KYPHON

1
KYPHON Balloon Kyphoplasty

• Orthopaedic Treatment of Vertebral Compression
  Fractures

2
Osteoporosis

• Osteoporosis is a systemic skeletal disease
  characterized by compromised bone strength that
  predisposes the affected bone to fracture.

National Institutes of Health. 200017136.
3
Epidemiology

• In the U.S., 700,000 vertebral compression
  fractures (VCFs) occur each year, more than the
  number of hip and wrist fractures combined.2
• Approximately 150,000 people in the U.S. are
  hospitalized due to pain and medical management
  associated with VCFs (average hospital stay of 8
  days), resulting in costs in excess of 1.6
  billion annually.2
• Osteoporosis-related disability confines patients
  to more immobile days in bed than stroke, heart
  attack or breast cancer.1
• Estimated national direct expenditures (hospitals
  and nursing homes) for osteoporotic and
  associated fractures are 17 billion in 2001 (47
  million each day) and the cost is rising,
  according to the National Osteoporosis
  Foundation.

1. National Osteoporosis Foundation 2. Cooper C
et al. J Bone Min Res. 19927221227.
4
Identifying Vertebral Fractures

• Approximately two thirds of all vertebral
  fractures go undiagnosed, in part due to
  difficulty determining cause of symptoms.
• Vertebral fractures are often asymptomatic.
• Pain ranges from mild to severe and may be
  chronic, but may disappear over several weeks.
• It is important to diagnose vertebral fractures,
  to understand the value of lateral spine
  radiographs, and to consider ordering additional
  radiographs if initial films do not show fracture.

Gold et al. The Downward Spiral of Vertebral
Osteoporosis, A Monograph, June 2003
5
Vertebral Fracture Associated Conditions
Postmenopausal women gt age 55
Prominent thoracic kyphosis
Low BMD
Loss of 2 or more inches in height
Diagnosis of osteoporosis
Glucocorticoid therapy( 7.5 mg prednisolone)
Ismail AA et al. Osteoporos Int. 19999206213.
6
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.

7
Radiologic Assessment
8 weeks post fracture
First week post fracture
MRI T2 Image
Courtesy of B. Boszczyk R. Bierschnieder, BG
Unfallklinik, Dept. of Neurosurgery, Murnau,
Germany
8
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
9
Location of Vertebral Fractures

• Are most commonly located at the midthoracic
  region (T7T8) and the thoracolumbar junction
  (T12L1)1
• Midthoracic regionthoracic kyphosis is most
  pronounced and loading (stress) during flexion is
  increased
• Thoracolumbar junctionthe relatively rigid
  thoracic spine connects to the more freely mobile
  lumbar segments2
• Correspond to the most mechanically compromised
  regions of the spine

Nevitt MC et al. Bone. 199925613619. Cooper C
et al. J Bone Min Res. 19927221227.
10
Vertebral Fractures Three types

• Wedge fractures are most common

Wedge
Biconcave
Crush
Genant HK et al. J Bone Miner Res.
1993811371148.
11
Long-term Consequences
12
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
13
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 Intl
8261-267
14
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 33rd percentile)

Ross et al. (1991) Annals of Internal Med. 114
(11) 919-923
15
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.
2000159931000.
16
Mortality

• Study of Osteoporotic Fractures cohort study
  Women 65 years (n9,515) 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.
199915912151220.
17
KYPHON Balloon Kyphoplasty

• Stabilizes the Fracture and Corrects Spinal
  Deformity caused by one or more VCFs

18
The Procedure

• Minimally invasive
• Bilateral, 1cm incisions
• Typically one hour per treated fracture
• General or local anesthesia
• Most are performed under general 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.
19
Case Study
Patient 91 YO FemaleDiagnosis Primary
osteoporosisFracture Reduced L-1, 4 months old
19o
3o
15mm
28mm
Courtesy of Alexander Hadjipavlou, M.D., Crete,
Greece
20
Case Study
Patient 78 YO FemaleDiagnosis Primary
osteoporosisFracture Reduced L-1 L-2 6 weeks
old
L1-L2 Height Restoration
(L3 Treated 6 Wks Prior)
Courtesy of Frank Phillips, MD, Chicago, IL
21
Experience to Date

