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Instruments and implantsapproved by the AO Foundation.

Zero-P and Zero-P chronOS. Zero profile anterior cervical interbody fusion (ACIF) device.

Surgical Technique

Image intensifier control

This description alone does not provide sufficient background for direct use of DePuy Synthes products. Instruction by a surgeon experienced in handling these products is highly recommended.

Processing, Reprocessing, Care and MaintenanceFor general guidelines, function control and dismantling of multi-part instruments, as well as processing guidelines for implants, please contact your local sales representative or refer to:http://emea.depuysynthes.com/hcp/reprocessing-care-maintenanceFor general information about reprocessing, care and maintenance of Synthes reusable devices, instrument trays and cases, as well as processing of Synthes non-sterile implants, please consult the Important Information leaflet (SE_023827) or refer to: http://emea.depuysynthes.com/hcp/reprocessing-care-maintenance

Surgical Technique Zero-P and Zero-P chronOS DePuy Synthes 1

Table of Contents

Introduction Zero-P and Zero-P chronOS. Zero profile anterior cervical interbody fusion (ACIF) device. 2

Zero-P pre-filled with chronOS 4

AO Principles 7

Indications and Contraindications 8

Surgical Technique Preoperative Planning 9

Considerations for Use Adjacent to a Prior Fusion 10

Patient Positioning, Exposure and Disectomy 12

Implant Insertion 14

Screw Fixation Option A: Aiming Device 20 Option B: Drill Guide and Freehand Screw 28 Option C: Threaded Drill Guide and Freehand Screw 34 Option D: Awl and Freehand Screw 40 Option E: Angled Instruments 46

Product Information Implant Removal 50

Implants 54

Instruments 57

Set 61

Dismantling Guide Screwdriver Stardrive 64

Holding Sleeve for Screws 65

Handle with Quick Coupling 66

Awl B 2.0 mm, with Sleeve 67

Bibliography Bibliography 68

2 DePuy Synthes Zero-P and Zero-P chronOS Surgical Technique

Zero-P and Zero-P chronOS. Zero profile anterior cervical interbody fusion (ACIF) device.

Stand-alone ACIF implant

Zero-P acts as a stand-alone implant for use in cervical inter-body fusions6–12. Its design combines the functionality of a cervical interbody spacer and the benefits of an anterior cervical plate.

Zero profile

Reduces risk of dysphagiaThe implant is contained within the excised disc space and does not protrude past the anterior wall of the vertebral body as do anterior cervical plates. This zero anterior profile may be beneficial in reducing the occurrence and severity of postoperative dysphagia1, 2, 3, 4. In addition, preparation of the anterior surface of the vertebral body is minimized because the implant does not lie against this surface.

Prevents adjacent level ossificationIt has been shown that cervical plates placed near adjacent level discs can contribute to bone formation near or around the adjacent level which may lead to future complications5. Zero-P minimizes this risk, as it remains as far as possible from the adjacent level disc spaces.

Ease of use – Because plate and spacer are preassembled, the plate is

automatically aligned upon implant insertion. This avoids the process of aligning and realigning an anterior cervical plate.

– The Zero-P screws have a one-step locking conical head which locks the screw to the plate by simply inserting and tightening the screw.


2.5° 2.5°

40°55°

10.5 mm

12 mm

13.5 mm

5 m

m

6.5

mm

7.5

mm

1.0

mm

13.5

mm

15 mm

17.5 mm

1.0

mm

16.5

mm

17.5 mm

2.5° 2.5°

40°55°

PEEK interbody spacer – Radiopaque marker for posterior visualization during

imaging – Spacer component is made of pure medical grade PEEK

Optima® (Polyetheretherketone) – PEEK Optima does not contain carbon fi bers reducing

the risk of systematic uptake and local connective tissue formation

– Teeth on the implant surface provide initial stability

Titanium alloy plate – Provides a secure, rigid screw locking interface – Stresses in plate are decoupled from spacer through

an innovative interface

Locking head screws – Screws form a bone wedge with a 40º ± 5º cranial/caudal

angle and 2.5º medial/lateral angle – One-step locking screws – Self-tapping screws improve thread purchase – Trilobular thread cutting fl utes are self-centering


Macropores (100 – 500 µm)Micropores (10 – 40 µm)

The use of b-tricalcium phosphate in the spinal column is a valuable alternative to allografts and autografts, even when larger amounts are required.22

Patient friendly, reduces surgery time – No extra filling step required, implant can be directly used

after unpacking. – Low patient morbidity as there is no need for secondary

surgery to remove autologous bone*. The operation time is also shortened.

– Easy handling as the cage is only saturated with blood or bone marrow.

* Studies have demonstrated that the chronic pain rate can still be 18.7%, two years after iliac crest surgery17, 19

Zero-P and Zero-P chronOS. Zeroprofile anterior cervical interbody fusion(ACIF) device.

Zero-P pre-filled with chronOS


100%

90%

80%

70%

60%

50%

40%

30%

20%

10%

0%

10%

20%

30%

40%

0% <100 160 240 320 400 500 >500

4 weeks 12 weeksTime

24 weeks

m Medullary Spacem Bone Matrixm chronOSTM

Perc

ent

by

Vo

lum

e

Histomorphometric volume-percent analysis for three different healing periods; (Buser, D. et al. 1998) 21

Size distribution of macropores

Remodeling and substitution of chronOS (24 weeks in an animal model). Some chronOS Granules are still lined by woven bone, other parts are directly covered by lamellar bone, or are exposed to the marrow space (arrow) where they undergo degradation by osteoclasts (Buser et al, 1998).21

OsteoconductiveInterconnecting macropores of a defined size (100 –500 µm) facilitate bone ingrowth. Interconnected micropores (10 – 40 µm) allow an optimum supply of nutrients. The patient’s blood, blood platelet concentrate or bone marrow aspirate enhances the properties of chronOS required for fusion.20

OsteopromotiveThe Zero-P chronOS implant can be simply and quickly satu-rated with the patient’s own blood or bone marrow during surgery. This supports bone integration and ensures rapid ongrowth to the implant.

