Vertebral Augmentation by Vertebroplasty and Kyphoplasty: Introductory concerns

1. Vertebroplasty and Kyphoplasty
Introductory Concerns
Mohamed Mohi Eldin,
Professor of Neurosurgery,
Faculty of Medicine,
Cairo University
One-Day Spine Clinic 4th workshop & hands-on,
27-28 December 2017

2. History
Acrylic cements have been used for bone
augmentation for over 5 decades
Stabilization of large tumor defects after (Vidal, 1969)
Hip replacement (Chamley, 1970)
First reported case of percutaneous
vertebroplasty in Amiens, France
Galibert and Deramond, 1984
50 year-old female with neck pain due to a cervical (C2)
hemangioma

3. Vertebral Augmentation
Cementoplasty
(X-ray guided spine augmentation)
• Vertebroplasty (1984): Injection of material (usually PMMA
cement) into vertebral body
• Kyphoplasty (1998): Injection after manipulation involving
cavity creation
• Spinoplasty
• Pediculoplasty
• Sacroplasty
• Cannulated, Fenestrated, Augmented Screws
Indicated for painful compression fractures
osteoporosis
cancer

4. PRACTICE GUIDELINE FOR THE PERFORMANCE OF VERTEBROPLASTY. American College of
Radiology. 2009.
Who are Qualified Personnel ?
1. Experience
1. 6 months of training involving cross-sectional imaging
2. 4 months of training involving interventional procedures
3. or equivalent experience
2. Performance of successful vertebroplasties in at least 5
patients as the primary operator, under the supervision of a
qualified consultant, and without complications
3. Relevant knowledge and skill of spine, radiation, etc.

5. Vertebroplasty / Kyphoplasty
What is it?
Vertebroplasty Kyphoplasty

6. Vertebroplasty
(V-plasty)
• A minimally invasive procedure done primarily
to relieve pain caused by fracture of the spinal
vertebrae (vertebral body).
• Injected bone cement (PMMA) into the
affected vertebra stabilizes the bone and
relieve pain.
• Most effective for fractures that are less than
six month old.

7. Vertebroplasty
“Internal Splint”
Treatment for
Painful Pathologic Vertebrae

8. Vertebroplasty Indications
Painful vertebra
(refractory to medical therapy)
from:
– Osteoporotic fracture
– Neoplastic fracture
– Tumor infiltration
– Trauma?

9. Vertebroplasty
Indications
Even without obvious loss of
vertebral body height
• Symptomatic vertebral body
microfracture as documented by
– magnetic resonance imaging [MRI]
– nuclear imaging, and/or
• Lytic lesion (seen on CT)
PRACTICE GUIDELINE FOR THE PERFORMANCE OF VERTEBROPLASTY. American College of
Radiology. 2009.

10. Symptomatic vertebral body
microfractures

11. Osteoporotic fracture
• Primary osteoporosis
– Elderly patient
– Female > male
• Secondary osteoporosis
– Young patient
– Steroid use
• Asthma,
• vasculitis,
• transplant,
• inflammatory bowel disease,
• tumor treatment

12. The Downward Spiral
1. Osteoporosis
2. VCFs
3. Spinal Deformity
4. Decreased lung
capacity
5. Decreased physical
function
6. Early Satiety
7. Sleep problems
8. Decreased activity
9. More bone loss
10. Increased fracture risk
11. Decreased pulmonary
function
12. Increased mortality

13. Osteoporotic fracture
(Actual Costs)
• Pain
• Diminished mobility
• Loss of employment
• Narcotic addiction
• Urinary retention
• Insomnia
• Depression
• Spinal cord compression
• Kyphosis
• Pulmonary restriction
• Constipation & GI disturbances

14. Osteoporotic Compression Fractures
Conservative Therapy
• NSAIDS
• Opioids
• Muscle relaxants
• Bed rest
• Orthotic bracing
VCF healing should occur in 6-12 weeks
Refractory in 15-20% of patients

15. Osteoporotic Compression Fractures
Traditional Management
Side effects can be significant
• Analgesics
– Temporary
– Side effects
• Bed rest
– Deep venous thrombosis
– Pneumonia
• Immobilization
– Variable success
– further demineralization
• Surgery
– Challenging
– For neuro compromise

16. Despite Traditional Management
Some do not heal (15-20%)
Chronically disabling

17. Pathologic Vertebra
(+/- Compression Fracture)
• Primary Neoplasm
– Hemangioma
– Myeloma
• Secondary Metastasis (30% overall)
• Malignant lymphoma of bone (osteolymphoma)

