surgical technique guide

Transcription

No-Profile® Anterior Cervical INTEGRATED INTERBODY™ System
SURGICAL TECHNIQUE GUIDE
TITANIUM-ENHANCED
PEEK TECHNOLOGY
featuring
Technology
No-Profile® Anterior Cervical INTEGRATED INTERBODY™ System
TABLE OF CONTENTS
Introductions & Indications for Use
3-5
Instrument Set
6-7
Surgical Technique
8
Disc Removal & Distraction
9
Device Trialing
10
Device Loading
11
Graft Packing
12
Device Orientation
12
Device Insertion
13
Placement & Confirmation
14
Pilot Hole Preparation
15
Screw Insertion
16 - 17
X-Ray Confirmation
18
Removal / Revision
19
Device Codes & Descriptions
20
About Centinel Spine
Centinel Spine began operations in August 2008,
through the merger-acquisition of two pioneering
medical device companies: Raymedica, LLC and
Surgicraft LTD.
Founded in 1990, Raymedica became the
recognized leader in nucleus replacement devices
through the development of revolutionary products
like the PDN® and HydraFlex®. Throughout its 18year history, the company developed pioneering
technologies and surgical approaches to the
spine that helped thousands of patients restore
function, reduce back pain, and avoid more invasive
procedures. Raymedica was also the first company
to develop a system for the Antero-Lateral TransPsoas Approach (ALPA)—implanting the PDN
device via lateral access to the spine.
In 1992, UK-based Surgicraft launched the
revolutionary
titanium
Hartshill
Horseshoe—
the first stand-alone anterior lumbar interbody
fusion “STALIF®” device. Following 12 years of
international clinical success, Surgicraft introduced
the highly successful STALIF TT™ to the US spine
market in 2004—thereby creating the No-Profile,
Integrated Interbody Device market. With superior
biomechanics and design rationale, Surgicraft had
an unparalleled clinical heritage in the Integrated
Interbody space, spanning its entire 26-year history.
From the foundation of knowledge gained from the
long-term clinical success of its lumbar products,
Centinel launched its cervical product, STALIF C®,
in 2008. Today, Centinel Spine still embraces the
pioneering culture developed at both Raymedica
and Surgicraft, continuing on its corporate mission
of:
•Becoming the leading anterior column
support spine franchise.
•Providing elegantly simple devices and
instruments that are tissue-sparing.
•Generating superior clinical outcomes.
4
STALIF C-Ti ™ | SURGICAL TECHNIQUE GUIDE
Introduction to
STALIF C-Ti™ is a novel, titanium-coated, PEEK
Integrated Interbody™ device design, based on the
successful STALIF C®. Commercially pure titanium
(CP Ti) is applied to the PEEK cage by a plasma
spray to create the STALIF C-Ti™ device. The unique
CP Ti coating system utilizes a robotic applicator,
enabling the creation of a high-quality, reproducible
titanium coating.
The STALIF C-Ti™ device is plasma spray coated with
CP Ti on the superior and inferior endplate contact
surfaces of the device. Analysis shows that the
plasma spray process provides uniform porosity
with controlled roughness and thickness. The
surface roughness is twenty times greater than that
of a typical PEEK device (Figure A). The increased
surface roughness and friction at the bony endplates
enhances stability upon implantation.1
Figure A:
SEM images (2000x magnification) showing the
difference in surface roughness between Standard
PEEK Device (left) and CP Ti-Coated PEEK Device (right)
The STALIF C-Ti™ device blends benefits of titanium
and PEEK integrated interbody devices. Our
porous CP Ti coating provides an osteoconductive
surface with hydrophilic properties that facilitate
human mesenchymal stem cell (hMSC) adhesion
and proliferation (Figure B).1, 2 The coating results
in bony on-growth to the device surface—further
promoting stability and load sharing. PEEK has
a modulus of elasticity that is similar to that of
cortical bone. Consequently, PEEK cages have a
lower subsidence rate than titanium cages whose
modulus of elasticity is significantly higher.3
STALIF C-Ti™ has undergone rigorous quality testing
according to FDA guidance documents and
international standards. Mechanical testing revealed
that our CP Ti coated device was equivalent to the
existing STALIF C® device. The CP Ti coating was
also shown to withstand loading under dynamic
testing conditions.
1
Figure B:
SEM image (2000x magnification) of adhesion
of hMSCs on CP Ti-Coated PEEK 1
References on File / Internal Reports.
Chen Y, Wang X, Lu X, Yang L, Yang H, Yuan W, Chen D (2013) Comparison of titanium and polyetheretherketone (PEEK) cages in the surgical treatment of multilevel cervical
spondylotic myelopathy: a prospective, randomized, control study with over 7-year follow-up. Eur Spine J http://dx.doi.org/10.1007/s00586-013-2772-y.
