Surgical Technique. DePuy International Ltd St Anthony s Road Leeds LS11 8DT England Tel: +44 (113) Fax: +44 (113)

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June Francis
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Surgical Technique DePuy Spine is a joint venture with Biedermann

This publication is not intended for distribution in the USA.

1 Surgical Technique DePuy Spine is a joint venture with Biedermann Motech GmbH. This publication is not intended for distribution in the USA. DePuy Spine, Slim-loc and Cam-loc are all trademarks of DePuy Spine, Inc. and Healos is a registered trademark of DePuy Spine, Inc. Conduit is a trademark of DePuy Orthopaedics, Inc DePuy International Limited. All rights reserved. Cat No: Issued: 03/06 DePuy International Ltd St Anthony s Road Leeds LS11 8DT England Tel: +44 (113) Fax: +44 (113)

Contents Introduction Step 1: Choosing Plate Size Step 2: Adjusting Plate Curvature Step 3: Placing Temporary Fixation Pins Step 4: Preparing Screw Hole Step 5: Drilling Holes Step 6: Selecting and

2 Contents Introduction Step 1: Choosing Plate Size Step 2: Adjusting Plate Curvature Step 3: Placing Temporary Fixation Pins Step 4: Preparing Screw Hole Step 5: Drilling Holes Step 6: Selecting and Using Drill Bits Step 7: Using The Tap Step 8: Inserting Screw Step 9: Locking the Cams Bone Graft Solutions Ordening Information The Slim-loc anterior cervical plate is a semi-rigid plate system for anterior intervertebral body fixation. It is indicated for stabilisation of the cervical spine from C2 to C7 employing the option of either uni-cortical or bi-cortical screw fixation at the anterior face of the vertebral bodies.

Introduction Slim-Loc Anterior Cervical Plate System Step 1: Choosing Plate Size The Slim-loc Plate is a semi-rigid plate system intended for anterior cervical intervertebral body fixation.

3 Introduction Slim-Loc Anterior Cervical Plate System Step 1: Choosing Plate Size The Slim-loc Plate is a semi-rigid plate system intended for anterior cervical intervertebral body fixation. The design principles of the Slim-loc Plate are built upon the clinical heritage of the comprehensive Codman ACP plate system, but have been modified in order to offer a lower and slimmer plate profile, as well as offer additional implant options. The Slim-loc System offers maximum implant versatility and integrated instrumentation. The Slim-loc Anterior Cervical Plate System is indicated for stabilisation of the cervical spine from C2 to C7 employing unicortical screw fixation at the anterior face of the vertebral bodies. Specific clinical indications for anterior cervical plating include: Instability caused by trauma Instability associated with correction of cervical lordosis and kyphotic deformity Instability associated with pseudoarthosis as a result of previously failed cervical spine surgery Instability associated with major reconstructive surgery for primary tumours or metastatic malignant tumours of the cervical spine Instability associated with single or multiple level corpectomy in advanced degenerative disc disease, spinal canal stenosis and cervical myelopathy Note: The described technique presents only one of many approaches to the stabilisation of the anterior cervical spine. The surgeon is encouraged to utilise the Slim-loc Anterior Cervical Plating System with those techniques most familiar to the operating surgeon. Slim-loc Anterior Cervical Plates are available in 1-5 level configuration with a length ranging from mm. When handling plates, use caution to avoid scratching or notching the plate surface as this can weaken and compromise the mechanical integrity of the device. Following anterior bone graft placement, use the forceps to select the appropriate plate size and place it on the vertebral column. Confirm that the length is appropriate. The plate should span the entire fusion segment, preferably using the shortest plate possible, therefore avoiding the adjacent disc space. Fluoroscopy may be utilised to optimise plate selection and screw placement. 2 3

Surgical Technique Step 2: Adjusting Plate Curvature Step 3: Placing Temporary Fixation Pins The Slim-loc Plate has a precontoured lordotic curvature, anatomically appropriate in the majority of

It is critical to bend the plate in the specified Bend Zone(s), which has a smooth under-surface and reduced cross-sectional thickness.

After selecting the appropriate plate, use the Temporary Fixation Pins (TFPs) to hold the plate in place while drilling and placing the screws.

Note: Temporary Fixation Pins are designed for single use.

