Fig. 25.1
Preoperative radiographs. (a) AP, (b) lateral, (c) extension, and (d) flexion
![A324742_1_En_25_Fig2_HTML.jpg](https://i0.wp.com/neupsykey.com/wp-content/uploads/2017/09/A324742_1_En_25_Fig2_HTML.jpg?w=960)
Fig. 25.2
Preoperative sagittal MRI
![A324742_1_En_25_Fig3_HTML.jpg](https://i0.wp.com/neupsykey.com/wp-content/uploads/2017/09/A324742_1_En_25_Fig3_HTML.jpg?w=960)
Fig. 25.3
Postoperative radiographs. (a) AP, (b) lateral, (c) extension, and (d) flexion
25.3 Interspinous Fusion
Interspinous fusion devices are being evaluated as an alternative to bilateral and unilateral pedicle screw constructs in augmenting lumbar interbody fusion rates. The devices are designed to take advantage of the biomechanical loading processes of the posterior aspect of the vertebral column in order to immobilize the affected segment, thus stabilizing the spine. The interspinous devices are intended to create construct stability comparable to pedicle screws, while being less invasive, therefore reducing blood loss, risk of infection, and postoperative muscle pain [42–45]. In contrast to interspinous process devices (IPDs), which primarily work as stand-alone decompressive materials (i.e., X-STOP), interspinous fusion devices (IFDs) are designed for fixation and fusion. Early attempts at interspinous fusion failed, as the pilot implants had a small surface area with the spinous processes, meaning all of the force due to the axial load of the superior spine was applied on a small area. Contemporary devices include paired plates with teeth or U-shaped device with wings that attach to the spinous process [46].
The US Food and Drug Administration (FDA) have approved a significant number of IFDs (Table 25.1). Despite the fact that they are composed of different designs and materials, they share similar indications and implantation techniques with the aim of maintaining a constant degree of distraction between the spinous processes and stabilize the spine in a minimally invasive manner [46]. As per 510 (k) premarket notifications, the indications for the use of these devices are to achieve supplemental fusion in the following conditions: degenerative disk disease (defined as back pain of discogenic origin with degeneration of the disk confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), and/or tumor (510 K doc). These devices can be used in elderly patients or those with bone quality too poor for pedicle screw instrumentation. The vast majority of devices are implanted via a midline incision followed by muscle dissection lateral to the supraspinous ligament. The paraspinal muscles are then stripped off the laminae, and the interspinous ligament is sacrificed. Before implantation, a microsurgical decompression is performed (per manufacturer instruction manual).
Table 25.1
Partial list of interspinous fixation devices that have received clearance to market by the FDA
# | Name | Company | 510 (K) approval | Image | Material | Testing performed | Clinical study? | Additional |
---|---|---|---|---|---|---|---|---|
1 | Spire™ | Medtronic | November 2004 | ![]() | Titanium | Cadaver testing: ±6.0 Nm nondestructive quasi-static loading in axial rotation, flexion/extension, and lateral bending with a constant displacement/rotation rate | X | Intended for use with autograft and/or allograft. For single use only |
2 | PrimaLOK™ | OsteoMed | August 2010 | ![]() | Titanium alloy | Static: compression, tension, and torsion Dynamic: compression and torsion | X | Intended for use at one level, with bone graft material |
3 | Inspan™ | Spine frontier | September 2010 | ![]() | Titanium alloy | Static: compression and torsion Dynamic: compression and torsion | X | Intended for use with bone graft material |
4 | Axle™ | X-spine | November 2010 | ![]() | Titanium alloy and PEEK | Cadaver testing Static: compression Bending, torsion Fatigue compression bending | Intended for use with bone graft material | |
5 | SP-Fix™ | Globus | January 2011 | ![]() | Titanium alloy and PEEK | Static: compression, torsion, plate dissociation, and tension Dynamic: compression and plate dissociation | Intended for single level with bone graft material | |
6 | BacFuse® | Pioneer surgical | March 2011 | ![]() | Titanium alloy | Static: compression, tension, torsion, locking mechanism Dynamic: flexion, extension, locking mechanism | For use at a single level. Intended for use with bone graft material | |
7 | BridgePoint™ | Alphatec | June 2011 | ![]() | Titanium | Cadaver testing Static and fatigue performance characteristics | Window allows for bone graft placement. Telegraphing plates allow for extension or compression | |
8 | Octave™ | Life spine | November 2011 | Unavailable | Titanium alloy | Static: axial compression, torsion, axial pullout, axial grip strength Dynamic: axial compression | Intended for use with bone graft material. Single-level use only | |
9 | Coflex-F® | Paradigm spine | February 2012 | ![]() | Titanium Alloy | Cadaver testing. Static: compression, rotation/torsion Dynamic: compression, tension | X | Intended for use at a single level |
10 | Aileron™ | Life spine | March 2012 | ![]() | Titanium | Static: axial grip Engineering analysis, compression Dynamic: compression | Intended for use with bone graft material. Single-level use only | |
11 | Aspen™ | Lanx, acquired by BioMet | September 2012 | ![]() | Titanium | Cadaver testing Static: compression bending, torsion Fatigue compression bending | X | Intended for use with or without bone graft material |
12 | Interbridge | LDR spine | March 2013 | Unavailable | Titanium | Static: axial, torsion, compression, pullout resistance, plate dissociation Dynamic: axial compression bending | Intended for single-level use only | |
13 | Affix™ | NcixuVasive | July 2013 | ![]() | Titanium | Static: axial compression, torsion, post distraction Dynamic: axial compression | In progress | The FDA issued a warning letter for selling the device for uses not approved by its 510 (k) clearance [7] |
14 | Zip Mis | Aurora spine | November 2013 | ![]() | Titanium alloy | Static: compression bending, torsion Dynamic: compression bending | X | Intended for use with bone graft material |
15 | Minuteman™ | Spinal simplicity | August 2015 | ![]() | Titanium alloy with hydroxyapatite coating | Static: shear strength Tensile strength Solubility, dissolution products and rates, XRD pattern, and FTIR spectra | Recruiting | Can be placed under fluoroscopy through lateral or posterior MIS approach. Intended for use with bone graft material. Single-level use only |
Currently, 15 IFDs have received clearance to market by the FDA. There are numerous designs to these implants as shown in Table 25.1, but each device claims the same advantages over the pedicle screw fixation including reduced risk of cerebrospinal fluid leakage and nerve damage, less muscle dissection and intraoperative estimated blood loss, shorter hospital stay and rehabilitation period, and reversibility of the surgical procedure that does not limit future surgical treatment options [47].