2
Olivares-Navarrete R, Gittens RA, Schneider JM, et al. Osteoblasts exhibit a more differentiated phenotype and increased bone morphogenetic protein
production on titanium alloy substrates than on poly-ether-ether-ketone. Spine J. 2012;12:265-272.
3
Indications for Use
Warnings & Precautions
The STALIF C-Ti™ is intended to be used as an
intervertebral body fusion device while serving as
a standalone system. It should be used with the
provided bone screws and requires no additional
supplementary fixation systems.
• Patients with previous spinal surgery at the
levels to be treated may not experience the
same clinical outcomes as those without a
previous surgery.
• Selection of an appropriately sized device
for the patient is important and increases the
likelihood of a satisfactory outcome.
• The implantation of the intervertebral body
fusion device should be performed only by
experienced spinal surgeons with specific
training in the use of this type of device.
• Do not use if the package is damaged or
opened. Contents may not be sterile.
• Do not use if current date exceeds label expiry
date.
• Do not re-sterilize sterile implants.
• Instrumentation provided with the implants
must be used in accordance with the approved
surgical technique.
• Do not use excessive force when introducing
and positioning the implant within the intervertebral body space to avoid damaging the
implant.
• Re-usable surgical instruments must be resterilized prior to next use.
• Do not reuse the device even if the device
shows no external signs of damage. Internal
stresses from previous use may cause early
failure.
• On insertion of the screw into the STALIF C-Ti™
device, ensure soft tissue is not trapped
between the head of the screw and the device.
• Should not be used with components of any
other system or manufacturer.
• Based on fatigue testing results, when using the
STALIF C-Ti™ system, the physician / surgeon
should consider the levels of implantation,
patient weight, patient activity level, other
patient conditions, etc., which may impact on
the performance of this system.
STALIF C-Ti™ is inserted between the vertebral
bodies into the disc space from levels C2 to T1 for
the treatment of cervical degenerative disc disease
(defined as neck pain of discogenic origin with
degeneration of the disc confirmed by history and
radiographic studies).
The device system is designed for use with autograft
bone and/or allogenic bone graft composed of
cancellous and/or corticocancellous bone graft, to
facilitate fusion.
STALIF C-Ti™ is intended to be used at one level.
The cervical device is to be used in a skeletally
mature patient who has had six weeks of nonoperative treatment prior to implantation of the
device.
Contraindications
• Osteoporosis, sepsis
• Infection or inflammation at or near the operative
site
• Fever of undetermined origin
• Allergy to implant materials
• Patient is unable or unwilling to follow post
operative instructions
• Disease or condition which precludes the
possibility of healing
• Prior fusion at the level to be treated
• Any conditions not described in the indications
5
6
Instrument Set
Straight Screwdriver
IN255
Punch Awl
IN351
Universal-Joint (UJ) Screwdriver
IN281
Universal-Joint (UJ) Awl
IN407
Ball-Joint Screwdriver
IN357
Ball-Joint Awl
IN408
Slap Hammer
IN236
Angled Awl Guide
IN239
Tamp
IN334
Rongeur (3mm Bite)
IN250
Introducer
IN235
”EZ-Out” Screw Remover Sleeve
IN282
Lordotic Trial Sizers (14mm A/P)
5.5mm, IN243
6.5mm, IN244
7.5mm, IN245
8.5mm, IN246
9.5mm, IN247
”EZ-Out” Screw Remover
IN283
7
8
Surgical Technique
The surgeon has a choice of 5 different STALIF C-Ti™
device heights in lordotic profiles. They are supplied
sterile and individually packaged.
A standard anterior approach is used to access the
cervical spine.
STALIF C-Ti™ Instrument Set
9
Disc Removal & Distraction
Locate and confirm the operative level. Using the
surgeon’s preferred method, resect the Anterior
Longitudinal Ligament (ALL) and perform a
complete discectomy (Figure 1).
Prepare the endplates and address any obstructive
osteophytes. While careful removal of the
cartilaginous endplate is critical to a successful
fusion, take care not to compromise the integrity
of the bony endplates. This will reduce the risk of
subsidence.
Figure 1:
Performing Discectomy
please
NOTE
Take care not to compromise the integrity of
the body endplates.
STEP 1
10
Device Trialing
The correct height and footprint of the STALIF C-Ti™
device are determined by inserting the trial sizers
into the disc space (Figure 2). If distraction has
been used, it must be relaxed prior to trial sizing.
To achieve the proper fit it may be necessary to use
gentle slap hammer impaction to tap the trial into
position.
