Best Spine Articles 2015

Brian D. Steinmetz, DO, FAAPMRInterventional Spine & Sports Medicine

OSS HealthOrthopedic & Spine Specialists

York, PA

Conflicts/Disclosures

• Nothing to disclose

Thanks to Justin Waltrous, MD for his contribution to preparation of this article summary

Background

• Steep rise in transforaminal epidural steroid injections from the year 2000 to 2011

• Particulate steroids traditionally used given perceived efficacy; however, spinal cord ischemia documented with triamcinolone, methyprednisolone and betamethasone acetate/phosphate

• Non-Particulate steroid (dexamethasone) has not been demonstrated to cause spinal cord ischemia

• Necessary to study head to head efficacy of particulate vs non-particulate steroids

Methods

• Study completed in two academic centers in Montreal, Canada

• Carried out between 12/2010 and 1/2013 and patients selected from ED or outpatient center with lumbosacral radicular pain

• One of three physicians, 1 anesthesiologist and 2 physiatrists, evaluated patients

Methods• Inclusion criteria:

• >18 years old• More radicular than lumbar pain• MRI findings of a herniation correlating to pain distribution

• Exclusion criteria:• Contraindication to procedure• Cauda equina syndrome• Tumors, infection, or inflammatory etiology of back pain• Previous surgery• ESI in past 3 months• Workers comp or disability insurance claims• Pregnancy or nursing

• Medications allowed as needed• Other treatments (like PT) discouraged

Methods

• Following anesthetic test dose of 1ml of 2% lidocaine:• One group 6mg betamethasone (1mL)• Second group received 7.5mg dexamethasone in

0.25mL saline (total of 1mL)• Injectate blinded to patient and treating physicians• Injection could be repeated at 1 month or later with

same steroid, no cross over• Decision to inject 1 or 2 levels up to treating physician

Results

• Demographic characteristics similar across groups

• 76 TFESI series, 99 total injected levels• L5=46, S1=43, L4=7, L3=3

Results

Results

Results

Results

Results

Results

Complications

• Most significant complication was dural puncture in one injection improved with blood patch, no long term side effects related to steroid use

• Complication rates similar to other studies

Discussion

• Similar results to recent studies by El Yahchouchi et al. (2013) and Kennedy et al. (2014) regarding non-inferiority of dexamethasone.

• Conflicting with Park et al. (2010) – triamcinolone superior

• O’Donnell et al. (2008) used non-equivalent steroid doses – triamcinolone superior

Limitations

• Biggest limitation is they did not reach statistical power

• Probably best utilized in a future Meta-analysis

Conclusion

• A third study suggesting non-inferiority of dexamethasone for lumbar transforaminal epidural steroid injections

• I switched to Dex last year as first line• Will consider particulate for impressive short-

term responders requiring a second injection– Informed consent regarding particulate risk

Questions?

Thanks to Simon Shapiro, DO for his contribution to preparation of this article summary

Introduction

• To improve safety of cervical interlaminar ESIs, the contralateral oblique (CLO) view has been proposed as a compliment or alternative to the lateral view to assess needle depth

• No study has assessed the optimal angle and predictability of the projection of the needle tip in the CLO view

• No study has compared the CLO view to the lateral view

Materials/Methods

• All patients scheduled for cervical interlaminar ESIs with available MRI

• No contrast allergies or posterior surgeries included

• 20g Tuohy needle placed with saline loss of resistance technique

• Fluoroscopic images in AP, lateral, 30⁰, 40⁰, 45⁰, 50⁰, isointense, measured angle

30 Degree Oblique

30 Degree Oblique

53 Degree Oblique

53 Degree Oblique

Results

• 24 subjects completed study• 15 men, 9 women• 36 to 76 years old, mean 53 years old• 9 injections C6-7, 15 at C7-T1• Mean measured CLO on MRI was 53⁰ (48-56⁰)

at C6-7 and 52⁰ (50-57⁰) at C7-T1• Mean ligamentum flavum thickness was

1.8mm at injection level

Results

Results

Results

• Of the 13 needles placed in AP zone 2: – 10 projected in lateral zones 2 or 3 and 2 were not

visualized

• Of the 9 needles placed in AP zone 1:– 6 projected in lateral zones 2 or 3 and 1 was not

visualized

Limitations

• Relatively small sample size• No attempt to optimize patient position for

lateral view (downward shoulder traction, swimmers view)

Conclusions

Questions?

