Aperius Interspinous Spacer vs open surgery in degenerative lumbar spinal stenosis ISLASS Guest Sess

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Aperius Interspinous Spacer vs open
surgery in degenerative lumbar spinal
stenosis ISLASS Guest Session,
10thEFORT Congress, Wien 3 June 2009

• Menchetti P.P.M., M.D., F.R.C.S. (US)
• Professor in Orthopaedics Sapienza University,
  Rome (Italy)

www.islass.org
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Epidemiology

• Degenerative Lumbar Spinal Stenosis (DLSS)
  
• Roughly 8 adult population affected by
  Degenerative Lumbar Spinal Stenosis (DLSS)
• - Hillibrand AS, Rand N Am Acad Orthop
  Surg 1999 7(4)
• 20 of patients with low back pain (LBP) have a
  DLSS
• - Zucherman et alSpine 2005 30
• - Boden et alJBJS 1990 72A(3)
• - Long DM et al J Spine Disorders 1996
  9(1)
• DLSS Surgery in over 65 yrs old patients
  increased a lot over the past 20 years
• - Katz JN Spine 1995 20 (24suppl)
• - Ciol MA et al J Am Geriatr Soc 1996
  44(3)
• - Andersson Adult Spine GBJ The 2 ed.
  1997

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Clinical findings

• Clinical evidence of chronic nerve root
  irritation and compression with
• narrowing of the spinal canal or neural
  foramina (Imaging )
• without vascular impairment to the lower
  extremities
• Insidious symptoms onset of leg and back pain and
  paresthesias
• with ambulation, increasing in extension and
  relieving in flexion ? Neurogenic
  Intermittent Claudication (NIC)
  
• 
  
  
  
  
  
  (Verbiest H. JBJS 1954 -36B(2))

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Natural History of SCS

• Approximately 50 of cases will experience
  increasing symptoms in spite of conservative care
  and eventually require surgery
• (Johnsson et al, Acta Orthop. Scand,
  1993)

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Current Treatment Options

• Conservative management
• Physical therapy and drugs
• Bracing
• Epidural Steroids
• Decompression surgery
• Open techniques
• Mininvasive technique
  (interspinous spacers)
• Decompression surgery is superior to
  conservative choice in terms of pain relief
  and patient satisfation but success rate of
  surgery vary widely
• (23 - 100) !!!!
• 
  Turner J et al. Spine 1992 171-8

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Retrospective Study
P.P.M. Menchetti, M.D., F.R.C.S. (US) University
of Florence, (Italy) F. Postacchini, M.D.
Chief Orthopaedics Dept. Sapienza University of
Rome , (Italy)
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Material

• 60 patients DLSS (related to preoperative Imaging
  mild, moderate, severe, very
  severe)
• GROUP I (30 patients DLSS mild to moderate)
• Aperius PercLID
• 16 males - 14 females
• Average age 72 yrs (63 - 79)
• F.U. mean 8.2 months (6 14)
• Spondylolisthesis lt 25 2 cases
• GROUP II (30 patients DLSS severe to very
  severe) Open Surgery
• 13 males 17 females
• Average age 67 yrs (57 78)
• F.U. mean 1.4 yrs (8m 2.6y)
• Spondylolisthesis gt 25 3 cases (no
  arthrodesis)
• 4 patients motor deficit

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GROUP I - Aperius

L3 L4
10 30 L4 L5
23 69 L3-L4,
L4-L5 3
1
ø
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Group I

• Inclusion Criteria
• - Symptomatic DLSS with/without NIC, imaging
  () resistent to conservative therapy more than
  6 months
• - Foraminal stenosis
• - Symptoms exacerbated by standing, extension,
  walking
• - Symptoms relieved by sitting, flexion
• - Levels L1-L5