Rapid resorption of b-tricalcium phosphatechronOS consists of pure b-tricalcium phosphate and is structurally and chemically similar to bone. Osteoclasts re-sorb chronOS like natural bone and degrade it rapidly.

Formation of new host bone within 6 –18 monthsWhile resorption is taking place, new bone is being formed. The key to success of chronOS is the remodeling process. Resorption and new bone formation happen simultaneously.

Timing is the critical factor for a bone graft to remodel into natural bone. If the resorption is too rapid, the osteoblasts lose the scaffold needed for the formation of new bone. If the resorption is too slow or incomplete, the graft will not be replaced by bone in an adequate time span. chronOS has been designed to remodel in an ideal time span. It is being replaced in the human body by host bone in 6 to 18 months; depending on the indication and the patient’s conditions.

Safe – no adverse reactionsAll investigations, according to ISO 10993 series, demon-strate the excellent biocompatibility of chronOS. No adverse reactions have been observed in the more than 25 years of clinical applications (see bibliography16 –23).

Pore size, µm


9

8

7

6

5

4

3

2

1

0

a b c

Flexion Extension Axial rotation Lateral bending

Ang

le (D

egre

e)

Intact Cage stand alone CSLP Vectra-T Test device

Biomechanical testing has shown the stability of the implant to be similar to that of traditional plates and spacers.

A new stand-alone cervical anterior interbody fusion device: comparison with established anterior cervical fixation devices Scholz M, Reyes PM, Schleicher P, Brantley AGU, Baek S, Kandziora F, Marciano F, Crawford NR

Abstract

Study design: A new low-profile cervical interbody fusion cage with integrated anterior fixation was compared biome-chanically to established anterior cervical devices using non-destructive flexibility testing in human cadaveric spines.Objective: To evaluate the fixation properties of the new stand-alone device (test device) and compare these proper-ties with established fixation methods under various loading modes. The hypothesis is that the new device will provide stability comparable to that provided by an anterior cervical cage when supplemented with an anterior plate. Methods: Twenty-four human cadaveric C4–C7 cervical spines were loaded non-destructively with pure moments in a non-constrained testing apparatus to induce flexion, exten-sion, lateral bending, and axial rotation (maximum 1.5 Nm) while angular motion was measured optoelectronically. The specimens were tested: 1) intact (N = 24) 2) after discectomy and anterior stabilization a) PEEK cage + CSLP [cage+CSLP] (N = 8) b) PEEK cage + Vectra-T [cage+Vectra-T] (N = 8) c) PEEK cage with integrated anterior fixation [test device]

(N = 8) 3) after ventral plate removal of group 2a and 2b [cage-only] (N = 16).

Stability similar to that of an anterior spacer and plate

Results: All fixation techniques decreased range of motion (ROM) and Lax Zone (LZ) (P<0.05) in all test modes com-pared to the intact motion segment and cage-only group. (All decreased, but one wasn’t significant (p<0.05). Test de-vice vs. cage-only group in extension p = 0.077). There were no significant differences between the test-device and cage + CSLP or cage + Vectra-T. Conclusions: The test-device provided a similar biomechani-cal stability to that of the established anterior fusion tech-nique using an anterior plate plus cage and has a potentially lower peri- and post-operative morbidity. These results sup-port progression to clinical trials using the test-device as a stand-alone implant.

Zero-P and Zero-P chronOS. Zeroprofile anterior cervical interbody fusion(ACIF) device.


In 1958, the AO formulated four basic principles, which have become the guidelines for internal fixation13. They are: – Anatomical reduction – Stable fixation – Preservation of blood supply – Early, active mobilization

The fundamental aims of fracture treatment in the limbs and fusion of the spine are the same. A specific goal in the spine is returning as much function as possible to the injured neu-ral elements13.

AO Principles as applied to the spine14

Anatomic reductionIn the spine, this means reestablishing and maintaining the natural curvature and the protective function of the spine. By regaining this natural anatomy, the biomechanics of the spine can be improved, and a reduction of pain can be expe-rienced.

Stable fixationStabilization of the spinal segment to promote bony fusion.Biomechanical tests have demonstrated that the Zero-P offers comparable stability to that of a spacer combined with anterior plate fixation in flexion, extension and lateral bend-ing, and torsion.

Preservation of blood supplyCreation of an optimal environment for fusion.

Early, active mobilizationMinimized damage to the spinal vasculature, dura, and neural elements, which may contribute to pain reduction and improved function for the patient.

AO Principles


The Zero-P system is intended for use following anterior cer-vical discectomy for reduction and stabilization of the cervi-cal spine (C2–C7).