Thanks to Amir Tahaei, MD for his contribution to preparation of this article summary

Background

• HF10, involves application of 10KHz, short duration (30 micro Seconds), Low Amplitude (1-5 mA)

• Traditional SCS stim frequency 40-60Hz• No perceptible paresthesia with HF10 like

traditional SCS• No need for paresthesia mapping during trial

typical of traditional SCS

SENZA-RCT study

• Safety and efficacy of HF10 SCS to traditional SCS in patient with back and leg pain

• Multicenter, Randomized, Controlled• Pivotal trial (Per FDA: pivotal study is a

definitive study in which evidence gathered to support the safety and effectiveness evaluation of the medical device for its intended use)

Study Design

• Primarily assess non inferiority and then superiority of HF10 K SCS to traditional SCS

• Chronic and intractable back and leg pain• Refractory to conservative management for 3 months• Average Back or leg pain of 5 /10 on VAS • ODI 41 to 80/100, and appropriate candidate for implant

surgery• Exclusion criteria: Active disruptive psychological or

psychiatric disorder, or other condition with improper perception of pain, mechanical instability in Flex/Ext X-ray, prior SCS experience

Study

• Randomized in 1:1 to HF10 (Senza system, Nevro Corp USA), vs commercially available (Boston Scientific)

• Randomized per gender and primary pain area• Both has two 8-contacts leads and a

rechargeable IPG placed• Due to practical consideration, study subjects,

and investigators were not masked

Interventions

• SCS trial for up to 14 days• 40% or greater pain reduction for permanent

placement (less than 50% endpoint requirement)• Oral analgesia stabilization 28 days before

enrollment• Traditional SCS in parallel at ~T8 with paresthesia

mapping• HF10 SCS overlapping near midline T9 T10

spanning T8 to T11, no mapping

Outcome assessment

• Assessment in Baseline, 1, 3, 6, 9 and 12 months• VAS, ODI, Global assessment• Adverse event• Neurological assessment (Motor, Sensory, reflex) • Responders or non-responders• Remitters (pain VAS =<2.5), non-remitters • Assess non-inferiority, if not inferior then assess

superiority

Results

• Randomized subjects: – 13.6 years since diagnosis – mean age 54.9– 86.6% previous back surgery– 77.1% failed back– 88.3% on opioids

• Baseline VAS: – back pain: 7.6 +1.2 – Leg pain: 7.3+1.4

Results

• 3 months: – Back Pain:• 84% back pain responder in HF10• 43.8% in traditional SCS (P<0.001)

– Leg Pain:• 83.1% leg pain responders in HF10• 55.5% in traditional (P<0.001)

Results

• 12 Months:– Back pain: • 80% responders in HF10• 50% in traditional SCS (P<0.001)

– Leg Pain:• 80% responders in HF10• 50-55% in traditional SCS (P<0.001)

Results

• 12 Months: – Remitters:

• 67% were back and leg pain remitters in HF10• Back pain 35% and leg pain 40% in traditional SCS (P<0.001)

– VAS decrease: • Back Pain:

– 67% in HF10– 44% in traditional SCS

• Leg Pain: – 70% in HF10– 49% in traditional SCS

Results

• 12 months: – Opioids:

• 35.5% off opioid therapy in HF10• 26.4% in traditional SCS (P=0.41)

– Patient satisfaction:• 55.4% in HF10• 32.3% in traditional SCS

• Significant improvements in ODI and Global Assessment of Function favoring HF10

• No uncomfortable stimulation in HF10 versus 46.5% in traditional group

Results

• 12 months: ODI improved by 16.5 in HF10, versus 13 for traditional SCS

• 12 months: Disability decreased 62.9% in HF10, versus 45.7% for traditional SCS (P=0.03)

• 12 months: Global assessment of functioning 70.8% in HF10, versus 59.3% for traditional SCS (P=0.15)

Adverse effects

• Adverse effects comparable• lead migration:– HF10 3.0%– Traditional SCS 5.2%

Discussion

• Both traditional and HF10 SCS demonstrated safety and efficacy

• Low incidence of study related adverse effects over 12 months (4-7.2%).

• Success of HF10 is superior traditional SCS for both leg and back pain

• Back pain coverage nearly 2x that of traditional SCS

Discussion

• HF10 SCS: 2/3 of patients achieved remitter (VAS<2.5) in back and leg pain, and 1/3 of patients decreased or eliminated opioid analgesic usage at 12 months

• Dramatic improvement of ADL, and quality of life

Discussion

• This article mirrors a previous observational study of HF10 in Europe

Limitations

• No masking of investigators• 30-45 mins of recharging daily in HF10 vs 5.2

times recharging for 2.3 hours monthly in traditional SCS

• Programming was not measured in this study

Conclusion

• HF10 therapy provides the first randomized, controlled trial demonstrating superiority of HF10 over traditional SCS for treatment of chronic back and leg pain

• Paresthesia free, no need for intra-operative paresthesia mapping, better tolerated

• Game Changer?