18. Vertebroplasty
Absolute Contraindications
Asymptomatic compression fractures
Active osteomyelitis of the target vertebra
Uncorrectable coagulopathy
Allergy to bone cement or opacification agent

19. Relative Contraindications
• Radiculopathy (unrelated)
• Retropulsion of a fragment
(severe canal compromise)
• Tumor extension into canal
• Systemic infection
• Improvement on medical
therapy.
• NO Prophylaxis in
osteoporosis
• Myelopathy at fracture level

20. Vertebroplasty
Objectives
• To provide relief from a
painful vertebra
• To provide stability
• To prevent further
vertebral collapse that
would
– Lead to further loss of
height
– Result in kyphosis
– Be associated with
fractures at adjacent levels

21. What about
Early Intervention ??
May Reduce
• Duration of
– acute pain
– Medication use
– immobilization
• Occurrence of chronic back pain
• Further collapse of the treated vertebra
– Height loss
– Kyphosis
– Incidence of pulmonary embolism and pneumonia

22. Vertebroplasty
Patient Selection Criteria
– Painful fracture (Increased on loading)
– Not responding after 4 weeks of treatment
– Acute or subacute compression fracture(s) on
plain radiographs or MRI (altered signal in body)
– Pain corresponding to level of the fracture (Local
tenderness over spinous process)

23. Vertebroplasty
Patient Good Selection
• Patients who tend to respond the best
– 1 to 3 levels of fractures.
– Focal pain and tenderness corresponding to the
level of edema by MRI
– Fracture present < 2 months
– Recent worsening of fracture
– No sclerosis of fractured vertebra

24. Vertebroplasty
Patient Bad Selection
• Patients who are less likely to respond
– Fracture present for >1 year
– Other causes for back pain
• Disc herniation,
• spinal stenosis,
• facet or sacroiliac joint disease
– Radicular pain related to disc herniation

25. Benefits of Vertebroplasty
• Pain relief
– Quick
– Complete: osteoporosis > neoplasia
• Improved mobility
– Patient able to stand and walk within first 24
hours
Success Rates Threshold for Review
Neoplastic 70% to 92% <60%
Osteoporosis 80% to 95% <70%
PRACTICE GUIDELINE FOR THE PERFORMANCE OF VERTEBROPLASTY. American College of Radiology. 2009.

26. Efficacy of Vertebroplasty
• Osteoporotic compression fracture
– 75-90% dramatic or complete relief of pain
within several to 72 hours
• Neoplastic compression fracture
– 59-86% marked reduction in narcotic
requirements or complete pain relief
Low complication rate
Very high success rate

27. Why Vertebroplasty Alleviate Pain?
• Stabilizes fracture
– microfractures
– macrofractures
• Allows healing to occur
• Destruction of sensitive nerve
endings (mechanical, chemical
and thermal forces)
• Prevents further collapse
• Tumors??
– Thermal effect
– Toxic effect
– Mass effect

28. Vertebroplasty
is a palliative procedure
does not correct the underlying cause
of vertebral fracture
So,
Medical management of osteoporosis or
malignancy must be initiated and continued

29. Pain recurrence after V-plasty
usually due to
NEW LESIONS

30. THE PROCEDURE

31. Pre-Procedure Imaging
Magnetic resonance imaging
T1, T2, STIR sequences.. Why ?!
– Assess for vertebral body marrow edema
– Exclude stenosis due to disc and/or facet disease
Computed tomography
– If MRI contraindicated
– Assesses cortical integrity of posterior vertebral
body and pedicles

32. Think twice!
• Fractures above T6
• Less than 55 yrs
without history of
trauma
• Patients with known
malignancy

33. Age of fracture
• Best indicator of age is
the history
• Plain films
• MRI
– Low signal T1
– High signal T2
– High signal STIR

34. Bone Scan
• Not as commonly used
as MRI
• Been show to have a
93% predictive value in
vertebroplasty!
• May be abnormal when
MRI is normal
• Maynard et al. Value of bone scan imaging
in predicting pain relief in vertebroplasty.
AJNR 2000;21:1807-12.