• Over insert number fractures in insert number
  patients treated worldwide since 1998
• Patient Outcomes include
• Vertebral body height restoration
• Angular correction of deformity
• Significant reduction in pain
• Reduced number of days in bed
• Improved quality of life
• Improvement in activities of daily living
• Improvement in mobility
• High rate of patient satisfaction

22
Data Sources

• Kyphon U.S. Study
• Multicenter prospective single-arm study
  documenting the outcomes of balloon kyphoplasty
• 155 patients enrolled, 100 completed at 2 yr.
  follow-up
• Peer-reviewed Published Literature
• Literature review (prospective and retrospective)
  of 1342 fractures treated with balloon kyphoplasty

23
Correction of Vertebral Body Deformity

• Studies report the following radiographic
  outcomes post balloon kyphoplasty
• Percent lost vertebral body height restored
• Percent vertebral body height increased
• Angular deformity correction

24
Correction of Vertebral Body Deformity

• Three studies analyzed how many fractures in the
  study populations were reducible (that is,
  achieved a measurable correction).
• In the U.S. study, reducible refers to
  measurable fractures where at least 15 of
  predicted height was lost due to fracture.
• In Lieberman et al (2001) a fracture was
  reducible if at least 10 of lost vertebral body
  height was restored with balloon kyphoplasty.
• Phillips et al. (2003) defined reducible as a
  decrease in local angulation of at least 5
  degrees.

Kyphon U.S. Study. Data on file at Kyphon Inc.
Lieberman et al (2001) Spine 26 2, 1631-1638
Phillips et al (2003) Spine 28, 19 2260-2267
25
Percent Lost Height Restored

• Based on the mean height measurement of the
  closest, unfractured vertebrae above and below
  the treated level.

• Anterior, midline, and sometimes posterior
  measurements are taken.

26
Example Percent Lost Height Restored
Lost Height Restored (24 20) / (30 - 20)
or 4/10 40
27
Percent Lost Height Restored
Study Vertebral Body Site Mean Fracture Age (mos.) Lost vertebral Body Height Restored Lost vertebral Body Height Restored Lost vertebral Body Height Restored Lost vertebral Body Height Restored
Study Vertebral Body Site Mean Fracture Age (mos.) All Fractures All Fractures Reducible Fractures Reducible Fractures
Study Vertebral Body Site Mean Fracture Age (mos.) 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
NR Not Reported
Kyphon U.S. Study. Data on file at Kyphon Inc.
Lieberman et al (2001) Spine 26 2, 1631-1638
Theodorou et al (2002) J Clin Imaging 261-5
28
Percent Vertebral Body Height Increased

• Estimates of total, pre-fractured vertebral
  body height
• Percent vertebral body height is based on the
  mean measurement of the closest unfractured
  vertebrae above and below the treated level.
• Using the same example, 30mm becomes 100

Pre-KP 20mm / 30mm 66
Post-KP 24mm / 30mm 80
29
Percent Vertebral Body Height Increased
Results Total Fractures Mean Fracture Age Percent Predicted Vertebral Body Height Percent Predicted Vertebral Body Height Percent Predicted Vertebral Body Height Percent Predicted Vertebral Body Height
Results Total Fractures Mean Fracture Age Anterior Pre-op Midline Pre-op Anterior Post-op Midline Post-op
Garfin (2001) 603 treated. (Number of fractures measured not reported.) Not reported 68 64 84 90
Ledlie (2003) 36 measured pre-op. 30 measured post-op. 2.4 mo 66 65 89 90
Theodorou (2002) 24 treated. 3.2 mo 79 (does not specify measurement site) 79 (does not specify measurement site) 92 (does not specify measurement site) 92 (does not specify measurement site)
Garfin et al (2001) Spine 261511-1515
Ledlie et al. (2003) J Neurosurg (Spine 1) 98
36-42
Theodorou et al (2002) J Clin Imaging 261-5
30
Correction of Angular Deformity

