Centinel Spine PRODISC C VIVO User manual

SURGICAL TECHNIQUE
PRODISC® CVIVO
Cervical disc prosthesis to restore
disc height and maintain segmental
motion.

Image intensifier control
Warning
This description alone does not provide sufficient background for direct use of
Centinel Spine products. Instruction by a surgeon experienced in handling
these products is mandatory.
Processing, Reprocessing, Care and Maintenance
For general guidelines, function control and dismantling ofmulti-part
instruments, as well as processing guidelines for implants, please contact your
local sales representative or refer to:
http://www.centinelspine.com/prodisc_reprocessing.html
For general information about reprocessing, care and maintenance of Centinel
Spine reusable devices, instrument trays and cases, please consult the
Important Information leaflet (SE_023827) or refer to:
http://www.centinelspine.com/prodisc_reprocessing.html

prodisc C Vivo Surgical Technique Centinel Spine 1
INTRODUCTION prodisc CVivo 2
Kinematics 3
Intended Use, Indications and Contraindications 4
SURGICAL TECHNIQUE Surgical Technique 5
Multi-Level Cases 14
Removal Procedure 15
PRODUCT INFORMATION Implants 17
Instruments 19
Pre-Cleaning Instructions 26
BIBLIOGRAPHY 28
TABLE OF CONTENTS

2 Centinel Spine prodisc C Vivo Surgical Technique
PRODISC CVIVO
prodisc C Vivo is intended to replace a
diseased and/or degenerated interver-
tebral disc of the cervical spine in
patients with symptomatic cervical disc
disease. The prodisc C Vivo procedure
is intended to significantly reduce pain
by allowing for the removal of the dis-
eased disc while restoring disc height
and providing the potential for motion
at the affected vertebral segment.
Simple surgical technique
•Simple technique with two main
steps: trial and implant insertion
Anatomical design
•Convex superior plate for
anatomical fixation
•Trapezoidal footprint design for
optimal anatomical fit and
maximum endplate coverage
Proven materials
•Superior and inferior implant plates
made from titanium alloy for
improved MRI compatibility.
•Rough surface coating of pure
titanium allows bony ongrowth
•Inlay made from ultra-high
molecular weight polyethylene
(UHMWPE)
•UHMWPE on CoCrMo alloy articu-
lation
Ball and socket articulation
•Permits a physiological range of
motion in flexion/extension,
rotation, and lateral bending
•Allows for restoration of anatomi-
cal balance
•Resists shear forces
FEATURES AND BENEFITS

360º
prodisc C Vivo Surgical Technique Centinel Spine 3
KINEMATICS
prodisc C Vivo has a center of rotation which is located just
below the inferior endplate of the prosthesis. Pure trans-
lation movements are controlled by the ball and socket
inter-face.
Flexion/extension
The location of the center of rotation (COR) and the flex-
ion radius are in accordance to the natural joint guidance
in the vertebral joints.
Lateral bending
The physiological range of motion in lateral bending is
restored.
Axial rotation
The axial rotation is limited by the anatomical structures
and not by the prosthesis.
min. 16.9°
min. 16.9°
COR COR
COR COR

4 Centinel Spine prodisc C Vivo Surgical Technique
INTENDED USE, INDICATIONS
AND CONTRAINDICATIONS
Intended use
prodisc C Vivo implants are used to replace a cervical inter-
vertebral disc, to restore disc height and maintain
segmental motion.
Successful clinical outcomes depend on a number of critical
factors, including:
•Completion of a training program on the use of
prodisc C, prodisc C Nova or prodisc C Vivo
•Proper patient selection
•Adequate bone quality (investigation todetermine
bone quality isrecommended)
•Complete and meticulous discectomy, decompression,
and remobilization of the disc space
•Optimal implant sizing and placement
•Postoperative treatment
Indications
Symptomatic cervical disc disease (SCDD), which is defined
as neck or arm (radicular) pain and/or a functional/neuro-
logical deficit with at least one of the following conditions
confirmed by imaging (CT, MRI, or x-rays):
•herniated nucleus pulposus
•spondylosis (defined by the presence of osteophytes)
•loss of disc height
Specific contraindications
•Fractures, infections, tumors
•Spinal stenosis by hypertrophic spondylarthrosis
•Severe facet joint degeneration
•Segmental instability
•Ossification of posterior longitudinal ligament (OPLL)
General contraindications
•Osteoporosis, osteochondrosis, and severe osteopenia
•Acute or chronic systemic, spinal, or localized
infections
•Systemic and metabolic diseases
•Any medical and surgical conditions precluding
the benefits of spinal surgery
•Foreign body sensitivity to the implant materials
•Pregnancy
•Severe obesity (Body Mass Index above 40)
Patient exclusion recommendations
Patient selection is one of the most important factors
contributing to the outcome of the total disc replace-
ment procedure. The following may affect clinical out-
comes:
•A condition of senility or mental illness, alcoholism
or smoking
•Dependency on pharmaceutical drugs or drug abuse
•The patient’s occupation or activity level
•Compromised vertebral bodies at affected level due
to current or past trauma (fractures)
•Substantial loss of disc height, where applied segmen-
tal distraction may lead to damage of the great vessels
•Involved vertebral endplate dimensionally smaller than
the minimum implant footprint size in both the medial-
lateral and the anteriorposterior directions
•Severe abnormality of the endplate (e.g. large Schmorl
nodes)

