Keep it Simple:

Percutaneous Facet Fusion

• Medical Director: Adventist Hinsdale
Hospital Pain Center of Excellence; Hinsdale,
Illinois.
• Founding President: Midwest Academy of
Pain & Spine; Chicago, Illinois.
• Interests:
• M.I.S.S.
• Disc Decompression
• Spinal Cord Stimulation
• Enjoys Backgammon, Chicago Bulls,
Classical Music, Traveling, and Painting.
• Contact: www.controlchicagopain.com
• Email: Ahmed2407@aol.com

Ahmed Elborno, M.D.

Goals
 Better understand the facet dowel’s
role in the treatment of low back pain.
 Review of biomechanics and
diagnoses that accompany back pain.
 Past and current surgical remedies
and products used to treat the
disorder.
 Better understand the rationale and
basis for facet dowels,its indications .
The degenerative cascade in
lumbosacral stenosis
 Facet joints:
 Synoviitis and hypomobility
 Continuing degeneration
 Capsular laxity
 Sublaxation
 Enlargement of articular processes.
 Age related changes:
 Dysfunction
 Herniation
 Instability
 Lateral nerve entrapment
 Stenosis
 Poor quality of life.
 Intervertebral disc:
 Circumferential tears
 Radial tears
 Internal disruption
 Disc resorption osteophyte formation
Back Pain
 LBP cost society $50 billion annually.

 For most patient has no clear identifiable cause.

 1-2% cause like tumor ,trauma,infection can be identified

 FACET MEDIATED IS THE MOST READILY AND RELIABLY

DIAGNOSED..

 80% of people experience at least one episode of low-back pain in

their lifetimes

 Recurrence rate of pain 20-40% annually.

 2004 more than one million spinal procedures were performed to

alleviates or mitigate back pain
LOW BACK PAIN
 LBP affect 60 million people represent 20% of US
populations
 60% RECOVER IN 6 WEEKS ,
 80---90% RECOVER WITHIN 6 MONTHS, WITH AND
WITH OUT TREATMENT.

 10-12 MILLION PEOPLE SUFFER CHRONIC LBP.

 ETIOLOGIES STEM FROM :

1. DISC PATHOLOGY.
2. FACET PATHOLOGY.
3. MUSCLE PATHOLOGY .
4. PSYCHOSOCIAL PATHOLOGY.
Spinal stenosis
 1911 bailey described spinal stenosis as a cause of neural
compression

 Surgical treatment of spinal stenosis was undertaken as early as

1900.

 Traditional treatment of spinal stenosis has involved wide

laminectomy ,undercutting of the medial facet with foraminotomy.

 More limited decompression proceudres include bilateral

foraminotomy .

 unilateral approach to decompression have been shown to be

effective.

 Minimally invasive procedures have now been successfully used.

Epidemiology of stenosis
 8-11% in US
 Lumbosacral stenosis is the most
common reason for spine surgery in
older people
 more than 125.000 laminectomy
procedures performed for LSS in
2003
 the rise untill 2010 is reaching up to
40 % increase.
Causes of neural
compression
 Disc bulge/herniation
 Hypertrophied ligamentum flavum
 Narrowed spinal canal
 Narrowed lateral recesses
 Hypertrophied facets
 Anterior subluxation of superior vertebral body
over inferior body (degenerative spondylolysis.
 Symptoms of neural compression are worse with
standing and spinal extension, relieved by sitting
and flexion.
 This is the concept behind distraction devices
like x-stop do away with the spine extension.
Lumbar stenosis
treatment options
 Current standard of care :
 Mild to
moderate:Analgesics/opiates;NSAIDS;S
elf limiting activities;exercise and Wt
reduction.;PT;Bracing ;epidural steroids
.
 More severe:
Decompressive surgery:
1. Foraminotomy
2. laminotomy
3. laminectomy(with and without fusion.
Facet pain
 Schwarzer estimates the prevalence of
facetogenic back pain at 15-40%
 NICOLI BOGDUK ESTIMATION 15% - 52% OF ALL
CHRONIC LOW BACK PAIN (1,500,000-
6,250,000).
 Facet pain transmitted via impulses from
medial branches of the lumbar dorsal rami
 Causes of the facet pain may be related to
mechanical stresses in the joints due to
degeneration or from inflammation or from
segmental instability due o incompetent
facets.
Facet pain evidence
 There is often a radiographic eveidence of
osteoarthritic changes in facet joints of patient
with back pain
 stimulation of facet joints or the nerve supply to
these joints causes pain similar to that described
in the facet syndrome.

