This document discusses vertebroplasty and its controversies. It covers the opposition faction's concerns about patient selection and study design flaws in vertebroplasty trials. Specifically, it notes criticisms of including patients with unclear fracture acuity or other pain sources. It also reviews proposed indications, complications, efficacy evidence from studies, and the debate around early vs. delayed intervention. In 3 sentences: The document examines the ongoing debate around vertebroplasty, with opponents arguing past studies had flaws like uncertain fracture timing and potential sham procedure issues, while supporters point to studies finding it reduced pain and improved function for vertebral compression fractures. It discusses factors like patient selection criteria, potential complications, and the question of whether early intervention impacts outcomes.

1. JUI-KUO HUNG MD,MHA
Changhua Christian Hospital
Department of Orthopedic Surgery
Pros and Cons ？
Insight of Vertebroplasty
and Clinical Application

2. Vertebroplasty
• Controversial topics
– Opposition faction
– Support faction
• Overview
– Indication/Contraindication
– Complication
– Efficacy
• Still a debate ！

3. Controversial Topics
-- Opposition Faction --

4. Controversial Topics
-- Opposition Faction --

5. Controversial Topics
-- Opposition Faction --

7. Controversial Topics
-- Support Faction --

8. Controversial Topics
-- Support Faction --

9. Controversial Topics
-- Support Faction --

10. • Patient Selection
– Fracture acuity
– Enrollment
– Control group
– Outcome
• Conclusion
Controversial Topics
-- Support Faction --

11. Patient Selection
-- Fracture Acuity --
• Acuity of VCF
– Influence the results of cement augmentation
• Positive response to VP on MRI image
– Decreased signal on T1-weighrted image
– Increased signal on T2 or a fat-suppressed image
• Pain from osteoporotic VCFs substantially
diminishes over time

12. • Improper inclusion criteria
– Fracture edema or a fracture line detected on MRI
– Q ： Fracture line is unclear if this is the sign of acute
fracture
• Improper definition of acute fracture
– Fracture less than one year in the studies
• 32% < 6 weeks in Buchbinder et al., 44% in Kallmes et al.
– Q ： Most-defined acute fracture ： < 4~6 weeks
– Inconsistency between previous and current studies
Patient Selection
-- Fracture Acuity --

13. • Enrolling patients if a PRCT is difficult
– Selection bias
– Kallmes et al.
• 131/1812
– Buchbinder et al.
• 78 patients in 4.5 years at four high volume centers
• Unquantifiable selection bias
– Small sample size
Patient Selection
-- Enrollment --

14. • Bias of sham procedure
• Origin of back pain in VCF patients
– Osteoporotic VCF
– DJD, facet arthritis, muscle fatigue….
• Sham procedure
– Injection of anesthetic to facet capsule/periosteum
– Cause of pain relief ？
• Perhaps dry needle injection is better
Patient Selection
-- Control Group --

15. • Overall back pain in Buchbinder’s study
– True fracture pain ？
– General body pain ？
• Average pain reduction of VAS
– － 3 at one month follow up in Kallmes
– － 2.3 in Buchbinder
– Similar other PRCT studies
– Different explanation in conclusion
Patient Selection
-- Outcome --

16. Conclusion

18. Controversial Topics
-- Opposition Faction --

19. Treating spinal compression fractures
New guideline recommends against use of
vertebroplasty

21. Recommendation 1
-- Moderate Strength --
• We suggest patients who present with an
osteoporotic spinal compression fracture on
imaging with correlating clinical signs and
moderate symptoms suggesting an acute injury
(0–5 days after identifiable event or onset of
symptoms) and who are neurologically intact be
treated with calcitonin for 4 weeks.

