New trend in the managment of lumbar canal stenosis niles

Back pain in Elder patients
Magdy A Osman
Professor of Neurosurgery
Ain Shams University

Causes of back pain usually due
to degenerative disc disease
Lumbar canal stenosis
Osteoarthritis
Osteoporothis
Infection / metastasis

Narrowing of the spinal canal, nerve root
canals, or intervertebral foramen.
The resultant nerve root compression
leads to nerve root ischemia and a clincal
syndrom of low back pain, leg and buttock
pain with claudication pain.

Management of back pain in
Elder
Mainly medical treatment
(conservative )
–NSAID
–Muscle relaxant
–Physical Therapy
–Acupunture
–Other Pain management modality

Types of Spinal Stenosis
Congenital-
developmental
Stenosis
- Idopathic
- Achondroplastic
Acquired stenosis
-Degenrative
-Combined congenital
and degenrative
stenosis.
-Spondylotic or
sponylolithetic
-Iatrogenic.
-Metabolic.
Posttraumatic.

Pathogenesis of The Degenrative
Spinal Stenosis
With aging, Mechanical and
Biochemical changes in the
intervertebral discs and facet joints
are responsible for the development
of S.S.
Eventually this leads to annular
tears, loss of disc height, annular
bulging, and osteophyte formation.
Also, degenrative changes in the
facet joints lead to joint erosion,
loss of cartilage, capsular laxity,
facet hypertrophy and osteophyte
formation.

Spinal Deformity and
PARKINSON DISEASE
(PD)
PD is a degenerative disorder that affect
over one million persons in the USA.
The Major Motor signs of PD are:
*Resting tremors 4-8 HZ. *Bradykinesia
* Rigidity *Hypotonia
*Flat facial expression.
The prevalence of Spinal deformity (SD) in
PD patient estimated around 33.5%

Pathogenesis of Spinal Stenosis
Central canal stenosis results from
Osteophytes on the inferior articular
process encroach medially beside the
bulging of the annulous and the
hypertrophy of the ligamentum falvum.
Lateral canal stenosis results from
osteophytes of the superior articular
process , the subligamentum flavum,
the uncenate process and bulging
anunulous encroch on the foraminal
canal

Management of Lumbar Spinal
Stenosis
Conservative
• Medication
• Physical therapy
• Injections and other pain
management techniques.
• Lumbar orthoses
Surgical
• Old fashioned wide
decompression with or
without fusion.
• Minimal decompression
with on situ fusion
(Dr.Benzel techniuques)
• Laminar osteoplasty.
• Inter-spinous spacer with
or without
decompression.

Lumbar Interspinous Devices
The X-STOP Interspinous
Process Decompression
Device is made of two
titanium pieces. The first
is implanted beside and
under the spinous
process. The second
piece is plate-like and is
placed on the opposite
side of the spinous
process and is then
attached to the first.

The Wallis interspinous
device, made by Abbott
Spine in Austin, Texas,
was developed in 1986.
The device’s original
design used a titanium
block inserted between
adjacent processes held
in place with a flat Dacron
cord

The lumbar Interspinous Devices
DIAM
The DIAM Spinal Stabilization
System, a non-rigid
interspinous spacer, is made by
Medtronic .

Interspinous Process Spacer
Superion

In October 2006, US FDA-
regulated clinical trials for were
initiated, comparing the
Coflex™ (made by Paradigm
Spine) with pedicle screw
fusion for patients with spinal
stenosis.
The Coflex™ is based on the
Interspinous U designed in
France in 1994. The height of
the device distracts the
foraminal opening, the “U”
shape allows controlled
movement in forward and
backward bending. Also used
in Europe with favorable
results reported at a 2005
spine conference.