 Facet joints in patients undergoing surgery for

degenerative disorders show unusually hi levels
of inflammatory cytokines supporting the idea of
pain being cause by inflammation.

Gordon et al ,neurosurgery focus vol23 dec 2007

Diagnosis of facet
pain
 Physical exam ,history: pain that worsens with
extension maneuvers and focal tenderness of
particular joint.
 Ct scan is sensitive but not specific .
 SPECT imaging is specific for hot facet joint
 McDonald et al have described a method to
marry SPECT (single photon emmission)and CT
scanning in identifying abnormal facet joints.in
this study the image quality allowed definitive
localization of hot lesion in all cases.

McDonald et al neurosurgey focus vol 22 jan 2007

Current treatment methods
for facet pain
 Mainstay treatment for facet-related pain is
intra articular injection and dorsal branch
rhizotomies .
 Draw back injection provides only short term
relief, necssitating numerous repeated
treatments,
 Rhyzotomy which denervates the facet joint
capsule,carries only moderate efficacy rate
and frequently requires repeated treatments as
well .
Intrarticular facet
injections
 THERAPEUTIC :
10% GET PERMANENT. RELIEF

 DIAGNOSTIC BLOCKS :
75%-100% TRANSIENT RELIEF FOR 2WEEKs
then PROCEED TO RFA.

RFA WILL GIVE A LONG LASTING RELIEF FOR 6

MONTHS TO 12 MONTHS .

IF PAIN RETURN AFTER 6 MONTHS REPEAT RFA

limit two per year.
IF PAIN RETURN BEFORE 6 MONTHS PROCEED TO
FACET FIXATION.
 RFA RED
FLAGS.
INDISCRIMINATE USE OF RFA AT MULTIPLE LEVELS

 denervates the multifidi muscles making the

individual susceptable to vertebral column
instability .
 SPONDYLOLISTHESIS.

 IATROGENICALLY PRECIPITATING A LUMBAR FUSION.

 FAILURE OF RFA MAY REQUIRE A MORE AGGRESSIVE

STABILISATION PROCEDURES INCLUDEING :

1. PEDICLE SCREWS FIXATION.

2. 360-DGREE FUSION
3. VARIATION FUSION OPTIONS
HIERARCHY OF FACET
JOINT MEDIATED CHRONIC
LOW BACK PAIN FACET FIXATION .
DOWELS.
PEDICLE SCREW.
360-DEGREE FUSION.

PHARMACOLOGICAL INJECTION
TREATMENT . TECHNIQUE.
NSAIDS. CHIROPRACTIC MANAGEMENT FACET INJECTION .
SMR. OR OSTEOPATHIC MANIPULATION.
HELPFUL
MBB.
PT FLEXION BASED . ACUTE :0-6 WEEKS RFA.
SUB ACUTE
6-12 WEEKS.
LITTLE BENEFITS
>12 WEEKS.
WATER ,GAS ,SOLID
Traditional fusions in
treating back pain
Normal spine
biomechanics
 Anterior subluxation of one vertebral body on
another is resisted by multiple spinal elements
.
 Shear forces :
1. Facet joints resist 33%.
2. Intervetebral disc resist 67%
 Flexion forces :
1. Supraspinous and interspinous ligaments
resist 19%
2. Facet capsular ligaments 39%
3. Intervertebral disc 29%

Normal spine
biomechanics
 Muscular attachments /insertions on
the facet capsule brace the facets
,improving their ability to resist
displacement.
 Saving as many elements of the
musculoligamentous complex as
possible during spinal procedures
may serve to avoid the development
of post operative complications
(spondylolisthesis).
Palmer S et all. Neurosurgery focus vol13 july 2002
Lumbar arthrodesis
 1911 the first lumbar arthrodesis of any kind for
TB .
 Later evolved to include the management of spinal
deformity and trauma .
 Facet fusions were considered to be an important
element of spinal fusion, but not initially tried as
stand alone procedure.
 In scoliosis surgery removing the carilage down to
the cancellous bone in the facet joint was believed
to be a critical element in any successful posterior
spinal fusion this was to achieve a solid fusion in
treating spinal deformity (scoliosis);but not
operating to treat pain.
Problems with pedicle
screws and rods.
 Pedicle screw and rod stabilization is
typically used as an adjunct in
anterior /post fusions.
 Concerns have been arisen
surrounding the highly rigid nature of
these constructs.
 Stress shielding of the interbody
graft is believed to be implicated in a
certain percentage of psuedo-
arthroses.
Khoueir P, neurosurgery focus vol.22 Jan 2007
Problems with pedicle
screws and rods.
 No difference in clinical outcome when
comparing spinal fusions for
degenerative spondylolysis either with
or without spinal instrumentation.
Fischgrund JS,et al. spine 22(24) 2807-12 Dec 1997
 Meta-analysis suggested that fusion with
pedicle srews produced a higher fusion rate
(90%) than fusion without instrumentation
although the difference was not statistically
significant and produced no difference in
clinical outcomes (86% vs.90%)
 Mardjetko SM,et al spine 20 (supp1)S2256-65,1994
Argument applies to use
of facet dowels
 Perioperative morbidity of patients
undergoing lumbar fusion using
translaminar facet screw fixation was
with decreased perioperative
morbidity compared to pedicle screw
fixation.
Tuli SK et al. orthopedics, 2005, August;28( 8) 773-8.