22. • Ibandronate and strontium relanate are
options to prevent additional symptomatic
fractures in patients who present with an
osteoporotic spinal compression fracture on
imaging with correlating clinical signs and
symptoms.
Recommendation 2
-- Weak Strength --

23. • We are unable to recommend for or against
bed rest, complementary and alternative
medicine or opioids/analgesics for patients
who present with an osteoporotic spinal
compression fracture on imaging with
correlating clinical signs and symptoms and
who are neurologically intact.
Recommendation 3
-- Inconclusive --

24. • It is an option to treat patients who present
with an osteoporotic spinal compression
fracture at L3 or L4 on imaging with
correlating clinical signs and symptoms
suggesting an acute injury and who are
neurologically intact with an L2 nerve root
block.
Recommendation 4
-- Weak Strength --

25. L2 Spinal Nerve-Block Effects on Acute Low Back Pain
From Osteoporotic Vertebral Fracture
Ohtori S, Yamashita M, Inoue G et al.
J Pain 2009;10(8):870-875.

26. • We are unable to recommend for or against
treatment with a brace for patients who
present with an osteoporotic spinal
compression fracture on imaging with
correlating clinical signs and symptoms and
who are neurologically intact.
Recommendation 5
-- Inconclusive Strength --

27. • We are unable to recommend for or against a
supervised or unsupervised exercise
program for patients who present with an
osteoporotic
spinal compression fracture on imaging with
correlating clinical signs and symptoms and
who are neurologically intact.
Recommendation 6
-- Inconclusive Strength --

28. • We are unable to recommend for or against
electrical stimulation for patients who present
with an osteoporotic spinal compression
fracture on imaging with correlating clinical
signs and symptoms and who are
neurologically intact.
Recommendation 7
-- Inconclusive Strength --

29. • We recommend against vertebroplasty for
patients who present with an osteoporotic
spinal compression fracture on imaging with
correlating clinical signs and symptoms and
who are neurologically intact.
Recommendation 8
-- Strong Strength --

30. • Kyphoplasty is an option for patients who
present with an osteoporotic spinal
compression fracture on imaging with
correlating clinical signs and symptoms and
who are neurologically intact.
Recommendation 9
-- Weak Strength --

31. • We are unable to recommend for or against
improvement of kyphosis angle in the
treatment of patients who present with an
osteoporotic spinal compression fracture on
imaging with correlating clinical signs and
symptoms and who are neurologically intact.
Recommendation 10
-- Inconclusive Strength --

32. • We are unable to recommend for or against
any specific treatment for patients who
present with an osteoporotic spinal
compression fracture on imaging with
correlating clinical signs and symptoms and
who are not neurologically intact.
Recommendation 11
-- Inconclusive Strength --

34. History
• Galibert in 1984
– Amiens, France
– First reported case of VP
– 50 year-old female with
neck pain due to a cervical
(C2) hemangioma

35. Indication
• Painful vertebra
– Osteoporotic fracture
– Neoplastic fracture
– Tumor infiltration
– Traumatic fracture
• Expanded indication
– Augmented instrumentation
– Prevention of adjacent fracture
﹖

36. Patient Selection
-- Better Response --
• Single level or only a couple of levels
• Focal pain and tenderness corresponding to
the level of edema by MRI
• Fracture present <2 months or recent
worsening of fracture
• Fracture limits activity
• No sclerosis of fractured vertebra

37. • Fracture present for >1 year
• Other causes for back pain
– Disc herniation, spinal stenosis,
facet or SI joint disease
– Structural imbalance
• Kyphosis
• Scoliosis
• –Radicular pain related to disc herniation
Patient Selection
-- Uncertain Response --

39. Neoplastic Compression Fracture
• Treat to alleviate pain
• Stabilize vulnerable vertebrae
• Opportunity to obtain biopsy
• Amount of pain reduction may be less than
osteoporotic compression fractures
• Greater risk for complications
– Pulmonary embolism
– Cardiovascular compromise

40. Contraindication
• Uncorrected coagulopathy
– Pathologic
– Iatrogenic
• Infection
– Spine
– Elsewhere

41. Patient Selection Criteria
• Painful fracture not responding after 4 weeks
of treatment
– How about acute fracture
• Acute or subacute compression fracture(s)
on plain radiographs or MRI
– Fracture cleft
• Pain corresponding to level of the fracture
﹖﹖

