GLOBUS MEDICAL, INC.
`EXHIBIT 1020
`IPR2015-to be assigned
`(Globus v. Bonutti)
`Page 1 of 15
`
`

`
`LANE AND MOORE
`
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`
`a surgical procedure dealing with the diseased disc has been devised, using
`the transperitoneal approach with ox bone implantation. The objective, ana-
`tomic and physiologic principles, operative treatment, and follow-up statistics
`are presented.
`The object of this procedure is:
`I. To completely remove the entire diseased disc with the cartilaginous
`end plates of the adjacent vertebrae.
`
`Incision
`
`Important pelvic structures, and
`FIG. 1.—Demonstrates abdominal incision.
`-
`location of 5th lumbar disc.
`
`2. To wedge the disc space open with an ox bone implantation in order to
`maintain normal space between the vertebrae until
`firm bony fusion is
`obtained.
`
`There are several undesirable features in the posterior approach by
`partial laminectomy, which have contributed in some degree to the large num-
`ber of unsatisfactory results. The usual approach by hemilaminectomy fre-
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`INTERVERTEBRAL DISC
`
`quently gives an inadequate exposure, so that only a small area of the disc
`space is visualized on the posterolateral side on which the laminectomy is
`performed. If the herniation of the diseased disc is in the intervertebral canal
`more anteriorly, it may not be visualized.
`In exposing the disc, retraction
`of the nerve roots may result
`in permanent damage or irritation to these
`structures. Hemorrhage from the anterior longitudinal veins often prevents
`
`FIG. 2.—Method of opening the anterior longitudinal ligament and adequately exposing
`the disc space and nucleus pulposus.
`
`adequate vision in demonstrating the lesion and has been found to be a factor
`in causing postoperative sequelae by hematoma formation followed by fibrosis
`and nerve root irritation with dural adhesions. Only a small portion of the
`disc and cartilaginous end plates can be removed by the posterior approach.
`Since the annulus fibrosus has been damaged, more trauma to the disc can
`539
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`LANE AND MOORE
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`:3-g-0 «,f_s;=r,-gr;
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`produce a further herniation of the remaining nuclear material, with a subse-
`quent return of symptoms. Due to removal of the nuclear material, there is a
`tendency, first, toward subsequent narrowing of the disc space with resulting
`imbalance of weight bearing between the vertebral bodies and the correspond-
`ing facets and, second, joint instability. We have not obtained the desirable
`features of bone graft fusion and normal disc space by the posterior approach.
`
`Wedes of annulus
`I‘ ‘
`1 \
`
`removed
`
`
`
`
`FIG. 3.—(A) Removal of all material within the disc cavity.
`
`ligament with defect after complete
`longitudinal
`(B) Shows exposure of posterior
`removal of disc contents.
`
`In removing diseased discs, by the anterior transperitoneal route, the fol-
`lowing results, which we believe beneficial, have been obtained.
`(1) Good
`exposure to the entire disc space and cartilaginous end plates.
`(2) The 3rd,
`4th, and 5th discs can be examined and treated through the same abdominal
`incision. (3) Removal of the entire disc and all cartilaginous end plates, sulfi-
`$40
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`gym 1321
`
`INTERVERTEBRAL DISC
`
`cient to obtain good bony union, can be accomplished. (4) Hemorrhage is
`easily controlled and does not occur into the spinal canal, and no trauma or
`retraction of the cord or nerve roots are necessary. (5) A large bone implan-
`tation can be wedged into the disc space to prevent narrowing until solid bony
`fusion between the adjacent vertebral bodies has taken place. These are major
`factors in determining a recovery from symptoms of degenerated disc.
`Some knowledge of anatomy of the abdominal cavity is necessary in carry-
`ing out the technic of the transperitoneal approach. The blood supply and
`mesenteric attachments of the lower ileum and colon, the relationship of the
`pelvic portions of the lower ureter to the spine and great vessels, and the
`relationship of the lower vena cava and common iliac vessels to the vertebral
`bodies should be thoroughly understood (Fig. I).
`
`
`
`ate of vert.
`
`"gongy bone pr.~»§v---«.....<.',
`
`
`
`
`
`
`V....4*‘€a>¢r"
`
`Perforation in post. lig.
