throbber
1
`
`NUVASIVE 1067
`NuVasive, Inc. v. Warsaw Orthopedic, Inc.
`IPR2013-00206
`IPR2013-00208
`
`

`

`
`
`SPINE Volume 23, Number 13, pp 14761-1484
`@1998, Lippincott—Raven Publishers
`
`I Minimally Invasive Anterior ‘
`Retroperitoneal Approach to the
`Lumbar Spine
`
`Emphasis on the Lateral BAK
`
`|V|D,* John J. Regan, MD,T W. Peter Gels, MD,i
`Paul C. lVchfee,
`and Ira L. Fedder,
`|\/lD*
`
`Study Design. Eighteen patients with lumbar inste-
`bility from fractures, postlamlnectomy syndrome. or in-
`fection were treated prospectively with minimally Inva-
`sive retroperitoneal lumbar fusions.
`Objectives. To determine if interbody Booby and
`Kuslich fusion cages and femoral eiiogratt bone dowels
`can be inserted in a transverse direction via a lateral
`endOeoorplc retroperitonaal approach to achieve spinal
`stability.
`Summary of Background Data. Endoscopic spinal
`approaches have been used to achieve lower lumbar
`fusion when instrumentation is placed through a laparofi
`ecopio, transparitoneal route. However. complications of
`using this approach include postoperative intra-ahdomlv
`nal adhesione. retrograde ejaculation. great vessel ins
`jury, and implant migration. This study is the first clini-
`cal series investigating the use of the lateral
`ratroperitoneel minimally invasive approach for lumbar
`fusions from L1 to L5.
`Methods. Eighteen patients underwent anterior inter-
`body decompression and/or stabilization via endoscopic
`retroperitoneal approaches. In most oases. three 12vmm
`portals were used. Two parallel transverse interbody
`cages restored the neurotoranrlnai height and the da-
`eired amount of lumbar lordoeie was achieved by in-
`serting a larger anterior cage. distraction plug, or bone
`dowel.
`.
`, Results. The overall morbidity of the procedure was
`lower than that associated with traditional "open" retro-
`peritoneai or leparotomy techniques, with a mean
`length of hospital stay at 2.9 days (range. outpatient
`procedure to 5 days). The mean estimated lntraopera-
`tive blood loss was 205 cc (range, 25in00 cc). There
`were no cases of implant migration. significant subsi-
`dence, or pseudoerthrosis at mean follow-up examina-
`tion of 24.3 months (rapes, 12-40 months) after
`surgery.
`
`
`
`From the *Scoliosis and Spine Center, St. Josephs Hospital, Baltimore,
`Maryland, the tTexas Back Institute and the Institute for Spine and
`Biomedical Research, Plano, Texas, and the iMinimally Invasive Ser-
`vices Training Institute, St. Josephs Hospital, Baltimore, Maryland.
`Acknowledgment date: August 28, 1997.
`First revision date: October 23, 1997.
`Acceptance date: December 2, 1997.
`Device status category: 9.
`
`1476
`
`Conclusions. This preliminary study of 18 patients
`illustrates that endoscopic techniques can be applied
`effectively through a ratroperltoneal approach with the
`patient in the lateral position. Unlike the patients who
`had undergone transperitoneal procedures described in
`previous reports, in these preliminary 18 patients, there
`were no cases of retrograde ejaculation, injury to the
`great vessels, or implant migration. [Key words: endo»
`scopic retroperitoneal, minimally invasive retroperlto—
`neal lumber fusions, transverse axis BAK] Spine 1998;
`23:1476—1484
`
`The use of minimally invasive and endoscopic ap-
`proaches has been described for multiple abdominal pro-
`cedures, including cholecystectomyfgfi1’32 appendecto—
`my,28 colon resection,12 and Nisson fuudoplication,”
`Recently, increased attention has been paid to the use of
`these approaches with lumbar discectomyZS’26 and lum—
`bar anterior interbody arthrodesis.1’4’8 Most endoscopic
`approaches described thus far have been transperitoneal
`and have depended on C02 insufi’lation to provide work—
`ing space and to retract the small bowel out of the sur—
`gical field. Gaur6 and McDougall et all24 were the first to
`describe retroperitoncoscopy, an endoscopic retroperi-
`toneal approach for urologic procedures. The current
`report describes the natural transition toward retroperi-
`toneal minimally invasive endoscopic spinal surgery,
`which does not require C02 insufflation, Trendelenburg
`position, entrance into the peritoneum, or anterior dis-
`section near the great vessels to provide safe exposure for
`spinal surgery.
`I Materials and Methods
`
`Twelve minimally invasive retroperitoneal lumbar procedures
`Were performed at St. Josephs Hospital in Baltimore, Mary-
`land, and six were performed at Presbyterian Hospital of
`Plano, Texas, between March 1994 and September 1996.
`There were 6 female and 12 male patients, with a mean age of
`53.4 years (range, 31—76 years).
`The indications for surgery included 13 cases of degenera-
`tive conditions, three Cases of infections, one unstable burst
`fracture, and one case of a retroperitoneal neurofibroma in-
`
`MC0000006
`
` 2
`
`

