Download OsteoStim® Cervical Allograft Systems

OsteoStim ® Cervical
Allograft Systems
Surgical Technique
Contents
Introduction ................................................ Page 1
Design Features .......................................... Page 2
Instrumentation .......................................... Page 3
Surgical Technique ...................................... Page 4
Closure And Postoperative Care .................. Page 6
Contraindications ........................................ Page 6
Warnings And Precautions .......................... Page 7
Storage And Shelf Life ................................ Page 7
Product Information .................................... Page 8
Further Information ..................................... Page 11
Introduction
The OsteoStim Cervical Allograft System is a line
Instrumentation
of precision-machined cervical allograft spacers.
The OsteoStim Allograft implants offer a unique set of
All OsteoStim Cervical Allograft is processed in facilities
instrumentation that is simple to use and designed with the
accredited by the American Association of Tissue Banks
intent of making a direct contribution to successful clinical
(AATB) and is cut to exacting standards for exclusive
results. The non-reflective finish on each instrument allows
distribution by Biomet Spine.
for better visualization into the operative site. There are
multiple sets of trials and rasps available to accompany both
Product Overview
the Composite and Cortical Allograft per surgeon preference.
They are color-coded and etched with their height in
OsteoStim Composite Cervical Allograft
millimeters to provide easy identification when determining
The OsteoStim Composite Cervical Allograft is composed
the appropriate implant size intraoperatively.
of cortical bone for strength and dense cancellous bone
for ingrowth. The graft, which consists of only two pieces,
The orientation of the teeth on the Trial Rasps has been
features a single piece of cortical bone to form the anterior
designed to cut on the backstroke in order to extract
and lateral aspects of the graft, and a dense cancellous dowel
cartilaginous material. Trial Rasps may be used for final
in the center. The dense cancellous bone is specifically
endplate preparation as well as to distract within
procured from the load-bearing anatomy, including
the vertebral space.
the talus, calcaneus and femoral head. Its strength has
been tested in undersized disc spaces to withstand repeated
The Inserter is designed to mimic the anterior aspect
impaction forces. The footprint of the composite graft
of the implant. Tines on the Inserter have a directional texture
measures 14mm wide with a depth of 13mm.
enabling them to engage the implant during insertion and can
be used as a remover if necessary. The handle enables
OsteoStim Cortical Cervical Allograft
impaction of implant with a mallet.
The original OsteoStim Cortical Allograft is composed of
a single piece of cortical bone and features a 3.5mm core hole
In addition to the Inserter, the Tamp permits controlled
to pack with bone material if desired. The cortical graft’s
positioning of the OsteoStim Allograft implant in the disc
footprint measures 14mm wide with a depth of 10mm.
space. The Tamp is designed to match the anterior curvature
of the implant in order to decrease contact pressure during
The available heights of both implants range from 5mm
insertion. The handle also facilitates gentle impaction
to 12mm in 1mm increments. Both spacers feature 9°
with a mallet.
of lordosis to closely approximate the curvature of the cervical
spine. In addition, each graft is machined with horizontal arcs
The Single Sided Rasp may be used in place of or in addition
to provide multi-directional expulsion resistance.
to the Trial Rasp to extract additional amounts of cartilaginous
materials necessary to prepare the endplate for insertion
of the implant.
1
Design Features
OsteoStim Composite Allograft
Both Implants Feature
Machined Ridges
• Aggressive teeth-like ridges minimize expulsion
AATB Accredited
• All tissue is procured from an AATB accredited
tissue bank
Solid Anterior Cortex
Two-Piece Construction
• Evenly distributes forces during impaction
• Maximizes structural stability
Lordotic Endplates
• Outer cortical portion allows for strength as the inner
cancellous portion allows for ingrowth
• 9° of lordosis approximates the curvature of the
cervical spine
• Porous composition of cancellous bone allows for rapid
absorption of blood into the implant
Supplied Freeze-Dried
• 5mm-12mm heights
• Conserves valuable hospital resources
OsteoStim Cortical Allograft
Streamlined Instrumentation
• Available with or without stops
• Available in shorter lengths for working under
a microscope
100% Cortical Bone
• Single-Piece Construction maximizes structural stability
• Full Range of Sizes
• 5mm-12mm heights
2
Instrumentation
Lordotic Trial
Inserter
Lordotic Rasp Trial
Tamp
Single Sided Rasp
3
Surgical Technique
1. Distraction
3. End Plate Preparation
The patient is placed in the supine position on the operative
Rasps Trials may be used for further endplate preparation as
table with a folded towel beneath the intrascapular region to
well as to distract within the vertebral space. This allows for
maintain the head in slight extension. The use of a head halter
removal of small irregularities along the endplate, ensuring a
attached to an outrigger for traction may be helpful. If
smooth surface for implant insertion. (Figure 1)
fluoroscopy is used, it may be utilized at this point to confirm
positioning and visualize the desired vertebral levels.