`
`FIG. 4.—(A) Anterior view demonstrating removal of cartilaginous end plates exposing
`cancelous bone to promote fusion.
`
`(B) Same procedure in cross section.
`
`SURGICAL PROCEDURE
`
`the incision is paramedian from the
`this procedure,
`In carrying out
`symphysis to 3 inches above the umbilicus (Fig. I). The rectus sheath is
`incised I inch lateral to the midline, rectus muscle retracted laterally, peri-
`toneum incised, and the abdomen explored for any pathologic condition.
`Slight Trendelenburg position is obtained to keep the intestines in the upper
`abdomen. The redundant part of the sigmoid, cecum, and small gut is then
`displaced in the upper portion of the abdomen and maintained with moist
`laparotomy sponges to give good exposure to the lower lumbar and pelvic
`portion of the posterior peritoneum. The pelvic portion of the colon is then
`retracted to the left, after identifying the ureters. An incision is made in the
`posterior pelvic peritoneum in the midline. beginning over the sacrum and
`541
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`LANE AND MOORE
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`extending to the bifurcation‘ of the aorta (Fig. I). The kidney bar on the
`operating table, previously placed beneath the 4th lumbar vertebra is now
`elevated sufficiently to push the lumbar spine into hyperextension and forward
`into the abdominal cavity. This gives better exposure and makes as wide as
`possible the intervertebral disc space in the lower lumbar spine, considerably
`increasing the access to the space to be opened. From I-2 inches below the
`
`End plates removed
`
`Graft in place
`
`FIG. 5.—Method of inserting ox bone crescent and peg in disc space.
`
`bifurcation of the aorta, the 5th disc is located by palpation between the
`common iliac vessels and is distinguished by the palpating finger by a distinct
`elevation with a rubbery consistency as contrasted to the hard vertebral bodies.
`The presacral sympathetic nerve plexus and veins are freed by blunt dissection
`and retracted to one side, thus completely visualizing the anterior longitudinal
`ligament over the prominence of the 5th lumbar disc. The disc can then be
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`INTERVERTEBRAL DISC
`
`examined for consistency. By lowering the kidney bar to reduce the lordosis,
`an estimate of disc narrowing is obtained.
`To enter the disc space the kidney bar is re-elevated and a transverse
`incision made across the anterior longitudinal ligament at the lower margin
`of the 5th vertebra sufficient to give access to the entire anterior disc space.
`A vertical incision is made from the mid portion of the transverse incision to
`the upper margin of the sacrum. This allows for the turning back of a flap
`of the anterior ligament to give access to the entire nuclear material (Fig. 2).
`The state of the nuclear material can then be easily ascertained. The contents
`of the disc space are easily removed by a curette, with a deep cup, and a sharp
`cutting edge, which facilitates the cutting away of
`the cartilaginous end
`
`
`
`
`
`
`
`
`
`
`
`FIG. 6.—Closure of disc space by suture of anterior longitudinal
`ligament
`
`plates, as well as the nuclear material. It is necessary for the handles of the
`curette to be about 8 inches in length, with a cross bar at the proximal end
`to get sufficient leverage and motion to cut away the bands of the annulus
`fibrosus and cartilage. The disc contents are removed until the ligaments
`retaining the disc are visible around the entire disc space (Fig. 3, A & B).
`Often there is relaxation and bulging of the ligament outward, due to previous
`degeneration of the disc material, allowing the disc space to narrow and bulge.
`This outward bulging may be most prominent on either side or posteriorly,
`and it is always more prominent in these locations than anteriorly since the
`annuli fibrosi are stronger and several times thicker anteriorly than on the
`sides or posteriorly. The ligaments at the posterior and lateral sides are then
`543
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`LANE AND MOORE
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`
`thoroughly explored with a small blunt instrument to indicate any weakness
`or defective space at the site where preoperative clinical findings have sug-
`gested nerve root pressure.
`If defects or openings are found, they are further
`spread open to ascertain if a portion of the nuclear material has been extruded
`through the defect (Fig. 3B). Such material,
`if found,
`is removed. After
`sufficient search has been made to determine that all nuclear material has been
`
`excised, the cartilaginous end plates are completely removed from the surface
`of the vertebrae by a sharp curette or chisel (Fig. 4, A & B). This pro-
`cedure is done last, as it may cause considerable oozing of blood.