`

`1477
`Endoscopic Retroperitoneal in terhody Fusions ° McAfee et al
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Figure 1. This 75-year-old man
`had back pain and right anterior
`thigh pain 2 years after he had
`undergone laminectomies from
`L3 to Sl with a posterolateral fu-
`sion from L4 to Si, The lateral (Al
`and anteroposterior (B)
`radio-
`graphs show “vacuum disk" sign
`at L3—L4 with lateral translation
`of the L3 vertebral body on L4.
`His characteristic pain was re-
`produced by an L3—L4 discogram
`performed by an independent ra-
`diologist. Lateral (C) and antero-
`posterior (D) radiographs were
`obtained after the procedure us—
`ing the endoscopic retroperito-
`neal approach was performed
`and a transversely oriented BAK
`fusion cage was inserted (15 mm
`in diameter and 24 mm lengthl.
`The patient's back and right leg
`pain resolved after surgery.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`volving the lumbosacral plexus. Ten of the 13 patients in the
`degenerative category had undergone previous destabilizing
`laminectomy procedures elsewhere before referral to the au-
`thors’ institutions. Flexion~ extension lateral radiographs dem—
`onstrated more than 3.5 mm of translation, and anteroposte—
`rior radiographs showed 10 degrees or more of scoliotic disc
`space collapse with “vacuum disc sign.” Positive discograms
`documented a provocative pain response at the unstable level
`(Figure 1). The one patient in the degenerative category who
`had not undergone previous destabilizing surgery had a mas-
`sive 1.2—L3 central disc herniation with left quadriceps weak~
`ness.
`
`The retroperitoneal approach proved to be very versatile in
`the range of vertebral levels addressed throughout the 18 cases.
`Four patients underwent procedures at Ll—LZ, seven patients
`at L3—L4, and two patients at L4—L5. There were four endo—
`scopic dccompressions and fusions at L2—L3. One patient with
`vertebral osteomyelitis underwent a decompressive procedure
`from L2 to L4.
`
`Surgical Technique. The approach is a combination of Video—
`assisted thoracoscopic and laparoscopic methods. The patient
`is put under general endotracheal anesthesia, then turned in the
`
`MCOOOOOO7
`
` 3
`
`

