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Title: 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 Female Diagnosis Primary
osteoporosis Fracture Reduced L-1, 4 months old
19o
3o
15mm
28mm
Courtesy of Alexander Hadjipavlou, M.D., Crete,
Greece
20
Case Study
Patient 78 YO Female Diagnosis Primary
osteoporosis Fracture 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 Kyphoplasty Clinical 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
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