• Measured using the Cobb Method
• Theodorou et al. (2002) (n24)
• Local angular deformity decreased from 26º to 16º
• Phillips et al. (2003) (n52)
• Mean local angular deformity correction was 8.8º
  (range, 0-29º)
• Among reducible fractures (5º improvement), mean
  angular deformity correction was 14º

Phillips et al (2003) Spine 28, 19 2260-2267
Theodorou et al (2002) J Clin Imaging 261-5
31
Case Study Correction of Angular Deformity

Immediate post- fracture
Post-fracture 4 days
Post-kyphoplasty
Kyphosis 25º
Kyphosis 10º
Kyphosis 16º
Lieberman et al. (2001) Spine 26 2, 1631-1638
32
KYPHON Balloon KyphoplastyClinical Outcomes
33
Clinical Outcomes

• Studies report the following clinical outcomes
  post balloon 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

34
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 (plt0.001) in
  bodily pain as measured by SF-36. Results
  persisted at three months.

Theodorou et al (2002) J Clin Imaging
261-5 Coumans JV, Reinhardt MK, Lieberman I
(2003) J Neurosurg (Spine 1) 9944-50
Garfin SR, Yuan HA, Reiley MA (2001). Spine
261511-1515
35
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
  (n100).

Kyphon U.S. Study. Data on file at Kyphon Inc.
36
Quality of Life

• Studies show that geriatric patients quickly
  return to a higher activity level after balloon
  kyphoplasty, gaining more independence at both
  short and long-term follow-up.
• In the U.S. study, SF-36 results were seen at one
  month in 7 out of 8 domains (all but general
  health).

PF Physical Function RF Role Physical
BP Bodily Pain GH General Health
V Vitality SF Social Function
RE Role Emotional MH Mental Health

• Results persisted or improved during the two year
  follow-up. (N100)

Kyphon U.S. Study. Data on file at Kyphon Inc.
37
Quality of Life SF-36 Survey

• Coumans et al (2003)
• Prospective study, 78 pts, 188 procedures
• Marked improvement in 7 domains only general
  health did not improve.
• Sustained at 18 mo f/u

Coumans et al. (2003) J Neurosurg (Spine 1)
9944-50
38
Activities of Daily Living

• Improvements in SF-36 physical function scores at
  seen in the prospective study by Coumans et al.
  (2003)
• Other measures in the clinical literature include
  ambulatory status, function, days of bed rest,
  and limited activity days.

Coumans et al. (2003) J Neurosurg (Spine 1)
9944-50
39
Ambulatory Status

• Ledlie et al (2002) (n79)
• 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
40
Function

• Coumans et al 15 improvement in Oswestry
  Disability Index (ODI) at early f/u
• Persisted at 12 and 18 month f/u

Coumans et al. (2003) J Neurosurg (Spine 1)
9944-50
41
Bed Rest and Limited Activity

• Prospective multicenter U.S. Study
• Measured number of days in bed during month prior
  to receiving kyphoplasty and number of days of
  limited activity due to back pain.
• Results at f/u (statistically significant)
• 100 reduction in median days spent in bed.
  Results maintained at two year f/u.
• 64 reduction in median number of days
  interrupted due to back pain at one and three
  month f/u and 93 reduction at one and two year
  f/u.

Kyphon U.S. Study. Data on file at Kyphon Inc.
42
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)
43
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
44
Procedure-Related Complication Rates

• Literature review conducted describes the results
  for 897 balloon kyphoplasty patients and 2408
  vertebroplasty.
• Overall procedure-related complication rate
  refers to bone cement and non-bone cement related
  complication rates combined.
• Results statistically significantly in favor of
  balloon kyphoplasty in the following areas
• Overall procedure-related complication rate
• Bone cement procedure-related complication rate

Data on file at Kyphon Inc. References listed at
end of presentation.
45
Overall Procedure-Related Complication Rate

• Overall procedure-related complication rate for
  balloon kyphoplasty-treated patients was 0.89
  versus 5.44 for vertebroplasty (p0.0009).
• Statistically significant difference also
  demonstrated in sub-analyses of fractures due to
  osteoporosis or cancer.