Indications include: – Degenerative disc disease (DDD, defined as neck pain of

discogenic origin with degeneration of the disc confirmed by history and radiographic studies)

– Spinal stenosis – Failed previous fusions – Pseudoarthrosis

Contraindications – Spinal fracture – Spinal tumor – Severe osteoporosis – Spinal infection

Indications and Contraindications


Preoperative Planning

Instruments

X000069 X-ray Template for Zero-P, parallel

X000070 X-ray Template for Zero-P, convex

X000071 X-ray Template for Zero-P, lordotic

Prior to surgery, determine the desired surgical approach and estimate the appropriate Zero-P spacer size. An initial esti-mate of the size can be made by comparing the x-ray tem-plate for Zero-P with the adjacent intervertebral discs on a lateral radiograph.

Definitive information on the appropriate size should be obtained by measuring the distracted disc space during the operation using the trial spacers.

Notes: – The height of the spacer indicated on the template is ap-

proximately 0.8 mm shorter than that of the actual spacer to account for penetration of the teeth into the vertebral end plate.

– With the segment fully distracted, the Zero-P must fit firmly between the end plates before locking head screws are inserted. When rocking the aiming device backward and forward in a cranial to caudal direction, no toggling of the implant should be evident.

– It is recommended to select the maximum implant size in order to optimize the stability of the segment through tension in the annulus fibrosus and longitudinal ligaments.

– Template images are 115% of actual implant size to corre-spond to typical radiographic magnification.


8.5 mm 9.5 mm

When implanting Zero-P adjacent to a prior fusion, take care to avoid placing the Zero-P spacer and screws in direct contact with previously implanted hardware. As necessary, remove adjacent-level hardware that prevents Zero-P from being implanted using the correct technique.

Precaution: Placement of Zero-P adjacent to a previous, multi-level fusion could result in increased loading. Supple-mental fixation should be considered in cases where Zero-P is placed adjacent to a previous, multi-level fusion.

Do not place Zero-P adjacent to previously implanted hard-ware if the adjacent level cannot be confirmed to be fused or where fusion has not occurred.

Warning: Use radiographic imaging to verify final implant position relative to the vertebral bodies in the AP and lateral direction and remaining implanted hardware associated with the previously fused level.

To accommodate previously placed hardware, orient the Ze-ro-P implants with lordotic and parallel sagittal profiles with either the medial screws facing cranially or caudally. Consider screw dimensions to determine desired orientation.

Precaution: Do not orient Zero-P implants having convex sagittal profiles with medial screws facing cranial. Orienting convex sagittal profile implants with medial screws facing cranial may prevent proper seating of the implant between vertebral bodies.

Considerations for Use Adjacent to a Prior Fusion


Warnings: – If adjacent hardware prevents less than four screws from

being implanted, a different device should be used, as increased loading may be placed on the screws leading to potential post-operative device failure and potentially increased harm to the patient.

– If any screw cannot be inserted at the correct trajectory or locked to the plate according to recommended techniques as described in steps A1-E4, a different device should be used to avoid the potential risk of screw back-out or screw failure.

– Confirm that the Zero-P implant is not placed in direct contact with implanted hardware associated with the pre-viously fused level. If the Zero-P implant remains in direct contact with hardware associated with the previously fused level, increased loading may be placed on the Ze-ro-P implant leading to potential post-operative device failure and potential harm to the patient.


Patient Positioning, Exposure and Disectomy

Using the standard surgical approach, expose the vertebral bodies to be fused. Prepare the fusion site following the appropriate technique for the given indication.

1Patient Positioning

Position the patient in a supine position on a radiolucent 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. For all cases, both vertebrae should be completely visible.

2Access

Optional set

187.797 Cervical Retractors and Distractors

Locate the correct operative level under radiographic control and incise.

Expose the intervertebral disc and the adjacent vertebral bodies through a standard anterior approach to the cervical spine.

Warning: Careful positioning of the retractor is required to avoid soft tissue damage.


3Discectomy

Prepare the fusion site following the appropriate technique for the given indication.

Optional set

187.797 Cervical Retractors and Distractors

Perform segmental distraction.

Note: Distraction of the segment is essential for restoring disc height and for providing good access to the inter-vertebral space.


1Determine appropriate implant

Instruments

03.617.720–729 Zero-P Trial Spacer, parallel, heights 5 – 12 mm, purple

03.617.750–759 Zero-P Trial Spacer, lordotic, heights 5 – 12 mm, blue

03.617.780–789 Zero-P Trial Spacer, convex, heights 5 – 12 mm, gold

03.617.730–739 Zero-P Trial Spacer, large, parallel, heights 5 – 12 mm, purple

03.617.760–769 Zero-P Trial Spacer, large, lordotic, heights 5 – 12 mm, blue

03.617.790–799 Zero-P Trial Spacer, large, curved, heights 5 – 12 mm, gold

Optional instruments

03.617.940 Handle with Large Quick Coupling

03.820.113 Mallet

Selection of the trial spacer depends on the height and depth of the intervertebral space, the preparation technique and the patient’s anatomy. Choose a parallel, lordotic or convex trial spacer of the appropriate height and depth.

Position the trial spacer in the correct cranial/caudal align-ment and carefully insert it into the disc space.

Implant Insertion


1 Choose the appropriate implant footprint and size to accomodate variations in patient anatomy; failure to do so may injure the patient.

Precaution: The trial spacers do not have a depth limiter; an image intensifier should be used to check the position during insertion. With the segment fully distracted, the trial spacer must fit tightly and accurately between the end plates.1

The mallet can be used to help insert and/or remove the trial spacer.

If preferred, a larger handle can be attached to the trial spacer.

Notes: – The trial spacers are color-coded by shape. – The height of the trial spacer is 0.8 mm less than that of

the corresponding implant to account for penetration of the teeth into the vertebral end plate.

