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Lumbar Interspinous Devices: Fusion and Motion Sparing

Dean G. Karahalios and Michael J. Musacchio Jr.

Introduction

Lumbar spinous process fixation for stabilization is a technique that has been used for several decades. Many early techniques involved wire and plate fixation [15]. These were intended to facilitate arthrodesis; however, they did not gain widespread adoption as a result of early failures and the perception that they did not provide ade­quate stiffness and durability. More contempo­rary strategies for fixation were subsequently developed, such as pedicle screw fixation (PSF), that proved to be more effective. However, mas­tery of PSF was found to require substantial subspecialty training as it involved anatomic structures less familiar than seen in the tradi­tional posterior midline approaches. In addition, PSF increased the potential risk of injury to critical neurovascular and visceral structures
69]. Despite these drawbacks, PSF techniques
[ rapidly became the gold standard for thoraco­lumbar fixation [
D.G. Karahalios, MD (*) Advocate Medical Group, Advocate Health Care, Downers Grove, IL, USA e-mail: dean.karahalios@advocatehealth.com
M.J. Musacchio Jr., MD North Shore University Health System, Neurosurgery and Spine Center, Evanston, IL, USA
mmusacchio@northshore.org
e-mail:
1013].
25
With the advent of percutaneous minimally invasive surgical (MIS) techniques for decom­pression and arthrodesis, PSF was adapted for internal fixation in these procedures. The lateral to medial axis of the pedicles required early gen­eration of MIS procedures to use a lateral trans­muscular approach [1417]. With the refinement of newer fixation technologies, including facet screws [18, 19], translaminar facet screws [20,
21], cortical screws [2224], and spinous pro-
cess fixation (SPF) [2528], both open and MIS midline techniques for decompression and arthrodesis have regained popularity. In addition to rigid fixation, a number of motion-preserving technologies have also been developed for this space and will be discussed in the second half of this chapter.
Midline stabilization technologies (MSTs), whether for rigid fixation to promote arthrodesis or motion preserving, may have advantages over more lateral approaches. These include greater surgeon familiarity with the midline anatomy, improved direct visualization of critical struc­tures, multiple fixation options, flatter learning curve, less need for imaging, and the ability to easily extend constructs to adjacent levels (may be off label in some cases).
However, there are several theoretical disad­vantages of interspinous devices [29]. The spi­nous processes must be preserved which may limit the extent of the decompression. Further, the midline approach requires muscle stripping
© Springer International Publishing AG 2017 L.T. Holly, P.A. Anderson (eds.), Essentials of Spinal Stabilization, DOI 10.1007/978-3-319-59713-3_25
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D.G. Karahalios and M.J. Musacchio Jr.
that may be more painful, leading to a longer recovery and protracted use of pain medications
30, 31]. Rigid interspinous fixation devices may
[ have less capability to restrict motion and may not be as durable as PSF and consequently not as effective in promoting arthrodesis [ tion, these devices may increase interspinous flexion and result in sagittal plane imbalance. For the motion-preserving technologies, the failure of early dynamic devices to prevent progression of degenerative disease and/or protect adjacent levels from accelerated changes has indicted the entire class [32, 29, 3337]. Newer iterations of MSTs have proven to be much more effective than their predecessors and in many cases approach and even surpass PSF and lateral approaches [27, 28, 38].
29]. In addi-