`If done
`before a thorough search of the disc has been made, it may obscure a defect
`in the ligament or a portion of nuclear material
`in the lateral gutter.
`If
`bleeding is too free following removal of the end plates, a tight packing with
`a gauze sponge for several minutes will usually suffice to control it.
`To maintain the disc space in its normal width while fusion is progressing,
`a specially prepared ox bone wedge is used. This was selected on the basis
`of surgical work previously reported by Orel1"’ working on fractures, in which
`he demonstrated that ox bone heterogenous implantations made an excellent
`bridge and were slowly absorbed over a period of from 12-20 months, grad-
`ually becoming a spongy mass through which new capillaries and osteoblasts
`could permeate and form new bone. This course of events permits gradual
`replacement of the ox bone wedge by homologous bone from the adjacent
`vertebral bodies and leaves less chance for narrowing during the fusion
`process. The ox bone wedge now used consists of a crescent shaped piece
`with beveled edges, which is driven into the posterior portion of the disc space
`with the spine hyperextended (Fig. 5B). Between the wings of the crescent
`wedge, a large square bone peg of the same material is driven, being pre-
`viously measured to fit just inside the wings of the crescent (Fig. 5C). This
`almost completely fills the disc space. Following wedging of the disc space,
`the flaps of the anterior ligament are closed and sutured over the disc space
`in their normal position, thus completely encasing the ox bone within the disc
`space (Fig. 6). The kidney rest is lowered, reducing the hyperextension of
`the spine and spreading the disc space open wider by impinging on the ox
`bone wedge.
`Exposure of the 3rd‘ and 4th disc spaces is slightly more technical than
`that of the 5th. However, complete visualization can be accomplished. This
`is due to the fact that the 5th disc lies below the bifurcation of the great
`vessels, whereas,
`the 3rd and 4th are beneath the aorta and vena cava.
`Exposure of the 3rd and 4th is readily achieved for examination, and it is
`always done if there is any clinical evidence of nerve root irritation or joint
`instability on examination previous to surgery. This is done by extension
`upward on the posterior peritoneal incision over the iliac vessels either to the
`right or left of the midline and along the lateral border of the spine, sufficiently
`to expose the 3rd and 4th discs. If the incision is on the right side, the ureter
`is retracted outward and the loose areolar tissue gently dissected through
`until the lateral border of the vena cava is visualized. A short bladed right
`544
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`Mame 127
`Number 3
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`INTERVERTEBRAL DISC
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`angle blunt retractor is placed beneath the lateral border of the vena cava,
`and with gentle retraction it is displaced to the left along with the aorta, until
`the disc space is adequately exposed.
`If exposure is done from a left sided
`approach instead of the right, the incision is the same as that of the right,
`except that the lateral border of the aorta is encountered first instead of the
`vena cava.
`In a like manner the aorta is freed at its lateral border and is
`
`retracted toward the right side, with the vena cava, until adequate exposure
`
`H Aofa
`
`4-ih. lumbar ver-l.
`
`
`
`FIG. 7.—Method used in exposing the 3rd or 4th disc spaces.
`
`If deemed necessary,
`of the disc space is obtained from this side (Fig. 7).
`this disc space may be treated in a similar manner as already described for
`the 5th. Closure, following the completion of this procedure, consists of
`suture of the anterior longitudinal ligament to its adjacent vertebra, com-
`pletely closing the intervertebral space. This is accomplished with sutures of
`cotton No. 30. Closure of the posterior and anterior peritoneal opening is
`obtained with sutures of interrupted cotton No. 70. Fascial
`layers of the
`anterior and posterior rectus sheaths are approximated with interrupted
`sutures of cotton No. 30.
`
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`Page 9 of 15
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`LANE AND MOORE
`
`POSTOPERATIVE CARE
`
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`
`Postoperative care has been most conservative, in order to arrive at a
`definite conclusion as to the ideal convalescence which will not interfere with
`
`fusion. Measures to combat gaseous distention and phlebitis are followed.
`The patients are placed in bed with firm rigid support beneath the mattress.