– Trial spacers are not for implantation and must be

removed before insertion of the Zero-P implant.

Warning: To minimize potentially increased risk to the patient, it is recommended to use shorter height trial spacers before using taller height trial spacers, and to use standard size footprint trial spacers before using large size footprint trial spacers.


2aPack implant with bone graft

Instruments

03.617.984 Packing Block for Zero-P

03.617.970 Cancellous Bone Impactor for Zero-P

It is recommended to pack the Synthes Zero-P implant with autologeous bone or bone graft substitute.

Place the appropriate Zero-P implant into the packing block.

Use the cancellous bone impactor to firmly pack graft material into the implant cavity.

Notes: – To ensure optimal contact with the vertebral end plates it

is important to fill the implant until the graft material pro-trudes from the perforations in the spacer.

– The Bone Impactor can only be used with the standard size footprints of Zero-P.

Implant Insertion


2bPrefilled Zero-P chronOS

Filling of the Zero-P implant is not required if the prefi lled Ze-ro-P chronOS is used:

To ensure rapid onset of fusion of the prefi lled Zero-P and subsequent remodeling of the chronOS insert, the implant must be dipped in autologous blood or bone marrow aspi-rate. Soaking in blood should be done for at least 15 sec-onds to ensure suffi cient perfusion of the chronOS insert.


Implant Insertion

3Insert implant

Instrument

03.617.963 Aiming Device for Zero-P


03.617.980 Implant Holder for Zero-P

03.820.113 Mallet

03.617.981 Impactor, flat

03.617.982 Impactor with pointed ball tip

Use the aiming device or implant holder to introduce the implant into the disc space. The recommended orientation is with the medial screws pointing caudally.

Precaution: The aiming device and the implant holder do not have a depth limiter, therefore an image intensifier should be used to check the position while inserting.

Using the aiming deviceAttach the aiming device to the implant by aligning the screw holes of the implant with the retention features on the aiming device and then expanding the aiming device. Once the implant is securely attached, carefully insert the implant into the distracted segment.

If necessary, the top of the aiming device can be tapped with the mallet to advance the implant into the disc space. If distraction has been applied, release the distraction while leaving the aiming device attached to the implant.


Using the implant holderThe implant can be inserted into the disc space with the for-ceps-type implant holder. Once the implant is partially intro-duced into the disc space the implant can be advanced to the correct posterior depth using the flat and/or the impac-tor with ball tip.

Warning: Verify final implant position relative to the verte-bral bodies in the AP and lateral direction with the help of an intraoperative x-ray. The PEEK spacer has a single posterior x-ray marker incorporated into the implant to enable accu-rate intraoperative radiographic assessment of the implant position.

Note: The recommended orientation for the implant is with the medial screws pointing caudally. For convex shaped spac-ers this is the only orientation possible.


2.5° 2.5°

2.5° 2.5°

40°55°

40°55°

A1Drill first pilot hole through drill and screw hole of aiming device

Instruments


03.617.912 Drill Bit B 2.0 mm, drilling depth 12 mm, 3-flute, for Quick Coupling



03.617.903 Handle with Quick Coupling

Select a drill bit of appropriate length. Insert the drill bit into the drill and screw hole of the aiming device and drill until the stop on the drill bit contacts the guide.

Screw FixationOption A: Aiming Device

The aiming device allows one screw to be inserted with the instrument attached to the implant. This helps to keep the implant in place while the other screw holes are prepared and screws inserted.


Warning: Intraoperative imaging should be used to verify drill position.

Remove drill bit.

Note: The drill bits are marked with a colored ring corre-sponding to the color-coded screw lengths.

Precaution: When using the drill bit in combination with the aiming device, take care to apply only axial forces to the drill bit. Bending forces applied when the tip of the drill bit is engaged in the aiming device can lead to the drill bit break-ing.


A2Insert first screw

Instruments

03.110.002 Torque Limiter, 1.2 Nm, with AO/ASIF Quick Coupling

03.617.902 Screwdriver Shaft Stardrive, T8, self-holding


Optional instrument

03.617.901 Holding Sleeve for Screws for use with No. 03.617.902

03.110.005 Handle for Torque Limiters 0.4/0.8/1.2 Nm

Select the appropriate screw length according to the preop-erative planning and intraoperative findings.

Assemble the torque limiter to the screwdriver shaft and handle.



Precaution: If the torque limiter is not used, breakage of the screwdriver may occur and could potentially harm the p atient.

Load a screw onto the screwdriver with torque limiter. The screw will self-retain to the screwdriver, however, for increased screw retention the holding sleeve may be used.

Note: Retract the sleeve when inserting the first screw through the aiming device.

Advance the screw until the head of the screw contacts the plate.

Warning: Intraoperative imaging should be used to verify screw position.

Precaution: The screws should be tightened only after all screws have been inserted.


A3Drill remaining pilot holes

Instruments






Select a drill bit of appropriate length. Insert the drill bit into a drill hole of the aiming device and drill until the stop on the drill bit contacts the guide.




Remove the drill bit.

Repeat for the remaining screw holes.

Note: The drill bits are marked with a colored ring corre-sponding to the color-coded screw lengths.

Precaution: When using the drill bit in combination with the aiming device, take care to apply only axial forces to the drill bit. Bending forces applied when the tip of the drill bit is engaged in the aiming device can lead to the drill bit break-ing.



A4Insert remaining screws

Instruments







Remove the aiming device from the implant.

Load the selected screw onto the screwdriver with torque limiter. The screw will self-retain to the screwdriver, however, for increased screw retention the holding sleeve may be used.Advance the screw until the head of the screw contacts the plate.