42. Imaging Evaluation
• Radiographs
– Compare with any prior
studies
• MRI
– T1, T2, STIR sequences
– Assess for vertebral body
marrow edema
– Exclude stenosis due to
disc and/or facet disease

43. Imaging Evaluation
• Computed tomography
– If MRI contraindicated
– Assesses cortical
integrity of posterior
vertebral body and
pedicles
• Bone scan
– If MRI cont raindicated
– With SPECT
– Often performed as part
of a metastatic workup

44. Complication
• Incidence
– Minor complications: 1-5%
– Major complications: <<1%
– Higher for metastases: 10%
• Majority of complications are transient and
self-limited
• Steroid therapy or surgery are rarely required

45. Complication
• Hemorrhage
– Rare
• Infection
– Rare
• Pulmonary embolism
• Fracture
– Lamina
– Pedicle
• Increased pain
– 1~2%
• Death

46. Complication
• Spinal cord or nerve root injury
– < 1%
– Direct
• Puncture
– Indirect
• Compression
• Hematoma
• Ischemia
• Thermal injury

47. Complication
• Symptomatic cement extravasation
– Incidence: depends upon etiology of fracture
• Osteoporosis 1-2% (?)
• Neoplasm 5-10% (?)
• Location
– Epidural
– Foraminal
– Paravertebral
– Disc

48. Complication
-- Cement Implantation Syndrome --
• Cardiopulmonary collapse
– Right heart failure and pulmonary hypertension
– Obese
• Time-limited phenomenon
– Early and aggressive hemodynamic support
– Acute pulmonary hypertension and secondary
RV failure are reversible
• Good luck is absolutely necessary !!

53. EFFICACY?

54. Efficacy of Vertebroplasty
Zoarski et al.
• Osteoporotic compression fracture
– 75-90% of patients experience dramatic or
complete relief of pain within several to 72 hours
• Neoplastic compression fracture
– 59-86% of patients experience marked reduction
in narcotic requirements or complete pain relief

55. Efficacy of Vertebroplasty
Zoarski et al.
• 30 pts, 54 fractures
• questionnaire pre- and post-procedure
• 80% improved
• 15-18 month follow-up: 22 of 23 patients
reported continued pain relief and
satisfaction with procedure.
• Pain improved (P<0.0001)

56. • 488 patients, 245 responding
• Phone interview average 7 months post-OP
• Pain: 8.9 →3.4 (P<0.001)
• Impaired ambulation: 72%→28% (P<0.001)
• Ability to perform ADL improved (P<0.001)
Efficacy of Vertebroplasty
Evans et al.

57. • MD Anderson cancer center
• 56 patients (21 myeloma, 35 other)
• 97 procedures, all fractures
• Recorded:
– VAS: pain, medication use, neurologic status and Pre-
post op 1, 3, 6, 9, 12 months
• Improvement or complete pain relief 84%
• No change 9%
• Not available 7%
• None worse
Efficacy of Vertebroplasty
Fourney et al.

58. Efficacy of Vertebroplasty
Fourney et al.
• Median pre-op VAS 7
• Median post-op VAS 2 (p<0.001)
• Pain reduction significant at each follow-up
interval through one year

59. Timing of Intervention

60. Early Intervention
-- May Reduce --
• Duration of acute pain
• Medication use
• Duration of
immobilization
• Occurrence of chronic
back pain
• Further collapse of the
treated vertebral body
• Height loss
• Kyphosis
• Incidence of pulmonary
embolism and
pneumonia

61. Early Intervention
• Diminishes analgesic use
• Facilitates quicker hospital discharge
• Lasting improvement (Trout AL. AJNR 2005; 26:1629-1633)
• But: Early intervention may not produce
better results than conservative care (Diamond TH.
MJA 2006; 184:113-117)

67. Thank You ！