prodisc C Vivo Surgical Technique Centinel Spine 5
SURGICAL TECHNIQUE
1
Prerequisites and patient positioning
Insertion of a prodisc C Vivo is dependent on the use of
anterior-posterior (AP) and lateral fluoroscopy throughout
the procedure. Patient positioning should allow for circum-
ferential use of the C-arm at the operative level.
Position the patient in a supine, neutral position on a radio-
lucent operating table. Ensure that the neck of the patient is
in a sagittally neutral position and supported by a cushion.
When treating C6–C7 make sure that the shoulders do not
limit the x-ray monitoring. In any case both vertebrae should
be completely visible.
2
Access
Use a standard anterior approach to the cervical spine. Mark
the level of the surgery and expose the intervertebral disc
segment and adjacent vertebrae.
Determine the median line using image intensifier control
and make a permanent midline mark on the superior and
inferior vertebral bodies, e.g. using an osteotome or electro
cauterization.

6 Centinel Spine prodisc C Vivo Surgical Technique
Surgical Technique
3
Fix retainer screw system
Instruments
03.820.100 Punch
03.820.101 Screwdriver
03.820.111 Vertebral Body Retainer
03.820.102– Retainer Screws
03.820.109
03.820.110 Locking Nut
Perforate the anterior cortex of the superior and inferior
vertebra in the lateral midline and vertical center with the
punch.
Insert retainer screws into the perforations and place them
close to the posterior cortical wall. Their trajectory should
be parallel to the endplates of the treated disc. Begin with
the smaller diameter screws (3.5 mm) of the longest possible
length. Use a larger diameter screw (4.5 mm) when extra
bone purchase is needed or a smaller screw diameter has
been used unsuccessfully (“rescue” screw).
Warning:
•Insert screws under image intensier control for
optimal trajectory and depth control.
•Do not perforate the posterior cortex with the tip
of the screw.
Slide the vertebral body retainer over the screws and lock it
in place with the locking nuts. This assembly secures parallel-
ism of the retainer screws and the vertebral endplates of the
operated level.
Avoid using the retainer to distract the segment. For proper
distraction refer to Step 4 on page 7.

prodisc C Vivo Surgical Technique Centinel Spine 7
4
Mobilize and distract the segment
Instrument
03.820.112 Vertebral Distractor
Start the discectomy using standard instruments.
Remove as much disc material as possible to allow the verte-
bral distractor tips to be placed as posteriorly as possible into
the intervertebral space. Mild predistraction with the retainer
can be applied to support disc removal.

8 Centinel Spine prodisc C Vivo Surgical Technique
Under fluoroscopic control, insert the tip of the vertebral
distractor to the posterior margin of the vertebral bodies.
Distract the intervertebral space with the vertebral distractor
to restore the height and to gain access to the posterior
intervertebral space. Readjust the retainer to the distracted
height of the intervertebral space. This step should be re-
peated until maximum distraction has been achieved. Then
release and withdraw the vertebral distractor.
Continue the discectomy and remove the cartilageous
endplate carefully. All soft tissue must be removed from the
endplates. Care should be taken to avoid damage of the
endplates.
Continue with the canal and foraminal decompression.
Precaution:
•Avoid using the vertebral body retainer as a dis-
tractor. Excess force on the vertebral body retainer
can lead to bending and/or pull-out of the screws
from the bone.
•Expose the posterior longitudinal ligament to
remobilize the segment. If required for decompres-
sion, the PLL may be resected.
Warning:
•Avoid overdistraction with the vertebral distractor
as this can lead to nerve root tension or improper
implant selection.
•Avoid excessive endplate damage or removal. This
increases the risk of implant subsidence.
•The uncinate process should be preserved. If re-
quired for adequate decompression, the posterior
third of the uncinatus process may be removed.
•Ensure the cartilageous tissue is removed from the
endplates. Cartilageous tissue may hinder osseo-
integration of the implant and reduce the xation
strength.
Surgical Technique