Repeat for the remaining screws.



Note: If the aiming device is difficult to remove, verify that the screw is advanced far enough so that the aiming device is not contacting the screw during removal.


A5Tighten screws

Instruments




Optional Instrument


To lock the screwhead in the plate, always use the torque limiter with the screwdriver to tighten each screw to the recommended 1.2 Nm torque.

Precaution: If the torque limiter is not used, breakage of the screwdriver may occur and could potentially harm the patient.

Note: Screws placed using the surgical technique may not always be flush with the plate, but will be sufficiently locked when 1.2 Nm torque is achieved.


2.5° 2.5°

2.5° 2.5°

40° 55°

40° 55°

If use of the aiming device is not the preferred surgical technique, follow these alternative technique steps.

B1Drill first pilot hole

Instruments

03.617.962 Drill Guide with Handle





It is recommended that the first hole be created for a caudally pointing screw.

Select a drill bit of appropriate length. Determine the entry point and trajectory for the screw. The correct angulations for the screws are 40° in the caudal or cranial direction. The medial screws point 2.5° laterally and the lateral screws point 2.5° medially.

Note: Lateral screws should always point medially.

Screw FixationOption B: Drill Guide and Freehand Screw


Insert the drill guide into the screw hole at the appropriate angle. The tip of the drill guide is designed to fit inside the screw hole of the plate and provide a “feel” for the correct angle.

Insert the drill bit into the guide and drill until the stop on the drill bit contacts the guide.

Remove the drill bit and guide.


Note: The drill bits are marked with a colored ring corre-sponding to the color-coded screw lengths. When the ring is flush with the top of the drill guide the appropriate depth has been reached.


B2Insert first screw

Instruments




Optional Instruments



Select the appropriate screw length according to the pre operative planning and intraoperative findings.


Screw FixationOption B: Drill Guide andFreehand Screw



Load the screw onto the self-retaining screwdriver with torque limiter. The screw will self-retain to the screwdriver, however, for increased screw retention the holding sleeve may be used.





04_Step

B3Insert remaining screws

Repeat steps B1 and B2 for the remaining screws.

B4Tighten screws

Instruments




Optional Instrument



Screw FixationOption B: Drill Guide andFreehand Screw


2.5° 2.5°

2.5° 2.5°

40°55°

40°55°

C1Drill first pilot hole

Instruments

03.617.968 Drill Guide with threaded tip

03.617.912 Drill Bit 2.0 mm, drilling depth 12 mm, 3-flute, for Quick Coupling




It is recommended that the first hole be created for a caudally pointing screw.

Determine the trajectory for the threaded drill guide. The correct angulations are 40° in the caudal or cranial direction.

Screw the threaded drill guide into the thread of the Zero-P plate at the appropriate angle until 2-finger tight. The thread of the drill guide is designed to fit inside the thread of the Zero-P plate.

Screw FixationOption C: Threaded Drill Guide and Freehand Screw


Determine a drill bit of appropriate length. Insert the drill bit into the guide and drill until the stop on the drill bit contacts the guide.

Remove the drill bit and and the threaded the drill guide.


Note: The drill bits are marked with a colored ring corre-sponding to the color-coded screw lengths. When the ring is flush with the top of the drill guide the appropriate depth has been reached.


Screw FixationOption C: Threaded Drill Guide andFreehand Screw

C2Insert first screw

Instruments











C4Tighten screws

Instruments




Optional Instrument


C3Insert remaining screws

Repeat steps C1 and C2 for the remaining screws.

Screw FixationOption C: Threaded Drill Guide andFreehand Screw


To lock the screwhead in the plate, always use the torque limiter with the screwdriver to tighten each screw to the rec-ommended 1.2 Nm torque.




2.5° 2.5°

2.5° 2.5°

40°55°

40°55°

If surgeon preference is to awl and not to use the drilling technique, this alternative technique may be used.

D1Awl first pilot hole

Instrument

03.617.990 Awl B 2.0 mm, with Sleeve

It is recommended that the first hole be created for a caudally pointing screws.

Determine the entry point and trajectory for the screw. The correct angulations for the screws are 40° in caudal or cra-nial direction. The medial screws point 2.5° laterally and the lateral screws point 2.5° medially.


Insert the awl at the appropriate angle into a screw hole in the plate and push down, while simultaneously twisting the handle.

Screw FixationOption D: Awl and Freehand Screw


Remove the awl, maintaining alignment of the hole and plate.

Warning: Intraoperative imaging should be used to verify awl position.

Note: The tip of the awl is designed to fit inside the screw hole of the plate and provide a “feel” for the correct angle.

Precaution: Take care that the awl does not move the im-plant relative to the vertebral body. For particularly hard bone, drilling is recommended to minimize implant move-ment.


D2Insert first screw

Instruments












D4Tighten screws

Instruments




Optional Instrument


D3Insert remaining screws

Repeat step D1 and D2 for the remaining screws.



2.5° 2.5°

2.5° 2.5°

40°55°

40°55°

Screw FixationOption E: Angled Instruments

For screws that are difficult to drill or insert because of inter-fering anatomy, the angled awl and angled screwdriver may be used.

E1Awl first pilot hole

Instruments

03.617.993 Awl B 2.0 mm, angled

03.820.113 Mallet

It is recommended that the first hole be created for a caudally pointing screws.

Determine the entry point and trajectory for the screw. The correct angulations for the screws are 40° in the caudal or cranial direction. The medial screws point 2.5° laterally and the lateral screws point 2.5° medially.