If required to achieve additional plate lordosis, the plate is placed between the lobes (Cam-loc facing up) of the Plate Bender. The weaken and compromise the mechanical integrity of the device.

4 Surgical Technique Step 2: Adjusting Plate Curvature Step 3: Placing Temporary Fixation Pins The Slim-loc Plate has a precontoured lordotic curvature, anatomically appropriate in the majority of procedures. If desired, the Plate Bender may be utilised to optimally contour the sagittal plane to ensure maximum bone / plate interface. It is critical to bend the plate in the specified Bend Zone(s), which has a smooth under-surface and reduced cross-sectional thickness. Bend Zone Bend Zone Note: Once the sagittal contour has been altered by the Plate Bender, do not bend in the reverse direction. During bending ensure the Cam-loc is facing upwards. After selecting the appropriate plate, use the Temporary Fixation Pins (TFPs) to hold the plate in place while drilling and placing the screws. Using one of the plate holders when it is necessary to strike the TFP to drive it into place. After placing the two TFPs, fluoroscopy can be used to confirm optimal screw placement and trajectory. Note: Temporary Fixation Pins are designed for single use. Please ensure that all Temporary Fixation Pins have been removed and are not Note: Pre-drilling is not required for Temporary Fixation Pin insertion. If required to achieve additional plate lordosis, the plate is placed between the lobes (Cam-loc facing up) of the Plate Bender. The weaken and compromise the mechanical integrity of the device. The fatigue life of the contoured implant in vivo cannot be precisely described in step 5, hold and lay the plate evenly on the anterior cervical spine. Place Any necessary adjustments may be done at this time and reconfirmed with placed back in the set for re-sterilisation and re-used. Bend Zone must be centrally located on the lower lobe of the Plate predicted. Do not bend the plates repeatedly, excessively, or any the TFP through the pinhole on the plate fluoroscopy. Removing soft tissue and Bender. Plate bending should be evenly distributed at the Bend more than absolutely necessary. using the TFP Holder. The TFP Holder has large osteophytes may improve bone-plate Zones along the length of the plate. Contouring titanium plates can a tamping platform at the proximal end for interface. 4 5

Surgical Technique Step 4: Preparing Screw Hole Step 5: Drilling Holes Before drilling it may be necessary to prepare

To use the Slim-loc Awl, place the tip of the awl shaft against the screw hole on the plate and press it in the

The screw angle may be selected and the plate stabilised during the drilling procedure.

Plate Holder / Drill Guide The Plate Holder / Drill Guide may be attached to the plate by placing the expandable end

Pistol Grip Plate Holder / Drill Guide The Pistol Grip Plate Holder / Drill Guide may be attached to the plate by

5 Surgical Technique Step 4: Preparing Screw Hole Step 5: Drilling Holes Before drilling it may be necessary to prepare the screw hole with an awl. To use the Slim-loc Awl, place the tip of the awl shaft against the screw hole on the plate and press it in the direction of the The awl will protrude into the desired hole (the awl also has a striking plate on the handle). The screw angle may be selected and the plate stabilised during the drilling procedure. The Slim-loc System has two styles of plate holder / drill guides. They A. Plate Holder / Drill Guide The Plate Holder / Drill Guide may be attached to the plate by placing the expandable end into a lateral screw hole B. Pistol Grip Plate Holder / Drill Guide The Pistol Grip Plate Holder / Drill Guide may be attached to the plate by placing the expandable end into a lateral screw hole Note: Before using the Drill Guides, inspect the prongs for any cracks or abnormality. Do not activate the plate holding feature of the Drill Guide when the expandable end is not fully seated in a screw hole. screw angle desired. both achieve the same results. and turning the knurled knob clockwise. and compressing the pistol grip handle. 6 7

Surgical Technique Step 6: Selecting and Using Drill Bits 7.5º Superior 7.5º Inferior 7.

confirmed by fluoroscopy. Typical screw Note: Avoid severe angulation of the superior screw (greater than 16 degrees) which may prevent optimal locking of the screw with the cam.

(Certain angles placement is 5-10 degrees medial angulation vertebra, the quality of the bone, diagnosis, may direct the screws at vulnerable with the screw directed 7.5 degrees rostral etc.