Confidential
Two Stage Procedure:
1) Surgical Decompression
2) Interspinous Device Implantation
(Stabilization w/o fusion)
Two Stage Procedure:
1) Surgical Decompression
2) Interspinous Device Implantation
(Stabilization w/o fusion)
Coflex™ Interspinous
Stabilization
Coflex™ Interspinous
Stabilization

Confidential
Surgical Procedure : Coflex™Surgical Procedure : Coflex™
Patient Positioning - NeutralPatient Positioning - Neutral

Confidential
Minimally Invasive ExposureMinimally Invasive Exposure

Confidential
Preserve Supraspinous LigamentPreserve Supraspinous Ligament

Confidential
Prepare Interspinous SpacePrepare Interspinous Space
1) Remove Interspinous
Ligament at index
level
2) Debride Spinous
Processes to laminae
with blunt and sharp
dissection

Confidential
Microsurgical DecompressionMicrosurgical Decompression

Bone Removal to Facilitate
Coflex™ Implantation
‘U’ Apex
‘U’ Apex
Bone Removal/
Decompression
Bone Removal/
Decompression
Bone Removal/
Decompression

Confidential
Surgical Procedure : coflex™Surgical Procedure : coflex™
CoflexTM Trial DistractionCoflexTM Trial Distraction
1) Trial should
Fit snuggly
2) Insert both
trials before
implanting devices
if 2-level case

Confidential
CoflexTM Wing Opening PliersCoflexTM Wing Opening Pliers

Confidential
CoflexTM Wing
Opening Pliers
CoflexTM Wing
Opening Pliers

Confidential
CoflexTM ImplantationCoflexTM Implantation

CoflexTM ImplantationCoflexTM Implantation

Confidential
Check CoflexTM PositionCheck CoflexTM Position
1) Apex of ‘U’ should
seat at the level of the
facet joint
2) Apex of ‘U’ will be
Approx 1-4mm from
dura

The apex of the ‘U’ stops 1-4 mm
from the dural sac
Check CoflexTM PositionCheck CoflexTM Position

« U »DIAM
Check coflexTM PositionCheck coflexTM Position
CoflexTM

Confidential
coflexTM Wing Closing PlierscoflexTM Wing Closing Pliers

Confidential
Resuture Supraspinous LigamentResuture Supraspinous Ligament

Confidential
2-Level coflexTM2-Level coflexTM
Proper position of
apex of ‘U’ for 2-level case

Confidential
Surgical Procedure: Coflex™Surgical Procedure: Coflex™
Animated CoflexTM Surgical TechniqueAnimated CoflexTM Surgical Technique

Confidential
Surgical Procedure : Coflex™
Preoperative MRI
Severe Stenosis
Preoperative MRI
Severe Stenosis

Confidential
Postoperative X-ray
Postoperative X-ray
Flex Ext
Coflex™ is DYNAMIC

Confidential
Benefits : Coflex™ TechnologyBenefits : Coflex™ Technology
Tissue Sparing- less native tissue morbidity
Minimally invasive & simple procedure
Decreased Morbidity (especially relative to
fusion + pedicle screws)
Motion preserving, maintaining segmental
motion while providing stability
Repeatable
Reversible
Tissue Sparing- less native tissue morbidity
Minimally invasive & simple procedure
Decreased Morbidity (especially relative to
fusion + pedicle screws)
Motion preserving, maintaining segmental
motion while providing stability
Repeatable
Reversible

Confidential
Benefits : Coflex™ TechnologyBenefits : Coflex™ Technology
Maintain foraminal distraction
Decreased stress on facet joints and disc at
operated level
Decreased stresses at adjacent levels
Decreased OR time
Decreased “Resource Consumption”
Maintain foraminal distraction
Decreased stress on facet joints and disc at
operated level
Decreased stresses at adjacent levels
Decreased OR time
Decreased “Resource Consumption”

Confidential
Case Example 1Case Example 1
Coflex™ Retrospective Data CollectionCoflex™ Retrospective Data Collection
Male, 54 years, Teacher
· Low back pain for years and unilateral radicular pain
right side for 12 months.
· No sensory deficit. Motor deficit right side
(M. triceps surae).
· Reduced walking distance (less than 1000 meters).
· Diagnosis: Lumbar stenosis at L4/5.
· Previous Therapy: Failed conservative treatment.
· Surgery: Resection of synovial cyst and bilateral
decompression of stenosis at level L4/5.
Implantation of coflex interspinous implant, 14 mm
at level L4/5.
· Follow-up after 26 months: Complete recovery of
radicular pain and low back pain. Patient very
satisfied with treatment.

