Fusion Device. Surgical Technique. Cervical Interbody Fusion with Trabecular Metal Technology

Size: px

Start display at page:

Download "Fusion Device. Surgical Technique. Cervical Interbody Fusion with Trabecular Metal Technology"

Cody Young
5 years ago
Views:

1 TM-S Fusion Device Surgical Technique Cervical Interbody Fusion with Trabecular Metal Technology

2 2 TM-S Fusion Device Surgical Technique Disclaimer This surgical technique is not intended for use in the United States. This document is intended exclusively for physicians and is not intended for laypersons. Information on the products and procedures contained in this document is of a general nature and does not represent and does not constitute medical advice or recommendations. Because this information does not purport to constitute any diagnostic or therapeutic statement with regard to any individual medical case, each patient must be examined and advised individually, and this document does not replace the need for such examination and/or advice in whole or in part. Information contained in this document was gathered and compiled by medical experts and qualified ZIMMER personnel. The information contained herein is accurate to the best knowledge of ZIMMER and of those experts and personnel involved in its compilation. However, ZIMMER does not assume any liability for the accuracy, completeness or quality of the information in this document, and Zimmer is not liable for any losses, tangible or intangible, that may be caused by the use of this information.

3 TM-S Fusion Device Surgical Technique 3 TM-S Surgical Technique Table of Contents Implant Description 4 Indications for Use 4 Mergence TM -S Instrumentation System Description 5 Pre-Operative Planning 6 Patient Positioning 6 Exposure 6 Discectomy 7 Endplate Preparation 7 Implant Selection 8 Bone Grafting 8 Implant Insertion 9 Final Implant Positioning 9 Post-Operative Management 11 Implant Removal/Revision 11

4 4 TM-S Fusion Device Surgical Technique Implant Description The TM-S Fusion Device consists of a single component comprised wholly of porous tantalum. The implants are available in three depth x width sizes, 11 mm x 11 mm, 11 mm x 14 mm and 14 mm x 14 mm. All three sizes are available in vertical heights of 5 mm to 10 mm in 1 mm increments. The height is measured from the posterior (shortest) aspect of the device. In addition, the implants have a 7 lordotic angle to help maintain the natural contour of the spine. TM-S has a central hole extending in the superior-inferior direction where autogenous bone graft may be placed. The device also has a small slot on its anterior face for mating with its insertion instrument. The superior and inferior surfaces of the device have a textured surface to provide increased stability. The implants are intended for single use only and must not be reused under any circumstances. Indications for Use The TM-S Fusion Device is intended for use in anterior cervical discectomy and fusion (ACDF) procedures in patients with symptomatic cervical disc disease from the C3-C4 to the C7-T1 disc. Please refer to the package insert for complete product information including contraindications, warnings, precautions, and adverse effects.

TM-S Fusion Device Surgical Technique 5 Mergence -S Instrumentation System Description The TM-S Fusion Device is a cervical interbody fusion device.

5 TM-S Fusion Device Surgical Technique 5 Mergence -S Instrumentation System Description The TM-S Fusion Device is a cervical interbody fusion device. It is designed to be implanted with the Mergence -S Instrumentation System. This surgical technique follows the Smith- Robinson technique and utilizes standard instruments except for those specifically related to the sizing and insertion of the TM-S Fusion Device. General Tamp Central Tamp Lateral Grasping Inserter Corner Tamp Central Inserter Provisionals and Rasps 11mm x 11mm, 7 11mm x 14mm, 7 14mm x 14mm, 7

6 TM-S Fusion Device Surgical Technique Pre-Operative Planning Pre-operatively, the surgeon must identify the proper

This may be done using diagnostic techniques such as radiographs, MRI, myelography, discography, patient history and physical

The posterior cervical spine is supported to establish and maintain normal lordosis and a right or left sided approach is chosen.