 50% ASD in the presence of pedicle screws

when both the cranial and caudal segments are
evaluated..
 Park JY, et al, KNS soc 2009 ,Feb 45(2):81-4
Transpedicular screws
and higher incidence of
ASD
 Adjacent segment disease is higher
in patients with transpedicular
instrumentation (12-18%) compared
with patients fused with other forms
of instrumentations or with no
instrumentations (5%).
 Study from the university of michigan neurosurgical
department.
Potential risk factors for
symptomatic ASD
 Type of instrumentation used .
 Fusion length.
 Facet injury and pre-existing
degenerative disease.
 Biomechanical changes consist of :
1. Increased intradiscal pressure.
2. Increased facet loading
3. Increased mobility at the facet joints
All Have been implicated in causing ASD
Potentially modifiable
risks factors for the
development of ASD
 Fusion with out instrumentation
 Protecting facet joint of adjacent
segment during placement of pedicle
screws
 Fusion length
 Saggittal balance .

Park P ,et al. spine 2004 Sep 1:29 (17)1938-44.

Dynamic Interspinous
Spacers (PDS)
 The concept is maintain and restore intervertebral
motion in a controlled fashion by:
1. restricting the extremes of spinal movement or by
2. damping the kinetic energy involved in motion .
 Treat facet pain in two ways :
1. Unloading the facet joint ,
2. allow for repair and restoration of the joint.