`

`
`1478 Spine ' Volume 23 ' Number 13 - 1998
`
`
`
`Figure 2. A view of a transparent optical trochar (Optiview, Ethi-
`con Endosurgery, Cincinnati, OH) that was used in dissecting the
`retroperitoneal space. Notice the "winged keel cutting edges,"
`which only wiil penetrate a fascial layer, such as the peritoneum,
`if the trochar is forcibly twisted backwards and forwards.
`
`lateral decubitus position on a radiolucent, graphite, Jackson
`Maximum lateral access table (0.5.1. Corporation, Union City,
`CA) made specifically for the endoscopic approach, with side
`rails designed to accommodate robotic arms7 and to facilitate
`c—arm fluoroscopy. A 1-cm incision is made at the anterior
`portion of the 12th rib for approaching from L1 or L2. Below
`L2, a lateral egarm fluoroscopic image is obtained, with a metal
`marker overlying the patient’s 5k in in the midaxillary line. This
`method optimizes the placement of the working portal directly
`over the unstable disc or vertebral segment. The three tech—
`niques used to dissect the rctropcritoncal space are: finger dis—'
`section, balloon insufflation, or the use of an optical, transpar-
`ent, dissecting trochar7 called an Optiview (Ethicon
`Fndosurgery, Cincinnati, OH; Figure 2).
`The 107mm laparoscope is inserted into the Optiview dis—
`secting trochar and refocused once the trochar enters the sub—
`cutaneous tissue. The trochar has two “winged keel” cutting
`surfaces that will not penetrate a fascia] layer such as the peri—
`toneum unless the trochar is twisted. Therefore, the three ab—
`dominal muscular layers overlying the peritoneum are pene—
`trated in sequence under direct visualization until the
`preperitoneal fat is encountered. The trochar is used to create a
`potential space that is superficial to the peritoneum until the
`laterally oriented fibers of the psoas major muscle are viewed.
`Usually, the genitofemoral nerve is visualized on the surface of
`the psoas muscle. At this juncture, a dissection balloon, such as
`that manufactured by Origin (Menlo Park, CA), can be filled
`with 1 liter of normal saline or air to dissect the rctropcritoncal
`layer, more correctly referred to as the retrotransversalis fascia.
`Alternatively, carbon dioxide insufflation can be forced into the
`rctropcritoncal cavity up to a pressure of 20 mm of mercury to
`create a working space to triangulate endoscopically.30 Once
`the retroperitoneal space is enlarged, at least three portals are
`used—working portal, for pituitary rongeur; curettes; a high—
`powered burr; or Kerrison rongeurs. A second portal is neces—
`sary for the ’l,O-mm laparoscope. A third portal is used for
`retraction of the psoas major muscle off of the spine in a pos-
`terior direction. The relatively avascular intervertebral discs are
`exposed first. Then, the respective midportions of the adjacent
`vertebral bodies are exposed, and the lumbar segmental vessels
`
`are ligated and divided. Occasionally, a fourth 10-mm portal is
`used for suctioning in highly vascular cases requiring corpecl‘oe
`mies for tumors or infections. Occasionally, for longer strut
`grafts or instrumentation, the 10—mm working portal is ex—
`tended in size as much as 5 cm, and an endoscopically assisted,
`mini~laparotomy type of rctropcritoncal exposure facilitates
`the corpectomy or spinal instrumentation. If the size of the
