pros and cons？ insight of vertebroplasty and clinical application

JUI-KUO HUNG MD,MHA

Changhua Christian Hospital

Department of Orthopedic Surgery

Pros and Cons ？ Insight of Vertebroplasty and Clinical Application

Vertebroplasty • Controversial topics

– Opposition faction– Support faction

• Overview – Indication/Contraindication– Complication– Efficacy

• Still a debate ！

Controversial Topics -- Opposition Faction --

Controversial Topics -- Opposition Faction --

Controversial Topics -- Opposition Faction --

Controversial Topics -- Support Faction --

Controversial Topics -- Support Faction --

Controversial Topics -- Support Faction --

• Patient Selection– Fracture acuity– Enrollment– Control group– Outcome

• Conclusion

Controversial Topics -- Support Faction --

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

• 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 --

• 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 --

• 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 --

• 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 --

Conclusion

Controversial Topics -- Opposition Faction --

Treating spinal compression fracturesNew guideline recommends against use of

vertebroplasty

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.

• 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 --

• 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 --

• 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 --

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.

• 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 --

• 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 --

• 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 --

• 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 --

• 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 --

• 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 --

• 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 --

History

• Galibert in 1984– Amiens, France– First reported case of VP – 50 year-old female with

neck pain due to a cervical

(C2) hemangioma

Indication

• Painful vertebra– Osteoporotic fracture– Neoplastic fracture– Tumor infiltration– Traumatic fracture

• Expanded indication– Augmented instrumentation– Prevention of adjacent fracture

﹖

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

• 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 --

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

Contraindication • Uncorrected coagulopathy

– Pathologic– Iatrogenic

• Infection– Spine– Elsewhere

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

﹖﹖

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

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

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

Complication

• Hemorrhage– Rare

• Infection– Rare

• Pulmonary embolism

• Fracture– Lamina– Pedicle

• Increased pain– 1~2%

• Death

Complication

• Spinal cord or nerve root injury– < 1%– Direct

• Puncture

– Indirect• Compression• Hematoma• Ischemia• Thermal injury

Complication• Symptomatic cement extravasation

– Incidence: depends upon etiology of fracture• Osteoporosis 1-2% (?)• Neoplasm 5-10% (?)

• Location– Epidural– Foraminal– Paravertebral– Disc

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 R

V failure are reversible

• Good luck is absolutely necessary !!

EFFICACY?

Efficacy of VertebroplastyZoarski 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

Efficacy of VertebroplastyZoarski 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)

• 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.

• 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.

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

Timing of Intervention

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

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)

Thank You ！