This document provides an overview of balloon kyphoplasty as an orthopaedic treatment for vertebral compression fractures. It describes how balloon kyphoplasty can stabilize fractures and correct spinal deformity by using an inflatable balloon to restore height to a fractured vertebra before injecting bone cement. Clinical studies discussed show that balloon kyphoplasty provides significant pain reduction, mobility improvements, and a low complication rate compared to alternative treatments like vertebroplasty.

1. Balloon Kyphoplasty Orthopaedic Treatment of Vertebral Compression Fractures

2. Vertebral Fracture: Associated Conditions Diagnosis of osteoporosis Glucocorticoid therapy (≥ 7.5 mg prednisolone) Postmenopausal women > age 55 Loss of 2 or more inches in height Prominent thoracic kyphosis Low BMD Ismail AA et al. Osteoporos Int . 1999;9:206–213.

3. Radiologic Assessment A lateral spine X-ray examination is a method that can be used to screen for the presence of vertebral compression fractures. STIR sequence MRI can be useful to determine index and/or plain radiograph culprit. Palpating each spinous process to rule out disc pain as the underlying culprit would also be of value in the initial assessment of the patient to differentiate between back pain and vertebral compression fracture pain.

4. Radiologic Assessment 8 weeks post fracture First week post fracture Courtesy of B. Boszczyk & R. Bierschnieder, BG Unfallklinik, Dept. of Neurosurgery, Murnau, Germany MRI: T2 Image

5. Vertebral Fracture Progression Some fractures may collapse acutely while others collapse progressively over time. Lyritis et al. (1989) Clin Rheum Suppl 2(8):66-69

6. Location of Vertebral Fractures Are most commonly located at the midthoracic region (T7–T8) and the thoracolumbar junction (T12–L1) 1 Midthoracic region – thoracic kyphosis is most pronounced and loading (stress) during flexion is increased Thoracolumbar junction – the relatively rigid thoracic spine connects to the more freely mobile lumbar segments 2 Correspond to the most mechanically compromised regions of the spine Nevitt MC et al. Bone . 1999;25:613–619. Cooper C et al. J Bone Min Res . 1992;7:221–227.

7. Vertebral Fractures: Three types Wedge Biconcave Crush Wedge fractures are most common Genant HK et al. J Bone Miner Res . 1993;8:1137–1148.

8. Long-term Consequences

9. Decreased Quality of Life Physical and functional performance lower in patients with VCF 1,2 Restricted ADL - patients need assistance from family or hired help Sleep disturbances Early satiety Patients suffer psychosocial consequences 3 anxiety, depression, low self-esteem, and alteration in social role 1. Lyles et al. (1993) Am J Med 94: 595-601 2. Silverman SL (1992) Bone 13, S27-S31 3. Gold DT (1996) Bone 3: S185-S189

10. Pulmonary Function Pulmonary function (FEV1) is significantly reduced in patients with osteoporotic VCF vs. non-osteoporotic patients with low back pain. Normal Posture Stooped Posture Schlaich C, et al. (1998) Osteoporosis Int’l 8:261-267

11. Future Fracture Risk After first VCF, risk of subsequent VCF is increased: 5-fold after first VCF 12-fold after 2 or more VCFs 75-fold after 2 or more VCFs and low bone mass (below the 33 rd percentile) Ross et al. (1991) Annals of Internal Med. 114 (11): 919-923

12. Risk of fracture from steroid use Users of oral glucocorticoids have a 2.6-fold increase risk of fracture van Staa TP et al. J Bone Miner Res. 2000;15:993–1000. Risk of vertebral fracture Oral glucocorticoid users (n=244,235) Age- and gender- matched controls (n=244,235)

13. Mortality Study of Osteoporotic Fractures cohort study: Women ≥ 65 years (n=9,515) with or without vertebral fracture Conclusions Women with prevalent vertebral fracture had a 23% higher age-adjusted mortality rate VCF patients are two to three times more likely to die of pulmonary causes Most common cause of death was pulmonary disease, i.e., COPD and pneumonia Kado DM et al. Arch Intern Med . 1999;159;1215–1220.

14. Balloon Kyphoplasty Stabilizes the Fracture and Corrects Spinal Deformity caused by one or more VCFs

15. The Procedure Minimally invasive Bilateral, 1cm incisions Typically one hour per treated fracture General or local anesthesia Can be performed under local anesthesia, often supplemented with conscious sedation. Among 155 prospectively enrolled patients in Kyphon U.S. study, only 1 complication was related to anesthesia. May require an overnight hospital stay Kyphon U.S. Study. Data on file at Kyphon Inc.