`No braces or casts are applied at this time. The patients are kept in a supine
`position on a hard surface for 30 days. X-rays of the lumbar spine are then
`taken and a body cast is applied to cover the entire lumbar spine and sacrum.
`
`FIG. 8.—-(a) (Left) AP X-ray for position of bone irnplantations 30 days postoperative.
`(a) (Right) Lat X-ray for position of bone implantation 30 days postoperative.
`
`The lumbar spine is held in slight hyperextension. Some patients have insisted
`on being out of bed on the 15th postoperative day because they have felt
`normal. Against our advice, this was done by three patients without support,
`and they developed no back complaints. The patients are allowed to be
`ambulant and to return to their homes after the application of the cast and
`examination, including roentgenograms, for evaluation of progress.
`If con-
`valescence is satisfactory, they are then supplied with a lumbosacral belt and
`instructed to refrain from strenuous use of the back; they return at monthly
`intervals for further check—up examination, including physical examination,
`check on symptoms, and roentgenograms, to determine the progress of fusion.
`546
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`fi$g=:,13‘-'7
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`IN TERVERTEBRAL DISC
`
`This procedure was first started at the Marine Hospital on February 27,
`1946, and to the present date all discs requiring surgery have been treated
`in this manner.
`
`CLINICAL MATERIAL
`
`A diagnosis of herniated nucleus pulposus was made in 97 cases admitted
`to this hospital between February I, 1946, and February I, 1947. All patients
`were treated conservatively by peridural block, traction, or plaster body cast,
`or a combination of these until such treatment was found ineffectual in the
`
`individual case. Thirty-six cases either failed to respond to such treatment
`or their improvement was insuflicient to allow return to a gainful occupation.
`These 36 cases were subjected to surgery and form the basis of this report.
`
`3|
`
`Of
`31>
`38’.
`
`O.
`
`(Left) AP X-ray for progress 5 mos. postoperative. Fusion present.
`FIG. 8.—(b)
`(b)
`(Right) Lat X-ray for progress 5 mos. postoperative. Fusion present.
`0
`
`Of the patients undergoing surgery, 29 were males and 7 females. The
`average age was 31.9 years—the youngest 18 years and the oldest 52. Twenty-
`nine of the patients followed manual occupations; 7 held sedentary positions.
`The average duration of symptoms at the time of surgery was 19.7 months.
`Of the 36 cases undergoing surgery; I case had sciatic neuritis alone, 3 cases
`had back complaints and findings without neurological changes in the lower
`extremities, and the remaining 32 cases had back and lower extremity symp-
`toms and neurological findings.
`Roentgen examination of the lumbar spine (A—P and lateral) revealed:
`Narrowing of the suspected space in 8 cases; evidence of previous partial
`hemilaminectomy in 4 cases; spondylolysis in 3 cases; spondylolisthesis in I
`case; congenital defect of the lamina in I case; and lumbarization of the Ist
`sacral vertebra in I case. Pantopaque myelography appeared indicated in 7
`patients to substantiate further the diagnosis of herniated nucleus pulposus
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`LANE AND MOORE
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`Marc
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`or to rule out intravertebral canal pathology. The test was suggestive of the
`former in 3 patients and negative in 4.
`
`FINDINGS AT SURGERY
`
`At the time of operation, 25 of the 36 cases (69.4 per cent) had single disc
`lesions as follows: Lumbar IV—3 patients; Lumbar V—22 patients. Eleven
`of the 36 cases (30.6 per cent) had multiple disc lesions as follows: Lumbar
`III and V—I patient, Lumbar IV and V—9 cases; Lumbar V and VI—
`I case.
`
`FIG. 9.—-(a) Lat X-ray for position of bone implantation 30 days postoperative.
`X-ray for progress II mos. postoperative. Fusion present.
