Balloon Kyphoplasty for Vertebral Compression Fractures
Balloon Kyphoplasty for Vertebral Compression Fractures
Balloon Kyphoplasty for Vertebral Compression Fractures
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BALLOON<br />
KYPHOPLASTY<br />
A Treatment option <strong>for</strong><br />
<strong>Vertebral</strong> Body<br />
<strong>Compression</strong> <strong>Fractures</strong><br />
Brian Drew M.D.
Epidemiology<br />
• In the U.S., 700,000 vertebral compression fractures (VCFs) occur each<br />
year, more than the number of hip and wrist fractures combined. 2<br />
• Approximately 150,000 people in the U.S. are hospitalized due to pain and<br />
medical management associated with VCFs (average hospital stay of 8<br />
days), resulting in costs in excess of $1.6 billion annually. 2<br />
• Osteoporosis-related disability confines patients to more immobile days in<br />
bed than stroke, heart attack or breast cancer. 1<br />
• Estimated national direct expenditures (hospitals and nursing homes) <strong>for</strong><br />
osteoporotic and associated fractures are $17 billion in 2001 ($47 million<br />
each day) and the cost is rising, according to the National Osteoporosis<br />
Foundation.<br />
1. National Osteoporosis Foundation<br />
2. Cooper C et al. J Bone Min Res. 1992;7:221–227.
ORTHOPAEDIC FRACTURE CARE<br />
Why have we been content<br />
to leave the spine in a<br />
physiologically and<br />
biomechanically<br />
compromised condition?
Fracture Treatment Objectives<br />
Four AO principles 1<br />
� Fracture reduction and fixation to restore anatomical<br />
relationships<br />
� Stability by fixation or splintage, as the nature of the<br />
fracture and the injury requires<br />
� Preservation of blood supply to soft tissues and bone by<br />
careful handling and gentle reduction techniques<br />
� Early and safe mobilization of the part and the patient<br />
*Arbeitsgemeinschaft Osteosynthesefragen<br />
(English translation: Association <strong>for</strong> the Study of Internal Fixation - ASIF)<br />
1 Ruedi & Murphy, AO Principles of Fracture Management,<br />
Thieme, Stuttgart, New York, 2000
<strong>Vertebral</strong> Body <strong>Compression</strong><br />
Fracture (VCF)<br />
Wedgeshaped<br />
Depressed<br />
endplate(s)<br />
Normal Fractured<br />
Spine<br />
shorter,<br />
tilted<br />
<strong>for</strong>ward
De<strong>for</strong>mity Progression<br />
16º<br />
kyphosis<br />
Aug 31, 2000 Sept 3, 2000<br />
Lieberman et al., Spine 2001<br />
25º<br />
kyphosis
Biomechanics of VCF<br />
� Center of gravity (CG) moves<br />
<strong>for</strong>ward<br />
� Large bending moment created<br />
� Posterior muscles and<br />
ligaments must counterbalance<br />
increased bending<br />
� Osteoporotic anterior spine<br />
must resist larger compressive<br />
stresses<br />
White III and Panjabi 1990<br />
CG
Biomechanics of VCF<br />
� Knees bend, pelvis tilts<br />
<strong>for</strong>ward to counteract<br />
<strong>for</strong>ward bending<br />
� Change in balance 1<br />
� Decrease in gait velocity 1<br />
� Increased muscle fatigue 1<br />
� Increased risk of falls and<br />
additional fractures 2<br />
1 Gold et al., Osteoporosis 2001<br />
2 Ross et al., Annals Int Med 1991
Physical Impact of VCF<br />
Age 50 Age 75<br />
National Osteoporosis Foundation
Increased Fracture Risk<br />
� After first VCF, risk of subsequent VCF is<br />
increased<br />
– 5 fold after first VCF<br />
– 12 fold after 2 or more VCFs<br />
– 75 fold after 2 or more VCFs and low bone<br />
mass (below the 33rd percentile)<br />
Ross et al., Ann Inter Med 1991 114 (11): 919-923
Increased Mortality<br />
Prospective study of 9,575 women<br />
followed > 8 years demonstrated:<br />
� Patients with VCF have a 23-34% increased mortality rate<br />
compared to patients without VCF<br />
� VCF patients are 2-3xs more likely to die of pulmonary<br />
causes<br />
� Most common cause of death was pulmonary disease,<br />
including COPD and pneumonia<br />
Kado et al., Arch Intern Med 1999
<strong>Vertebral</strong> <strong>Compression</strong> <strong>Fractures</strong><br />
Economic Cost<br />
� 161,000 PCP office visits per year 1<br />
� 150,000 hospitalizations per year 1<br />
� Mean length of stay (LOS) is 10.1 days 2<br />
� VCFs are among the top 3 conditions<br />
accounting <strong>for</strong> LOS 2<br />
� $12,300 average hospital charge 3<br />
1 Riggs and Melton, Bone 1995<br />
2 Papaioannou et al., Osteoporosis Int’l 2001<br />
3 MedPAR 1996
<strong>Vertebral</strong> <strong>Compression</strong> <strong>Fractures</strong><br />
Economic Cost<br />
� Long-term increased morbidity and<br />
mortality<br />
� Bone loss up to 2% per week reported after<br />
prolonged bed rest1 1 Johnell et al., Osteoporosis Int 2000
Long-term Consequences