`working portal is extended, of course, the CO2 insufflation is
`lost, and the working space in the retroperitoneum has to be
`maintained by using retractors. This technique is advantageous
`because the spinal decompression can be accomplished without
`airtight seals, and because standard thoracoscopic instruments
`can be used on the lumbar spine. In other words, throughout
`the remainder of the procedure, spine instruments of heterog—
`enous shaft diameters can be used, and airtight seals around
`trocars are not required.
`Once the vertebral level is confirmed fiuoroscopically, the
`transversalis fascia, pcrinephric fascia, and rctropcritoncal
`contents are retracted anteriorly (Figure 3). Electrocautery is
`used to mark the intervertebral discs adjacent to the involved
`lesion. For example, for an L1 corpectomy, the Ll—LZ and the
`T’lZ—Iil, intervertebral disc spaces are marked. A left-sided ap~
`proach to the surgery is preferred to a right—sided approach,
`because it is easier to dissect the aorta off the spine than to
`dissect around the more friable inferior vena cava; this is par—
`ticularly true in cases of pyogenic vertebral osteomyelitis or
`cases of neoplasm that occur after radiation therapy with ret-
`roperitoneal fibrosis. The psoas muscle is retracted posteriorly,
`and the ureter is retracted anteriorly.
`If a corpectotny is being performed21 after the two adjacent
`discectomies, the surgeon must have access to three methods of
`hemostasis: 1) Endo-Avitene Microfibrillar Collagen (Alcon,
`lnc., Humacao, Pucrto Rico), 2) Gelfoam (Upjohn Corp.,
`Kalamazoo, MI) soaked in Thrombin (GenTrac Corp, Middle—
`town, \WI), and 3) bipolar endoscopic electrocautery. At this
`point, the segmental vessels are dissected from the underlying
`bone and elevated with a right—angled clamp. It is importanl to
`use two vascular clips or an endoloop on the high—pressure side
`of the vessels; the vessels are divided with endoshears. As a
`general rule, with any spine procedure the segmental vessels are
`ligated and divided in the anterior half of the vertebral body to
`allow collateral circulation to the neuroforamen and spinal
`cord to occur to its maximum potential. If the lesion is a tumor
`or infection, then a culture and a frozen section are obtain ed at
`this time in the procedure. A 45—degree, 47mm~wide endo—
`scopic Kerrison rongcur is used to resect the pedicle. Starting
`cephalad, the instrument is pointed caudad to protect the exit-
`ing spinal roots. Either Kaneda (Acromed Corp., Cleveland,
`OH) heavy—duty rongeurs or a high-powered, 5~mm burr, such
`as the Ziinmer (Wausau, IN) Ultra—power or Anspach with
`long extensions, can be used to hollow out the vertebral body.
`Curettes and small 2e3—mm Kerrison rongeurs are used to com~
`plctc the corpectomy. It is important to decompress the spinal
`canal all the way across to the base of the opposite pedicle.
`Decompression is accomplished only when the opposite pcdiclc
`is palpated or visualized. An autogenous iliac strut graft is
`ramped into place, filling the anterior portion of the corpec-
`tomy defect.
`Alternatively, if the patient only requires a discectomy or
`one-level fusion, an anterior interbody fusion can be accom—
`plished endoscopically. The disc space height is restored by
`using a distraction plug placed from the side. Optitnally, two
`
`MCOOOOOOB
`
` 4
`
`