Figure 1 Exposure The anterior cervical anatomy is exposed in the standard fashion by identifying a dissection plane between the

6 6 TM-S Fusion Device Surgical Technique Pre-Operative Planning Pre-operatively, the surgeon must identify the proper intervertebral level to fuse. This may be done using diagnostic techniques such as radiographs, MRI, myelography, discography, patient history and physical examination. Patient Positioning The patient is placed in face up recumbent position. The posterior cervical spine is supported to establish and maintain normal lordosis and a right or left sided approach is chosen. The symptomatic level is identified and a transverse skin incision is made to the corresponding pathology. [Figure 1]. Figure 1 Exposure The anterior cervical anatomy is exposed in the standard fashion by identifying a dissection plane between the trachea and esophagus. Exposure is then held in place utilizing selfretaining retractors. The proper level is confirmed using a needle as a marker and fluoroscopy imaging. A vertebral distractor can then be placed through the open incision in the adjacent vertebrae to the discectomy.[figure 2]. Figure 2

TM-S Fusion Device Surgical Technique 7 Discectomy A standard cervical discectomy and decompression is performed by resecting the anterior longitudinal ligament over the corresponding vertebrae.

7 TM-S Fusion Device Surgical Technique 7 Discectomy A standard cervical discectomy and decompression is performed by resecting the anterior longitudinal ligament over the corresponding vertebrae. Remove the anterior osteophytes followed by the anterior portion of the annulus fibrosis. A window is then made corresponding to the size of the implant. The intervertebral disc is removed out to the uncovertebral joints using general instrumentation such as curettes or rongeurs [Figure 3]. Distract the disc space. A Caspar Distractor is recommended for the distraction. Caution: Great care should be taken to ensure that all exposed blood vessels are properly retracted prior to the discectomy so as to avoid unintended contact with the curettes and rongeurs. Figure 3 Endplate Preparation Complete a neural decompression by trimming large posterior osteophytes (if present). Prepare the endplates by using Mergence -S size-specific rasps, standard curettes or burrs. Remove a minimal amount of the cartilaginous endplates to create a flat surface of bleeding bone. [Figure 4]. Caution: Using excessive force with the instrumentation can inadvertently rupture the posterior annulus or damage the vertebral endplates. Note: For ease of selection, size-specific Rasps and Trials are color coded based on footprint (11 x 11 mm, 11 x 14 mm or 14 x 14 mm). Figure 4

8 TM-S Fusion Device Surgical Technique Implant Selection Implant size is determined by measuring the disc space using the Mergence -S Provisionals (Trial).

The proper Provisional will tension the soft tissue crossing that selected disc space. Proper tension is determined by the amount of force necessary to fully seat the Provisional.

Note: Provisionals precisely match the dimensions of the TM-S implants.

8 8 TM-S Fusion Device Surgical Technique Implant Selection Implant size is determined by measuring the disc space using the Mergence -S Provisionals (Trial). Insert a Provisional and select the size that sufficiently fits the disc space [Figure 5 shows fully seated provisional]. The proper Provisional will tension the soft tissue crossing that selected disc space. Proper tension is determined by the amount of force necessary to fully seat the Provisional. If the Provisional seats without force, it is too small. Continue increasing the Provisional size until force is necessary to fully seat the Provisional. Note: Provisionals precisely match the dimensions of the TM-S implants. Caution: If the Provisional used within the disc space is solidly engaged and difficult to realign laterally when proper position has been obtained within the disc space, consider implanting a device 1 mm smaller than the provisional being used. Figure 5 Note: In 1993, An et. al. used cadaver studies to establish the optimal thickness for Smith-Robinson-type cervical fusion grafts. They concluded that the ideal thickness is approximately 2mm greater than the pre-operative measured disc height. Bone Grafting The hole in the center of the implant may be filled with autogenous bone harvested from the iliac crest [Figure 6]. Figure 6

TM-S Fusion Device Surgical Technique 9 Implant Insertion Select an Implant Inserter to hold the device for final placement

Lateral Inserter: Ensure that the Lateral Inserter is engaging the anterior convex edge of the device by evaluating the

Figure 7 Central Inserter: Insert the tab into the slot on the anterior convex face of the device, and then rotate the

The implant can be placed into the space with the central inserter.

Final Implant Positioning It may be necessary to use a Mergence-S Tamp for final implant seating.

It may be necessary to tap moderately on the tamp to fully seat the implant posteriorly.

