the fractured vertebral body. Kyphoplasty was performed using balloon-assisted vertebral body expansion followed by cement augmentation under fluoroscopic guidance.

Baseline demographic characteristics, fracture details, VAS scores, Oswestry disability index (ODI) scores, and radiological parameters were recorded at enrolment. Patients were followed up at 3 months, 6 months, and 12 months after treatment. At each follow-up visit, pain intensity, functional disability, radiological vertebral height restoration, and treatment-related complications were assessed and documented.

Data were entered into Microsoft Excel and analysed using Statistical package for social sciences (SPSS) version 25.0. Continuous variables were expressed as mean±standard deviation, whereas categorical variables were expressed as frequencies and percentages. Intergroup comparisons were performed using one-way analysis of variance (ANOVA) for continuous variables and Chi-square test for categorical variables. Repeated measures ANOVA was used to compare changes in VAS scores over time. A p value of less than 0.05 was considered statistically significant.

RESULTS

A total of 220 patients diagnosed with osteoporotic vertebral compression fractures were included in the final analysis.

Baseline characteristics

The demographic and clinical profiles of patients across all three groups were comparable, with no statistically significant differences observed at baseline. The mean age ranged between 65 and 67 years, and female predominance was noted in all groups. Baseline pain and disability scores were similar, ensuring homogeneity for comparison. (Table 1) summarizes the baseline characteristics of the study population.

Pain assessment (VAS scores)

All three treatment groups demonstrated a statistically significant reduction in pain scores over time (repeated measures ANOVA, p<0.001). However, the magnitude and rate of improvement differed across groups. Patients undergoing kyphoplasty (Group C) showed the most pronounced reduction in pain at all follow-up intervals, followed by vertebroplasty (Group B). Conservative management (Group A) resulted in gradual but comparatively lesser improvement. At 3 months, Group B and Group C showed significantly lower VAS scores compared to Group A (p=0.01). At 12 months, Group C maintained the lowest mean VAS score (p=0.03). These findings are detailed in Table 2.

Functional outcome (ODI scores)

Functional disability, assessed using the Oswestry disability index, showed significant improvement in all groups over the study period (p<0.001). At 12 months, patients in group C exhibited the greatest improvement, followed by group B, while group A showed comparatively modest recovery. The difference between groups at final follow-up was statistically significant (p=0.01). These results are presented in Table 3.

Radiological outcomes

Radiographic analysis demonstrated a marked difference in vertebral height restoration among the groups. Kyphoplasty (Group C) achieved the highest restoration, followed by vertebroplasty (Group B), while minimal change was noted in the conservative group. The intergroup difference was statistically significant (p<0.01).

Complications

The overall complication rate was low across all groups. Cement leakage was observed only in the interventional groups, with a slightly higher incidence in vertebroplasty. However, these differences were not statistically significant (p=0.27). Adjacent vertebral fractures were noted in all groups, with comparable frequencies. Details are provided in Table 4.

DISCUSSION

OVCFs significantly impact elderly populations, often leading to chronic pain and disability.¹⁰ This study highlights differences in outcomes among conservative and interventional approaches. Conservative management remains widely used but often results in slower recovery.¹¹ In our study, group A showed gradual improvement but inferior outcomes compared to interventional groups. Vertebroplasty has been shown to provide rapid pain relief due to mechanical stabilization.¹² Our findings align with previous studies demonstrating early VAS improvement.¹³

Kyphoplasty offers additional advantages by restoring vertebral height and correcting kyphosis.¹⁴ In this study, kyphoplasty resulted in superior long-term pain relief and functional outcomes, consistent with earlier reports.¹⁵ The statistical significance observed (p<0.05) confirms the superiority of kyphoplasty in selected patients. However, cost and availability remain limiting factors in resource-constrained settings.¹⁶ Complication rates were low and comparable across groups, consistent with literature.¹⁷ This multicentric study strengthens external validity and provides region-specific data for India.

CONCLUSION

In summary, the findings of this multicentric prospective study indicate that kyphoplasty is associated with superior long-term clinical and functional outcomes in patients with osteoporotic vertebral compression fractures. Vertebroplasty, while slightly less effective in long-term restoration, demonstrates the advantage of providing rapid and significant early pain relief. Conservative management remains a reasonable option, particularly for patients with mild symptoms or those who are not suitable candidates for interventional procedures. Overall, the choice of treatment should be tailored to the individual patient, taking into account clinical severity, comorbid conditions, functional demands, and the availability of healthcare resources.