`

`
`
`Endoscopic Retroperitoneal Interbody Fusions - McAfee et al 1479
`
`distraction plugs are tamped into the disc space: one anteriorly
`and one posteriorly. At this point, either a single—barrel or dou-
`ble-barrel drill tube is placed over the distraction plugs. The
`position of the distraction plugs is monitored with anteropos-
`terior and lateral fluoroscopy. The center of the distraction
`plugs will correspond with the center of the BAK interbody
`fusion cages or endoscopic bone dowels.1 The double-barrel
`tube is tamped into place to engage its teeth into the superior
`and inferior vertebral bodies to maintain the normal height of
`the disc space (luring the reaming and tapping of holes into the
`intervertebral endplates. The BAK fusion cage or laparoscopic
`bone dowels, which are composed of femoral allograft, are
`packed with autogenous iliac graft. The morselized iliac au-
`tograft can be harvested with minimally invasive techniques
`through a 12—mm incision by using a disposable T—shaped awl.
`After surgery, the patient is placed in a warm and form
`corset (interbody fusion) or a thoracolumbar sacral orthosis
`(after a corpectomy), until radiographic fusion is accom—
`plished. Intraoperatively, it is important to countersink the
`BAK fusion cages or laparoscopic bone dowel. The authors
`advocate packing additional bone graft superficial to the cage.
`At 3—6 months after surgery, arthrodesis can be confirmed if
`solid trabecular bone is observed to bridge one vertebrae to the
`adjacent level; this is the most reliable radiographic sign of a
`solid arthrodesis. Three-dimensional, computed—tomography
`reconstruction images of the bone within the cages and flexion—
`extension lateral radiographs also can provide useful informa—
`tion.
`
`femoral allograft. The long axes of the implants were
`positioned in a transverse direction.
`There were no cases of implant migration or pseudo-
`arthrosis. There were no cases of a radiolucent interface
`between the implant and the vertebral body. There were
`no cases of subsidence more than 1 mm, and there was
`trabccular bony bridging across the adjacent vertebrae
`laterally by 6 months after surgery.
`One additional patient did not undergo an endoscopic
`stabilization procedure. He was a 47—year—old man with
`an unstable burst fracture who had undergone left ante-
`ri or Kaneda instrumentation at the referring institution 3
`months earlier. He had had an incomplete neurologic
`deficit; a preoperative computed tomography scan had
`demonstrated continued right-sided cauda equina com—
`pression. A right-sided endoscopic decompression was
`performed at the authors’ institution, and additional sta-
`bilization was not required.
`For all 18 cases, the mean duration of the surgical
`procedure, including the harvesting of iliac crest bone
`autograft, was 115.2 minutes (range, 60 —260 minutes).
`The mean estimated blood loss, which, at the authors’
`institutions, is determined by the attending anesthesiol-
`ogist, was 205 cc (range, 25—1000 cc). The mean length
`of hospital stay was 2.9 days (range, outpatient proce—
`dure to 5 days).
`
`I Results
`
`The mean length of the postoperative follow—up period
`was 24.3 months (range, 12—40 months). Fourteen pa—
`tients underwent left-sided retroperitoneal approaches,
`and, in four patients, the pathology was addressed more
`easily on the right side. There were four patients who in
`whom a single incision was made of 5 centimeters or less.
`Fourteen patients had either three or four portals mea-
`suring approximately 12 mm in length. These fourteen
`patients had CO2 insufflation to assist the retrotransver-
`salis dissection. The patients with one incision of 5 cen-
`timeters or less had lesions compatible with infection or
`tumor, and the use of C02 insufflation was avoided to
`prevent pressurizing the tumor cells or bacteria systemi-
`cally into the patient’s bloodstream.9’10’11’15
`Fusions were performed in 15 of 18 cases by using
`structural bone graft and/or interbody fusion cages. A
`38—year—old radiologist’s wife with a neurofibroma aris-
`ing from the lumbosacral plexus adjacent to the left com—
`mon iliac vein did not demonstrate preoperative or in-
`traoperative instability; therefore, a fusion procedure
`was not indicated.
`
`Ten patients underwent fusion surgery with custom
`BAK interbody fusion cages. The long axes of the cages
`were in the transverse direction (Figure 4).4 In each case,
`the cages were packed with autogenous iliac bone graft
`harvested using a minimally invasive, T—shaped trochar,
`that was 10 mm in diameter. Four patients underwent
`placement of laparoscopic bone dowels fashioned from
`
`Complications
`There were three patients with postoperative complica—
`tions. Case 2 was a 71-year—old man on renal dialysis
`who presented with sepsis. Endoscopic, retroperitoneal,
`L3—l.4 discectomy; debridement; and fusion were per-
`formed to culture and manage an L3—L4 pyogenic osteo-
`Inyelitis. Six weeks after surgery, after treatment with
`intervenous antibiotics, the patient underwent posterior,
`segmental stabilization with Texas Scottish Rite Hospi-
`tal implants from L1—L5 for more definitive stabilization
`and fusion. The single—level, anterior, interbody, endo—
`scopic fusion was not believed to be adequate to prevent
`long-term lumbar kyphosis and instability.
`The second complication occurred intra operatively in
`Case 3, when a laparoscopic bone dowel partially frac-
`tured at the point of attachment of the driver into the
`central drilling peg in the femoral cortical allograft. The
`fractured piece of allograft was extremely small (approx—
`imately 0.5 cm X 0.5 cm X 0.5 cm), and the patient’s
`spinal stability was not jeopardized. There were no long-
`term sequelae, and the patient had a solid arthrodesis,
`which was facilitated by morselized iliac autograft
`placed in the central chamber of all laparoscopic bone
`dowels.
`
`The third complication occurred in a 69-year-old man
`who underwent transverse BAK cage insertion for post-
`laininectomy instability at L3—L4. The patient developed
`a hematoma in the psoas muscle at L3—L4 after surgery.
`This resulted in a temporary genitofemoral nerve palsy,
`which resolved spontaneously within 3 months.
`
`MCOOOOOOQ
`
` 5
`
`