 Total facet replacement devices allow for complete

removal of the facet ,as a pain generator ,as well as
preserving the remaining functional segment unit. Of the
spine.
Indications for PDS
devices
 Controlled motion in the
iatrogenically destabilized spine
 Increased anterior load sharing to
augment interbody fusion
 Protection and Restoration of
Degenerated Facet Joints and
Intervertebral Discs
 Prevention of Fusion Related
Sequelae
Classification of PDS
devices
 Interspinous spacer devices
 Indication: neurogenic claudication
 Examples: Wallis, X-STOP, DIAM, coflex, EstenSure, CoRoent
 Pedicle screw/rod-based devices
 Indication: unload discs and facets, promote fusion, prevent
adjacent-segment disease
 Examples: Graf ligament, Dynesys, AccuFlex rod, Medtronic
PEEK rod, Scient'X Isobar
 Total facet replacement systems
 Indications: Replacement for facet disease as part of a
functional spine unit reconstruction, to control motion in
iatrogenically destabilized spine
 Examples: TFAS, TOPS, Stabilimax NZ
Biomechanics of facet
fusions
 Facet fusion alone relieves or reduce
back pain is based on the concept
that the facet ,synovium-lined joint
,causes back pain through facet
arthrosis and nerve root pressure.
 Facet blocks and facet rhizotomy
have been better at short term than
long term.
 That imply the need for more durable
solution which may be facet fusion.
Bone plugs (dowels)
 1993 STEIN won a young invistigator
award when he demonstrated in
canines that drilling and surgical
insertion of bone plugs into the facet
joints was feesible with promissing
results.
 These plugs were placed
percutaneously with X-R guidance.
Stein M,et al journal of vascular and interventional radiology
;jvir.4(1)69-74.1993.
Instrumented facet
fusion
 The safety and efficacy of stand-
alone facet fusions has been studied
and results have been positive.
 A two-year neurosurgical study of 99
patients, with Grade I or II
degenerative spondylolisthesis and
stenosis that underwent lumbar and
lumbosacral isolated facet fusion.
 They reported no technique-related
complications.
Facet fusion
 The overall 2-year success rate of fusion was
96%: 99% in the single level fusions and 88%
in two-level fusions.
 Degenerative spondylolysis had the highest
success rate at 100%,
 the success rate in patients with concurrent
stenosis experienced the lowest success rate:
80%.
 They concluded, "Instrumented facet fusion
alone is a simple, safe, and effective surgical
option for the treatment of patients with single-
level disorders, especially patients with
degenerative spondylolysis. (2)
 Park,youn-kwan,et al neurosurgery july 2002-vol.3,no 1 2009
Translaminar facet screw
(magerl’s)fixation
 Translaminar facet screw fixation (TLFS)
achieves stabilization by screws inserted at the
base of the spinous process, through the
opposite lamina, traversing the facet joint, and
ending in the base of the transverse process.
 Supplemental translaminar facet screw fixation
has been used to enhance stability of motion
segments treated with an anterior threaded
cage, particularly during conditions of low
compressive preloads, the very condition in
which the cage alone is least effective in
providing stability.
Phillips FM,etal spine 2004AUG15 1731-6
Translaminar facetal screw
(Magerl's) fixation
This argument also applies to
facet dowel.
 In an excellent review article,
Rajasekaran discusses the
biomechanics, surgical technique and
outcomes of TLFS, noting its lower
cost, low morbidity, shorter operative
times, and the fact that it does not
interfere with adjacent facet joints.
 Rajassekaran S ,neurology india vol53 no ,2005 520-24
Noninstrumental facet
fusion
TRANSFACET BONE BLOCK
FOR LUMBOSACRAL FUSION
 EARL D.McBRIDE J BONE JOINT SURG
AM.1949,31:385-399.
 135 CASES IN WHICH FUSION WAS
ACHIEVED BY THIS METHOD .
 NO DEATH OR SERIOUS
COMPLICATIONS.
 the facet fusion as an important
component in achieving fusion in thoraco
lumbar scoliosis, 266 patients review
Moe JBJS 40529-551,1958
History of Facet Stabilization
Southern med JI,vol70,no
2,feb 1977
 In 1962, Harrington began using a "dowel" facet fusion
technique (31) In a series of 51 spinal fusions for
scoliosis using hook and rod instrumentation and a
cylindrical inlay facet fusion,
 the authors found that no additional posterior bone
grafting was needed to achieve a successful fusion.
 Technique: A distraction device was placed to separate
the joint. "The facet joints...were removed with a
cylindrical plug cutter and the cylindrical grafts were
impacted. The distraction apparatus was removed. The
cylindrical grafts were taken from spinous processes or
iliac area.
 Without using supplemental iliac graft, there was less
bleeding and shorter operative time.” Overall
pseudoarthrosis rate was 6%.
Concept of Facet Interference
Fixation
 Biomechanical testing of the lumbar
facet interference screw ,spine
2005,jan 15; 30(2):E34-9

 Translaminar screws have been

shown to significantly increase spinal
fusion rigidity when added to anterior
fusion constructs.
Percutaneous Spinal
Stabilization
mis vs open surgery.
 Percutaneous spinal stabilization
minimizes muscle trauma.
 Open surgery contributes to morbidity
through muscle denervation, retraction
necrosis,
 blood loss and inflammation,
 extended recovery periods,
 and compartment syndrome.
MIS VS OPEN SURGERY
 effects of open surgery may accelerate the
process of adjacent segment disease.

 MIS reduce the need for large incisions and

muscle stripping.

 Dilating the muscle , allowing the instruments

and implants to be placed through a closed
tube, avoiding denervation and generation of a
systemic inflammatory response.
Orthopedic surgery update
vol.3,no.1 2009
 two reported Mayo Clinic studies in 2005 and
2006 evaluating the safety and efficacy of
percutaneous techniques to treat unstable
fractures and fractures associated with
ankylosing spondylitis, results showed that
"all percutaneous cases were instrumented
without complication or neurologic deficit."
The investigators concluded that open
techniques resulted in significantly greater
perioperative morbidity and mortality than
percutaneous techniques. (1)
flouroscopy
Fluoroscopy has been
shown to be a valuable
tool in accurate and
safe placement of
percutaneous implants.
FACET FIXATION BY BONE
DOWELS
 FIRST GENERATION :1985
BLUME HG ,MD DEPARTMENT OF
ORTHOPEDIC SURGERY PRESENTED A
SERIEDS OF 216 PATIENTS
,UNILATERAL FIXATION WITH
PLACEMENT OF UNILATERAL BONE
DOWELS.

 THE BENEFITS OF THE PROCEDURE

WAS TO PRESERVE THE LIGAMENTUM
FLAVUM.
FACET FIXATION FIRST
GENERATION
 CD RAY MD.1988
 EXPANDED ON THE CONCEPT .

 BILATERAL FACET FIXATION.

