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Importance of Fracture Reduction and Anatomy Restoration in Patients with Vertebral Compression Fractures

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... sex and BMD. Komp does not use a ... Pain (0 [worst] to 100 [best] scale) Baseline. 6 months. EVOS Score. Balloon Kyphoplasty. Non-surgical Management. VAS Pain ... – PowerPoint PPT presentation

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Title: Importance of Fracture Reduction and Anatomy Restoration in Patients with Vertebral Compression Fractures


1
Importance of Fracture Reduction and Anatomy
Restoration in Patients with Vertebral
Compression Fractures
2
Common Beliefs and Practices
  1. No one has shown that vertebral deformity causes
    problems.
  2. I manage patients non-operatively for one to
    three months because the pain might go away. I am
    performing balloon kyphoplasty to address pain.
  3. There is no evidence that kyphoplasty restores
    height.
  4. Sometimes I can restore height with balloon
    kyphoplasty, but it is not reliable.
  5. Vertebroplasty restores height.
  6. I perform balloon kyphoplasty because it is
    safer than vertebroplasty. I do not care about
    fracture reduction.
  7. I do not perform balloon kyphoplasty on a
    fracture older than three months because you
    cannot restore height in old fractures.
  8. Balloon kyphoplasty and vertebroplasty are pain
    operations. No one has shown any difference in
    the pain benefit, so why should I spend more
    money or time to perform balloon kyphoplasty?
  9. Ballon kyphoplasty increases the rate of
    adjacent fractures more than vertebroplasty,
    because bone cement stiffens the vertebral body,
    while vertebroplasty is better because it
    preserves the bone and only fills the
    trabeculae.
  10. No one has shown any benefit to balloon
    kyphoplasty.

3
Impact of Deformity due to VCFs
  • Spinal deformity correlates with
  • Impaired gait, poor balance (Gold 1996, Sinaki
    2004)
  • Disability, reduced quality of life
    (Leidig-Bruckner 1997)
  • Reduced lung function (Leech 1990, Culham 1994,
    Schlaich 1998)
  • Early satiety, gastric distress (Gold 1996)
  • Future facture risk (Kado 2003)
  • Excess mortality (Kado 1998, Kado 2004, Huang
    2005)

Consequences are independent of acute fracture
pain
4
Kyphotic Deformity, Not Acute Back Pain, Accounts
for Long-term Consequences
5
Deformity Impairs Pulmonary Function
Significant negative correlation between
kyphosis angle and lung function measures
  • Medically stable kyphotic patients with no acute
    back pain versus age-matched controls (n30)
  • Excluded patients with pre-existing pulmonary
    disease, previous spine surgery

  Normal Osteoporosis Diff
T1-T12 kyphosis (º) 34.9 58.3 67
Rib mobility (centimeters) Rib mobility (centimeters) Rib mobility (centimeters) Rib mobility (centimeters)
Anterior expansion 3.5 2.3 34
Lung volume (liters) Lung volume (liters) Lung volume (liters) Lung volume (liters)
Total lung capacity 4.4 3.8 14
Vital capacity 2.7 2.2 19
Inspiratory capacity 2.2 1.6 27
All differences plt0.05
Culham - Spine 1994
6
Deformity Impairs Pulmonary Function
Kyphotic deformity reduces pulmonary function
compared to chronic low back pain patients
matched for back pain
Adjusted for age, sex and height at age 25 No
acute back pain
Chronic Low Back Pain Osteoporosis (1 VCF) P value
Patients (n) 51 34 -
Vital Capacity 105 94 lt0.05
Forced Expiratory Vol (1 sec) 92 85 lt0.05
Schlaich Osteoporos Int 1998
7
Prior Fracture Increases Future Fracture Risk
  • Lindsay 2001 analyzed VCF risk within one year in
    patients with 0, 1 or 2 or more prior VCFs.
    (JAMA 2001)
  • Lindsay 2005 used the same patient cohort to
    analyze VCF risk within one year in patients with
    0, 1, 2, 3, 4, 5, 6, 7, or 8 prior VCFs.
    (Osteoporos Int 2005)

Lindsay Osteoporos Int 2005
8
Fracture Deformity and Risk
Increasing fracture risk with increasing deformity
Black J Bone Min Res 1999
9
Future VCF Risk Predicted by Biomechanics
  • According to mechanical principles, kyphosis
    increases anterior stress, predicting increases
    in future fracture risk