`

`1480 Spine 0 Volume 23 0 Number 13 0 1998
`
`l Discussion
`
`Retropcritoneal lumbar fusion and stabilization offers
`several advantages over conventional anterior transperi-
`toneal laparoscopic approaches of the lumbar spine.8
`Retroperitoncal approaches obviate the risk of small
`bowel obstruction or postoperative intraperitoneal ad-
`hesions.16’17 Additionally, there should be a reduced risk
`of retrograde ejaculation, because the autonomic plexus
`is not dissected, in contrast to preliminary reports of
`transperitoneal laparoscopic approaches.13’22’30 The pa-
`tient is in the lateral decubitus position, which facilitates
`exposure of the lumbar spine, as gravity helps retract the
`abdominal contents anteriorly. With the straight, lateral
`position, as opposed to the supine Trendelenburg posi—
`tion required for transperitoneal laparoscopy, it is easier
`to get orthogonal to the disc space and spine with later—
`ally directed placement of interbody threaded fusion
`cages. The surgeon can use two longer cages in the trans-
`verse axis, with a larger—diameter cage anterior and a
`smaller-diameter cage posterior, thus “customizing” or
`“dialing in” the optimal degree of intervertebral lordosis
`(Figure 5). The same effect of altering the sagittal plane
`alignment was achieved in the majority of patients in this
`study by using distraction plugs of different diameters to
`adjust the degree of lordosis even before reaming the
`cage diameter. Two longer cages placed laterally via the
`retroperitoneal approach should be biomechanically
`more stable, because the surface area of the vertebral
`body cage contact area is greater than that achieved
`when using a transperitoneal approach. In addition, the
`anterior longitudinal ligament and posterior longitudi-
`nal ligament are not violated with the lateral retroperi—
`toneal approach. With the transperitoneal approach, if
`the surgeon reams, taps, or drills too deeply, the spinal
`canal contents are at risk. With the lateral retroperito-
`neal approach, however, the orthopedic drilling, ream-
`ing, tapping, and cage insertion are directed toward the
`contralateral psoas muscle instead of the neurologic
`structuress’zz
`In the report of the laparoscopic BAK study13 submit—
`ted to the Food and Drug Administration, the incidence
`of iatrogenic intraoperative disc herniation in patients
`undergoing surgery at one level was 2.8% (6 of 215
`patients) and that in patients undergoing transperito-
`neal, two-level BAK was 12% (3 of 25 patients). Overall,
`for BAK implants inserted via a straight anterior—to-
`
`
`posterior direction, the incidence of reoperation for iat-
`rogenic penetration or for pushing intervertebral disc
`material into the spinal canal was 2.3%. Furthermore,
`lateral retroperitoneal proceduresyobviate the need to
`dissect and mobilize the common iliac vein and artery, as
`is necessary with transperitoneal exposure of the L4 —L5
`intervertebral disc. The authors have found that it is eas~
`icr to make the long axis of two retroperitoneal cages or
`bone dowels parallel via a shotgun or double—barrel tro—
`char than via a transperitoneal independent trochar.
`Mayer18 reported on 20 patients who underwent ret-
`roperitoneal, microsurgical, anterior lumbar interbody
`fusion between January 1, 1995 and January 31, 1996.
`In this procedure, an extensive quadrilateral retraction
`frame was used, but anterior stabilization implants were
`not. All patients had undergone an additional posterior
`pedicle screw instrumentation procedure 1—2 weeks ear—
`lier.
`Boden et al2 described a video-assisted, lateral, inter-
`transverse—process arthrodesis in a rabbit and a non—
`human primate model. This was a posterior approach,
`which did not involve spinal stabilization.
`Ordway et al27 compared the biomechanical charac-
`teristics of a transversely oriented carbon-fiber cage with
`those of an anteriorly oriented cage in the bovine lumbar
`spine and found that, in most cases, the differences were
`not statistically significant. In addition, Ordway et al
`compared two anteriorly oriented cages with just one
`transversely oriented cage, which is a biased comparison.
`However, the carbon fiber cage has been studied exten—
`sively at the current authors’ laboratory as well3; it is
`basically an unreamed spacer that is not screwed into
`place. The BAK system is inherently more stable than the
`carbon fiber cage because it uses preinsertional distrac-
`tion via distraction plugs, which results in better liga-
`mentotaxis. The BAK involves a tap that cuts threads
`into the two adjacent vertebral end plates, and the BAK
`reduces the strain and micromotion on the bone graft
`contained within the cage more successfully than does
`the rectangular carbon-fiber design.14
`There are several potential disadvantages of the min-
`imally invasive, retroperitoneal approach. Particularly at
`L4 —L5, it may be necessary to remove part of the iliac
`crest or place the docking portal through the ili ac wing to
`be orthogonal to the L4 —I,5 disc space.22’30 In addition,
`a large mass of psoas muscle containing lumbosacral
`)
`
`Figure 3. A, Schematic diagram showing the orientation for the retroperitoneal approach. The ”X” marks the anterosuperior iliac spine,
`and the three portals are shown by black dots. B, Initial lateral radiograph of a 76-year-old, dialysis-dependent man with biopsy-confirmed
`osteomyelitis at L3—L4. Initially, he was treated at another institution with intravenous antibiotics and a thoracolumbosacral orthosis. When
`he arrived at the authors' institution, he was in septic shock. c, A sagittal magnetic resonance image revealing vertebral collapse with
`an associated retropulsed vertebral body fragment and thecal sac compression. D, A schematic diagram depicting the laparoscopic View
`through the transversalis fascia as the L3—L4 intervertebral disk is exposed. E, A laparoscopic view of the retroperitoneal space. The black
`arrows demonstrate the interval used to reach the vertebral body. The psoas major (Pl
`is posterior, and the ureter (U)
`is anterior.
`Perinephric fat (K) is dissected bluntly to expose the interval. F, A schematic diagram showing debridement of the infected granulomatous
`tissue with the anterior thecal sac exposed between the L3 and L4 vertebral bodies posterior to the pituitary rongeur. G, A laparoscopic
`photograph showing a pituitary rongeur debriding the infected L3—L4 intervertebral disc.
`
`mcoooom o 7
`
` 6
`
`