46
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 (p0.0008).
  
• The calculation of bone cement-related
  complications excluded asymptomatic cement
  extravasations.

47
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 (KYPHON
  HV-R?) under low pressure and fine manual
  control.

Phillips et al. (2002) Spine 272173-2179 Togawa
et al. (2003) Spine 281521-1527
48
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.

49
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.
50
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.

51
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) 10032-37
• Coumans et al (2003) Kyphoplasty for vertebral
  compression fractures 1-year clinical outcomes
  from a prospective study. J Neurosurg (Spine 1)
  9944-50
• Dudeney et al. (2002) Kyphoplasty in the
  treatment of osteolytic vertebral compression
  fractures as a result of multiple myeloma. J Clin
  Oncol 202382-2387
• Fourney et al. (2003) Percutaneous vertebroplasty
  and kyphoplasty for painful vertebral body
  fractures in cancer patients. J Neurosurg (Spine
  1) 9821-30
• Garfin SR, Yuan HA, Reiley MA (2001) Kyphoplasty
  and vertebroplasty for the treatment of painful
  osteoporotic compression fractures. Spine
  261511-1515
• 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
  33431-438
• 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
  261-5
• Voggenreiter G, Sadik M, Majetschak M, et al.
  (2004) Treatment results of the kyphoplasty
  balloon technique. MedReview17-18
• Wilhelm K, Stoffel M, Ringel F, et al. (2003)
  Preliminary experience with balloon kyphoplasty
  for the treatment of painful osteoporotic
  compression fractures. Fortschr Rontgenstr
  1751690-1696
• Wong W, Reiley MA, Garfin SR (2000)
  Vertebroplasty / Kyphoplasty. J Womens Imaging
  2(3)