In contrast, while biomechanical studies indicate that IFDs may be similar to pedicle screw-rod constructs in limiting the range of flexion-extension, they may be less effective in reducing axial rotation and lateral bending [48]. Also, there is a potential for a negative impact on the interbody cage and bone graft due to focal kyphosis resulting from the interspinous device [48]. Due to the lack of long-term clinical studies and these uncertainties, further prospective clinical studies are needed to compare the functional outcomes between interspinous fusion devices and pedicle screw constructs.
25.3.1 Case Example
A 51-year-old male presented with worsening low-back and leg pain and paresthesia in his feet. He attempted multiple forms of conservative treatment including physical therapy, epidural steroid injections, acupuncture, and massage without significant relief of his symptoms. Figure 25.4 displays his preoperative plain radiographs, which confirm the presence of degenerative disk disease with narrowing at L4–L5, anterior and posterior osteophytes, and mild degenerative retrospondylolisthesis. A one-level X-LIF procedure and posterior bilateral fusion at L4–L5 with Coflex-F® stabilization were performed. Eleven months postoperatively, the patient reported complete improvement of his preoperative symptoms. Postoperative radiographs (Fig. 25.5), performed 11 months after surgery, demonstrated fusion at L4–L5, increased disk and foraminal height, and no motion with flexion.
![A324742_1_En_25_Fig4_HTML.gif](https://i0.wp.com/neupsykey.com/wp-content/uploads/2017/09/A324742_1_En_25_Fig4_HTML.gif?w=960)
![A324742_1_En_25_Fig5_HTML.jpg](https://i0.wp.com/neupsykey.com/wp-content/uploads/2017/09/A324742_1_En_25_Fig5_HTML.jpg?w=960)
![A324742_1_En_25_Fig4_HTML.gif](https://i0.wp.com/neupsykey.com/wp-content/uploads/2017/09/A324742_1_En_25_Fig4_HTML.gif?w=960)
Fig. 25.4
Preoperative radiographic images of a 51-year-old male. From left to right: lateral view, AP, flexion, and extension. The flexion image shows a Cobb angle of 12.3°, whereas the extension shows a Cobb angle of 19.1°
![A324742_1_En_25_Fig5_HTML.jpg](https://i0.wp.com/neupsykey.com/wp-content/uploads/2017/09/A324742_1_En_25_Fig5_HTML.jpg?w=960)
Fig. 25.5
Radiographic images at 11 month post-surgery. From left to right: lateral view, AP, flexion, and extension. A one-level X-LIF procedure and posterior bilateral fusion at L4–L5 with Coflex-F® stabilization was performed. Cobb angle in the flexion image (15.3°) is less than 1°, and then the Cobb angle in the extension image (16.2°) confirming the procedure decreased motion
25.4 Integrated Fixation Fusion
The combination of fixation integrated into interbody fusion cages provides greater segmental rigidity and more physiologic loading through the segment, promoting optimal stability. Although integrated designs are used extensively in anteriorly placed cages both in lumbar and cervical, there are possible drawbacks associated with the introduction of these supplemental devices from a lateral approach. Screw angle, screw fixation, and plate designs are quite different than an anterior approach. However, additional surgical approaches may lead to prolonged operating time, larger skin incisions, soft tissue injuries, and higher infection rates. Certain authors reported screw or plate dislodgments, higher incidences of adjacent level degenerations, and heterotrophic ossifications [49] in multiple approach procedures. If sufficient stabilization can be achieved in a single approach without supplemental fixation from a secondary approach, then it may avoid such adverse effects resulting from additional posterior surgery and minimize the hospitalization time. Integrated fixation cages are a recently developed technology to reduce adverse effects from procedures involving interbody fusion cages.
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