W bodys center of gravity M muscles and
ligaments in the back ? vertebral body
Figures from Yuan J Spinal Disord Tech 2004
10
Correlation between Number of VCFs and
Progressive Decrease in QOL
1,425 women on 2 doses of an osteoporosis drug or
placebo, followed for 3 years
Silverman Arthr Rheum 2000
11
The Profound Impact of Radiographically-Detected
VCF on QOL (SF-12)
  • Study of 334 people 65 y.o. assessed by
    radiographs and SF-12
  • Loss of quality of life in patients with
    radiographic vertebral fractures was comparable
    to that of patients with CHRONIC OBSTRUCTIVE
    PULMONARY DISORDER (COPD) OR CARDIAC DISEASE
  • Patients with 3 or more VCFs had a loss of
    quality of life comparable to that of patients
    with STROKE OR CANCER

Van Schoor Osteo Int 2005
12
Patients With Acute VCFs Do Not Get Better
  • SF-36 Physical Function Scores unchanged at 2
    years (Hallberg 2004)
  • VCF patients treated with non-surgical management
    did not show improvement in pain and function
    compared to balloon kyphoplasty patients (Komp
    2004, Grafe 2005)
  • Worse SF-36 outcomes than hip fx patients at 2
    and 5 years (Hallberg 2004, Hall 1999, Zethraeus
    2002)
  • Mortality greater than hip fx pts at 4-5 years

    (Cauley 2000, Johnell 2004)
  • VCFs are NOT stable
  • Not always apparent on initial X-ray, collapse
    can take 18 months (Lyritis 1989, Heggeness 1993,
    Heggeness 1994,
    Komp 2004, Grafe 2005)

13
Deformity alone leads to serious health
consequences
  • The highest standard of non-surgical management
    does not prevent deformity, leading to
  • Future fracture
  • Impaired health
  • Loss of physical function
  • Loss of QOL

Reginster Osteoporos Int 2002
14
Orthopaedic Principles of Fracture Management
  • Anatomy restoration
  • Rigid fixation
  • Minimal tissue disruption
  • Safe and early mobilization

Conservative management does not fulfill
Orthopaedic principles of fracture management
Helfet J Bone Joint Surg Am 2003
15
Patient Outcomes After Balloon Kyphoplasty
Literature Summary
Number or Rate
Studies 35
Prospective 19 (54)
Concurrently Controlled (with NSM) 2 (5.7)
Retrospective 14 (40)
Balloon Kyphoplasty Patients 1,888
Osteoporosis 1658 (88)
Cancer 203 (12)
Procedure-Related Complications, PMMA 0.32
Procedure-Related Complications, All 1.06
Analysis current as of 04/2006
Data on file at Kyphon. Studies reported in
analysis provided at end of presentation.
16
Balloon Kyphoplasty Studies Consistently Show
Positive Outcomes
Outcome Osteo only Cancer only Both Total
Pain (NRS or Descriptive) 18 3 7 28/28
Ambulation / Activities of Daily Living 6 0 3 9/9
Oswestry or Roland Morris Disability Indices 4 1 3 8/8
Karnofsky Score 1 0 0 1/1
SF-36 QOL Medical Outcomes Survey 1 1 2 4/4
Vertebral Height Restoration 11 4 7 22/23
Angular Deformity Correction (Kyphosis) 10 2 4 16/16
Analysis current as of 04/2006
Data on file at Kyphon. Studies reported in
analysis referenced at end of presentation.
17
Balloon Kyphoplasty Improved Pain and Function
Compared to NSM in Pts with ACUTE Fxs
Prospective concurrently controlled study N19
KP, 17 NSM mean fracture age 1 month
VAS Pain Scores Oswestry Back Disability
Index
Komp J Miner Stoffwechs 2004
18
Balloon Kyphoplasty Improved Pain and Function
Compared to NSM in Pts with CHRONIC Fxs
Prospective concurrently controlled study N60
KP, 30 NSM all fractures at least one year old
(Kasperk - J Bone Miner Res 2005)
statistically significant difference BK-NSM (p
0.007) Scale 0 severe pain 100 no pain
statistically significant difference BK-NSM (p
0.03)
Similar results reported at one-year
follow-up (Grafe Osteoporos Int 2005)
19
Anatomy Restoration with Balloon
Kyphoplasty Recent Height Restoration Results
Paper of Estimated Pre-Fracture Height of Estimated Pre-Fracture Height of Estimated Pre-Fracture Height Reducible
Paper Pre-op Post-op 2 yrs Reducible
Crandall-acute Crandall-chronic 58 56 86 79 N/R N/R 92 80
Gaitanis-midline Gaitanis-anterior 71 73 87 87 N/R N/R 92 92
Ledlie-midline Ledlie-anterior 61 61 87 81 88 81 90 N/R
N/R Not Reported
Crandall Spine J 2004, Gaitanis Eur Spine J
2005, Ledlie Spine 2006
20
Anatomy Restoration With Balloon
Kyphoplasty Recent Angular Deformity Correction
Results
Paper Local Angulation () Local Angulation () Local Angulation () Last Follow-up Last Follow-up Reducible ()
Paper Pre () Post () Corrected () Follow-up () Follow-up () Reducible ()
Gaitanis 16 8 53 N/R N/R 90
Crandall-acute Crandall-chronic 15 15 8 10 47 34 N/R N/R N/R N/R N/R N/R
Open surgery 14 4 72 10 29 N/R
N/R Not Reported
Crandall Spine J 2004 Gaitanis Eur Spine J
2005 Ledlie Spine 2006 Open surgery, 11 papers
with modern pedicles screws published 1990-2003
(References provided at end
of presentation)
21
Anatomy Restoration With Balloon
Kyphoplasty Comparison to Postural Reduction
  • Postural reduction through patient positioning
    provides some improvement
  • Balloon kyphoplasty doubled improvement, and
    final height achieved after balloon kyphoplasty
    was maintained.