 SERIES OF 50 PATIENTS WHO

UNDERWENT EITHER UNILATERAL
OR BILATERAL FACET FIXATION
WITH BONY DOWELS.
2ND GENERATION OF FACET
FIXATION
 TRUFUSE (MINSURG
CORPORATION).
THIRD GENERATION
 FUSIO (FRONTIER
DEVICES,INC.PEHLAM AL.)
FOURTH GENERATION
 OSTEOLOCK BACFAST BY
BACTERIN.
FIFTH GENERATION
INDICATION FOR FACET
FIXATION
 PATIENTS WITH FACET MEDIATED CHRONIC LOWBACK
PAIN,UNRESPONSIVE TO CONSERVATIVE CARE .

 PATIENTS THAT HAVE UNDERGONE A FACET BLOCK,WITH 75-100 %

SUBJECTIVE PAIN RELIEF,LASTING AT LEAST 2 WEEKS BEFORE THE
PAIN RETURNS.

 PATIENTS THAT HAVE UNDERGONE RFA OF THE MB WITH FAIR TO

GOOD RESULTS AND THE PAIN HAS RETURNED IN LESS THAN 6
MONTHS.

 PATIENT WITH SPINAL STENOSIS WHO UNDERGONE DECOMPRESSIVE

LAMINECTOMY AND FORAMINOTOMY,WHICH HAVE EITHER SPINAL
STABILITY OR GRADE 1 SPONDYLOLISTHESIS.

 IN THE COURSE OF AN OPEN PROCEDURE IF THE MEDIAL 1/3 OF THE

FACET HAS BEEN BREACHED
INDICATION OF FACET JOINT
FIXATION
IF THE ANTERIOR LUMBAR INTERBODY FUSION HAS BEEN
PERFORMED AND THE SURGEON DESIRES POSTERIOR
FIXATION WITH OUT PEDICLE SCREWS

 STABILISATION OF THE LUMBAR SPINE FOLLOWING

DECOMPRESSIVE PROCEDURES OR WHERE MINOR
INSTABILITY EXISTS OR PRESENTS POST OPERATIVELY.

 IN THE PRESENCE OF MINOR INSTABILITY (GRADE I, 1-2 MM

LISTHESIS)

 POSTERIOR SUPPLEMENTAL FIXATIONTO INTERBODY

FUSION.

 AS AN ADJUNCT TO MOTION LIMITING DEVICES .

FACET FIXATION
CONTRAINDICATIONS
 PARS INTERARTICULARIS DEFECT(SPONDYLOLYSIS.

 GRADE II OR GRADE III SPONDYLOLLISTHESIS

 This distance is then reported as a percentage of the total

superior vertebral body length:

 Grade 1 is 0–25%
 Grade 2 is 25–50%
 Grade 3 is 50–75%
 Grade 4 is 75–100%

 .
Potential Complications
FOR NONE INSTRUMENTAL FACET
FUSION

 Dowel Pull-Out
 Pseudoarthrosis
 Infection (Allograft
Manufacturing Process)
ADVERSE EVENTS REPORTED IN TWO OR MORE STUDIES
FOR
INSTRUMENTED LUMBAR FUSION .
HEALTH TECHNOLOGY CLINICAL COMMITTEE

REPORT.

INFECTION(SUPERFICIAL
OR DEEP) 14 0%- 9%

NEUROLOGIC
12 NO STUDY REPORT 0
0.7% TO 25%
BLEEDING/VACULAR
INJURY 10 0% TO 12.8%

THROMBOSIS
11 0% TO 4%

DURAL INJURY
10 NO STUDY REPORTED
0.5% TO 29%
HEMATOMA 7 NO ONE REPORTED 1%TO 4%
ZERO

RETROGRADE 6 NO STUDY .7%TO 6%

EJACULATION REPORTED ZERO

DEVICE RELATED 13. 0%TO 17.8%

1 REPORTED ZERO
EVENTS WITH
ASPECIFIC TYPE OF
FUSION
REOPERATION 18(1 REPORTED 0 0% TO 46%
EVENTS)

DEATH 4 0% TO 2%
ERROR IN ASSESSING
TREATMENT EFFICACY IN LBP
BIOMECHANICAL TESTING OF SPINAL
SEGMENT IMPLANTED WITH TRUFUSE
DOWELS
 TOV VESTAGAARDEN MS,SUNIL
SAIGAL,DAVID PETERSEN ,.MD

 AXIAL COMPRESSION,AXIAL
ROTATION
,FLEXION,EXTENSION,AND LATERAL
BENDING,RESPECTIVLY .

 MINSURG CORPORATION 2008 .