Insert the awl at the appropriate angle into the screw hole of the plate and tap with the mallet until the awl is seated.

Remove the awl, maintaining alignment of the hole and plate.

Warning: Intraoperative imaging should be used to verify awl position.


E2Insert first screw

Instrument

03.617.900 Screwdriver Stardrive, T8, self-holding, angled, with Sleeve





03.617.905 Shaft for angled Screwdriver, with Quick Coupling


Load a screw onto the angled screwdriver. Advance the screw until the head of the screw contacts the plate.



E3Insert remaining screws

Repeat steps E1 and E2 for the remaining screws.

E4Tighten screws

Instruments








Screw FixationOption E: Angled Instruments


Implant Removal

If a Zero-P implant must be removed, the following technique is recommended.

1Remove screw

Instruments



Attach the handle to the screwdriver shaft, then engage the assembled driver into the drive recess of the screw to be removed. Rotate the driver counterclockwise to first loosen the screw from the Zero-P implant. Continue to rotate the driver counterclockwise to remove the loosened screw from the implant.

Note: If multiple screws need to be removed, it is recom-mended to first loosen all screws before removing any of the screws from the implant. Loosening all screws before removal of any screw ensures the implant will be properly secured during removal.

Note: Torque limiting attachment should not be used with driver to remove screws.


Optional technique

1aRemove screw with Conical Extraction Screw

Instruments

03.617.971S Extraction Screw, conical

03.617.975S Drill Bit B 2.0 mm, 2-flute, for Quick Coupling


In the event the screwdriver cannot properly engage the drive recess of the screw to loosen the screw, or if the screw recess is damaged, the conical extraction screw may be used to remove the screw.

First, use the 2.0 mm drill bit to prepare the screw recess. Under full power and on axis with the screw, insert the drill bit into the screw head to lightly pre-drill the screw recess. Advance the drill bit until the stop of the drill bit contacts the top of the screw. This facilitates deeper anchoring of the conical extraction screw into the screw recess.


Warning: Drilling into the screw recess with the 2.0 mm drill bit will cause metal debris. Use of suction and irrigation is recommended to remove the debris from the wound.

Connect the conical extraction screw to the handle with quick coupling. Insert the tip of the conical extraction screw into the screw recess on axis with the screw. Turn counter-clockwise until the extraction screw grasps into the screw re-cess. Continue to turn counterclockwise to remove the screw.

Precaution: Do not use the conical extraction screw with power tools. Use of power tools with the conical extraction screw may potentially damage the screw recess and/or extraction screw, preventing subsequent removal.

Precaution: Do not use the conical extraction screw with torque-limiting attachment, as this prohibits removal of the screws and may cause additional damage to the instrumen-tation.

Note: The conical extraction screw is single-use only. Multiple screws in the same removal procedure may be removed with a single new 2.0 mm drill bit.

Implant Removal


2Extract implant

Instrument


Once all screws are removed, the Zero-P implant may be removed using the aiming device. Attach the aiming device to the implant by aligning the screw holes of the implant with the retention features on the aiming device and then expanding the aiming device.

After the implant is securely attached, carefully remove the implant.

Note: Use of distraction at the disc space is recommended to facilitate removal.


Implants

Zero-P Spacers – Supplied sterile and preassembled (spacer with anterior

fi xation plate) – Available in 3 different shapes: convex, lordotic and parallel – Available in three material combinations:

1. Spacer component PEEK Optima, plate component titanium alloy (TAN)

2. Spacer component PEEK Optima prefi lled with chronOS, plate component titanium alloy (TAN)

3. Spacer and plate component: Titanium alloy (TAN) – TAN spacer components and trial spacers are color-coded

(convex – gold, lordotic – blue, parallel – purple)