`
`(b) Lat
`
`POSTOPERATIVE COMPLICATIONS
`
`Postoperative complications occurred in 5 patients, or 14 per cent, as
`follows: Phlebothrombosis (femoral vein) 2 cases (5.6 per cent); wound
`separation I case (2.8 per cent) ; hypostatic pneumonia I case ( 2.8 per cent) ;
`cystitis (acute) I case (2.8 per cent). Of the 2 cases of phlebothrombosis,
`I
`was of minor intensity and had no sequelae. The other patient continues to
`have minor residual swelling of the involved extremity. The postoperative
`wound separation occurred on the 11th postoperative day in a very obese and
`uncooperative patient. Evisceration did not occur. However, he developed
`a ventral hernia which has subsequently been repaired. The hypostatic pneu-
`monia occurred on the 5th postoperative day and was controlled within 48
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`“"“"'° 1"
`Number 3
`
`INTERVERTEBRAL DISC
`
`hours by chemotherapy. The patient had no sequelae. The complication of
`postoperative cystitis appeared on the 5th day of convalescence and was sec-
`ondary to catheterization. Forced fluids and sulfadiazine controlled this com-
`plication within a period of three days.
`
`RESULTS
`
`Since the time of surgery, the patients have been followed as outlined
`previously. All cases, with one exception, have returned for monthly
`check-ups. This patient was last seen after his 4th postoperative month, at
`
`TABLE I.
`
`Leg
`Back
`Symptoms Symptoms
`
`Neurologic
`Findings
`
`General Status
`——
`
`Cases
`
`Percent Total
`
`Less than 4 months
`( 10 cases)
`
`4-8 months
`(14 cases)
`
`8-12 months
`(11 cases)
`
`Unchanged
`Improved
`Asymptomatic
`
`Unchanged
`Improved
`Asymptomatic
`
`Unchanged
`Improved
`Asymptomatic
`
`2
`8
`0
`
`0
`13
`1
`
`I
`4
`6
`
`1
`1
`8
`
`0
`8
`7
`
`1
`2
`8
`
`1
`1
`8
`
`0
`-I
`10
`
`0
`4
`7
`
`1
`9
`0
`
`0
`13
`1
`
`1
`S
`S
`
`2.9 per cent
`25.1 per cent
`
`37.0 per cent
`2.9 per cent
`
`2.9 per cent
`14.3 per cent
`14.3 per cent
`
`Total unchanged
`Total improved
`Total asymptomatic
`
`5.8 per cent
`77.0 per cent
`17.2 per cent
`
`TABLE I.—Tabulation of symptoms and general status of cases in postoperative periods
`from I to 4 mos.—4 to 8 mos.—and 8 to 12 mos.
`
`which time he was asymptomatic. Since he has subsequently been lost for
`follow-up examination, his case has been excluded from the result series.
`Final results at the time of this writing are, of course,
`impossible to
`evaluate, since inadequate time has elapsed. Furthermore, the series is too
`small for statistical value. However, definite trends toward an ultimate result
`can be seen. For convenience of analysis the postoperative status of these
`cases has been divided into 4-month periods as follows:
`
`Less than 4 months ~— I0 patients
`4 to 8 months
`-— 14 patients
`8 to I2 months — II patients
`
`Table I utilizes the above grouping and tabulates the status of the patients
`at the time of this writing.
`In brief, 2 or 5.8 per cent, of the 35 cases are
`unchanged, and 6, or 17.2 per cent, are asymptomatic. The remaining 27
`cases, or 77 per cent, are improved. However, without exception in this
`improved group, residual symptoms and findings have decreased in intensity
`549
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`LANE AND MOORE
`
`gg-_=-g-cgr_s;-gsgrg
`
`and frequency in direct relationship to the length of time from the date of
`surgery. This observation tends to indicate that eventually these patients will
`be classified as symptom-free. Generally the chart demonstrates that this
`complete recovery is slow. This is to be expected, since advaiced bony fusion
`of the involved intervertebral joint is necessary before the patient becomes
`completely asymptomatic. This principle is substantiated in the roentgen-ray
`findings which are tabulated in Table 2. Those patients in whom there is
`demonstrated bony fusion by roentgen-ray are asymptomatic.
`It has been found that bony callus appears in 3-4 months in some cases.
`Fusion is usually not seen by roentgenograms until the 8-12 month period.
`
`Time Intervals
`
`TABLE II.—X-ray Findings.
`Callus Absent
`Callus Present
`
`Fusion Present
`
`Less than 4 months (10 cases) . . . . . .
`4-8 months (14 cases) . . . .
`.
`. . .
`. .
`. .
`.
`8-12 months. .
`.
`. . .
`. . .