35. Pre-Procedure Consultation
• Examination under fluoroscopy
– Concordance between painful sites and levels of
vertebral body compression
– Occasionally needed
• Informed consent

36. Pre-Procedure Care
• NPO after midnight
• Antibiotics
– Optional.
– Recommended for immune compromised patients.
– Systemic.
– Local: Added to cement.
• Patient Positioning and Draping
– Patient prone.
– Strict sterile technique.

37. Pre-Procedure Care
• Anesthesia
– Intravenous sedation
• Sedation: Versed
• Analgesia: Fentanyl
– Local
• 1% Lidocaine
• Bipivicaine
– General Anesthesia
• Rarely required
• Patient Monitoring
– Nursing
– Intravenous line
– Continuous Monitoring
– Parameters
• Vital signs
• Oxygen saturation

38. Complications
• Incidence.
– Minor complications <3%
– Major complications <1%
• Majority are transient and self limiting.
• Steroid therapy or surgery are rarely required.
• Spinal cord or nerve root injury <1%.
• Hemorrhage, infection and PE – Rare
• Fracture
– Lamina
– Pedicle
• Increased pain.
• Death.

39. Complications
• Symptomatic cement extravasation.
– According to etiology of fracture.
• Osteoporosis 1-2%
• Neoplasm 5-10%
• Location
– Epidural
– Foraminal
– Paravertebral
– Disc

40. American College of Radiology. 2009.

42. Cement Dislodgment After
Percutaneous Vertebroplasty
(A Rare Complication)

43. Other Uses
Tumours
Trauma
Myeloma

44. Spinoplasty
APPLYING VERTEBROPLASTY TO POSTERIOR ARCH
(posterior arch & spinous processes/laminae complex)
Needle placement in the spinous processes. Fluoroscopic ventral
limit to avoid central canal violation is the posterior margin of the
inferior articular process

45. Spinoplasty

46. Spinoplasty
PMMA distribution in spinous processes and
laminae

47. Interspinous spacer, following
spinoplasty

48. Spinoplasty + Interspinous spacer

49. Pediculoplasty
Similar to vertebroplasty but with increased procedural risks because of the
immediate vicinity of neural structures,
performed under high-quality biplane fluoroscopic guidance

50. Sacroplasty
A Treatment for Sacral Fractures

51. Sacroplasty Indications
• Sacral fracture
– Insufficiency
fracture
– Pathologic fracture
– Post-traumatic
fracture
• Painful sacral
neoplasm/mass
severe osteoporosis and bilateral comminuted
fractures of the sacral alae

52. Sacral insufficiency fractures
Occur when the quality of the sacral bone has become
insufficient to handle the stress of weight bearing (weak
bone) usually because of osteoporosis
Occur most often in older women.
characteristic H-shaped sacral
insufficiency fracture
bilateral ill-defined sacral lucencies
(sacral ala fractures)

53. Sacral insufficiency fracture
Associated abnormalities
• Vertebral compression fractures
• Other pelvic insufficiency fractures:
– Acetabular roof,
– pubic rami,
– pubic bone

54. Sacroplasty

55. Best performed
under CT
guidance.

56. Kyphoplasty

57. Kyphoplasty
• Minimally-invasive
• Percutaneous
• Can restore lost vertebral
height
• Immediate pain reduction
• Fewer complications
compared to vertebroplasty
• By 2005, performed on
170,000 patients

58. How does it work?
• Structural support – but no good correlation
with amount of cement injected
• Thermal properties
• Decompression
• Placebo effect

59. How is it done?
Preoperative on-table reduction

60. On-table reduction
A Preoperative guide

61. How is it done?
• Usually under general anaesthetic
• in prone position
• 3-4 cm bilateral incision
• via the pedicles using
– trocar,
– guidewire,
– cannula,
– bone tamp,
– cement
• Maximum of 3 vertebral bodies

62. How is it done?

63. Balloon tamp in vertebra plana fracture

64. Indications for
vertebroplasty/kyphoplasty
• Only needed in a small
subset of patients
• High signal on STIR.
• Pain on percussion
• Increased activity on
bone scan
• T5 and below-
kyphoplasty
• Timing?

65. Contraindications
• Infection
• Uncorrectable
coagulopathy
• Anaesthetic Risk
• Neurology
• Middle column
compromise is NOT.

66. Timing
• The best evidence is that the best results are
achieved within 6 weeks of onset!
• 50% + get better within 6 weeks
conservatively treated.
• Philosophical when to treat.
• Most fractures treated > 3 months old.