A standard anterior approach to the cervical spine is utilized.
This can be through one of several incisions with the exposure
medial to the carotid sheath and lateral to the trachea and
esophagus. Adequate fascial plane release is important for
optimal exposure. After identification of the disc space is
confirmed with x-ray, preparation of the site is commenced.
(Figure 1)
2. Disc Space Preparation
4. Trialing
A discectomy should be performed. Osteophytes at the
After the endplates are prepared, Trials are used to determine
operative levels may be resected at the surgeon’s discretion.
the appropriate size of the implant to be inserted. Trials also
All cartilaginous material should be removed and bleeding
provide the surgeon with tactile feedback as it relates to the
subchondral bone should be exposed. An intact endplate
distraction of the vertebral space. (Figure 2)
allows for distraction of the interspace while minimizing the
possibility of a subchondral fracture and subsidence.
(Figure 2)
4
5. Bone Graft Placement
Rehydrate the graft for as long as possible in normal saline or
the patient’s blood prior to insertion.
NOTE: The core of the Cortical Allograft implant may be
packed with autogenous bone material at this time.
6. Implant Insertion
(Figure 3)
Load the graft onto the Inserter by placing it between the tines
and manipulating the instrument to fully engage the implant.
(Figure 3)
Introduce the implant into the vertebral disc space using the
Inserter. The implant should be the same height or slightly
larger than the size determined by the Trial and should be
seated securely within the disc space.
(Figure 4)
Tap the distal tip of the Inserter with a mallet to gently seat the
Repeat steps to insert additional OsteoStim Cervical Allograft
implant. The implant may be inserted flush with the anterior
Spacer System Implants.
rim of the adjacent vertebral bodies or may be countersunk
past the anterior rim at the physician’s discretion.
Final positioning of all implant(s) should be confirmed using
fluoroscopy. Additional autogenous bone material may be
Disengage the Implant from the Inserter and remove the
placed beside the implants at the surgeon’s discretion.
instrument. The Tamp may be utilized to further advance the
implant in the disc space. Carefully inspect the interbody
Proceed with the application of anterior cervical
fusion bed. (Figure 4)
instrumentation and closure.
5
Closure And Postoperative Care
Contraindications
• The operative site should be closed per hospital protocol
and the surgeon’s discretion
1. Infection at the surgical site and/or distant foci of infections
• Prior to adequate fusion, the physician may prescribe
additional external support to accommodate full
load bearing
• The patient should receive adequate instruction regarding
the appropriate post-operative activity levels
• The patient should be instructed to report unusual changes
at the operative site and the physician should closely
monitor the patient if the unusual changes are reported
that may spread to the surgical site.
2. Uncooperative patient, or patient with neurologic disorders
who is incapable of following directions, including weight
control and activity levels.
3. Pregnancy.
4. Disorders or diseases that may impair bone formation.
6
Warnings And Precautions
Storage And Shelf Life
• This product contains donated human tissue
Maintain product at ambient temperature (59°-86°F or
• This tissue was processed using some or all of the
following agents: Bacitracin (50 u/ml), Polymyxin B Sulfate
(500 u/ml), Allowash™, Alcohol and/or Hydrogen Peroxide.
Although the tissue was rinsed with sterile water or sterile
saline throughout the processing procedure, traces of the
medications and chemicals may remain
15°-30°C). No refrigeration is necessary. See package label
for expiration date. It is the responsibility of the Tissue
Dispensing Service and/or end-user to maintain this product
in the appropriate storage conditions prior to transplant.
Allowash is a trademark of LifeNet, Inc.