Interspinous process spacers
As seen in Figure 1 the spinous processes are located in the very back of the spinal column near
the skin surface. In fact, by passing the hand down the center of the low back one is usually able
to feel several small prominences. These are the spinous processes. The near proximity of the
spinous processes to the skin allows for the implantation of interspinous process spacers with
minimal operative intervention and spinal morbidity (unwanted aftereffects of the surgery). The
interspinous process devices are designed to distract (open) the foramen, where the nerve
endings pass away from the center of the spinal region and into the legs. It is thought that these
devices may also unload the intervertebral disc. They may limit spinal extension (the position the
spine takes on when bending backward). This backward bending position may be painful for
patients with spinal stenosis because it reduces the space available for the nerve roots in the
exiting foraminal openings.
The interspinous devices may be implanted with the patient under a mild sedative and local
anesthesia as a day surgery procedure (patient goes home the same day) or under light
anesthesia. This may be particularly beneficial for elderly patients for whom more extensive open
surgery may present too great of a surgical risk due to less favorable general health and fitness
level.
There are several types of interspinous devices. Many of the devices profiled below are still in
relatively early stages of development and testing, so data about indications for use,
effectiveness, and potential risks and complications are often preliminary and further testing is
needed before conclusions may be drawn.

The X-STOP for lumbar spinal
stenosis
The X-STOP Interspinous Process Decompression Device (Figure 2), made by
Kyphon, Inc., in Sunnyvale, California, is made of two titanium pieces. The first is
implanted beside and under the spinous process. The second piece is plate-like and
is placed on the opposite side of the spinous process and is then attached to the first.
The X-stop device recently received FDA approval for use in patients with spinal
stenosis in the US. In the study evaluating the device, the primary indications were
age of at least 50 years, lower extremity pain (with or without back pain) secondary to
a confirmed diagnosis of lumbar spinal stenosis that was relieved with flexion
(forward bending), and able to walk at least 50 feet. Patients were not enrolled in the
study if they had a fixed motor deficit or more than mild grade spondylolisthesis.
Results of the multi-center trial conducted in the US indicated that among patients
with pain arising from neurogenic claudication (a symptom of spinal stenosis), the X-
STOP provided significantly greater pain relief than epidural steroid injections (the
treatment used as a comparative control).

degenerative disc disease and
spinal stenosis
The Wallis interspinous device, made by Abbott Spine in Austin, Texas, was developed in 1986.
The device’s original design used a titanium block inserted between adjacent processes held in
place with a flat Dacron cord or ribbon. A clinical trial, conducted outside the United States, was
initiated in 1988, involving 300 patients who were all treated for recurrent disc herniation.1
Patients whose surgery incorporated the Wallis device with a second discectomy had significantly
better results than those who did not receive the device.
The primary change in the second generation of the Wallis implant (Figure 3) was changing the
study including twelve-month follow-up for 137 patients material of the interspinous block to
PEEK, polyetheretherketone, a strong plastic-like polymer that has more elasticity and is therefore
less rigid that the previously used titanium. Results from a European undergoing implantation of
the new generation of the device were presented at a 2005 spine conference.2 Patients had
significant reduction in pain severity.
The current generation of the Wallis device is being evaluated in a multi-center FDA-regulated
clinical trial in the US. It is hypothesized that the Wallis device might be a treatment option for low
back pain associated with degenerative disc disease as well as lateral recess and central spinal
stenosis. A clinical trial evaluating the efficacy and safety of the Wallis device for treatment of
symptomatic degenerative disc disease has recently been started. This trial for degenerative disc
disease will compare the Wallis to a total disc replacement. A second clinical trial of the Wallis to
treat spinal stenosis trial is being contemplated.

The Lumbar Intrspinous Devices
The primary change in the
second generation of the Wallis
implant was changing of the
interspinous block to PEEK,
polyetheretherketone, a strong
plastic-like polymer that has
more elasticity and is therefore
less rigid that the previously
used titanium. Results from a
European undergoing
implantation of the new
generation of the device were
presented at a 2005 spine
conference.

Magdy Osman, M.D.
Professor of Neurosurgery
New Trend in the management of Lumbar Spinal Stenosis

New trend in the managment of lumbar canal stenosis niles

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