`. . .
`. .
`.
`. . .
`. .
`.
`
`.
`. .
`.
`.
`. . .
`.
`.
`. .
`
`S
`0
`0
`
`5
`
`5
`13
`5
`
`23
`
`0
`1
`6
`
`7
`
`TABLE II.—X-ray findings in postoperative cases indicating progress of fusion in the
`4 mos. period of the Ist year.
`
`At the present time one case demonstrates early fusion in the 4—8 month group
`(Fig. 8). One of the cases in the 8-12 month group demonstrates fusion and
`is illustrated in Fig. 9.
`All patients have been advised most conservatively in regard to returning
`to duty or work. It has been our feeling that definite harm to the softened
`bone graft and early callus might be produced by too strenuous activity.
`Though many patients have felt capable of performing duty after three
`months of convalescence, we have not recommended their return to work
`until there is adequate evidence of early fusion or advanced callus formation.
`Table 3 tabulates the work status of the 35 cases. As may be seen in the
`table,
`these patients do not return to duty until after the 4th month of
`convalescence. Fourteen patients or 40 per cent have returned to duty.
`At this time, one of the 8-12 month group is considered as unsatisfactory.
`The patient’s symptoms of back pain have not shown enough improvement
`for any rehabilitation, the sciatic symptoms are improved, and callus forma-
`tion is present on roentgen-ray examination.
`This procedure has been devised as an attempt to improve on some of the
`undesirable features of the posterior approach and the surgical treatment of
`symptoms caused by degeneration of the intervertebral disc. It is realized that
`meticulous care must be used to exclude other diseases and intra-spinal
`lesions before carrying out
`this procedure; although it gives excellent
`exposure to the disc, it does not allow for complete exploration of the spinal
`canal and cord. Further, it is our opinion that all clinical symptoms and
`physical findings should be carefully analyzed to localize the nerve roots and
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`INTERVERTEBRAL DISC
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`disc spaces before surgery, thus efiecting a better evaluation of the findings
`at operation with the preoperative symptoms. It is realized that as small a
`series of cases as is now presented will not be sufiicient to make a definite
`evaluation as to its efiiciency in treating degenerated discs. Neither is the
`duration of time that has elapsed since surgery sufficient to allow a final con-
`clusion on this small series. However, we believe there are certain aspects
`in the principles applied and trends in the beneficial results so far obtained
`which make this publication worth while.
`
`TABLE III.—Duty Status.
`
`Time Interval
`
`Of? Duty
`
`Light Duty
`
`Full Duty
`
`. . .
`. .
`Less than 4 months (10 cases) . . . . .
`4-8 months (14 cases) . . . . . . .
`. . . . . . . .
`. .
`8-12 months (11 cases) . . . . . .
`. . . . . . . . . .
`
`10
`9
`2
`
`0
`3
`3
`
`0
`2
`6
`
`21
`(60 per cent)
`
`6
`(17.1 per cent)
`
`8
`(22.9 per cent)
`
`31
`(60 per cent)
`
`6
`(17.1 per cent)
`
`8
`(22.9 per cent)
`
`TABLE III.—Duty status of postoperative cases, arranged in 4 mos. periods during Ist year.
`
`CONCLUSIONS
`
`I. A method of complete removal of either the 3rd, 4th, or 5th lumbar
`intervertebral disc, with technic to fuse the joint, is presented.
`2. The principles and technic are outlined.
`3. This procedure has been used since February 27, 1946, in 36 cases of
`herniated intervertebral discs. Postoperative complications have occurred in
`five patients. There have been no deaths.
`4. A preliminary survey of monthly follow-up studies on 35 of the 36
`postoperative cases reveals six cases asymptomatic, 27 improved, and two
`unchanged. The course of improved cases is toward complete recovery from
`symptoms existing prior to surgery. Fourteen patients have resumed either
`light or regular duty.
`5. The obliteration of the involved disc space by bony fusion is necessary
`for complete amelioration of symptoms.
`BIBLIOGRAPHY
`1 Poppen, James L.: Herniated Intervertebral Disc: An Analysis of 400 verified cases.
`New England J. Med., 232: 211,
`2 Kirstein, Lemart: Follow-up Examination of Operated and Non-operated Cases, with
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