16. Case Study 19 o 3 o 15mm 28mm Patient: 91 YO Female Diagnosis: Primary osteoporosis Fracture Reduced: L-1, 4 months old Courtesy of Alexander Hadjipavlou, M.D., Crete, Greece

17. Case Study Patient: 78 YO Female Diagnosis: Primary osteoporosis Fracture Reduced: L-1 & L-2 6 weeks old Courtesy of Frank Phillips, MD, Chicago, IL (L3 Treated 6 Wks Prior) L1-L2 Height Restoration

18. Correction of Vertebral Body Deformity Studies report the following radiographic outcomes post kyphoplasty: Percent lost vertebral body height restored Percent vertebral body height increased Angular deformity correction

19. Example: Percent Lost Height Restored % Lost Height Restored = (24 – 20) / (30 - 20) or 4/10 = 40% 20 mm 24 mm Avg. 30 mm

20. Percent Lost Height Restored Kyphon U.S. Study. Data on file at Kyphon Inc. Theodorou et al (2002) J Clin Imaging 26:1-5 Lieberman et al (2001) Spine 26: 2, 1631-1638 NR = Not Reported Study Vertebral Body Site Mean Fracture Age (mos.) % Lost vertebral Body Height Restored All Fractures Reducible Fractures % N % N U.S. Study Midline 4.3 30.2 65 58 47 Lieberman (2001) Midline 5.9 35 70 47 49 Theodorou (2002) Midline 3.2 66 24 NR NR Theodorou (2002) Anterior 3.2 52 24 NR NR

21. Case Study: Correction of Angular Deformity Kyphosis = 25 º Kyphosis = 10 º Kyphosis = 16 º Immediate post- fracture Post-kyphoplasty Post-fracture + 4 days Lieberman et al. (2001) Spine 26: 2, 1631-1638

22. Balloon Kyphoplasty Clinical Outcomes

23. Clinical Outcomes Studies report the following clinical outcomes post kyphoplasty: Correction of vertebral body deformity Significant reduction in pain Improvement in quality of life Improvement in ability to perform activities of daily living Low complication rate

24. Reduction in Pain Following Balloon Kyphoplasty, patients report significant pain reduction at short-term follow-up, sometimes within hours of the procedure. In a retrospective analysis (Garfin et al (2001)), patients discontinued use of narcotics for fracture-related pain, changing to over-the-counter analgesics post operatively. Coumans et al. (2003) prospectively followed 78 consecutive patients for 12 to 18 months and reported substantial improvement (p<0.001) in bodily pain as measured by SF-36. Results persisted at three months. Garfin SR, Yuan HA, Reiley MA (2001). Spine 26:1511-1515 Theodorou et al (2002) J Clin Imaging 26:1-5 Coumans JV, Reinhardt MK, Lieberman I (2003) J Neurosurg (Spine 1) 99:44-50

25. Reduction in Pain In the prospective multicenter U.S. study, there was an average of 60% reduction in pain at one week follow-up. Results persisted for two years (n=100). Kyphon U.S. Study. Data on file at Kyphon Inc.

26. Ambulatory Status Ledlie et al (2002) (n=79) 80% were fully ambulatory at one week follow-up. 27 of the pts. followed at one year maintained full ambulatory status. 90% of all patients who were wheelchair-bound pre-operatively were ambulatory at one week follow-up. Ledlie et al. (2003) J Neurosurg (Spine 1) 98: 36-42

27. Risk of Subsequent Fracture Komp et al (2004) A controlled, prospective study 21 patients underwent balloon kyphoplasty and 19 underwent conservative treatment. Patient populations were similar in age, gender, fracture history, and other risk factors. After six months, 7 out of 19 evaluable balloon kyphoplasty patients had new fractures (37%), whereas 11 out of 17 conservatively-treated patients (67%) had new fractures. Conclusions: Incidence of adjacent and non-adjacent fracture in both arms corresponds to other published data. A larger study is needed to assess risk of subsequent fracture. Komp, et al. (2004) J Miner Stoffwechs 11(Suppl 1):13-16 (German)

28. Low Complication Rate U.S. Study = no serious procedure-related complications in 214 fractures in 155 patients treated One patient experienced an intraoperative arrhythmia (PSVT) Kyphon U.S. Study. Data on file at Kyphon Inc. * Lit review: See bibliography at end of presentation

29. Overall Procedure-Related Complication Rate Overall procedure-related complication rate for balloon kyphoplasty-treated patients was 0.89% versus 5.44% for vertebroplasty (p=0.0009). Statistically significant difference also demonstrated in sub-analyses of fractures due to osteoporosis or cancer .

30. Bone Cement Procedure-Related Complication Rates The total bone cement procedure-related complication rate for balloon kyphoplasty was 0.22% versus 3.07% for vertebroplasty (p=0.0008). The calculation of bone cement-related complications excluded asymptomatic cement extravasations.