Voggenreiter Spine 2006
22
Anatomy Restoration with Balloon Kyphoplasty
Correction of Vertebral Morphology
VBs abnormalities predict future fracture risk
(Ismail Osteoporos Int 2003) Using
osteoporosis literature definitions, nearly 50
of VBs were normalized by KP
(Ledlie Spine 2006)
Definitions according to Genant J Bone Miner
Res 1993 Vertebral Fracture Assessment Using a
Semiquantitative Technique
23
Adjacent Fractures and Bone Cement
  • Theory
  • Bone cement stiffness alters load transfer in the
    spine
  • This leads to adjacent fractures
  • Facts
  • Not true on mechanical principles
  • Not shown in biomechanical studies
  • Not demonstrated in clinical studies

24
Biomechanics of the Spine
The Functional Spine Unit is Mechanically
Equivalent to Three Springs in a Series
Bone is MORE STIFF 100 MPa Disc is LESS STIFF
lt 3 MPa Bone is MORE STIFF 100 MPa
VB
Disc
VB
Functional Spine Unit (FSU)
25
Biomechanics of the Spine
The Response of the FSU to a Load is Driven
by its Least Stiff Component, the Disc
VB
Disc
VB
Functional Spine Unit (FSU)
26
Biomechanics of the Spine
Stiffening the Stiffer Component Does Not Alter
Load Transfer
VB
Disc

VB
PMMA
Functional Spine Unit (FSU) with STIFF
BIOMATERIAL
Vertebral augmentation helps restore normal
mechanics to a fractured VB
27
Biomechanics of the Spine
Fusion Does Alter Load Transfer because the
Least Stiff Component (the disc) has been
stiffened
?
28
Biomechanics Stiffness
Table 3 from Kyphons White Paper Feb 2006
29
Subsequent VCF Rates after using PMMA
  • Rates vary by study, not by method
  • Cannot compare rates in these studies due to
  • Different fracture definitions
  • Different time spans
  • Influence of confounding factors age, sex, BMD,
    prior fracture, and bone-affecting drugs
    (steroids)

Subsequent fracture rates cannot be interpreted
unless the study population controls for all
important risk factors
Table 2 from Kyphons White Paper Feb 2006
30
Natural History of Subsequent VCFs
  • 58 of patients had adjacent fractures (Silverman
    2001)
  • Likely explanations for adjacent fractures
  • Biomechanics Stresses highest at apex of curve
  • Forces on index VB likely to damage nearby VBs
  • Adjacent fracture underway but overlooked

Silverman Arthrit Rheum 2001
31
Balloon Kyphoplasty Reduced the Subsequent VCF
Rate in Prospective Concurrently Controlled
Studies
The only two prospective concurrently controlled
balloon kyphoplasty vs. non-surgical mgmt studies
show significant decrease in new fractures after
balloon kyphoplasty
Komp J Miner Stoffwechs 2004 Grafe
Osteoporos Int 2005
32
Collection of Level 1 Evidence from Clinical
Studies in Progress
  • FREE (300 patient enrollment complete)
  • Objective Level I evidence that osteoporosis
    patients significantly benefit from balloon
    kyphoplasty compared to non-surgical management
  • CAFE (enrollment ongoing)
  • Objective Level I evidence that cancer patients
    significantly benefit from balloon kyphoplasty
    compared to non-surgical management
  • KAVIAR (study in development)
  • Objective Level I evidence that correcting
    spinal deformity results in balloon kyphoplasty
    superiority over vertebroplasty

33
Meanwhile, the Clinical Literature Reports that
Deformity Correction is Important
  • Deformity
  • Debilitation
  • Disability
  • Depression
  • Death

34
  • 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. For complete information
    regarding indications for use, warnings,
    precautions, adverse events and methods of use,
    please reference the devices Instructions for
    Use.

35
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37
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