Possible causes of VCFs<br />
� Primary osteoporosis<br />
� Secondary osteoporosis<br />
– Drug-induced (corticosteroids, tobacco,<br />
barbituates, heparin)<br />
– Endocrine (hyperparathyroidism, diabetes)<br />
– Miscellaneous (renal failure, COPD,<br />
rheumatoid arthritits, hepatic disease or<br />
transplant)<br />
Merck Manual, 16 th ed., 1992
Possible causes of VCFs<br />
� Osteolytic lesions<br />
– Multiple Myeloma<br />
– Bone metastases<br />
– Paget’s disease<br />
• Trauma<br />
– ½ of all trauma cases are misclassified
• Identify painful level<br />
Diagnosis<br />
• Define fracture configuration<br />
• Define fracture age<br />
• Consider fracture etiology
Identifying <strong>Vertebral</strong> <strong>Fractures</strong><br />
• Approximately two thirds of all vertebral fractures go<br />
undiagnosed, in part due to difficulty determining cause of<br />
symptoms.<br />
• Pain ranges from mild to severe and may be chronic, but<br />
may disappear over several weeks.<br />
• It is important to diagnose vertebral fractures, to understand<br />
the value of lateral spine radiographs, and to consider<br />
ordering additional radiographs if initial films do not show<br />
fracture.<br />
Gold et al. The Downward Spiral of <strong>Vertebral</strong> Osteoporosis, A Monograph, June 2003
Acute Event:<br />
Signs of VCF<br />
� Sudden onset of back pain<br />
with little or no trauma<br />
Chronic Manifestation(s):<br />
� Loss of height<br />
� Spinal de<strong>for</strong>mity<br />
(“Dowager’s hump”)<br />
� Protuberant abdomen<br />
Gold et al., Osteoporosis 1996,2001
Physical Examination<br />
• Does direct pressure on suspect vertebral<br />
bodies elicit pain?<br />
• Palpating each spinous process to rule out disc pain as the<br />
underlying culprit would also be of value to help<br />
differentiate between back pain and vertebral compression<br />
fracture pain.<br />
• BUT the absence of tenderness does not<br />
indicate that the level is not painful.
Physical Examination<br />
• Pain findings on physical exam should be<br />
concordant with radiographic findings<br />
• Some patients will have multiple vertebral<br />
bodies
Radiologic Assessment<br />
• A lateral spine X-ray examination is a<br />
method that can be used to screen <strong>for</strong> the<br />
presence of vertebral compression fractures.<br />
• Older films may be useful to asses fracture<br />
progression<br />
• STIR sequence MRI can be useful to<br />
determine index and/or plain radiograph<br />
culprit.
Radiologic Assessment<br />
• T1 weighted shows high intensity <strong>for</strong> fat,<br />
subacute hematomas and Gadolinium<br />
enhanced substances<br />
• T2 weighted shows high intensity <strong>for</strong><br />
conditions that increase free water, such as<br />
acute fractures<br />
• STIR MRI sequence is most sensitive <strong>for</strong><br />
water content when assessing fractures
• The age of the fracture<br />
may not be as important if<br />
MRI signal change is<br />
observed<br />
• Anecdontal reports exist<br />
of fractures treated<br />
months or years of<br />
symptoms with relief of<br />
pain<br />
MRI
Radiologic Assessment<br />
First week post fracture<br />
Courtesy of B. Boszczyk & R. Bierschnieder, BG Unfallklinik, Dept. of<br />
Neurosurgery, Murnau, Germany<br />
8 weeks post fracture<br />
MRI: T2 Image
<strong>Vertebral</strong> Fracture Progression<br />
• Some fractures may collapse acutely while<br />
others collapse progressively over time.<br />
Lyritis et al. (1989) Clin Rheum Suppl 2(8):66-69
•CT Scan<br />
CT & Bone Scan<br />
– Shows structure of bone<br />
– Extremely high contrast between calcified<br />
structures(cortical & trabecular bone) and soft<br />
tissue<br />
– Assess posterior aspect of vertebral body <strong>for</strong><br />
cortical breach
CT & Bone Scan<br />
• Use CT plus bone scan to determine<br />
fracture when MRI cannot be used<br />
– Implantable metal devices<br />
– other MRI contraindications
Location of <strong>Vertebral</strong> <strong>Fractures</strong><br />
Nevitt MC et al. Bone. 1999;25:613–619.<br />
Cooper C et al. J Bone Min Res. 1992;7:221–227.<br />
• Are most commonly located at the<br />
midthoracic region (T7–T8) and the<br />
thoracolumbar junction (T12–L1) 1<br />
– Midthoracic region–thoracic kyphosis is<br />
most pronounced and loading (stress)<br />
during flexion is increased<br />
– Thoracolumbar junction–the relatively<br />
rigid thoracic spine connects to the more<br />
freely mobile lumbar segments 2<br />
• Correspond to the most mechanically<br />
compromised regions of the spine
<strong>Vertebral</strong> <strong>Fractures</strong>: Three types<br />
• Wedge fractures are most common<br />
Wedge Biconcave Crush<br />
Genant HK et al. J Bone Miner Res. 1993;8:1137–1148.