Overview Biomechanics compare favorably with
pedicle screw systems and outperform
facet screws
RESULTS OF BIOMECHANICAL
STUDIES.
 IMPLANTATION OF THE TRUFUSE DOWEL RESULTED IN A
SIGNIFICANT INCREASE IN STIFNESS COMPARED TO
CONTROL .

 THE STIFFNESS INCREASED 127% IN FLEXION ,120%IN

EXTENSION .

 PROMISING RESULTS ON STABILIZING THE SPINE AND HAS

COMPARATIVE STIFFNESS TO TRADITIONAL METHODS OF
FACET FIXATION.

 PS FIXATION IT GIVE A GOOD FIXATION BUT IT IS AT HIGH

RISK OF CAUSING PERMANENT DAMAGE.

 IT IS ALSO TECHNICALLY DEMANDING PROCEDURE.

 TRUFUSE IS SIMILAR TO LUMBAR FACET INTERFERENCE
SCREW. BUT TRUFUSE IS NMADE FROM ALLOGRAFT.
BIOMECHANICS OF BONE
FUSION
BONE FUSION :
 IN SITU
 ONLAY.
 AND INTERBODY FUSION.(BEAR
AXIAL LOAD).
INSITU
 WHEN FUSIONS ARE USED WHEN
NATIVE BONE IS ALLOWED TO COME
IN CONTACT WITH OTHER NATIVE
BONE THAT WAS PREVIOUSLY
PREVENTED FROM DOING SO
BECAUSE OF INTERVENING SOFT
TISSUE .eg (denuding of facet carilage
performed in conjunction with placing
lateral mass plate system).
 Onlay fusion
 Decorticated graft bed and the subsequent
application of cortical and cancellous
autograft.

 eg,. Facet joint fusion with intrafacetal dowel

.
Interbody implants
 Provide the spine with the ability to bear an axial
load,.
 They function optimally when placed along the
neural axis and thus produce little if any significant
bending movement.

 They may be comprised of bone ,nonbone

materials such as acrylic,or combination of
both.such as interbody cages.
 All three methods may be used alone or in
combination with other implants that can be
applied through anterior or posterior applications.
Fusion with out
instrumentations
 Hildibrand ,NASS 1997.
 HEAD TO HEAD COMPARISON WITH FOUR
ANTERIOR CERVICAL STRATEGIES.
 STRUT WITH HALO.
 ANTERIOR PLATE WITH STRUT.

 ANTERIOR STRUT GRAFT WITH A KICKPLATE.

 ANTERIOR STRUT COMBINED WITH POSTERIOR
INSTRUMENTATION.
 CONCLUSION:
 FUSION WITH OUT INSTRUMENTATION WAS
EFFICACIOUS
Overview
What is FACET FUSION

• It is a specially
engineered dowel
made from allograft or
absorbable synthetic
material.

• Inserted into the plane

of the facet joints C2-
S1, it stops motion and
stabilizes the
vertebrae, allowing
fusion to occur.
Overview

Why facet fusion?

 It works with human biology

to achieve natural fusion.

 It is less invasive, less

destructive, less expensive
and will not preclude other
options in the event that it is
not successful.

 Represents a surgical
alternative earlier in the
continuum of care.
 Morbidity is superior
Overview

Average Blood OR Time Length of Stay

Loss (cc) (hr/min) (days)

Posterior Lateral Fusion3 1,490 3:55 4

Pedicle Screw Fixation4 322 2:55 3-6

Translaminar Facet
137 1:54 NDA
Screw Fixation4
XLIF with Pedicle
88 2:30 2
Screws2
XLIF with facet fusion1 43 1:40 1
Stand Alone facet fusion1 10 25--40 <1
1. Preliminary data only - skin to skin - outpatient facet fusion procedure 20 minutes.

2. Wright, Neil,M.D. XLIF: The Initial U.S. Experience 2003-2004.AANS;34610.

3. Kim, Ki-Tack, et al. Clinical Outcomes of 3 Fusion Methods through the Posterior Approach in lumbar spine. Spine
2006;31(12):1351-1357.