Rigid Interspinous Fixation for Fusion

Early techniques for interspinous stabilization were performed to limit motion in order to pro­mote arthrodesis. These techniques commonly involved the wiring of adjacent spinous pro­cesses. Unfortunately, these techniques were prone to failure due to breakage or tearing out of the wires, fracture of the spinous processes, and pseudoarthrosis secondary to the inability to effectively restrict motion. Fixation devices such as the Daab [ improvement but were bulky and also prone to failure. With the subsequent development of PSF techniques, attention shifted away from the midline.
More recently, a number of spinous process appliances for rigid fixation to promote arthrod­esis have been developed (Table plate (Medtronic, Memphis TN) was the first to come to market with a device consisting of a pair of plates with spikes that could easily be applied to the spinous processes to provide immediate rigid stability [25]. The adoption of this device was limited, most likely related to its perceived similarity to the X-stop motion preserving device (Medtronic, Memphis, TN) that was associated with a fairly high rate of failure [
1] and Wilson [2] plates were an
25.1). The Spire
32, 29, 3337].
The Aspen device (Zimmer-Biomet, Broomfield, CO) brought design improvements over the Spire plate, including a graft-containing cylinder of varying diameters that would fill the interspinous space. A biomechanical test com­pared the Aspen device to PSF in transforaminal interbody fusion (TLIF) [ interbody fusion (ALIF) [27] constructs. In the TLIF construct, the interspinous device was as effective as PSF in limiting flexion-extension but was less effective in axial rotation and lateral bending. Similar results were seen in the ALIF construct but with an overall reduction in range of motion (ROM) that was statistically equiva­lent to bilateral PSF. The excellent performance of this device, especially in flexion-extension, is likely related to the large cylinder that fills the interspinous space and acts as an extension block. It has also been shown that while there is typi­cally some associated flexion at the index level, there is also a compensatory extension at the adjacent levels and as such there is no significant change in overall sagittal balance [27, 39]. There is also an advantage of increased foraminal height that can be effective in addressing associ­ated radicular issues.
One criticism of the Aspen device is its inabil­ity to provide compression on an interbody device and may promote stress shielding and eventual pseudoarthrosis. However, fusion rates have been shown to be comparable to PSF [40]. To further address this potential shortcoming, a newer Aspen-like device called Alpine was developed (Zimmer-Biomet, Broomfield, CO). This translating device allows for distraction and compression and also provides a mechanism that can expand and fit snugly within the interspinous space. A similar device named BridgePoint has been also been developed by Alphatec Spine (Carlsbad, CA).
Despite the encouraging biomechanical results seen with SPF devices [ performance in clinical practice has been the sub­ject of debate [ successful arthrodesis has been demonstrated [40, 38]. In our own experience, we typically not only see robust fusion mass in the disc space and posterolaterally but also between the spinous
29]. Radiographic evidence of
28] and anterior lumbar
27, 28, 26], their
25 Lumbar Interspinous Devices: Fusion and Motion Sparing
Table 25.1 Select rigid interspinous fixation devices (listings are not comprehensive, nor an endorsement of any indi­vidual device)
Device Company Prominent feature(s)
Affix NuVasive, San Diego, CA Small footprint, zero-step locking
Aileron, Aileron Expandable, Aileron-TRX
Aspen Zimmer Biomet, Broomfield, CO Integrated interspinous graft chamber,
Alpine Zimmer Biomet, Broomfield, CO Provides distraction and compression
BacFuse Pioneer Surgical, Marquette, MI Wide range of sizes
Bridgepoint Alphatec, Carlsbad, CA Provides distraction and compression
Interbridge LDR Spine (now Zimmer Biomet),
SP-Fix Globus Medical, Audubon, PA PEEK interspinous barrels, zero-step
Spire, Spire Z Medtronic, Memphis, TN First to market in modern era. Spire Z
UniVise Stryker, Kalamazoo, MI One-piece implant, streamlined
LifeSpine, Huntley, IL Custom fit, multiple sizes, large graft
Broomfield, CO
containment, bullet tip, facilitates anterior placement
contoured for optimal ventral positioning, wide range of sizes
across interspace
across interspace, large bone graft window, large bone contact area
Facilitates preservation of supraspinous ligament, simplified insertion instruments and technique
locking
with revised shape to better accommodate anatomy
instrumentation and locking
323
Fig. 25.1 Sagittal reconstructed computed tomographic (CT) view of an SPF construct demonstrating robust bone growth bridging between adjacent spinous processes (Alpine, Zimmer-Biomet, Broomfield, CO)
processes (Fig. 25.1). Radiographic success does not necessarily relate to good clinical outcomes. However, in the case of SPF, there is evidence to suggest that clinical outcomes are favorable and comparable to PSF [
1, 2, 41, 25, 40].
There are some potential advantages of SPF over PSF technologies. As previously discussed, the anatomy is familiar to all surgeons. As such, very little in the way of training is required and the learning curve is relatively flat. There is also some evidence to suggest that operative times are shorter, there is less blood loss, less pain, and quicker recovery [
40]. The technique is also safer
in that there is less risk of injury to neurovascular and visceral structures. Typically, less imaging is required and thus the dose of radiation to the patient is less. The positioning of SPF devices places them medial and inferior to the cephalad facet complexes (Fig. 25.2a–b), which may have implications for mitigating the acceleration of adjacent level degenerative changes [40].