VCF Treatment Options<br />
Medical Management<br />
� Treatment Protocol<br />
–Bed rest<br />
– Narcotic analgesics<br />
– Braces<br />
� Shortcomings<br />
– May fail to relieve pain<br />
– Does not provide long-term functional improvement<br />
– May exacerbate bone loss<br />
– Does not attempt to restore the anatomy
VCF Treatment Options<br />
• Best option <strong>for</strong> treatment clearly is to<br />
prevent the osteoporotic fracture from<br />
happening through prevention and treatment<br />
of osteoporosis<br />
• Once a fracture has occurred treatment of<br />
the underlying osteoporosis is of paramount<br />
importance to lessen the risk of subsequent<br />
fractures
Symptomatic VCFs<br />
� 260,000 pts/yr refractory to medical therapy 1<br />
� Only fracture not treated in an orthopaedic manner<br />
– Open surgical repair too invasive<br />
– Poor outcomes (osteopenic bone)<br />
� No orthopaedic treatment may lead to long-term<br />
increased morbidity, mortality<br />
1 Cooper et al., J Bone Min Research 1992
VCF Treatment Options<br />
Open Surgical Treatment<br />
� Indication<br />
– Only if neurologic deficit (very rare, only 0.05%)<br />
– Instrumented fusion, anterior or posterior<br />
� Shortcomings<br />
– Invasive<br />
– Poor outcomes in osteopenic bone
Vertebroplasty<br />
VCF Treatment Options<br />
� Designed to stabilize painful VCFs<br />
� Shortcomings<br />
– Risk of filler leaks (27-74% reported 1,2,4,5,6,7,8,9,10 )<br />
– High pressure injection<br />
– Uncontrolled fill<br />
– High complication rate (1-20% reported 3,4,5 )<br />
– Freezes spinal de<strong>for</strong>mity<br />
– Does not reduce fracture or restore anatomy<br />
– Not designed to reposition bone<br />
1 Cortet et al., J Rheum 1999 5 Jensen et al., AJNR 1997 8 Grados et al., Rheumatology 2000<br />
2 Alvarez et al., Eurospine 2001 6 Cotten et al. Radiology 1996 9 Peh et al., Radiology 2002<br />
3Padovani et al., AJNR 1997 7 Gaughen et al., AJNR 2002 10 Ryu et al., J Neurosurgery 2002<br />
4 Weill et al., Radiology 1996
Pros & Cons Vertebroplasty<br />
• Efficacious in the majority of patients<br />
• Pain relief is expected in greater than 80%<br />
of patients<br />
• Can be per<strong>for</strong>med as an outpatient<br />
• Rapid pain relief and earlier rehab.
Pros & Cons Vertebroplasty<br />
• Complications are low but but they can be severe<br />
• Cement is injected while it is quite liquid<br />
• It flow into vertebral interstices<br />
• Potential to enter the venous sinuses and<br />
embolize systemically or to leak out through the<br />
vertebral wall into local structures<br />
• Usually asymptomatic but reports of PE,<br />
neurologic injury and death have been reported
Why Fracture Reduction?<br />
• What is orthopaedic reduction?<br />
– The restoration, by surgical or manipulative procedures,<br />
of a part to its normal anatomical relation 1<br />
• What is the goal?<br />
– To produce optimal outcomes with early diagnosis and<br />
treatment 2<br />
– To accommodate the frail physical status and comorbidities<br />
of geriatric patients 2<br />
1 Stedman’s Concise Medical Dictionary. 1997. Williams and Wilkins.<br />
2 Brakoniecki, Anesthetic Management of the Trauma Patient with Skeletal Injuries, Skeletal<br />
Trauma, W.B. Saunders Company, 1998, 1:7:171-172
New VCF Treatment Option<br />
Minimally Invasive Fracture Reduction
Minimally Invasive Fracture Reduction<br />
KyphX ® Inflatable Bone Tamp has<br />
been developed <strong>for</strong> patients with<br />
symptomatic VCFs
The Procedure<br />
• Minimally invasive<br />
– Bilateral, 1cm incisions<br />
• Typically one hour per treated fracture<br />
• General or local anesthesia<br />
– Most are per<strong>for</strong>med under general anesthesia<br />
– Can be per<strong>for</strong>med under local anesthesia, often<br />
supplemented with conscious sedation.<br />
– Among 155 prospectively enrolled patients in Kyphon U.S.<br />
study, only 1 complication was related to anesthesia.<br />
• May require an overnight hospital stay<br />
Kyphon U.S. Study. Data on file at Kyphon Inc.