`

`
`Endoscopic Retroperitoneal Interbody Fusions - McAfee et al
`1481
`
` Retractor
`
`ACamera
`
`Endoshears
`
`
`
`,nephreniqv
`
`, Fat\\ ‘
`
`Rongeur
`
`Pituitary
`
`MCOOOOO11
`
` 7
`
`

`

`1482 Spine - Volume 23 - Number 13 - 1998
`
`
`
`Figure 4. Anteroposterior and
`lateral
`radiographs of
`two pa—
`tients obrained after endoscopic
`retroperitoneal BAK interbody iw
`sion was performed and instru-
`mentation for postlaminectomy
`instability was placed. A and B
`Show a one—cage technique. 0
`and D Show a two-cage tech-
`nique.
`
`nerve roots may need to be mobilized laterally. However,
`the authors of this study still prefer mobilizing the psoas
`muscle to mobilizing the common iliac vein and artery,
`as is necessary with transperitoneal approaches. The po—
`sition of the ureter constantly needs to be considered in
`transperitoneal and retroperitoneal minimally invasive
`approaches. One additional advantage of the retroperi-
`toneal approach is that spine surgeons probably will be
`more comfortable performing the approach without de—
`pending on a general surgical “access surgeon.”
`Obviously, it is difficult to prove statistically that the
`incidence of complications associated with the retroper—
`itoneal approach is lower than that associated with the
`intraperitoncal endoscopic spinal procedures, because
`even transperitoneal spinal fusion is only a recently de-
`scribed procedure and is still
`in its infancy. However,
`
`many general surgical, gynecologic, and urologic proce—
`dures in which the retroperitoneal approach is used have
`been reported showing fewer complications than their
`transperitoneal operative counterparts. Leverant et al17
`showed that intra—abdorninal adhesions do occur with
`
`laparoscopy. They found intraperitoneal adhesions in 79
`of 124 patients whose only prior surgery was laparos—
`copy; none of the 91 controls without prior laparosco—
`pies in that study had adhesions. lajer et al16 reported a
`1% incidence of hernias in trocar ports after abdominal
`laparoscopy. Hernias through trocar ports have not been
`described with retroperitoneal approaches.
`The authors of the current study have performed more
`than 150 endoscopic spinal procedures, and have had a
`patient with postoperative small bowel obstruction. This
`obstruction occurred in a patient 2 weeks after he had
`
`
`
`
`
`
`
`
`
`
`
`
`
`MCOOOOO12 I
`
` 8
`
`