31. Bone Cement Procedure-Related Complication Rates The combination of compaction of cancellous bone , cavity creation , and controlled cement delivery suggests the difference in adverse events is caused by cement extravasation. Compaction of Cancellous Bone: Balloon inflation compacts the cancellous bone, disrupts internal venous pathways and fills fracture lines, reducing leak pathways. Cavity Creation and Controlled Bone Cement Delivery: Upon balloon removal, an intervetebral cavity is left behind, allowing for the delivery of a known volume of doughy bone cement (KyphX ® HV-R  ) under low pressure and fine manual control. Phillips et al. (2002) Spine 27:2173-2179 Togawa et al. (2003) Spine 28:1521-1527

32. Adverse Events Although the complication rate with Balloon Kyphoplasty has been demonstrated to be low, as with most surgical procedures, there are risks associated with Balloon Kyphoplasty, including serious complications. Serious adverse events, some with fatal outcome, associated with the use of acrylic bone cements include cardiac arrest, cerebrovascular accident, myocardial infarction, and pulmonary embolism. Other reported adverse events relevant to the anatomy being treated with acrylic bone cements include deep or superficial wound infection, fistula, hematoma, hemorrhage, heterotopic new bone formation, nerve entrapment due to extrusion of bone cement beyond the region of its intended use, pyrexia due to allergy to bone cement, short-term conduction irregularities, thrombophlebitis, and transitory fall in blood pressure. Physicians should review the product Instructions for Use for a full discussion of the risks.

33. Patient Satisfaction: U.S. Study Reports patient satisfaction with the outcomes of the kyphoplasty procedure Measured on a scale of 1 – 20 1 = completely dissatisfied 20 = completely satisfied RESULT: 17.5 at one week and maintained at 2 yrs Kyphon U.S. Study. Data on file at Kyphon Inc.

34. Conclusion VCFs occur more than hip and wrist fractures combined. Balloon kyphoplasty is an available option associated with a low complication rate for patients suffering from painful VCFs. Balloon kyphoplasty can provide fracture stabilization and correction of spinal deformity. Patients experience significant reduction in pain and improvement in mobility, thus increasing overall quality of life.

35. References: Literature review of 1342 fractures treated with kyphoplasty Boszczyk et al. (2004) Microsurgical interlaminary vertebro- and kyphoplasty for severe osteoporotic fractures. J Neurosurg (Spine 1) 100:32-37 Coumans et al (2003) Kyphoplasty for vertebral compression fractures: 1-year clinical outcomes from a prospective study. J Neurosurg (Spine 1) 99:44-50 Dudeney et al. (2002) Kyphoplasty in the treatment of osteolytic vertebral compression fractures as a result of multiple myeloma. J Clin Oncol 20:2382-2387 Fourney et al. (2003) Percutaneous vertebroplasty and kyphoplasty for painful vertebral body fractures in cancer patients. J Neurosurg (Spine 1) 98:21-30 Garfin SR, Yuan HA, Reiley MA (2001) Kyphoplasty and vertebroplasty for the treatment of painful osteoporotic compression fractures. Spine 26:1511-1515 Komp et al. (2004) Minimally invasive therapy for functionally unstable osteoporotic vertebral fracture by means of kyphoplasty: Prospective comparative study of 19 surgically and 17 conservatively treated patients. J Miner Stoffwechs 11 (Suppl 1):13-15 Kyphon U.S. Multicenter Prospective Single Arm Study. Data on file at Kyphon Inc. Lane et al. (2002) Minimally invasive options for the treatment of osteoporotic vertebral compression fractures. Orthop Clin N Am 33:431-438 Ledlie J, Renfroe M (2003) Balloon Kyphoplasty: One Year Outcomes in Vertebral Body Height Restoration, Chronic Pain, and Activity Levels. J Neurosurg (Spine 1) 98: 36-42 Lieberman et al (2001) Initial Outcome and Efficacy of Kyphoplasty in the Treatment of Osteoporotic VCFs. Spine 26: 2, 1631-1638 Lieberman IH, Reinhardt M-K (2003) Vertebroplasty and kyphoplasty for osteolytic vertebral collapse. Clin Orthop 415(Suppl):S176-S186 Phillips et al. (2003) Early radiographic and clinical results of balloon kyphoplasty for the treatment of osteoporotic vertebral compression fractures. Spine 28, 19: 2260-2267 Phillips et al. (2002) An In Vivo Comparison of the Potential for Extravertebral Cement Leak After Vertebroplasty and Kyphoplasty. Spine 27, 19: 2173-2179 Theodorou DJ, Theodorou SJ, Duncan T, Garfin SR, Wong W (2002) Percutaneous Balloon Kyphoplasty for the Correction of Spinal Deformity in Painful Vertebral Compression Fractures. J Clin Imaging 26:1-5 Voggenreiter G, Sadik M, Majetschak M, et al. (2004) Treatment results of the kyphoplasty balloon technique. MedReview:17-18 Wilhelm K, Stoffel M, Ringel F, et al. (2003) Preliminary experience with balloon kyphoplasty for the treatment of painful osteoporotic compression fractures. Fortschr Rontgenstr 175:1690-1696 Wong W, Reiley MA, Garfin SR (2000) Vertebroplasty / Kyphoplasty. J Women’s Imaging 2(3)

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