KyphX ® Introducer Tool Kit<br />
Allows precise, minimally invasive access to the<br />
vertebral body and provides a working channel
KyphX ® IBT Inflation<br />
Reduces the fracture, compacts the bone,<br />
and may elevate the endplates
KyphX ® IBT Removal<br />
Leaves a defined cavity within the<br />
vertebral body
<strong>Balloon</strong> <strong>Kyphoplasty</strong><br />
Stabilizes the Fracture and Corrects Spinal<br />
De<strong>for</strong>mity caused by one or more VCFs
Minimally Invasive Fracture Reduction<br />
KyphX® Inflatable Bone Tamp (IBT)<br />
For use as a conventional bone tamp <strong>for</strong> the<br />
reduction of fractures and/or creation of a void<br />
in cancellous bone in the spine, hand, tibia, radius<br />
and calcaneus.
<strong>Kyphoplasty</strong> vs Vertebroplasy<br />
• The cement is allowed to polymerize more<br />
completely & is more viscous when injected<br />
• The cement is injected into a cavity<br />
• It is under less pressure<br />
• These factors lower the leakage rate
19 o<br />
Case Study<br />
Patient: 91 YO Female<br />
Diagnosis: Primary osteoporosis<br />
Fracture Reduced: L-1, 4 months old<br />
3 o<br />
15mm 28mm<br />
Courtesy of Alexander Hadjipavlou, M.D., Crete, Greece
Case Study<br />
Patient: 78 YO Female<br />
Diagnosis: Primary osteoporosis<br />
Fracture Reduced: L-1 & L-2 6 weeks old<br />
Courtesy of Frank Phillips, MD, Chicago, IL<br />
L1-L2 Height<br />
Restoration<br />
(L3 Treated 6<br />
Wks Prior)
Summary<br />
� The general goal <strong>for</strong> fracture treatment is restoration of<br />
anatomy and early return to function<br />
� Conventional therapy not always effective<br />
� KyphX ® IBT is a new option <strong>for</strong> VCFs designed to:<br />
− reduce the fracture<br />
− move cancellous bone (elevate endplates)<br />
− create void inside vertebral body<br />
� As with hip fracture surgery, early diagnosis and<br />
intervention are important <strong>for</strong> fracture reduction
The Literature
Experience to Date<br />
• Over 115,000 fractures in 100,000 patients treated worldwide<br />
since 1998<br />
• Patient Outcomes include:<br />
� <strong>Vertebral</strong> body height restoration<br />
� Angular correction of de<strong>for</strong>mity<br />
� Significant reduction in pain<br />
� Reduced number of days in bed<br />
� Improved quality of life<br />
� Improvement in activities of daily living<br />
� Improvement in mobility<br />
� High rate of patient satisfaction
Correction of <strong>Vertebral</strong> Body<br />
De<strong>for</strong>mity<br />
• Studies report the following radiographic<br />
outcomes post kyphoplasty:<br />
– Percent lost vertebral body height restored<br />
– Percent vertebral body height increased<br />
– Angular de<strong>for</strong>mity correction
Correction of <strong>Vertebral</strong> Body<br />
De<strong>for</strong>mity<br />
• Three studies analyzed how many fractures in the study<br />
populations were “reducible” (that is, achieved a measurable<br />
correction).<br />
– In the U.S. study, “reducible” refers to measurable fractures where<br />
at least 15% of predicted height was lost due to fracture.<br />
– In Lieberman et al (2001) a fracture was reducible if at least 10% of<br />
lost vertebral body height was restored with balloon kyphoplasty.<br />
– Phillips et al. (2003) defined reducible as a decrease in local<br />
angulation of at least 5 degrees.<br />
Phillips et al (2003) Spine 28, 19:<br />
2260-2267<br />
Lieberman et al (2001) Spine 26: 2,<br />
1631-1638<br />
Kyphon U.S. Study. Data on file at Kyphon Inc.