`

`Endoscopic Retroperitoneal Interbody Fusions - McAfee et al
`
`1483
`
`Kyphosis
`
`Neutrai
`
`Lordos’is
`
`
`
`
`
`
`
`Retreperitoneal “Transverse Axis" Cages canoe used 7
`to "dial in" tne'deslred kyphosis or lordosis.
`
`'
`
`Figure 5. A schematic diagram illustrating how differential sizing
`of transversely oriented distraction plugs, interbody bone dowels,
`or fusion cages can "dial
`in" or adjust the desired amount of
`lumbar kyphosis or lordosis through a minimally invasive retroper—
`itoneal approach.
`
`undergone anterior transperitoneal laparoscopic L4—L5
`fusion, when the greater olmentum became adherent to
`the posterior peritoneum.
`Tiusanen et al34 reported an incidence of retrograde
`ejaculation of 5.9% as a complication of anterior inter-
`body fusions and found that it occurred only after trans—
`abdominal procedures. In the report of the first series of
`240 laparoscopic BAK interbody fusions and stabiliza—
`tions13 submitted to the Food and Drug Administration,
`there were 12 cases (5%) of retrograde ejaculation that
`occurred as a complication of laparoscopic procedures.
`Although the numbers are too small to analyze statisti—
`cally, there probably is a higher incidence of this compli—
`cation at LS—Sl exposure than at L4 —L5 exposure; it has
`been described to occur after anterior fusions to L4 and
`
`with periaortic lymph node dissection. Retroperitoneal
`exposure, either endoscopic or conventional, is associ-
`ated with a lower incidence of this postoperative compli—
`cation. ‘8730
`It is difficult to compare the morbidity of traditional
`versus minimally invasive, endoscopic, anterior, retro-
`peritoneal approaches in the orthopaedic literature di—
`rectly, because the length of hospital stay, operative time,
`and length of time out of work have not been reported.
`However, there are three studies of traditional, retroper—
`itoneal, anterior decompressions of the spine in which
`the current authors have participated and reported: those
`of McAfee et ad20 with 70 patients, McAfee19 with 185
`patients, and McAfee and Zdeblick23 with 23 patients.
`Overall, it is the authors’ impression that the incidence of
`complications and morbidity is much lower for endo-
`scopic procedures; in particular, associated medical peri—
`operative complications are reduced, including urinary
`tract infections, post-operative atelectasis, and pneumo—
`nia. However, further experience is clearly necessary to
`confirm this impression. The authors currently are par-
`ticipating in a prospective, multicenter trial by the Na-
`tional Institute of Health to investigate further the coni—
`
`plication rates of conventional versus minimally invasive
`techniques.
`In summary, in this report of 18 cases of minimally
`invasive, lateral retroperitoneal, lumbar procedures, the
`main advantages were:
`
`1 ) the length of stay was less than that associated with
`larger muscle-splitting “open approaches,”
`2) the need for mobilization of the great vessels was
`reduced compared with that of transperitoneal lapa-
`roscopic approaches,
`3) the procedure allowed for two larger cages to be
`inserted parallel to one another in a transverse direc-
`tion, horizontal, rather than perpendicular, to the spi—
`nal canal.
`
`4) by varying the diameter of the retroperitoneally
`placed interbody fusion cages, interbody allograft
`bone dowels, or distraction plugs, customization of
`the amount of lumbar lordosis was possible without
`increasing the risk of implant dislodgement or
`pseudoarthrosis.
`
`Eighteen cases is not a large series, but the results are
`favorable compared with preliminary results of alterna-
`tive techniques.
`
`References
`
`1. Bagby G. Arthrodesis by the distraction—compression
`methods using a stainless steel implant. Orthopaedics 1988,11:
`931—4.
`2. Boden SD, Moskovitz PA, Morone MA, Toeibitaby Y.
`Video—assisted lateral intertransverse process arthrodesis: Val—
`idation of a non-minimally invasive lumbar spinal fusion tech-
`nique in the rabbit and non—human primate (Rhesus) models.
`Spine 1996;21:2689—97.
`3. Brantigan jW, McAfcc PC, Cunningham BW, Wang H,
`Orbegoso CM. Interbody lumbar fusion using a carbon fiber
`cage implant versus allograft bone: An investigational study in
`the Spanish goat. Spine 1994;19:1436—44.
`4. Brodke DS, Dick JC, Kunz DN, McCabe R, Zdeblick TA.
`Posterior lumbar interbody fusion: A biomechanical compari—
`son including a new threaded cage. Spine 1997;22:26~31.
`5. Cook TA, Dehn TC. P

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.

throbber

A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.


Access Government Site

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket