Jeffrey M. Spivak , M.D. December 8, 2018

1. Department of Orthopedic Surgery Vertebroplasty vs Kyphoplasty and the Osteoporotic Fracture: Is it worth the time, who should do it, and why? Jeffrey M. Spivak, M.D. December 8, 2018

2. Osteoporotic Compression Fractures Division of Spine Surgery • Fracture of the body of the vertebra • Associated with poor bone quality (osteopenia or osteoporosis) • 750,000 Americans per year • Sudden back pain is most common symptom, but many (?most) are silent and result in little or no symptoms

3. Initial Management Division of Spine Surgery • Diagnosed typically by x-ray • MRI can be very helpful in assessing acuity • Initial management is usually nonsurgical: • Pain control • Possibly bracing and/or physical therapy • Medical management of osteoporosis • Nonsurgical treatment is typically trialed for at least 2-3weeks • Pain symptoms typically subside over 6-8 weeks in patients treated non-operatively

4. Percutaneous Cementation Procedures Division of Spine Surgery • Indications: • Continued pain/dysfunction despite 2-3 weeks of nonoperative treatment • Acute kyphosis >20 degrees • Progressive collapse/kyphosis • Relative contraindications: • > 70% loss of vertebral body height • Fracture fragments abutting neural structures (burst component) • Neurologic symptoms • Healed fractures • Vertebroplastyvs. Kyphoplasty

5. Vertebroplasty • Unilateral trochar centrally in vertebral body • ‘Wet’ cement injected at high pressure to interdigitage between fracture fragments • Any kyphosis correction is positional Division of Spine Surgery

6. Kyphoplasty Division of Spine Surgery • Unilateral or bilateral trochars to introduce balloon(s) • Balloon inflation creates cavity, compresses fracture fragments, reduces kyphosis. • Balloons are removed and thicker cement is inserted under lower pressure, filling the cavity.

7. Potential Complications Division of Spine Surgery • Trocharmalplacement • CSF leakage, neurologic • pneumothorax • Cement leakage • More common in vertebroplasty • Possible locations: • disc space • spinal canal • Intravascular Possible PE • Infection • Very uncommon

8. Outcomes: Vertebroplasty vs Sham Procedure Division of Spine Surgery • In 2010 AAOS recommended “strongly” against vertebroplasty for treatment of compression fractures based on two level 1 multi-center NEJM studies comparing vertebroplasty to sham procedure • These studies concluded there was no significant difference in outcomes between vertebroplasty and sham procedure (anesthetic injection) for compression fracture • Both heavily criticized for methodology

9. Outcomes: Vertebroplasty vs Sham Procedure Division of Spine Surgery Kallmes Study Criticisms • Did not require MRI imaging • No nonoperative group • Outcomes taken only at 1 month post-procedure • By 3 months 43% of sham group had crossed over to vertebroplasty making longer term follow-up impossible • Fracture chronicity: only 40% of fractures were less than 3 months old; remainder from 3-12 months • Large number of Workers Compensation patients

10. Outcomes: Vertebroplasty vs Sham Procedure Division of Spine Surgery Buchbinder Study Criticisms • Required MRI but not physical exam • No nonoperative group • Follow-up was only up to 6 months • Fracture chronicity: only 32% of fractures were less than 6 weeks old • 68% of subjects were from one center

11. Outcomes: Vertebroplasty vs Nonoperative Management -Klazen CA et al., Lancet. 2010 Sep 25;376(9746):1085-92. • The 2010 VERTOS II Trial compared vertebroplasty to non-operative/medical treatment • Was criticized for lack of blinding but excluded fractures > 6 weeks old • Concluded that: • Vertebroplasty yielded better pain relief at 1 year • Vertebroplasty resulted in satisfactory pain relief 3 months faster than nonoperative management • Most nonoperative subjects achieved sufficient pain relief at 3 months leading authors to conclude that vertebral augmentation may be justified in patients without sufficient pain relief after 3 months of nonoperative management Division of Spine Surgery

12. Outcomes: Vertebroplasty vs Sham/NonoperativeTreatment -Anderson PA, et al., J Bone Miner Res. 2013 Feb;28(2):372-82. • There have since been multiple prospective RCTs • Conclusions difficult to draw given heterogenous results • A 2013 meta-analysis concluded that vertebroplasty had improved pain, functional and HRQOL outcomes compared to non-operative management or sham procedures at early and late follow-up points • Despite these more recent studies, vertebroplasty is less commonly used in treatment of compression fractures given 2010 AAOS recommendations Division of Spine Surgery

13. Outcomes: Kyphoplasty vs Vertebroplasty Division of Spine Surgery AAOS has provided a “limited” recommendation supporting the use of kyphoplasty for compression fractures based on separate studies comparing kyphoplasty to non-operative treatment A few prospective RCTs have compared vertebroplasty directly to kyphoplasty

14. Outcomes: Kyphoplasty vs Vertebroplasty -Han S, et al. IntOrthop. 2011 Sep;35(9):1349-58. -Van Meirhaeghe J, et al, Spine. 2013 May 20;38(12):971-83. -Wang et al., J OrthopSurg Res, 2018 Oct 22;13(1):264. -GuCN, et al, J Neurointerv Surg. 2016 Jun;8(6):636-42. -Chandra RV, et al, Am J Neuroradiol. 2018 May;39(5):798-806. A systematic review concluded no significant difference in pain or disability outcomes at 1-year follow-up between the two Kyphoplastyachieves greater correction of kyphotic deformity than vertebroplasty, but this has not been shown to be clinically significant A 2016 meta-analysis additionally determined that kyphoplasty resulted in lower incidence of cement leakage though no significant difference in symptomatic cement leakage Overall complication rate in both less than 1% Division of Spine Surgery

15. Cost Effectiveness of Vertebral Augmentation -EdidinAA, et al., Appl Health Econ Health Policy. 2012 Jul 1;10(4):273-84. A 2012 study of Medicare patients concluded: • Vertebral augmentation (both vertebroplasty and kyphoplasty) more cost-effective than nonoperative management in terms of cost per life-year-gained, including in patients above 85 years of age • Kyphoplasty procedure more expensive than vertebroplasty procedure but more cost-effective in terms of cost per life-year-gained Division of Spine Surgery

16. Who’s Doing Vertebral Augmentation? -Degnan AJ et al.,. J Am CollRadiol. 2017 Aug;14(8):1001-1006. A 2017 study of Medicare records from 2001-2014 showed: • Vertebroplasty first became a billable code in 2001, and kyphoplasty in 2006 • Majority (roughly 2/3) of vertebroplasties have been performed by radiologists every year from 2001-2014 • Kyphoplasties performed predominantly by orthopedists from 2006 until 2012 • Predominance of kyphoplasties (roughly 1/3) were performed by radiologists beginning 2012 • Neurosurgeons and a small group of other providers also performing vertebral augmentation Division of Spine Surgery

17. Summary Division of Spine Surgery • Some controversy persists regarding vertebral cement augmentation for use in osteoporotic compression fractures; studies are ongoing • At present vertebroplastynot commonly used given 2010 AAOS recommendations • Kyphoplastyis commonly used, and is accepted as efficacious • It can provide improved pain and function sooner than non-operative treatment • Kyphoplasty is more commonly being done by interventional radiologists