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Multicenter study to assess the efficacy and safety of sacroplasty in patients with osteoporotic sacral insufficiency fractures. 2012

Interventional Spine

A. Orlando, Ortiz, MD, MBA, FACR
Keith, Kortman, MD, Non ASSR Member
Todd, Miller, MD, Non ASSR Member
Allan, Brook, MD, Non ASSR Member
John, Mathis, MD, Non ASSR Member
Bassem, Georgy, MD, Non ASSR Member

Paper/Non-Mentor

Purpose

To assess the outcomes and safety after CT guided percutaneous sacroplasty in patients with sacral insufficiency fractures

Methods & Materials

A retrospective multicenter analysis of consecutive patients undergoing image guided sacroplasty for painful sacral insufficiency fractures. All procedures were performed with CT, CT and fluoroscopy or CT fluoroscopy. The inclusion criteria consisted of severe sacral pain not responding to conservative medical management with imaging (MRI, CT and/or skeletal scintigraphy) evidence of unilateral or bilateral sacral insufficiency fractures. The presence of other pelvic or spinal fractures was also recorded. The number of bone needles (13 or 11 g) and the volume of injected acrylic bone cement were also documented. Outcome measures included hospitalization status (inpatient or outpatient), pre-treatment and post treatment visual analog scale (VAS) scores, analgesic use and complications. Patients were followed at approximately 1 month and up to one year and beyond their sacroplasty procedure.

Results

194 patients were included in this study. 168 patients were female and 26 were male with an average patient age of 77.0 years. 164 patients had bilateral sacral insufficiency fractures and 30 had unilateral fractures. 56 patients had additional fractures of the axial skeleton consisting of 39 pelvic fractures, 21 vertebral compression fractures and one coccyx fracture. 107 patients were evaluated and treated as inpatients and 87 patients were managed as outpatients. The average pre-treatment VAS score of 9.2 +/- 1.1 was significantly improved after sacroplasty to 1.8 +/-1.6 in patients with sacral insufficiency fractures (p<0.001; 2-tailed paired t-test). The mean pain score before and after the procedure in patients with unilateral sacral insufficiency fractures was 8.7 +/- 1.5 and 2.4 +/- 1.8, respectively. Furthermore 63 of the 194 patients (32%) reported complete pain relief. Significant reductions in analgesic use were observed. Sacroplasty facilitated inpatient discharge in those patients who were already hospitalized. There were no procedure-related deaths, infections, pulmonary emboli or hemorrhages. One patient experienced radicular pain due to local extravasation of cement which subsequently required surgical decompression for symptomatic relief (0.51% complication rate). Another patient in this series developed progressive fracture dislocation one week after sacroplasty. Three patients with unilateral fractures were diagnosed with contralateral sacral insufficiency fractures; these were subsequently treated resulting in symptomatic relief.

Conclusion

CT guided percutaneous sacroplasty is a safe and effective procedure in the treatment of painful sacral insufficiency fractures. CT guided sacroplasty is associated with prompt and durable pain relief and should be considered as an effective treatment option in this patient population.

References/Financial Disclosures

1. Kortman, Mathis JM, Ortiz AO: Sacroplasty, in Mathis JM, Deramond H, Belkoff SM (eds): Percutanoous Vertebroplasty and Kyphoplasty 2nd ed. New York, NY, Springer, 2006, pp 197-209 2. Ortiz AO, Brook A. Sacroplasty. Tech Vasc Interventional Rad 2009;12:51-63 3. Frey ME, DePalma JM, Cifu DX, et al. Percutaneous sacroplasty for osteoporotic sacral insufficiency fracutes: a prospective, multicenter, observational pilot study. The Spine Journal 2008; 8:367-373 AO Ortiz: Speakers Bureau - Medtronic Spine, Orthovita Spine

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