Figure 2:
Trial Sizer Insertion
please
NOTE
STEP 2
Imaging should be performed to verify proper
trial sizer fit.
11
Device Loading
After selecting the appropriate STALIF C-Ti™ device,
attach the device to the Introducer. Rotate the
tensioning knob fully counterclockwise (marked
“RELEASE”, see Figure 3). Align the small arrow
on the device with the central pin on the Device
Introducer.
Secure the device to the Introducer by placing the
pins into the three screw apertures (Figure 4) and
rotating the tensioning knob clockwise (marked
“LOAD”, see Figure 5). Tighten securely to ensure
a snug fit between the device and the Introducer.
Figure 3:
Tensioning Knob
tech
TIP
Figure 4:
Figure 5:
Securing Device
Tensioning Knob
Once the Introducer has been tightened, check
to verify a snug fit between the device and
Introducer.
STEP 3
12
Graft Packing
Device Orientation
The central cavity of the STALIF C-Ti™ device is filled
with autograft bone and/or allogenic bone graft
composed of cancellous and/or corticocancellous
bone graft. The autograft and/or allograft should be
packed so that it exceeds the superior and inferior
surfaces of the device by 1mm each (Figure 6).
When implanting the STALIF C-Ti™ device, the single
screw hole can be positioned either cephalad or
caudally (Figures 7a and 7b) to accommodate
patient anatomy.
Figure 6:
STALIF C-Ti™ with Bone Graft
please
NOTE
STEP 4
Figure 7a:
Figure 7b:
Device Oriented Cephalad
Device Oriented Caudal
Uncoated areas on the bottom of the device
are intentional. These areas are too small to
obtain a uniform plasma spray thickness.
13
Device Insertion
Insert the STALIF C-Ti™ device into the disc space
(Figure 8), ensuring that the device center is aligned
with the center of the vertebral body.
please
NOTE
Gentle slap hammer impaction can be used against
the strike surface of the Introducer to tap the device
into position (Figure 9). The Introducer is removed
and distraction can now be released.
Figure 8:
Figure 9:
Device Insertion
Positioning Device with Gentle Impaction
Care should be taken to prevent rotation of
the device during insertion.
Do not use excessive force when striking the
Introducer, as this may damage the device.
STEP 5
14
Placement & Confirmation
STALIF C-Ti™ device positioning should be 1mm
proud of the vertebral anterior plane (Figure 10).
This allows for additional device movement when
preparing pilot holes and tightening the Cancellous
Lag Screws. This will result in a device that is flush
with the anterior plane.
It is advisable to take Anterior/Posterior (A/P)
and lateral images (Figures 11 and 12) to ensure
that the device is correctly oriented and sits fully
within the disc space. If necessary, the device can
be repositioned by re-attaching the Introducer or
with the provided Tamp.
1mm
Figure 11:
A/P Image
Figure 10:
Device Positioning
Figure 12:
Lateral Image
tech
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If the two posterior markers are not closely
aligned, either the x-ray may not be a true lateral
or the device may be rotated.
STEP 6
15
Pilot Hole Preparation
Once device positioning is confirmed, the preferred
awl and awl guide (Figures 13 and 14) are used to
create a pilot hole for each screw. The STALIF C®
Angled Awl Guide directs the screw’s trajectory,
ensuring it provides the desired lag compression of
the vertebral bodies onto the device.
To allow optimal awl guide access to the screw, a
rongeur is provided to remove a small portion of
the vertebral body anterior lip, if necessary.
Figure 13:
Universal-Joint (UJ) Awl and Angled Awl Guide
Figure 14:
The Punch Awl is Self-Seating
please
NOTE
It is critical that the awl guide be seated and
used with the angled awls so the pilot hole is
concentric.
STEP 7
16
Screw Insertion
Prior to screw insertion, any soft tissue around
the screw hole should be removed to prevent
entrapment between the screw head and device.
There are three screwdriver options (Figures 15a,
15b and 15c) for screw insertion: Straight, UniversalJoint (UJ), or Ball-Joint.
The appropriate length STALIF C® screw is selected
and loaded onto the preferred screwdriver.
Adopt a thumb and two-finger-style grip (Figure
16) to achieve optimal compressive fixation. This
reduces the risk of stripping the bone thread by
over tightening.
Figure 15a:
Straight Screwdriver
Figure 15b:
Universal-Joint (UJ) Screwdriver
Figure 16:
Thumb and Two-Finger-Style Grip
Figure 15c:
Ball-Joint Screwdriver
STEP 8
The first screw is inserted through the center hole in
the device and screwed into the adjacent vertebral
body. The second and third screws are then inserted.
Do not fully tighten the first screw until all other
screws have been placed and tightened.
Both Standard and Revision Cancellous Screws
feature an Anti Back-Out (ABO®) titanium split ring
(Figure 17) which first compresses and then deploys
during insertion. Each screw head must be fully
seated within the device screw apertures to ensure
the ring is properly deployed (Figures 18a and 18b).
Figure 18a:
Screw Heads Not Fully Seated
Figure 17:
Cancellous Screw with
ABO® Titanium Split Ring Deployed
Figure 18b:
Screw Heads Fully Seated
please
NOTE
17
The ABO® titanium split ring is properly deployed
when the screw head is fully seated (see above).

18
X-Ray Confirmation
A/P & lateral X-rays should be taken prior to closing
to ensure proper device position by assessing the
marker pin positioning. Two markers are clearly
evident on an A/P film; on a ‘true’ lateral X-ray, two
parallel markers in close approximation may be
identified, or the appearance of a single marker if
the markers are superimposed (Figures 19a & 19b).
Figure 19a:
Figure 19b:
A/P View (with Single Screw Oriented Cephalad)
Lateral View (with Single Screw Oriented Cephalad)
STEP 9
19
Removal / Revision
Revision involves reversing the steps of implantation.
The screwdriver can be used to remove the screws
if the thread pattern is intact. In the event that the
bone thread has been compromised and a screw
cannot be removed with the screwdriver, a screw
removal instrument (IN283/1) has been included in
the STALIF C-Ti™ instrument set. The Screw Remover
is designed to be used in conjunction with the Screw
Remover Sleeve (IN282) provided (Figure 20).
Place the Screw Remover Sleeve over the affected
screw head (the convex screw head profile must
sit against the concave sleeve tip) and maintain
downward pressure. The placement angle of the
sleeve must match the insertion angle of the screw
(Figure 21).
Figure 21:
“EZ-Out” Screw Remover Sleeve
Carefully slide the Screw Remover into the sleeve
until it contacts the screw head (Figure 22).
Maintaining downward pressure on the sleeve to
prevent the screw from spinning, slowly rotate the
screw remover T-handle counterclockwise until
purchase is felt.
Once purchase is established, release downward
pressure on the sleeve and—while rotating
counterclockwise—pull back slowly but evenly on
the T-handle to collapse the ABO® split ring and
extract the screw (Figure 23).
Figure 22:
“EZ-Out” Screw Remover Slides into the Sleeve
Figure 20:
Screw Remover and Sleeve
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TIP
Should difficulty with screw purchase be
encountered, a gentle slap hammer tap of
the T-Handle will assist in screw engagement.
Figure 23:
Screw Extraction
20
Device Codes & Descriptions
STALIF C-Ti™ DEVICES (CP Ti Coated PEEK)*:
STANDARD BILL OF MATERIALS (BOM)
Product Code
Anterior
Height (mm)**
Profile
Posterior
Height (mm)**
AP
Depth (mm)
Lateral
Width (mm)
Cavity
Volume (cc)
Recommended
Bone Graft Volume (cc) †
C145541-3Tc
5.5
Lordotic
4.1
14
16.5
0.28
0.39
C146551-3Tc
6.5
Lordotic
5.1
14
16.5
0.33
0.44
C147561-3Tc
7.5
Lordotic
6.1
14
16.5
0.39
0.50
C148571-3Tc
8.5
Lordotic
7.1
14
16.5
0.44
0.55
C149581-3Tc
9.5
Lordotic
8.1
14
16.5
0.50
0.61
STALIF C® SCREWS*
STALIF C® ABO® Primary Screws
ABS1440
STALIF C® 14mm Long Primary ABO® Screw (Ti), 4mm diameter, (1 pack)
ABS1540
ABS1640
STALIF C® ABO® Revision Screws ‡
RAB1440
STALIF C® 14mm Long Revision ABO® Screw (Ti), 4mm diameter, (1 pack)
RAB1540
RAB1640
* Additional screws, revision screws, and devices are available by special request. Call customer service for availability.
** Titanium coating layer adds less than .5mm of height to the device.
†
This allows for 1mm of excess bone graft, both superiorly and inferiorly.
Bronze colored Revision screws have a modified thread profile as compared to the Standard screws. If a Revision screw is required, it is recommended
that the longest (safest) length is selected.
‡
Centinel Spine™, Inc.
900 Airport Road, Suite 3B
West Chester, PA 19380
Tel: 484.887.8810
Fax: 800.493.0966
[email protected]
www.centinelspine.com
Centinel Spine™, STALIF C-Ti™ and INTEGRATED
INTERBODY™ are trademarks of Centinel Spine™, Inc.
STALIF C®, ABO®, and No-Profile® are registered
trademarks of Centinel Spine™, Inc. All rights reserved.
LBL032 rev 6 CN889