Percent Lost Height Restored<br />
• Based on the mean height<br />
measurement of the closest,<br />
unfractured vertebrae above and below<br />
the treated level.<br />
• Anterior, midline, and sometimes<br />
posterior measurements are taken.
Example: Percent Lost Height Restored<br />
Avg.<br />
30 mm<br />
20 mm<br />
24 mm<br />
% Lost Height Restored =<br />
(24 – 20) / (30 - 20) or 4/10 = 40%
Study<br />
U.S. Study<br />
Lieberman (2001)<br />
Theodorou (2002)<br />
Theodorou (2002)<br />
Percent Lost Height Restored<br />
<strong>Vertebral</strong><br />
Body Site<br />
Midline<br />
Midline<br />
Midline<br />
Anterior<br />
Mean<br />
Fracture Age<br />
(mos.)<br />
4.3<br />
5.9<br />
3.2<br />
3.2<br />
Kyphon U.S. Study. Data on file at Kyphon Inc.<br />
Lieberman et al (2001) Spine 26: 2,<br />
Theodorou 1631-1638 et al (2002) J Clin Imaging<br />
26:1-5<br />
%<br />
30.2<br />
35<br />
66<br />
52<br />
% Lost vertebral Body Height Restored<br />
All <strong>Fractures</strong><br />
N<br />
65<br />
70<br />
24<br />
24<br />
Reducible <strong>Fractures</strong><br />
%<br />
58<br />
47<br />
NR<br />
NR<br />
N<br />
47<br />
49<br />
NR<br />
NR<br />
NR = Not Reported
Percent <strong>Vertebral</strong> Body Height Increased<br />
• Estimates % of total, pre-fractured vertebral body<br />
height<br />
• Percent vertebral body height is based on the mean<br />
measurement of the closest unfractured vertebrae<br />
above and below the treated level.<br />
• Using the same example, 30mm becomes 100%<br />
% Pre-KP<br />
% Post-KP<br />
20mm / 30mm<br />
24mm / 30mm<br />
66%<br />
80%
Percent <strong>Vertebral</strong> Body Height Increased<br />
Results<br />
Garfin (2001)<br />
Ledlie (2003)<br />
Theodorou<br />
(2002)<br />
Total <strong>Fractures</strong><br />
603 treated.<br />
(Number of<br />
fractures measured<br />
not reported.)<br />
36 measured<br />
pre-op.<br />
30 measured<br />
post-op.<br />
24 treated.<br />
Garfin et al (2001) Spine 26:1511-1515<br />
Ledlie et al. (2003) J Neurosurg (Spine 1)<br />
98: 36-42<br />
Theodorou et al (2002) J Clin<br />
Imaging 26:1-5<br />
Mean<br />
Fracture<br />
Age<br />
Not<br />
reported<br />
2.4 mo<br />
3.2 mo<br />
Percent Predicted <strong>Vertebral</strong> Body Height<br />
Anterior<br />
Pre-op<br />
68%<br />
66%<br />
Midline<br />
Pre-op<br />
64%<br />
65%<br />
79% (does not specify<br />
measurement site)<br />
Anterior<br />
Post-op<br />
84%<br />
89%<br />
Midline<br />
Post-op<br />
90%<br />
90%<br />
92% (does not specify<br />
measurement site)
Correction of Angular De<strong>for</strong>mity<br />
• Measured using the Cobb Method<br />
• Theodorou et al. (2002) (n=24)<br />
– Local angular de<strong>for</strong>mity decreased from 26º 26 to 16º 16<br />
• Phillips et al. (2003) (n=52)<br />
– Mean local angular de<strong>for</strong>mity correction was 8.8º 8.8 (range, 0-<br />
29º)<br />
– Among reducible fractures (5º improvement), mean angular<br />
de<strong>for</strong>mity correction was 14º 14<br />
Phillips et al (2003) Spine 28, 19:
Case Study: Correction of Angular<br />
Immediate<br />
post- fracture<br />
Kyphosis = 16º 16<br />
Lieberman et al. (2001) Spine 26: 2, 1631-<br />
1638<br />
De<strong>for</strong>mity<br />
Post-fracture +<br />
Post-kyphoplasty<br />
Post kyphoplasty<br />
4 days<br />
Kyphosis = 25º 25 Kyphosis = 10º 10
<strong>Balloon</strong> <strong>Kyphoplasty</strong><br />
Clinical Outcomes
Clinical Outcomes<br />
• Studies report the following clinical<br />
outcomes post kyphoplasty:<br />
– Correction of vertebral body de<strong>for</strong>mity<br />
– Significant reduction in pain<br />
– Improvement in quality of life<br />
– Improvement in ability to per<strong>for</strong>m activities<br />
of daily living<br />
– Low complication rate
Reduction in Pain<br />
• Following <strong>Balloon</strong> <strong>Kyphoplasty</strong>, patients report significant pain<br />
reduction at short-term follow-up, sometimes within hours of the<br />
procedure.<br />
• In a retrospective analysis (Garfin et al (2001)), patients<br />
discontinued use of narcotics <strong>for</strong> fracture-related pain, changing<br />
to over-the-counter analgesics post operatively.<br />
• Coumans et al. (2003) prospectively followed 78 consecutive<br />
patients <strong>for</strong> 12 to 18 months and reported substantial<br />
improvement (p
Reduction in Pain<br />
• In the prospective multicenter U.S. study, there was an average<br />
of 60% reduction in pain at one week follow-up. Results<br />
persisted <strong>for</strong> two years (n=100).<br />
Kyphon U.S. Study. Data on file at Kyphon Inc.
