14.01.2013 Views

Balloon Kyphoplasty for Vertebral Compression Fractures

Balloon Kyphoplasty for Vertebral Compression Fractures

Balloon Kyphoplasty for Vertebral Compression Fractures

SHOW MORE
SHOW LESS

Transform your PDFs into Flipbooks and boost your revenue!

Leverage SEO-optimized Flipbooks, powerful backlinks, and multimedia content to professionally showcase your products and significantly increase your reach.

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


THANK YOU

Hooray! Your file is uploaded and ready to be published.

Saved successfully!

Ooh no, something went wrong!