1a Zero-P, spacer component PEEK Optima, plate component TAN

Convex Lordotic Parallel

Implant Implant Trial spacer Implant Trial spacer Implant Trial spacerheight

5 mm 04.617.135S 03.617.785 04.617.125S 03.617.755 04.617.115S 03.617.725

6 mm 04.617.136S 03.617.786 04.617.126S 03.617.756 04.617.116S 03.617.726

7 mm 04.617.137S 03.617.787 04.617.127S 03.617.757 04.617.117S 03.617.727

8 mm 04.617.138S 03.617.788 04.617.128S 03.617.758 04.617.118S 03.617.728

9 mm 04.617.139S 03.617.789 04.617.129S 03.617.759 04.617.119S 03.617.729

10 mm 04.617.130S 03.617.780 04.617.120S 03.617.750 04.617.110S 03.617.720

11 mm 04.617.131S 03.617.781 04.617.121S 03.617.751 04.617.111S 03.617.721

12 mm 04.617.132S 03.617.782 04.617.122S 03.617.752 04.617.112S 03.617.722

1b Zero-P, spacer component PEEK Optima, plate component TAN, chronOS filler

Convex Lordotic

Implant Implant Trial spacer Implant Trial spacerheight

5 mm 04.617.035S 03.617.785 04.617.025S 03.617.755

6 mm 04.617.036S 03.617.786 04.617.026S 03.617.756

7 mm 04.617.037S 03.617.787 04.617.027S 03.617.757

8 mm 04.617.038S 03.617.788 04.617.028S 03.617.758

9 mm 04.617.039S 03.617.789 04.617.029S 03.617.759

10 mm 04.617.030S 03.617.780 04.617.020S 03.617.750

11 mm 04.617.031S 03.617.781 04.617.021S 03.617.751

12 mm 04.617.032S 03.617.782 04.617.022S 03.617.752


2. Zero-P, spacer and plate component TAN, color-coded


Implant Implant Trial spacer Implant Trial spacer Implant Trial spacerheight

5 mm 04.617.195S 03.617.785 04.617.185S 03.617.755 04.617.175S 03.617.725

6 mm 04.617.196S 03.617.786 04.617.186S 03.617.756 04.617.176S 03.617.726

7 mm 04.617.197S 03.617.787 04.617.187S 03.617.757 04.617.177S 03.617.727

8 mm 04.617.198S 03.617.788 04.617.188S 03.617.758 04.617.178S 03.617.728

9 mm 04.617.199S 03.617.789 04.617.189S 03.617.759 04.617.179S 03.617.729

10 mm 04.617.190S 03.617.780 04.617.180S 03.617.750 04.617.170S 03.617.720

11 mm 04.617.191S 03.617.781 04.617.181S 03.617.751 04.617.171S 03.617.721

12 mm 04.617.192S 03.617.782 04.617.182S 03.617.752 04.617.172S 03.617.722

1c Zero-P, large, spacer component PEEK Optima, plate component TAN


Implant Implant Trial spacer Implant Trial spacer Implant Trial spacerheight Large Large Large Large Large Large

5 mm 04.617.235S 03.617.795 04.617.225S 03.617.765 04.617.215S 03.617.735

6 mm 04.617.236S 03.617.796 04.617.226S 03.617.766 04.617.216S 03.617.736

7 mm 04.617.237S 03.617.797 04.617.227S 03.617.767 04.617.217S 03.617.737

8 mm 04.617.238S 03.617.798 04.617.228S 03.617.768 04.617.218S 03.617.738

9 mm 04.617.239S 03.617.799 04.617.229S 03.617.769 04.617.219S 03.617.739

10 mm 04.617.230S 03.617.790 04.617.220S 03.617.760 04.617.210S 03.617.730

11 mm 04.617.231S 03.617.791 04.617.221S 03.617.761 04.617.211S 03.617.731

12 mm 04.617.232S 03.617.792 04.617.222S 03.617.762 04.617.212S 03.617.732


Implants

3. Cervical Spine Locking Screws, B 3 mm– Self-tapping– Self-centering– Titanium alloy (TAN)– Screw lengths are color coded:

12 mm, blue 14 mm, gold 16 mm, purple

Art. No. Length Color

04.617.812 12 mm Blue

04.617.814 14 mm Gold

04.617.816 16 mm Purple

Art. No. Length Units

04.617.812.02S 12 mm pack of 2 units, sterile




Instruments

03.617.720–729 Zero-P Trial Spacer, parallel, heights 5 – 12 mm

03.617.750–759 Zero-P Trial Spacer, lordotic, heights 5 – 12 mm03.617.780–789 Zero-P Trial Spacer, convex, heights 5 – 12 mm





03.617.730–739 Zero-P Trial Spacer, large, parallel, heights 5 – 12 mm

03.617.760–769 Zero-P Trial Spacer, large, lordotic, heights 5 – 12 mm 03.617.790–799 Zero-P Trial Spacer, large, convex, heights 5 – 12 mm






03.617.962 Drill Guide with Handle


03.617.968 Drill Guide with threaded tip

03.820.113 Mallet

Instruments


03.617.984 Packing Block for Zero-P

03.617.990 Awl B 2.0 mm, with Sleeve

03.617.993 Awl B 2.0 mm, angled


03.617.980 Implant Holder for Zero-P

03.617.970 Cancellous Bone Impactor for Zero-P

03.617.981 Impactor, flat

03.617.982 Impactor with pointed ball tip


Instruments


03.617.940 Handle with Large Quick Coupling

03.617.975S Drill Bit B 2.0 mm, 2-flute, for Quick Coupling

03.617.931 Adapter for Quick Coupling

03.617.930 Shaft Extension for Quick Coupling


03.617.971S Extraction Screw, conical

Removal Tools*

*Sterile, for single use


68.617.001

68.617.002

Set

68.617.000 Vario Case for Zero-P, without Contents (Contains one screw and one trial spacer

module 68.617.001 and 68.617.002)

68.617.001 Zero-P Module for Screws

68.617.002 Zero-P Module for Trial Spacers

68.000.101 Lid for Modular Tray, size 1/1

684.060 Lid for Modular Tray, size 1/2

68.000.102 Lid for Modular Tray, size 1/4

Set


Also Available from Synthes: chronOS Putty – Spine

Indications*chronOS Putty with autologous bone marrow and/or blood is intended for use in spine indications, such as: – Intraoperative fi lling of IBF cages and the space around

them – Posterolateral fusion

* For complete indications, contraindications, precautions and warning notices, please refer to the instructions for use (Item No. 74255).

Benefi ts of chronOS Putty

No wash-out

X-ray visibility

Added osteoinductivity

Accelerated remodeling


chronOS Putty for Spine*

710.801S chronOS Putty, 1 cc

710.802S chronOS Putty, 2.5 cc



Bone Marrow Aspiration System (BMAS)

Art.No. Diameter Length Syringe

710.111S 11 ga 11 cm 20 ml

710.151S 11 ga 15 cm 20 ml

* Manufactured by: Mathys AG Bettlach, Güterstrasse 5, CH-2544 Bettlach

Distributed by: DePuy Synthes Spine

Ordering information


2

1

3

1

2

1

2

4

03.617.900Screwdriver Stardrive


2

1

3

1

2

03.617.901Holding Sleeve for Screws


2

1

03.617.903Handle with Quick Coupling


2

1

21

03.617.990Awl B 2.0 mm, with Sleeve


1. Bazaz R, Lee MJ, Yoo JU (2002) Incidence of dysphagia after anterior cervical spine surgery: a prospective study. Spine 27:2453–2458.