Funding: No funding sources

Conflict of interest: None declared

Ethical approval: The study was approved by the Institutional Ethics Committee

REFERENCES

1. 1. Kanis JA. Diagnosis of osteoporosis. Lancet. 2002;359(9321):1929-36.
2. 2. Johnell O, Kanis JA. An estimate of the worldwide prevalence and disability associated with osteoporotic fractures. Osteoporos Int. 2005;16(S2):S3-7.
3. 3. Hernlund E, Svedbom A, Ivergård M, Compston J, Cooper C, Stenmark J, et al. Osteoporosis in the European Union: medical management, epidemiology and economic burden. Arch Osteoporos. 2013;8(2):136.
4. 4. Silverman SL. The clinical consequences of vertebral compression fracture. J Bone Miner Res. 1992;7(5):1187-91.
5. 5. Old JL, Calvert M. Vertebral compression fractures in the elderly. Am Fam Physician. 2004;69(1):111-6.
6. 6. Klazen CAH, Lohle PNM, De Vries J, Jansen FH, Tielbeek AV, Blonk MC, et al. Vertebroplasty versus conservative treatment in acute osteoporotic vertebral compression fractures (Vertos II): an open-label randomised trial. Lancet. 2010;376(9746):1085-92.
7. 7. Galibert P, Deramond H, Rosat P, Le Gars D. Preliminary note on the treatment of vertebral angioma by percutaneous acrylic vertebroplasty. Neurochirurgie. 1987;33(2):166-8.
8. 8. Lieberman IH, Dudeney S, Reinhardt MK, Bell G. Initial outcome and efficacy of kyphoplasty in the treatment of painful osteoporotic vertebral compression fractures. Spine (Phila Pa 1976). 2001;26(14):1631-8.
9. 9. Buchbinder R, Osborne RH, Ebeling PR, Wark JD, Mitchell P, Wriedt C, et al. A randomized trial of vertebroplasty for painful osteoporotic vertebral fractures. N Engl J Med. 2009;361(6):557-68.
10. 10. Cauley JA. Public health impact of osteoporosis. J Gerontol A Biol Sci Med Sci. 2013;68(10):1243-51.
11. 11. Kallmes DF, Comstock BA, Heagerty PJ, Turner JA, Wilson DJ, Diamond TH, et al. A randomized trial of vertebroplasty for osteoporotic spinal fractures. N Engl J Med. 2009;361(6):569-79.
12. 12. McGraw JK, Cardella J, Barr JD, Mathis JM, Sanchez O, Schwartzberg MS, et al. Society of Interventional Radiology quality improvement guidelines for percutaneous vertebroplasty. Radiology. 2003;226(2):366-72.
13. 13. Voormolen MHJ, Mali WPTM, Lohle PNM, Fransen H, Lampmann LEH, Van der Graaf Y, et al. Percutaneous vertebroplasty compared with optimal pain medication treatment for patients with acute osteoporotic vertebral compression fractures: short-term clinical outcome of the VERTOS study. AJNR Am J Neuroradiol. 2007;28(3):555-60.
14. 14. Wardlaw D, Cummings SR, Van Meirhaeghe J, Bastian L, Tillman JB, Ranstam J, et al. Efficacy and safety of balloon kyphoplasty compared with non-surgical care for vertebral compression fracture (FREE): a randomised controlled trial. Lancet. 2009;373(9668):1016-24.
15. 15. Berenson J, Pflugmacher R, Jarzem P, Zonder J, Schechtman K, Tillman JB, et al. Balloon kyphoplasty versus non-surgical care for cancer-related vertebral compression fractures: a multicentre, randomised controlled trial. Lancet Oncol. 2011;12(3):225-35.
16. 16. Chen AT, Cohen DB, Skolasky RL. Impact of nonoperative treatment, vertebroplasty, and kyphoplasty. Spine J. 2014;14(10):2497-503.
17. 17. Taylor RS, Fritzell P, Taylor RJ. Balloon kyphoplasty in the management of vertebral compression fractures. Spine. 2007;32(24):2849-55.