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Group I

• Exclusion Criteria
• generally accepted contraindications,
  nevertheless each case must be evaluated
• - Low Back Pain
• - Degenerative spondylolisthesis gt 25
• - Very Severe stenosis with bone spurs
• - Scoliotic deformity with Cobb angle gt25
• - Ankylosis at the affected level
• - Kyphosis requiring surgical correction
• - Severe Osteoporosis
• - Active infection / spine tumors

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Male, 68 yrs, L4-L5 right foraminal
stenosis preop
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Postop CT Scan
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Male, 74 yrs L4-L5, DLSS postop CT
Scan
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Female, 65 yrs old,
L4-L5 DLSShypertrophic ligamentum flavum
enfolding posteriorly
Aperius reducing enfolding effect
15
Male, 77 yrs, L4-L5 right foraminal History of
T.I.A., Diabetes, severe hearth problems Preop
MRI and intraoperatory C-arm control
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GROUP II Open Surgery


L2 L3
2
7 L3 L4
10
33 L4 L5
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60 5 cases both L3-L4,
L4-L5 1 case L2-L3, L3-L4
Unilateral Laminotomy
10 33
Bilateral Laminotomy

6 20 Bilateral Decompression
Unilateral approach 8
27 Bilateral Laminectomy
6 20

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Male, 67 yrs L4-L5 DLSS
Bilateral laminotomy L4-L5
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Male, 76 yrs L2-L3, L3-L4 DLSSBilateral
laminectomy L2-L3, L3-L4
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Methods

• EVALUATION
• VAS
• ODI
• Modified ZCQ related to Symptoms
  Severity

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Results VAS (0 - 10 Scale)
Group I - Aperius
Group II Open
7,3
8

2,0
No Significant difference (plt0.05)
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Results ODI
Group I - Aperius
Group II - Open
No Significant difference (plt0.05)
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Results Modified ZCQ
Symptoms severity Group I Aperius

Group II - Open
No Significant difference (plt0.05)
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Results

• Group I Aperius
• 
  
• Poor Results
  5 17
• Removal and open surgery
• (decompression and arthrodesis)
  2 7
• in degenerative spondylolisthesis

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Conclusion

• Aperius vs Open surgery
• No statistically significant difference (plt0.05)
• Mild ? Moderate DLSS ? Aperius Successful
• Poor Results in degenerative Spondylolisthesis
• Severe ? Very Severe DLSS ? Open Surgery
  Successful
• How Aperius does act ?
• it should reduce the posteriorly enfolding
  effect of hyperthrophied ligament flavum,
  reloading the disc in a more physiological
  pattern

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Conclusions
Interspinous Spacer ADVANTAGES Postop standing
after few hous Fast functional recovery (no
bracing) Fast return to daily activities Postop
rehabilitation not necessary
Good patients satisfaction, compliance and
results if right indications ? Mild to Moderate
DLSS
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Conclusions
ADVANTAGES Local Anesthesia Avoid risks due to
general anesthesiological procedures Pecutaneous
Technique Reduction of operating time (10/-5
min) Reduction of risks and complications due to
open surgery (Bigger skin incision, bleeding,
bone removal, muscle damage, Postsurgical
scar) No sovraspinous ligament removal (in
comparison to other Interspinous Spacers) Can
be used even in spine deformities (scoliosis lt25
Cobb angle)
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Past Anatomys Lesson of Doctor Tulip
(Rembrandt, 1632)
Future Focusing Less is More
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ROME SPINE 2009

• IV International Meeting
• Tradition and Innovation in
• Spine Surgery
• December, 4-5, 2009
• www.spineinstitute.it
• info_at_formazionesostenibile.it

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• Thank You

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Surgical technique
Percutaneous Trocar Insertion under C-arm A-P
/ L-L view
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Surgical Technique
Percutaneous Stand Alone Lumbar Interspinous
Decompression
Aperius PercLID - Medtronic
Patient position
Instrumentation
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Surgical technique
Local Anesthesia
1cm lateral skin incision
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Pathophysiology