Quality of Life: SF-36 Survey<br />
• Coumans et al (2003)<br />
– Prospective study, 78<br />
pts, 188 procedures<br />
– Marked improvement<br />
in 7 domains; only<br />
general health did not<br />
improve.<br />
– Sustained at 18 mo f/u<br />
Coumans et al. (2003) J Neurosurg (Spine 1) 99:44-50
Activities of Daily Living<br />
• Improvements in SF-36 physical function<br />
scores at seen in the prospective study by<br />
Coumans et al. (2003)<br />
• Other measures in the clinical literature include<br />
ambulatory status, function, days of bed rest,<br />
and limited activity days.<br />
Coumans et al. (2003) J Neurosurg (Spine 1) 99:44-50
• Ledlie et al (2002) (n=79)<br />
Ambulatory Status<br />
– 80% were fully ambulatory at<br />
one week follow-up.<br />
– 27 of the pts. followed at one<br />
year maintained full ambulatory<br />
status.<br />
– 90% of all patients who were<br />
wheelchair-bound preoperatively<br />
were ambulatory at<br />
one week follow-up.<br />
Ledlie et al. (2003) J Neurosurg (Spine 1) 98: 36-42
Function<br />
• Coumans et al: 15% improvement in<br />
Oswestry Disability Index (ODI) at early F/U<br />
• Persisted at 12 and 18 month f/u<br />
Coumans et al. (2003) J Neurosurg (Spine 1) 99:44-50
Bed Rest and Limited Activity<br />
• Prospective multicenter U.S. Study<br />
– Measured number of days in bed during month prior to<br />
receiving kyphoplasty and number of days of limited<br />
activity due to back pain.<br />
• Results at f/u (statistically significant)<br />
– 100% reduction in median days spent in bed. Results<br />
maintained at two year f/u.<br />
– 64% reduction in median number of “days interrupted due<br />
to back pain” at one and three month f/u and 93%<br />
reduction at one and two year f/u.<br />
Kyphon U.S. Study. Data on file at Kyphon Inc.
Risk of Subsequent Fracture<br />
• Komp et al (2004)<br />
– A controlled, prospective study<br />
– 21 patients underwent balloon kyphoplasty and 19 underwent<br />
conservative treatment.<br />
– Patient populations were similar in age, gender, fracture history,<br />
and other risk factors.<br />
– After six months, 7 out of 19 evaluable balloon kyphoplasty<br />
patients had new fractures (37%), whereas 11 out of 17<br />
conservatively-treated patients (67%) had new fractures.<br />
– Conclusions:<br />
• Incidence of adjacent and non-adjacent fracture in both arms<br />
corresponds to other published data.<br />
• A larger study is needed to assess risk of subsequent fracture.<br />
Komp, et al. (2004) J Miner Stoffwechs 11(Suppl 1):13-16 (German)
Procedure-Related Complication Rates<br />
• Literature review conducted describes the results <strong>for</strong><br />
897 <strong>Balloon</strong> <strong>Kyphoplasty</strong> patients and 2408<br />
vertebroplasty.<br />
• Overall procedure-related complication rate refers to<br />
bone cement and non-bone cement related<br />
complication rates combined.<br />
• Results statistically significantly in favor of <strong>Balloon</strong><br />
<strong>Kyphoplasty</strong> in the following areas:<br />
– Overall procedure-related complication rate<br />
– Bone cement procedure-related complication rate<br />
Data on file at Kyphon Inc. References listed at end of presentation.
Overall Procedure-Related<br />
Complication Rate<br />
• Overall procedure-related<br />
complication rate <strong>for</strong><br />
balloon kyphoplastytreated<br />
patients was<br />
0.89% versus 5.44% <strong>for</strong><br />
vertebroplasty (p=0.0009).<br />
• Statistically significant<br />
difference also<br />
demonstrated in subanalyses<br />
of fractures due<br />
to osteoporosis or cancer.