4. Sasso, Rick. Translaminar Facet Screw Fixation. WSJ 2006;1(1):34-39.

Overview
Where facet fusion Fits In the Marketplace

• Broad, well-researched pending

patent

• Unique approach, modern

technique

• Does not try to overcome

biology with metal constructs

• Does not compete with motion

limiters or rod and screw based
devices
Overview
Where facet fusion Fits In the Marketplace

• Treats minor instability,

mechanical back pain and
degenerative joint disease

• Burns no bridges

• Minimally invasive, less

destructive

• True percutaneous option

that can be performed
stand alone in about 20
minutes - outpatient
 Overview
• Most often used to prevent
or treat minor instability in
laminectomy
/decompression cases – 6-
8 minutes added table time

• Supplements anterior
interbody fusion with
posterior support
intraoperatively or
postoperatively

• Treats or prevents
adjacent segment
deterioration
 Overview
• Most often used to prevent
or treat minor instability in
laminectomy
/decompression cases – 6-
8 minutes added table time

• Supplements anterior
interbody fusion with
posterior support
intraoperatively or
postoperatively

• Treats or prevents
adjacent segment
deterioration
Overview

• All non-traumatic
indications for facet
fusion

• Grade 2
spondylolisthesis,
other instability

• Other causes of
mechanical back pain
INSTRUMENTED LUMBAR
FUSION 11/16 /2007
 HEALTH TECHNOLOGY CLINICAL
COMMITTEE BENEFIT EVALUATION
REPORT :

 GIVEN THE INCREASED COST AND

ADDITIONAL HARMS CAUSED BY THE
SURGERY ,COMMITTEE DISCUSSED
CONDITIONS FOR COVERAE,
FOCUSED ON ENSURING THE
INSTRUMENTED SPINAL FUSION IS
THE LAST RESORT OPTION
HTCC REPORT
 COMPELLING CONSIDERATIONS
INCLUDED :
 THE CHRONIC NATURE OF THE
CONDITION.
 ALTERNATIVES THAT WERE NOT
EFFECTIVE FOR ALL PATIENTS
OR PROVIDED NO GREATER
BENEFITS.
HTCC REPORT
 HARMS OF SPINAL FUSIONS
ALSO APLLIED FOR OTHER
INSTRUMENTAL
INTERVENTIONS.
 THE INABILITY TO DETERMINE
WHICH PATIENTS BENEFIT AND
THE POTENTIAL TO REDUCE
UTILIZATION TO ONLY THOSE
THAT HAVE TRIED NON-INVASIVE
ALTERNATIVE FIRST
Overview
Where facet fusion Fits In the Marketplace
Overview
Surgical Science Behind facet fusion
Facet Joint Anatomy

• The facet joint consists of two

opposing bony surfaces with
cartilage between them
surrounded by a capsule.

• They are comprised of:

• Superior Articular Process
• Inferior Articular Process
• Capsule of Zygapophyseal joint
Overview
Surgical Science Behind facet fusion
Wolff’s Law

• Bone is deposited and resorbed in

accordance with the stresses placed
upon it.
• New bone will begin growing where
there are stimulating stresses.
• Micro-motion is needed to allow bone
fusion to occur.
• The facet fusion cortical allograft dowel
was developed to “lock” the facet(s) in
place while allowing micro-motion.
Overview
Surgical Science Behind facet fusion
Wolff’s Law

• Bone is deposited and resorbed in

accordance with the stresses placed
upon it.
• New bone will begin growing where
there are stimulating stresses.
• Micro-motion is needed to allow bone
fusion to occur.
• The facet fusion cortical allograft dowel
was developed to “lock” the facet(s) in
place while allowing micro-motion.
Overview

Surgical Science Behind facet fusion

Factors Promoting Fusion

• Allograft is partially replaced

over time with living tissue by
Creeping Substitution.

• A growing body of evidence

indicates that initial primary
healing occurs around the dowel
within weeks, then into the dowel
within months.
Overview

• Primary cause of failure is

dowel pullout

• Reported in about 5% of
cases

• Suspected in about 10% or

more

• >50% of pullout cases

remain asymptomatic
Overview
Surgical Science Behind facet fusion
Efficacy

• Primary causes of pullout:

• No pain limiter post op

• Patient compliance in
wearing back brace to limit
flexion and lateral bending
can be problematic
Overview

Facet fusion posterior L5-S1 with

pull-out (right) due to excessive
flexion.
No clinically adverse outcome –
patient reports no pain or discomfort
> 120 days.

Dowel left in situ.

Overview
Surgical Science Behind facet fusion
Efficacy

• Obtaining the best

outcomes:
• Stay on label and start with
direct visualization

• Fit the patient with a

reinforced lumbar brace to
limit flexion and lateral
bending

• Instruct the patient to wear

the brace for at least six weeks
Overview
Surgical Science Behind facet fusion
Efficacy
• Obtaining the best outcomes:

• Advanced designs in
allograft.

• Advanced designs in
polymer.