6 Surgical Technique Step 6: Selecting and Using Drill Bits 7.5º Superior 7.5º Inferior 7.5º The Slim-loc Anterior Cervical Plate System offers the ability to select various angles of screw placement to conform to Depth of screw insertion and angular orientation of the screw must also be confirmed by fluoroscopy. Typical screw Note: Avoid severe angulation of the superior screw (greater than 16 degrees) which may prevent optimal locking of the screw with the cam. The drill length should correspond to the depth of the bone purchase required, taking into consideration the size of the individual patient anatomy. (Certain angles placement is 5-10 degrees medial angulation vertebra, the quality of the bone, diagnosis, may direct the screws at vulnerable with the screw directed 7.5 degrees rostral etc. The Slim-loc System is available with The Variable Depth Drill can be adjusted in end of the Variable Depth Drill. Utilising one of the Drill Guides described Insert the drill bit into the Drill Guide and vascular and neural tissues). Use & caudal to correspond with the superior 12 mm (blue), 14 mm (gold) and 16 mm 1 mm increments from 12 mm to 26 mm as Ensure that the release button is locked in in step 5, select the angle of screw drill the initial lateral hole into the vertebral fluoroscopy to confirm drill bit penetration and inferior disc space respectively. (magenta) fixed length drill bits. The desired. The precise length of the Variable place at the desired length before using the trajectory. Attach the desired drill bit into body. depth and angular orientation to ensure colours correspond to their respective Depth Drill Bit is determined by adjusting Variable Depth Drill. the Quick Couple Handle or a power drill. that those structures are not at risk. screw size colours. the release on the cylinder gauge at the 8 9

Surgical Technique Step 7: Using The Tap Step 8: Inserting Screws Note: The setting for both the Variable Depth Drill and the Tap can be approximated by pre-operative radiographic measurements (CT or

The use of intra-operative fluoroscopy while drilling and tapping, will further improve the accuracy of screw length selection.

7 Surgical Technique Step 7: Using The Tap Step 8: Inserting Screws Note: The setting for both the Variable Depth Drill and the Tap can be approximated by pre-operative radiographic measurements (CT or MRI) or by intra-operative measurement of the exposed vertebral endplates following decompression. The use of intra-operative fluoroscopy while drilling and tapping, will further improve the accuracy of screw length selection. 12 mm = Blue 13 mm = Purple 14 mm = Gold 15 mm = Light Blue 16 mm = Magenta 17 mm = Copper 18 mm - 26 mm = Silver Select the appropriate screw length Note: Ensure that the Variable Depth Tap sleeve is assembled on the Tap and adjusted to the appropriate length prior to use. corresponding to the hole drilled. Using the Hex Driver, pick up the screw from the tray and insert it through the plate. Drill the first hole, tap if desired, and place screw without tightening completely. After The Slim-loc screws are available as For identification purposes the mm For self-tapping screws, the entire screw confirming proper plate positioning, drill, The Slim-loc System is provided with The length of the Tap that will extend beyond self-drilling (4.5 mm major diameter) in screws are colour coded for length and is uniformly coloured. tap if desired and place screws in all self-tapping screws. Hence, tapping is not the soft tissue protection sleeve is set by lengths ranging from mm or screw type. The most common lengths are For self-drilling screws, only the heads remaining screw holes. Begin with the always necessary. However, if tapping is turning the cylinder gauge mounted near the selftapping (4.5 mm major diameter) in colour-coded to correspond with the fixed are coloured. lateral hole that is opposite and diagonal required to prepare the passage of the handle of the Tap in either direction. Please lengths ranging from mm. Large drill shafts. For large-diameter screws, only the to the first prepared hole. screw, the Variable Depth Tap can be ensure that the release button is locked in diameter screws (4.8mm major diameter) threads are coloured. Length is denoted Remove Temporary Fixation Pins and adjusted in 1 mm increments to correspond place at the desired length before using the are available in 12, 14 and 16 mm lengths. by the following colours and should perform final tightening of all screws in to the drill depth setting. Variable Depth Tap. always be confirmed with a screw gauge: the same sequence as mentioned above

Surgical Technique Step 9: Locking the Cams Bone Graft Solutions 3-Dimensional, osteoconductive matrix Structural integrity and 95% porosity: constructed of cross-linked type 1 3-D cross-linked

memory effect, retaining its structural Strong affinity for osteoprogenitor cell integrity and porosity, even when attachment and an ideal environment for hydrated.