Questions?

Background

• Previous Medicare database studies have demonstrated increased all cause mortality in conservatively managed patients compared to patients after cement augmented vertebral compression fractures (VCFs)

• Goal to compare non-surgically managed VCF to balloon kyphoplasty (BKP) and vertebroplasty (VP) treated patients

Methods

• Medicare database study of all ICD-9 codes indicating new vertebral compression fractures from 2005-2009

• 1-year look back period for 12 specific comorbidities and used to determine pre-morbid health status

• Also recorded diagnosis of pneumonia within 90 days of death

Methods

• Exclusion criteria:–Cement augmentation procedure in look

back period– Younger than age 65 (ie disability)–Managed Medicare patients– Spinal fusion in year following VCF

Methods

• Statistical analysis included Propensity Matching–VP and BKP patients were matched to 3

non-surgical patients most closely matching pre-morbid health for analysis

• 4 year morbidity, mortality, treatment risks calculated

Results

• 1,038,956 patients met criteria• BKP 141,343 (13.6%)• VP 75,364 (7.3%)• Non-surgical (79.1%)• Augmented patients more likely to be Dx with

pathologic fracture• Non-surgical more likely to be Dx with

traumatic fracture

Results

• 4 year adjusted mortality:–Non-surgical cohort risk is 55% higher than

the BKP cohort and 25% higher than the VP cohort

• Non-matched 4 year mortality:–Non-surgical 49.4%, VP 46.2%, BKP 41.8%

Results

• Compared to BKP at 4 years:– Non-surgical cohort carried higher adjusted risk of

pneumonia, MI, DVT, UTI– Non-surgical cohort carried lower adjusted risk of

subsequent augmentation/fusion, and pulmonary/respiratory complications

• Compared to VP at 4 years:– Non-surgical cohort carried higher adjusted risk of UTI– Non-surgical cohort carried lower adjusted risk of

subsequent augmentation/fusion, and pulmonary/respiratory complications, and PE

Results

• For osteoporotic VCF:– Non-operative carries 70% higher adjusted 4 year

mortality risk compared to BKP– BKP carries 17% lower adjusted 4 year mortality

risk compared to VP

Discussion

• Improved risk of mortality may be from improved pulmonary function, earlier mobility, decreased opioid and NSAID use

• Differences between BKP and VP may be from height restoration or higher/more controlled cement volume in BKP

• Similar results seen in other large population based studies

Limitations

• Fracture severity was not assessed –More severe fractures, especially in sicker

individuals may go untreated• Obesity and smoking not evaluated due to

database limitations• Did not look at younger VCF patients

Conclusion

• Multiple database studies now saying increased mortality if fractures conservatively managed

• Should we be more aggressive at offering this?• Counseling should include this in discussion• Is it really the balloon?

Questions?

Background

• Lumbar flexion-extension radiographs are often helpful in evaluating for spondylolisthesis and segmental instability

• Study is often limited by quality of X-ray tech and patient tolerance to motion

• Various measurement conventions are used for define instability

• Most common technique is in standing position

Background

• Comparison of upright lateral to supine saggital MRI may be useful and has not been formally studied

• Objectives:– Compare observed mobility between upright

(U) X-ray and saggital MRI (S) (combined, US)– Compare US measurements to lateral flexion-

extension X-ray (FE)– Identify factors associated with findings on

each

Methods

• Power analysis required 58 patients• 68 consecutive patients with lumbar

spondylolisthesis at a single outpatient center• FE films obtained in a single radiology

department in a standardized manner• % saggital translation measured by 2 similar

published criteria– >8% of the width of the above adjacent vertebra

considered unstable

F E

U S

Results

• Demonstrated mobility statistically higher in US (7.68±5.34%) compared to FE (4.90±3.82%, p=0.001)

• 70.6% had greater mobility with US• 29.4% had greater mobility with FE• Greater translation in U or F compared with E

or S• Dynamic instability identified in 42.6% on US

compared to 17.6% on FE (P=0.003)

Results

• Females and shorter stature demonstrated more mobility on FE

• Lack of back pain demonstrated increased mobility on FE

• No difference with age, weight, BMI, level, grade, type on FE

• High BMI, Grade II/III listhesis and isthmic listhesis had greater mobility on US

Discussion

• Similar findings to a prior study comparing upright X-ray to supine CT

• Similar findings to a prior study which showed that extension films added little compared to upright and flexion

• Back pain and muscle tension may account for differences compared to supine MRI

• Flexion may paradoxically reduce translation in higher grade listhesis in some patients

Conclusion

• Comparing upright films to supine MRI is high yield for demonstrating instability

• May reduce cost, radiation exposure, and patient discomfort

Facet Diastasis

Questions?

Thank you