Surgical Indications

Spinous process fixation devices are versatile and can be utilized to provide stabilization to promote fusion in a number of clinical scenarios. These
324
D.G. Karahalios and M.J. Musacchio Jr.
Fig. 25.2 (a). Anteroposterior (AP) and (b). lateral plain radiographic images demonstrating an SPF device (Medtronic Spire Z, Memphis, TN) used to stabilize a
include posterior interlaminar fusion, posterolat­eral fusion, ALIF, TLIF alone, TLIF with unilat­eral pedicle screws, direct lateral fusion, topping off long PSF constructs, and in revisions address­ing adjacent level degeneration.
Preoperative Considerations
The technique for SPF is relatively straightfor­ward as the anatomy is familiar and the applica­tion of the device is not typically challenging. However, there are some important consider­ations in planning, technical nuances, and some minor variations depending on the particular device. Contraindications include pars defects and osteoporosis. However, in the aging spine, there may be a significant differential between the density of the posterior elements and the vertebral bodies, favoring posterior fixation (Table 25.2).

Surgical Technique

A midline incision 4–5 cm in length is planned over the rostral and caudal spinous processes to be fixated. It is important to remember that the rostral spinous process will be in the axial plane
direct lateral interbody arthrodesis (DLIF) procedure (Medtronic Clydesdale system, Memphis, TN). Note that the SPF device is centered just below the index disc space
Table 25.2 Main contraindications to the placement of rigid spinous process fixation devices for the purpose of arthrodesis
Posterior spinal elements weakened or missing due to prior surgery, trauma, or congenital defect
Pars defect
Morbid obesity
Osteopenia or osteoporosis
Neuromuscular disorder
Smoking
Infection
Contact with other implants of varying metallurgy
Allergy to titanium
of the interspace that represents the level to be fused (Fig.
25.2a–b). The paraspinal musculature
is then reflected off of the spinous processes and lamina. The facets and transverse processes may also be exposed for decompression and arthrod­esis purposes.
Partial laminectomies can be performed along the inferior aspect of the rostral segment and the superior aspect of the caudal segment. Redundant ligamentum flavum can be resected with Kerrison punches. Partial medial facetectomies and foram­inotomies can also be performed. In the setting of a TLIF procedure, a total facetectomy can be
25 Lumbar Interspinous Devices: Fusion and Motion Sparing
325
performed unilaterally. Care must be taken to not weaken or fracture the spinous processes during decompression or application of the SPF device.
The supraspinous ligament may be removed or left intact based on the surgeon’s preference. Preservation of this structure is important for the application of some motion-sparing devices like X-Stop that require it to remain contained within the interspinous space. However, for SPF devices that provide rigid stabilization by attaching to the spinous processes themselves, it may be resected. Further, for translating SPF devices that provide distraction and compression, it is removed with a Leksell rongeur. Next, the interspinous space is measured with calipers or trials in order to select the appropriately sized device that will maxi­mally fill the space. For the translating SPF devices, this is not necessary, since the device may be expanded to fit this space prior to engag­ing the spinous processes (Fig. 25.3a). In either case, the instruments used to prepare the interspi­nous space or the translating SPF devices can be used to apply distractive forces. Careful visual inspection, tactile feedback, and the surgeon’s judgment are all critical in preventing fracture or weakening of the spinous processes through these maneuvers. The plates on either side of the midline are then compressed so that the spikes integral to the medial aspect of the plates engage the cortical bone of the spinous processes (Fig. 25.3b). Care must be taken to avoid over­compression, as this may fracture or weaken these structures as well. At this point, some devices are self-locking and others require subse­quent steps to lock the device to the spinous processes.
The translating fixation devices can be dis­tracted and subsequently collapsed and/or com­pressed rostrocaudally (Fig. 25.3a) and locked to secure an interbody graft or device (Fig. 25.3c). Many devices have integral graft containment capability in the portion of the device that passes through the interspinous space. These can be pre­or post-packed with graft material. Additional graft can be placed over remaining decorticated lamina, facets, and/or transverse processes (Fig. 25.3d). Final anterior posterior (AP) and
lateral fluoroscopic imaging is typically per­formed to confirm adequate placement of the instrumentation over the appropriate levels.

Illustrative Case (Rigid Fixation for Arthrodesis)

History A 58-year-old male underwent an L3-4 microdiscectomy. Initially he responded well, but approximately 1 year after surgery, he developed new symptoms that were slightly different than the previous unilateral L4 radicular pattern. He failed conservative management that included physical therapy, epidural injections, and facet blocks.
Physical Examination His examination was consistent with a bilateral L3 radiculopathy.
Radiographical Imaging MR imaging revealed accelerated changes at the L3-4 level with disc space collapse, Modic changes, and foraminal stenosis (Fig. 25.4a).
Treatment He was taken to surgery for an
instrumented TLIF procedure with spinous pro­cess fixation (Figs. 25.4b–c).
Outcome Postoperatively, his radicular pain
resolved as did his mechanical back pain. At 2-year follow-up, he remains asymptomatic.