• Canal constriction meccanically affects the cauda
  nerve bundle and the free flow of cerebrospinal
  fluid around this bundle
• In turn the nerve fiber is constricted and
  changes occur in the pia-arachnoid
• By increasing the demand on the cauda (patient
  walking), because of mechanical constriction and
  associated ischemia, nutritional needs of the
  nerve roots cannot be satisfied
• ( Watanabe and
  Parke, J. Neurosurg, 1986)

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• soft stenosis, due to ligament flavum
  hypertrophied enfolding posteriorly. More severe
  stenosis with facet joints subluxation up to
  degenerative spondylolisthesis and bone spurs
  does not result successfully. Related to our
  results, we may conclude that Aperius
  interspinous spacer acts in order to limit
  extension of the spine, reducing the posteriorly
  enfolding effect of ligament flavum , reloading
  the disc in a more physiological pattern
  (reducing the pressure on the posterior annulus
  of more than 60). From the above considerations,
  the right indication for using seems to be the
  soft spinal canal and foraminal stenosis. No
  complications has been detected at 1 year f.u..
  

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Male, 74 yrs L3-L4 DLSS
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Male, 69 yrs L3-L4, L4-L5 DLSS
Bilateral laminotomy L3-L4, L4-L5

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Pathoanatomy

• Degenerative changes
• Ligamentum flavum (hypertrophied enfolding
  posteriorly)

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Pathoanatomy

• Degenerative changes
• Facet joints (hypertrophied up to facet
  subluxation of a degenerative spondylolisthesis)
• Disc space (annular bulging contributing to
  narrowing of the canal)

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Interspinous Spacers

• - Combined with decompression surgery
• Wallis (Wall Inter Spinously placed)
• Coflex (Co-promotes flexion)
• DIAM (Device for Intervertebral Assisted
  Motion)

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Interspinous Spacers

• - Stand Alone Intespinous Decompression
• In-Space
  Aperius
• X-Stop (eXtension Stop)

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Stand Alone Interspinous Decompression

• What indications are best for stand alone?
• - Foraminal Stenosis
• - DLSS with neurogenic intermittent claudication
• - Discogenic pain
• - No indication to a fusion surgery
• - Failed conservative treatment ( gt 6 months)

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Stand Alone Interspinous Decompression Systems
(IDS)

• - Stand Alone Decompression Systems vs
  Decompression Surgery
• SF 36 Data for Stand Alone Superior outcomes
  at 1 yr
• Stromqvist et al. Spine Journal 2004 vol.
  4, issue 5, suppl 1, S58-59
• SF 36 profiles before and 1 yr after spinal
  stenosis surgery a prospective comparison of two
  techniques in two nations
• - Stand Alone Decompression Systems vs
  conservative
• Better symptoms severity score and patient
  satisfaction at 2yr (ZCQ)
• Zucherman et al. Spine 2005 301351-1358

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Surgical Technique

• Advantages
• - Percutaneous
• Stand Alone Decompression System
• Unilateral approach
• Respect thoracolumbar fascia and
  sovraspinous ligament

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Surgical Technique
Increasing sizing 8 14 mm under C-arm
A-P / L-L
Avoiding overdistraction by proper implant
selection
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Surgical technique
Implant positioning and progressive wings
deployment from lateral to medial under C-arm
A-P / L-L
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Biomechanical Effects

• Limitation of extention, minimal effects on
  flexion
• axial rotation and lateral flexion ?
• Reload the disc in a more physiological
  pattern
• ( - 62,8 pression on the posterior annulus)
• No overloading at adjacent levels
• 
  Richards et al. Spine 2005 30(7)
• 
  Siddiqui et al. Spine 2005 30(23)
• 
  Cadaver Lab Studies, Kyphon, 2006

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Biomechanical Effects
Preop Postop
Increase dimensions of spinal canal, reduce
dural sac impingment, no postural change
Increase dimension of the foramen (25)
Cadaver Lab Studies, Medtronic