• Although this product has been tested and screened
for selected human pathogens, processed under aseptic
conditions, human derived tissue may still transmit
infectious agents
• Do not use product if package integrity has
been compromised
• This product is intended for use in one patient on a single
occasion only
• Once user breaks the container seal, the product must
be transplanted or discarded
• This product may not be sterilized or re-sterilized
• The patient is to be made aware of general risks
associated with treatment and the possible adverse effects
7
Product Information
OsteoStim Composite Cervical Allograft Implants (Cat #80112)
Universal Lordotic Instruments No Stops (Cat #14-531220)
Catalog #
Description
Catalog #
Description
45-5555
5mm Composite Allograft Cervical Spacer
55001914
14mm Inserter
45-5556
6mm Composite Allograft Cervical Spacer
55002198
11mm Tamp
45-5557
7mm Composite Allograft Cervical Spacer
55002195
Single Sided Rasp
45-5558
8mm Composite Allograft Cervical Spacer
55002115
5mm Lordotic Trial
45-5559
9mm Composite Allograft Cervical Spacer
55002116
6mm Lordotic Trial
45-5560
10mm Composite Allograft Cervical Spacer
55002117
7mm Lordotic Trial
45-5561
11mm Composite Allograft Cervical Spacer
55002118
8mm Lordotic Trial
45-5562*
12mm Composite Allograft Cervical Spacer
55002119
9mm Lordotic Trial
55002120
10mm Lordotic Trial
55002121
11mm Lordotic Trial
Lordotic Cervical Allograft Implants (Cat #80110)
55002122* 12mm Lordotic Trial
Catalog #
Description
55002215
5mm Lordotic Rasp
45-5535*
5mm Lordotic Cervical Allograft Spacer
55002216
6mm Lordotic Rasp
45-5536
6mm Lordotic Cervical Allograft Spacer
55002217
7mm Lordotic Rasp
45-5537
7mm Lordotic Cervical Allograft Spacer
55002218
8mm Lordotic Rasp
45-5538
8mm Lordotic Cervical Allograft Spacer
55002219
9mm Lordotic Rasp
45-5539
9mm Lordotic Cervical Allograft Spacer
55002120
10mm Lordotic Rasp
45-5540
10mm Lordotic Cervical Allograft Spacer
55002221
11mm Lordotic Rasp
45-5541*
11mm Lordotic Cervical Allograft Spacer
55002222* 12mm Lordotic Rasp
45-5542*
12mm Lordotic Cervical Allograft Spacer
* Special order items, not in standard kit.
8
Short Lordotic Cervical Instruments With Stops (Cat #80115)
Lordotic Cervical Instruments No Stops (Cat #80195)
Catalog #
Description
Catalog #
Description
05553
Rasp
05502
Rasp
05554
Tamp
05503
Mallet
05555
Inserter
05534
Tamp
05556
6mm Trial
05535
Inserter
05557
7mm Trial
05583*
5mm Trial
05558
8mm Trial
05576
6mm Trial
05559
9mm Trial
05577
7mm Trial
05560
10mm Trial
05578
8mm Trial
05561
11mm Trial
05579
9mm Trial
05562
12mm Trial
05580
10mm Trial
05565*
5mm Rasp
05581*
11mm Trial
05566
6mm Rasp
05582*
12mm Trial
05567
7mm Rasp
05586
6mm Rasp
05568
8mm Rasp
05587
7mm Rasp
05569
9mm Rasp
05588
8mm Rasp
05570
10mm Rasp
05589
9mm Rasp
05571
11mm Rasp
05590
10mm Rasp
05572
12mm Rasp
05591*
11mm Rasp
05503
Mallet
05592*
12mm Rasp
* Special order items, not in standard kit.
9
Product Information (Continued)
Lordotic Cervical Instruments With Stops (Cat #80120)
Catalog #
Description
05502
Rasp
05503
Mallet
05534
Tamp
05535
Inserter
05536
6mm Trial
05537
7mm Trial
05538
8mm Trial
05539
9mm Trial
05540
10mm Trial
05541*
11mm Trial
05542*
12mm Trial
05546
6mm Rasp
05547
7mm Rasp
05548
8mm Rasp
05549
9mm Rasp
05550
10mm Rasp
* Special order items, not in standard kit.
10
Further Information
Please refer to the OsteoStim Cervical Allograft System
For further information, please contact the Customer Service
package insert for complete indication and labeling limitations.
Department at:
CAUTION: Federal Law (USA) restricts this device to sale by or
Biomet Spine
on the order of a physician.
100 Interpace Parkway
Parsippany, NJ 07054
The OsteoStim Cervical Allograft Surgical Technique is
(973) 299-9300 - (800) 526-2579
presented to demonstrate the surgical technique utilized
www.biometspine.com
by R. David Bauer, M.D. Biomet Spine, as the manufacturer
of this device, does not practice medicine and does not
recommend this product or any specific surgical technique
for use on any individual patient. The surgeon who performs
any implant procedure is responsible for determining the
appropriate product(s) and utilizing the appropriate
technique(s) for said implantation in each individual patient.
11
Notes:
12
100 Interpace Parkway
Parsippany, NJ 07054
www.biometspine.com
800-526-2579
All trademarks are the property of Biomet, Inc.,
or one of its subsidiaries, unless otherwise indicated. Rx Only.
Copyright 2008 Biomet, Inc. All rights reserved. P/N 209057L 06/08