52
Procedure-Related Complication Rates Literature
Review References

• Al-Assir I, Perez-Higueras A, Florensa J, et al.
  (2000) Percutaneous vertebroplasty A special
  syringe for cement injection. AJNR Am J
  Neuroradiol 21159-161
• Amar AP, et al. (2003) Use of a screw-syringe
  injector for cement delivery during kyphoplasty
  technical report. Neurosurgery 53(2)380-383
• Appel NB, Gilula LA (2004) Percutaneous
  vertebroplasty in patients with spinal canal
  compromise. AJR 182947-951
• Barr J, Barr M, Lemley T, et al. (2000)
  Percutaneous vertebroplasty for pain relief and
  spinal stabilization. Spine 25923-928
• Berlemann U, et al. (2004) Kyphoplasty for
  treatment of osteoporotic vertebral fractures a
  prospective non-randomized study. Eur Spine J,
  2004 Feb 25
• Bernhard J, Heini PF, Villiger PM (2003)
  Asymptomatic diffuse pulmonary embolism caused by
  acrylic cement An unusual complication of
  percutaneous vertebroplasty. Ann Rheum Dis
  6285-86
• Boszczyk BM, Bierschneider M, et al. (2004)
  Microsurgical interlaminary verterbro- and
  kyphoplasty for severe osteoporotic fractures. J
  Neurosurg 100(1 Suppl)32-37
• Brown DB, Gilula LA, et al. (2004) Treatment of
  chronic symptomatic vertebral compression
  fractures with percutaneous vertebroplasty. AJR
  182319-322
• Chen H-L, Wong C-S, Ho S-T, et al. (2002) A
  lethal pulmonary embolism during percutaneous
  vertebroplasty. Anesth Analg 951060-1062
• Cohen JE, Lylyk P, et. al. (2004) Percutaneous
  vertebroplasty technique and results in 192
  procedures. Neurol Res. 26(1)41-49
• Cortet B, Cotton A, Boutry N, et al. (1997)
  Percutaneous vertebroplasty in patients with
  osteolytic metastases or multiple myeloma. Rev
  Rhum 64177-183
• Cortet B, Cotton A, Boutry N, et al. (1999)
  Percutaneous vertebroplasty in the treatment of
  osteoporotic vertebral compression fractures An
  open prospective study. J Rheumatol 262222-2228
• Cotten A, Dewatre F, Cortet B, et al. (1996)
  Percutaneous vertebroplasty for osteolytic
  metastases and myeloma Effects of the
  percentage of lesion filling and the leakage of
  methyl methacrylate at clinical follow-up.
  Radiology 200525-530
• Cotten A, Boutry N, Cortet B, et al. (1998)
  Percutaneous vertebroplasty State of the art.
  Radiographics 18(2)311-20 discussion 320-323.
  18311-320
• Coumans J-VC, Reinhardt M-K, Lieberman I (2003)
  Kyphoplasty for vertebral compression fractures
  1-year clinical outcomes from a prospective
  study. J Neurosurg (Spine 1) 9944-50
• Crandall D, et al. (2004) Acute versus chronic
  vertebral compression fractures treated with
  kyphoplasty Early results. Spine J 4(4)418-424
• Cyteval C, Sarrabere MPB, Roux JO, et al. (1999)
  Acute osteoporotic vertebral collapse Open
  study on percutaneous injection of acrylic
  surgical cement in 20 patients. Am J
  Roentgenology 1731685-1690
• Debussche-Depriester C, Deramond H, Fardellone P,
  et al. (1991) Percutaneous vertebroplasty with
  acrylic cement in the treatment of osteoporotic
  vertebral crush fracture syndrome. Neuroradiology
  33 Suppl149-152
• Deramond H, Depriester C, Galibert P, et al.
  (1998) Percutaneous vertebroplasty with
  polymethylmethacrylate. Technique, indications,
  and results. Radiol Clin North Am 36533-546

53
Procedure-Related Complication Rates Literature
Review References

• Diamond TH, Champion B, Clark WA (2003)
  Management of acute osteoporotic vertebral
  fractures A nonrandomized trial comparing
  percutaneous vertebroplasty with conservative
  therapy. Excerpta Medica
• Donovan MA, et al. (2004) Multiple adjacent
  vertebral fractures after kyphoplasty in a
  patient with steroid-induced osteoporosis. J
  Bone Miner Res 19(5712-713)
• Dudeney S, Lieberman IH, Reinhardt M-K, et al.
  (2002) Kyphoplasty in the treatment of osteolytic
  vertebral compression fractures as a result of
  multiple myeloma. J Clin Oncol 202382-2387
• Evans AJ, Jensen ME, Kip KE, et al. (2003)
  Vertebral compression fractures Pain reduction
  and improvement in functional mobility after
  percutaneous polymethylmethacrylate
  vertebroplasty - retrospective report of 245
  cases. Radiology 226366-372
• Fourney DR, Schomer DF, Nader R, et al. (2003)
  Percutaneous vertebroplasty and kyphoplasty for
  painful vertebral body fractures in cancer
  patients. J Neurosurg (Spine 1) 9821-30
• Galibert P, Deramond H, Rosat P, et al. (1987) A
  preliminary note on the treatment of vertebral
  angiomas by percutaneous vertebroplasty with
  acrylic cement. Neurosurg 33166-168
• Gangi A, Dietemann JL, Guth S, et al. (1999)
  Computed tomography (ct) and fluoroscopy-guided
  vertebroplasty Results and complications in 187
  patients. Sem Intervent Radiol 16137-142
• Garfin SR, Yuan HA, Reiley MA (2001) New
  technologies in spine Kyphoplasty and
  vertebroplasty for the treatment of painful
  osteoporotic compression fractures. Spine
  261511-1515
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