Technical Pearls

• Preoperative CT scans are helpful to confirm that the relevant bony anatomy is sound, that there are no pars defects, and for S1 that there is a spinous process that is large enough for the device to engage.
• Preoperative bone density studies may be mis­leading and should be interpreted with caution, as the posterior elements may be relatively sclerotic compared to the vertebral bodies.
• Care should be taken to advance the device as far ventrally as possible, so that it rests on the lamina rostrally and caudally. It may be
326
D.G. Karahalios and M.J. Musacchio Jr.
Fig. 25.3 Schematic drawing of Alpine XC device place­ment. (a). The device is inserted into the interspinous space and expanded provisionally by rotating the knob on the inserter until the graft containment portion of the device passing across the midline fills the space. (b).
necessary to drill down the medial aspects of the facet complexes to achieve proper positioning.
• Avoid excessive compression when engaging the spiked plates to the spinous processes as this may cause a fracture or weakening. The spikes, but not the plates, should sink into the cortical bone.
• For the devices that allow for distraction and compression across the interspace, forces should be applied with caution to avoid frac­ture or weakening of the spinous processes.
Compression is applied securing the spikes along the inner aspect of the plates to the spinous processes. (c). Final implant configuration. (d). Graft material is packed over the exposed decorticated bony elements, around the device, and through the interspinous space

Complications and Strategies for Avoidance

The most common serious complication that can occur is the fracture of the spinous pro­cesses. This can lead to pain, migration of inter­body implants, and pseudoarthrosis leading to the need for revision. Fractures can occur intra­operatively during placement of the device due to excessive compression of the spiked plates into the spinous processes or by excessive dis­traction and compression across the interspace.
25 Lumbar Interspinous Devices: Fusion and Motion Sparing
327
Fig. 25.4 (a). Sagittal T2-weighted magnetic resonance image of the lumbar spine demonstrating advanced degenerative and post-operative changes involving the L3-4 disc space. There is marked loss of disc space height and Modic changes. (b). AP and (c). lateral plain radio-
This can be avoided by careful visual inspec­tion of the spinous processes as these forces are applied and attention to tactile feedback that provides a subjective but meaningful assess­ment of bony element strength. The risk of frac­ture can also be mitigated by positioning the device as ventral as possible, where the spinous processes are usually wider and stronger as they transition to the lamina. The surgeon must also counsel the patient preoperatively that if the anatomy is not conducive or a fracture occurs an alternative fixation technique may be required.
Postoperative fractures can occur due to
excessive activity or trauma/falls. Patients should be carefully selected for compliance to activity restrictions. In addition, bracing may be used as well to limit excessive motion.
Wound dehiscence may occur at a slightly
higher rate than in other fixation techniques, and is likely related to the relatively close proximity of the device to the midline and skin surface. This risk can be mitigated by performing a meticulous multi-layered closure, with coverage of the device by muscle and a tight closure of the fascia.
graphic views of a Stryker UniVise spinous process fixa­tion device (Stryker, Kalamazoo, MI) used to stabilize a Stryker AccuLIF expandable interbody device (Stryker, Kalamazoo, MI) in a TLIF construct

Interlaminar/Interspinous Motion Preservation

The concept of motion sparing interspinous tech­nology was developed as a means to relieve
symptoms of degenerative spinal disease with MIS and without fusion. While multiple devices have been introduced, only a limited number are available in the US market. The two most influ­ential dynamic MSTs, the Wallis Interspinous Device (Abbott Spine, Abbott Park, IL) intro­duced for treatment of patients with recurrent disc herniations and the X-stop Interspinous Spacer (Medtronic, Memphis, TN) for mild to moderate stenosis, are no longer available for clinical use. Another device, Diam (Medtronic, Memphis, TN), intended for use as an indirect decompression device for spinal stenosis, failed to receive FDA clearance for use in the USA. Despite these early failures, there are sig­nificant benefits to be gained by exploiting the posterior midline for motion preserving stabiliza­tion devices.
Interlaminar and interspinous motion-
preserving devices represent an evolution of