Bone Cement Procedure-Related<br />
Complication Rates<br />
• The total bone cement procedure-related<br />
complication rate <strong>for</strong> balloon kyphoplasty was<br />
0.22% versus 3.07% <strong>for</strong> vertebroplasty (p=0.0008).<br />
• The calculation of bone cement-related<br />
complications excluded asymptomatic cement<br />
extravasations.
Bone Cement Procedure-Related<br />
Complication Rates<br />
• The combination of compaction of cancellous bone,<br />
cavity creation, & controlled cement delivery<br />
suggests the difference in adverse events is caused<br />
by cement extravasation.<br />
• Compaction of Cancellous Bone: <strong>Balloon</strong> inflation<br />
compacts the cancellous bone, disrupts internal venous<br />
pathways and fills fracture lines, reducing leak pathways.<br />
• Cavity Creation and Controlled Bone Cement<br />
Delivery: Upon balloon removal, an intervetebral cavity<br />
is left behind, allowing <strong>for</strong> the delivery of a known<br />
volume of doughy bone cement under low pressure and<br />
fine manual control.<br />
Phillips et al. (2002) Spine 27:217<br />
Togawa et al. (2003) Spine 28:152
16000122-01<br />
Metastatic Bone Disease<br />
and<br />
Multiple Myeloma
Metastases to Bone<br />
Metastatic bone carcinoma<br />
•Originates from other cancers, such<br />
as breast, prostate, lung, renal cell,<br />
etc.. and spreads to bone<br />
•Metastatic cancer causes skeletal<br />
complications every 3-4 months 1<br />
1 Janjan, N. (2001). "Bone Metastases: Approaches to Management." Seminars in<br />
Oncology 28(4): 28-34.
Metastasis<br />
• Cancer typically spreads to 1: .<br />
– Lymphatic system<br />
– Lungs<br />
– Liver<br />
–Skeleton 2<br />
�Vertebrae 75%<br />
�Pelvis 40%<br />
�Femur 25%<br />
1 Levesque, J et al.. A Clinical Guide to Primary Bone Tumors. Baltimore: Williams &<br />
Wilkins; 1988.
Classifications<br />
• Osteoblastic lesions<br />
– Increase bone density<br />
– Do not change bone strength<br />
– Decrease bone stiffness<br />
– Characterized by increased bone<br />
<strong>for</strong>mation<br />
• Example:<br />
– Metastatic osteoblastic carcinoma
Metastatic<br />
Osteoblastic<br />
Carcinoma
Classifications<br />
• Osteolytic lesions<br />
- Decrease both bone strength and stiffness<br />
- Characterized by increased bone resorption,<br />
causing swiss cheese type lesions on bone<br />
• Examples:<br />
- Multiple Myeloma<br />
- Metastatic osteolytic carcinoma
Metastatic<br />
Osteolytic<br />
Carcinoma
Metastases to Bone<br />
• Cancers that frequently metastasize to the<br />
skeleton include 1 :<br />
•Breast cancer<br />
– 75% of cases<br />
» 65% of the lesions are lytic 2<br />
•Lung cancer<br />
– 35% of cases<br />
» 80% of the lesions are lytic 2<br />
•Kidney cancer<br />
– 25% of cases<br />
1 Kleerekoper, M. et al (eds.) The Bone and Mineral Manual: A Practical Guide. Academic<br />
Press; 1999.<br />
2 Mirra, J. Bone Tumors: Clinical, Radiologic, and Pathologic Correlations. Philadelphia: Lea<br />
& Febiger; 1989.
Metastases to the Vertebrae<br />
• > 70% of patients who die from cancer have<br />
vertebral metastases 1<br />
• Lytic destruction of the anterior portion of the<br />
vertebral body 1<br />
• Lytic lesions are associated with higher<br />
fracture risk<br />
• Metastatic bone disease is painful 2<br />
– Up to 2/3 of patients experience severe pain and<br />
disability<br />
1 Harrington, K. (1986). Journal of Bone and Joint Surgery 68-A(7): 1110-<br />
1115.<br />
2 Janjan, N. (2001). Seminars in Oncology 28(4): 28-34.
Fracture Risk<br />
• Osteolytic lesions = higher<br />
fracture rate<br />
• Fracture probability increases<br />
with the duration of metastatic<br />
involvement1 • Certain cancers almost always<br />
metastasize with osteolytic<br />
lesions2 1 Coleman, R. (2001). Cancer Treatment Reviews 27: 165-176.