9 TM-S Fusion Device Surgical Technique 9 Implant Insertion Select an Implant Inserter to hold the device for final placement into the disc space. Lateral Inserter: Ensure that the Lateral Inserter is engaging the anterior convex edge of the device by evaluating the implant's geometry carefully [Figure 7]. This inserter has a flat bar at the proximal end to facilitate impaction. Figure 7 Central Inserter: Insert the tab into the slot on the anterior convex face of the device, and then rotate the instrument 90 degrees [Figure 8]. Turn the knob clockwise until the device is secure on the inserter [Figure 9]. The implant can be placed into the space with the central inserter. Note: It may be necessary to apply additional distraction to facilitate insertion. Final Implant Positioning It may be necessary to use a Mergence-S Tamp for final implant seating. The concave surfaces of the tamps match the convex anterior wall of the device. It may be necessary to tap moderately on the tamp to fully seat the implant posteriorly. Tapping on the device should move the implant posteriorly [Figure 10]. If no motion occurs, remove the device and check for an obstruction of bone or a narrow posterior opening. Figure 8 Figure 9 Caution: If difficulty inserting the TM-S device is encountered, do not vigorously tap on the implant. Excessive force on the implant may deform or damage the device. Rather remove the implant and check for an impediment. Additional endplate preparation may be required. Figure 10

10 TM-S Fusion Device Surgical Technique Central Tamp: Insert the tab into the slot on the anterior surface of the device to guide the direction of insertion [Figure 11].

Figure 11 Corner Tamp: The Corner Tamp may be used for lateral or rotational positioning.

10 10 TM-S Fusion Device Surgical Technique Central Tamp: Insert the tab into the slot on the anterior surface of the device to guide the direction of insertion [Figure 11]. General Tamp: The concave surface of the General Tamp is designed to match the convex anterior wall of the device. Figure 11 Corner Tamp: The Corner Tamp may be used for lateral or rotational positioning. Final placement of the implant should be slightly posterior to the anterior aspect of the vertebral bodies [Figure 12]. Lateral and A/P radiographs may be taken to assure proper implant placement. Supplemental Fixation After implantation anterior or posterior supplemental fixation may be used at the discretion of the surgeon. Only titanium alloy (ASTM F-136) systems should be used. Figure 12

11 TM-S Fusion Device Surgical Technique 11 Post-Operative Management Post-operative regimens may include the following: The patient should limit activities that result in overhead lifting, repetitive neck bending (especially neck extension) and heavy lifting until a physician determines solid bony fusion is achieved. An orthotic brace may be worn following surgery for support. The attending physician, based upon each patient's clinical progress, will determine whether a brace is appropriate and, if necessary, the length of time the brace is prescribed. Non-steroidal anti-flammatory and steroidal drugs should be avoided for at least 45 days, or as directed by a physician, post-operatively. Implant Removal/Revision Should removal/revision of the device be determined necessary by the surgeon, an osteotome can be used at the interface between the bone and both superior and inferior faces of the implant. This effectively cuts the fused column of bone at the level of the boundaries of the implant. Once the fused column is completely cut, forceps can be used to remove the implant from the space. This may be done under slight distraction. For a revision follow the standard surgical technique.

12 Length x Width (mm) Height (mm) Angle Part Number x x x DESCRIPTION INSTRUMENT CATALOG NUMBER Central Inserter Lateral Grasping Inserter General Tamp Central Tamp Corner Tamp LIP038 Rev.A 2009 Zimmer Spine, Inc. Contact your Zimmer Spine representative or visit us at Lit.No Ed.06/2009 +H /$090601F09/ 0120 EC REP Zimmer UK Limited SN3 4FP, U.K Zimmer Spine Cité Mondiale 23, parvis des Chartrons Bordeaux - France Tel +33(0) Fax 33 (0)

Commander Cervical Cage - SURGICAL TECHNIQUE

Commander Cervical Cage - SURGICAL TECHNIQUE D e s i g n e d to c l o s e l y f i t yo u! Commander Cervical Cage - SURGICAL TECHNIQUE Indications Commander cervical cages are designed primarly for restoring