Excellent graft handling characteristics: Flexible, sponge-like strip moulds into place for complete graft site coverage, even in irregular or uneven surfaces.

number of factors and may vary within the typical locking zone. Do not turn the cam past 270. Healos Bone Graft Replacement, just prior to hydration with bone marrow aspirate.

Locking all screws within the plate is the Cam Tightener to the cam slot during the The Cam Tightener incorporates a torque and caudal screw trajectories more than 16 last step in the plating

7 in-lbs) that degrees, the cam may not interfere with the screws should be secured to the vertebral inadvertently tear or strip the cam slot.

8 Surgical Technique Step 9: Locking the Cams Bone Graft Solutions 3-Dimensional, osteoconductive matrix Structural integrity and 95% porosity: constructed of cross-linked type 1 3-D cross-linked structure provides collagen fibres, coated with non-crystal excellent strength and a shape- hydroxyapatite. memory effect, retaining its structural Strong affinity for osteoprogenitor cell integrity and porosity, even when attachment and an ideal environment for hydrated. Open 0 Lock Advancing 90 Typical Locking Zone the cellular proliferation needed in the bone formation process. Excellent graft handling characteristics: Flexible, sponge-like strip moulds into place for complete graft site coverage, even in irregular or uneven surfaces. Note: Failure to maintain proper alignment of the Cam Note: Exact position of a locked cam is dependent on a Tightener may result in a stripped cam. number of factors and may vary within the typical locking zone. Do not turn the cam past 270. Healos Bone Graft Replacement, just prior to hydration with bone marrow aspirate. Hydrated, compacted Healos Bone Graft Replacement. Shape memory is retained in hydrated Healos Bone Graft Replacement, resulting in excellent porosity within the site. Locking all screws within the plate is the Cam Tightener to the cam slot during the The Cam Tightener incorporates a torque and caudal screw trajectories more than 16 last step in the plating procedure. All entire locking procedure so as not to limiting feature (0.76 Nm or 6.7 in-lbs) that degrees, the cam may not interfere with the screws should be secured to the vertebral inadvertently tear or strip the cam slot. will release when appropriate torque levels screw head and therefore the torque limiter bodies as previously described before Additional exposure may be temporarily are exceeded and the screw is locked into will not release. In this case, the cam beginning the cam locking procedure. required to properly align the Cam place. If this occurs, an audible click will be should be positioned within the locking To lock the screw, engage the Cam-loc Tightener with the cam. Rotate the Cam heard. For screw trajectories less than 16 zone to provide screw backout resistance. Conduit TCP Granules are made entirely of ß-TriCalcium Phosphate, the porous, mechanism by fully seating the Tightener clockwise, resistance will be felt degrees, a lock is obtained when the Cam osteoconductive ceramic similar to the mineral constituents of natural bone (i.e. 70%). Cam Tightener straight into the slot of the as the cam contacts the head of the screw. Tightener torque limiter releases (indicated The partially connected pore structure of Conduit TCP Granules is well-suited for cam. It is important to maintain a relatively Ensure you do not rotate the cam beyond by the audible click ) or when the cam is cell-to-cell interaction, nutrition and vascularisation. Its high degree of surface area perpendicular orientation of the 270 degrees (vertical slot). positioned in the locking zone. For rostral provides a generous field for cellular attachment. 6-9 months resorption rate

10 ml 2761-01-015 Conduit TM TCP Granules 15 ml 2761-01-030 Conduit TM TCP Granules 30 ml

9 Ordening Information Notes Catalogue No. Description Components Conduit TM TCP Granules 05 ml Conduit TM TCP Granules 10 ml Conduit TM TCP Granules 15 ml Conduit TM TCP Granules 30 ml Healos Bone Graft Replacement 2.5 ml Strip Healos Bone Graft Replacement 5 ml Strip Healos Bone Graft Replacement 2 x 10 ml Strips 14 15

10 16 Notes

Table of Contents.

Table of Contents. surgical technique The Ambassador TM Anterior Cervical Plate System is a versatile system of implants and instruments with a variety of sizes to provide optimal anatomic compatibility. The integrated cam