Radiation Therapy<br />
• May leave bone unstable<br />
• Radiation may increase risk of<br />
fracture 1<br />
– Up to 41% of patients who undergo<br />
radiation experience bone fractures<br />
• Cannot correct an anatomic<br />
abnormality such as a fracture 2<br />
1 Patel, B. and H. DeGroot III (2001). Orthopedics 24(6): 612-7.<br />
2 Janjan, N. (2001). Seminars in Oncology 28(4): 28-34.
Fracture Treatment<br />
• Pain is due to spinal instability<br />
– radiotherapy or systemic treatment will not relieve<br />
the pain 1<br />
• Stabilization is required <strong>for</strong> pain relief 1<br />
• Spinal cord involvement and neurologic<br />
deficit possible if not stabilized 2<br />
1 Coleman, R. (2001). Cancer Treatment Reviews 27: 165-176.<br />
2 Harrington, K. (1986). Journal of Bone and Joint Surgery 68-A(7): 1110-1115.
Multiple Myeloma<br />
Myeloma<br />
cells<br />
Picture courtesy of the International Myeloma
Multiple Myeloma<br />
• Cancer of the bone marrow<br />
• 75,000 – 100,000 patients in the US at any<br />
one time<br />
• Over 13,500 new cases diagnosed each<br />
year in the US<br />
• Male to female ratio is 3:2<br />
• Trend towards patients under the age of<br />
55<br />
From “Multiple Myeloma: Cancer of the Bone Marrow.” International<br />
Myeloma Foundation, 2001 edition.
Multiple Myeloma<br />
• Disruption of bone<br />
marrow function<br />
• Suppression of immune<br />
function<br />
• Osteoclasts activated<br />
• Osteoblasts inhibited<br />
• Hallmark is osteolytic<br />
lesions<br />
Picture courtesy of the International<br />
Myeloma Foundation
Common Sites <strong>for</strong> Bone Involvement<br />
�Skull<br />
�Spine<br />
�Pelvis<br />
�Long bones<br />
Picture courtesy of the International Myeloma<br />
Foundation
T-10<br />
fracture<br />
due to<br />
multiple<br />
myeloma<br />
Photo courtesy of Steve
T2 weighted<br />
MRI showing<br />
myeloma related<br />
fracture at L3<br />
and L4
16000121-<br />
02<br />
Case Studies
Case Study<br />
Patient: 55 YO Male<br />
Diagnosis: Secondary osteoporosis<br />
Fracture Reduced: L-1, 3 day old
Case Study<br />
Patient: 80 YO Male<br />
Diagnosis: Steroid-induced osteoporosis<br />
Fracture Reduced: T-8, 10 weeks old
Case Study<br />
Patient: 61 YO Female<br />
Diagnosis: Multiple Myeloma<br />
Fracture Reduced: T11-L2, 1 ½ yrs old
Case Study<br />
Patient: 73 YO Female<br />
Diagnosis: Primary Osteoporosis<br />
Fracture Reduced: L1, 6 months old
• 84 year old women<br />
Mrs. V.J.<br />
• C/o mid thoracic spine pain<br />
• Began 4 months ago<br />
• After making potato salad
PMHx<br />
• Previous T7 fracture treated with calcitonin<br />
• Bowel resection from Crohn’s disease<br />
• Angina<br />
• Severe osteoporosis<br />
• cholecystectomy
• Actonel<br />
• Atenolol<br />
•ASA<br />
•Folic acid<br />
• Diltiazem<br />
Meds
Physical Examination<br />
• Kyphotic spine—worsening<br />
• Loss of height<br />
• Mininal thoracic extension<br />
• Generalized tenderness mid thoracic spine<br />
• Neuro exam normal
T7, T8, T9
• Patient is booked <strong>for</strong> T9 kyphoplasty<br />
• In holding area patient is reviewed and<br />
states her pain is alittle worse
• 63 year old female<br />
Mrs. P.D.<br />
• Sudden onset of upper thoracic spine pain<br />
• Started insidiously 6 months ago<br />
• A history of a variety of aches and pains<br />
• Pain partially mechanical
•Breast Ca<br />
• Lumpectomy<br />
PMHx<br />
• Then lymph node excision<br />
• Osteoporosis<br />
• Osteoarthritis<br />
• hypertension<br />
• Ulcerative colitis<br />
• fibromyalgia
Physical Examination<br />
• Mild upper thoracic kyphosis<br />
• Local boney tenderness<br />
• Some soft tissue tenderness (mild)<br />
• Neurological exam normal
T4 & T6
Next step?
Bone Scan<br />
• Increased activity at T6 and to a lesser<br />
extent at T4<br />
• No other abnormalities other that changes<br />
compatible with OA
CT guided biopsy<br />
• Unable to per<strong>for</strong>m due to technical and<br />
patient factors
• Prevention<br />
• Prevention<br />
• Prevention<br />
Remember<br />
• Treatment of osteoporosis<br />
• Treatment of the fracture
• History<br />
• Physical Exam<br />
Diagnostic workup<br />
• X-rays—Old films are helpful<br />
• CT—r/o cancer<br />
• MRI—STIR sequence if multiple fractures of<br />
unknown age
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