2. Smith-Hammond CA, New KC, Pietrobon R et al. (2004) Prospective analysis of incidence and risk factors of dyspha-gia in spine surgery patients: comparison of anterior cervical, posterior cervical, and lumbar procedures. Spine 29:1441–1446.

3. Lee MJ, Bazaz R, Furey CG et al. (2005) Influence of ante-rior cervical plate design on Dysphagia: a 2-year prospective longitudinal follow-up study. J.Spinal Disord.Tech.18:406-409.

4. Yue WM, Brodner W, Highland TR. (2005) Persistent swallowing and voice problems after anterior cervical discec-tomy and fusion with allograft and plating: a 5- to 11-year follow-up study. Eur Spine J. 14: 677–682

5. Park JB, Cho YS, Riew KD (2005) Development of adja-cent-level ossification in patients with an anterior cervical plate. J.Bone Joint Surg.Am. 87:558–563.

6. Kaiser MG, Haid RW Jr., Subach BR et al. (2002) Anterior cervical plating enhances arthrodesis after discectomy and fusion with cortical allograft. Neurosurgery 50:229–236.

7. Barsa P, Suchomel P (2007) Factors affecting sagittal malalignment due to cage subsidence in standalone cage assisted anterior cervical fusion. Eur.Spine J. 16:1395–1400.

8. Herrmann AM, Geisler FH (2004) Geometric results of anterior cervical plate stabilization in degenerative disease. Spine 29:1226–1234.

9. Caspar W, Geisler FH, Pitzen T et al. (1998) Anterior cervi-cal plate stabilization in one- and two-level degenerative disease: overtreatment or benefit? J.Spinal Disord. 11:1–11.

10. Fraser JF, Hartl R (2007) Anterior approaches to fusion of the cervical spine: a metaanalysis of fusion rates. J.Neuro-surg.Spine 6:298–303.

11. Mobbs RJ, Rao P, Chandran NK (2007) Anterior cervical discectomy and fusion: analysis of surgical outcome with and without plating. J.Clin.Neurosci. 14:639–6342.

12. Moftakhar R, Trost GR (2004) Anterior cervical plates: a historical perspective. Neurosurg.Focus.;16:E8

13. Müller ME, Allgöwer M, Schneider R, Willenegger H (1995) Manual of Internal Fixation. 3rd, exp. a. completely rev. ed. 1991. Corr. 3rd printing. Berlin, Heidelberg, New York: Springer

14. Aebi M, Arlet V, Webb JK (2007) AOSPINE Manual (2 vols), Stuttgart, New York: Thieme

15. Scholz M, Reyes PM, Schleier P, Sawa A, Baek S, Kandziora F, Marciano F, Crawford N (2009) A new stand-alone cervical anterior interbody fusion device: Biomechani-cal comparison with established anterior cervical fixation devices: Spine 34: 156–160.

16. Becker S, Maissen O, Ponomarev I, Stoll T, Rahn B, Wilke I (2006) Osteopromotion by a Tricalcium Phosphate/Bone Marrow Hybrid Implant for Use in Spine Surgery. Spine 31 (1): 11–17.

17. Goulet JA, Senunas LE, DeSilva GL, Greenfield ML (1997) Autogenous iliac crest bone graft. Complications and func-tional assessment. Clin Orthop 339:76–81.

18. Muschik M, Ludwig R, Halbhübner S, Bursche K, Stoll T (2001) Beta-tricalcium phosphate as a bone substitute for dorsal spinal fusion in adolescent idiopathic scoliosis: prelimi-nary results of a prospective clinical study. Eur Spine J. 10 (2):178–84.

19. Silber JS, Anderson DG, Daffner SD, Brislin BT, Leland JM, Hilibrand AS, Vaccaro AR, Albert TJ (2003) Donor site morbidity after anterior iliac crest bone harvest for sin-gle-level anterior cervical discectomy and fusion. Spine 15; 28(2):134–139.

Bibliography


20. Allmann M, Florias E, Stoll T, Hoerger F, Bart F (2002)Haematological evaluation of blood samples after vacuum-like impregnation of a Beta-TCP ceramic bone substitute be-fore implantation (internal communication).

21. Buser D, Hoffmann B, Bernard JP, Lussi A, Mettler D, Schenk RK (1998) Evaluation of filling materials in mem-brane-protected bone defectsClinical Oral Implants Research: 9:137-150.

22. Steffen T, Stoll T, Papin P, Reindle F, Marchesi F, Schenk R, Aebi M (2000) Beta Tricalcium Phosphate Bone Graft Substi-tutes in Spinal Fusion – Preliminary results from a Sheep and Baboon Study. Abstract, DGBM, Ulm, Germany.

23. Stoll T, Maissen O, Meury T, Becker S (2004)New aspects in osteoinduction.Mat.-wiss. U. Werkstofftech 35(4): 198-202.

Synthes GmbHEimattstrasse 34436 OberdorfSwitzerlandTel: +41 61 965 61 11Fax: +41 61 965 66 00www.depuysynthes.com 0123 ©

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Not all products are currently available in all markets.

This publication is not intended for distribution in the USA.

All surgical techniques are available as PDF files at www.depuysynthes.com/ifu

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