67. Timing
Older fractures
• No randomised control trials for efficacy of
treatment of old fractures.
• There are trials suggesting similar success
rates to acute fractures of 80% success in
fractures a year or older.
• Brown et al. Treatment of Chronic symptomatic vertebral compression
fractures with percutaneous vertebroplasty . AJN 2004;182:319-312.

68. Complications
• Cement Extravasation
– Pulmonary embolism
– Abscesses
– Disc damage
• Adjacent VCFs post
surgery—20-30%
• General complication
rate 1-2%

70. Balloon Kyphoplasty Case Study
Patient: 76 YO Female
Diagnosis: Metastatic Lung Cancer
Fracture Reduced: T8, 8 weeks old
Courtesy of Henry Small, M.D., Houston, TX

71. Conclusions
• Kyphoplasty is a safe and effective treatment
for back pain due to osteoporotic VCFs.
• Providers should include kyphoplasty in the
discussion of options for the VCF patient
• Reimbursement available by Medicare and
private insurance companies

72. Vertebroplasty v Kyphoplasty
My best protocol
• Fractures less than 6
weeks old who need to be
hospitilised.
• Failure of conservative
treatment after 3 months
• Vertebroplasty for all
except where middle
column is involved –
Kyphoplasty,
• Bone scan +ve

73. Vertebroplasty v Kyphoplasty
How is it done?
Vertebroplasty
Kyphoplasty

74. Vertebroplasty v Kyphoplasty
Vertebroplasty
• Cheaper
• Quicker
Kyphoplasty
• Expensive
• Takes longer
• Restoration of vertebral
height?
• Less adjacent fractures
• Less cement leakage
• Quality of life

75. Vertebroplasty v Kyphoplasty
A review of 168 studies
Vertebroplasty
• Mean change in VAS 5.68
• New fracture 17.9%
• Cement leak 19.7%
Kyphoplasty
• Mean change in VAS 4.60
p<0.001
• New fracture 14.1%
p<0.01
• Cement leak 7.0%
p<0.001
• Comparison of vertebroplasty and
kyphoplasty in vertebral compression
fractures: a meta-analysis of the
literature. Spine J 2008;8:488-97.

76. Meta-Analysis of Complications
Total Procedure-
Related
Complications
Cement-Related
Complications
Access-Related
Complications
Non-Device-
Related
Complications
Balloon Kyphoplasty
N = 1947 patients
14
(0.7%)
3
(0.2%)
4
(0.2%)
7
(0.4%)
Vertebroplasty
N = 6808 patients
199
(2.9%)
132
(1.9%)
28
(0.4%)
39
(0.6%)
p-value 0.0002* <0.0001* 0.3791 0.8781
*Balloon kyphoplasty has statistically significant lower complication
rates compared to vertebroplasty
Data on file, Medtronic Spine LLC.

77. Taylor Study*
Cement Leakage Results
p < 0.0001
BK: 90/1111 = 8%
VP: 614/1551 = 40%
(p-value not reported)
BK: 0/1094 = 0%
VP: 8/275 = 3%
Taylor, Taylor, Fritzell. Spine. 2006;31:2747–2755 – See Table 6.
*Includes fracture of all etiologies. BK = balloon kyphoplasty. VP = vertebroplasty.

78. Taylor Study
Adverse Events
0.3%
0%
0.3%
1.8%
0.5%
2.5%
0.0%
1.0%
2.0%
3.0%
4.0%
Pulmonary embolism Spinal cord
compression
Nerve root pain/
radiculopathy
Adverse Events per Patient
Balloon Kyphoplasty
Vertebroplasty
BK: 1/291 = 0.3%
VP: 15/803 = 1.8%
BK: 0/195 = 0%
VP: 3/631 = 0.5%
BK: 1/322 = 0.3%
VP: 32/1100 = 2.5%
Taylor, Taylor, Fritzell. Spine. 2006;31:2747–2755 – See Table 6.

79. Problems
Fracture acuity
Bone marrow oedema indicates
an acute fracture
but a detectable fracture line sufficed for
inclusion.
Sometimes in MRI or Bone scan
fracture age was uncertain.

80. Developments
• Calcium phosphate in young patients with traumatic
fractures
• Prophylaxis
• Adding chemotherapy agents or radioactive isotopes
to the cement in tumour

81. Conclusions
Vertebroplasty/Kyphoplasty
Useful in the treatment of
vertebral osteoporotic fractures
Low morbidity
Should be considered in painful fractures
over 6 weeks old

82. 16001110
Questions and Discussion