• Epoxies such as Genex that

serve as bone growth
stimulators.
Overview
Instrumentation

• Open
• Minimally Invasive
• Percutaneous
Overview
Facet fusion Open Instrumentation

Inserter (2), Impacter (2) Graft Holder (1).

Standard Instruments Reamer (2)
• Medical grade stainless steel.
• Requires sterilization before use
• Multiple-use - Replace Inserter
and Drill Guide after 25 surgeries.

Drill Guide (2)

Overview
Facet fusion Open/MI Instrumentation

• Drill Guide - The Guide is

centered over the facet joint
in a superior to inferior
manner.

• The Guide’s superior and

inferior larger teeth are
placed into the joint to
distract the joint slightly
and stabilize the Guide.
This allows for facet joint
reaming in the plane of the
facet joint.
Overview

Facet fusion Open/MI Instrumentation

• Reamer – A compaction
drilling process that packs
subchondral bone against
the tunnel walls. A drill stop
is on the Reamer and Guide
to prevent drilling too deep.
Overview
Facet fusion Open/MI Instrumentation

• Inserter Assembly – Inserted into

the Drill Guide after reaming. The
TruFUSE dowel is picked from
the graft holder.
• The graft is impacted at the same
angle that the facet joint was
drilled until it is fully seated.
Overview
Facet fusion Open/MI Instrumentation

• Graft Holder - Used to

hold the dowels large
side up to be picked
up by the Inserter
Assembly.
Overview
Facet fusion Minimally Invasive Instrumentation

 Dilator Tubes - Used

minimally
invasively to
visualize the facet Dilator Tube 1

joint.

Dilator Tube 2
Overview
Facet fusion Percutaneous Instrumentation

 Dilator - Slides over the

guide wire ensuring proper
orientation of the Guide
into the facet joint.

 Spatula – Used to locate

the facet joint and ensure
proper Guide orientation.
Overview
Facet fusion Instrumentation Demonstration

• Open
• Minimally
Invasive
• Percutaneous
 Part Two

Patient Selection
Patient Selection
Specific Indications

• Facet Joint Pain

Trauma, inflammation, infection, and disc
degeneration are suggested causes of facet
joint pain. The facet joint is innervated by a
small nerve that branches out from a spinal
nerve.

• Arthritic Facet Joint

Osteoarthritis (degenerative arthritis) can
cause breakdown of cartilage between the
facet joints. When the joints move, the lack
of the cartilage causes pain as well as loss
of motion and stiffness.
Open Surgical Procedures
Augmentation Alternatives

• Anterior Interbody
Supplementation (ALIF, XLIF)

• Adjacent level to Posterior to

prevent adjacent level disease

• Laminectomy Decompression

ALIF XLIF
Open Surgical Procedures
Revision Alternatives

• Adjacent Segment Disease

• PLIF Removal/Instability
• Unstable Anterior Interbody (subsidence)
• Unstable Laminectomy
• Unstable Decompression
• General Instability/Facet Based Pain Post-OP
MI or Percutaneous Procedures
Surgical Alternatives

• Facet Pain (Mechanical

Back Pain)
• Osteoarthritis
• Facet based Pain
• Minor Instability NOT
requiring Instrumented or
Interbody Fusion
Patient Selection
Specific Contraindications

Grossly Unstable Spine

• PARS Defect - Floating lamina
• Severe Osteoporosis Severe Osteoporosis

• Trauma, Fracture
• Vertebral Dislocation
Active or Latent Infection
• Steroid Use
• Abnormal White Count >15
• Increased Body Temperature
Vertebral Dislocation
• Positive Urine Culture
Synovial Cysts
Outcome Expectations
Post Surgical Rehabilitation
• Aftercare
• RTNA
• Post-Op Expectations
• Lumbar Corsets
• Physical Therapy Indications

Outcome Expectations
• 4-6 weeks post-op - initial
healing of cancellous bone
growth with allograft providing
support
• 3 months - cancellous fusion
• 1 year – complete fusion with
allograft
Benefits
Patient Advantages
 Minimized tissue and nerve
damage
 Dramatic and instant reduction in
pain
 Substantially reduced hospital
stays
 Much faster healing
 Much faster recovery
 Less rehabilitation required
 Recognized by all insurers
 Reduced time in hospital
 Return to normal activity faster
Benefits
Physician Advantages

 Rapid training
 Less time in the OR
 Less physically demanding
cases
 Less hospital rounding time
 Less follow-up visits
Benefits
Hospital Advantages
 Reduction OR time
 Much shorter
stays
 Substantially less
risk
 Cost effective
fusion option
 Less staff training
 Same
reimbursement
 Positive revenue
flow