SPINE Volume 25, Number 11, pp 1437–1446
©2000, Lippincott Williams & Wilkins, Inc.
Lumbar Interbody Fusion Using the Brantigan I/F Cage
for Posterior Lumbar Interbody Fusion and the
Variable Pedicle Screw Placement System
Two-Year Results From a Food and Drug Administration
Investigational Device Exemption Clinical Trial
John W. Brantigan, MD, Arthur D. Steffee, MD, Mary L. Lewis, Linda M. Quinn, MS, and
J. Maarten Persenaire, MD
Study Design. A carbon fiber–reinforced polymer cage
implant filled with autologous bone was designed to sep-
arate the mechanical and biologic functions of posterior
lumbar interbody fusion.
Objectives. To test the safety and efficacy of the car-
bon cage with pedicle screw fixation in a 2-year prospec-
tive study performed at six centers under a protocol ap-
proved by the Food and Drug Administration, and to
present the data supporting the Food and Drug Adminis-
tration approved indications.
Summary of Background Data. The success of poste-
rior lumbar interbody fusion has been limited by mechan-
ical and biologic deficiencies of the donor bone. Some
failures of pedicle screw fixation may be attributable to
the absence of adequate load sharing through the ante-
rior column. Combining an interbody fusion device with
pedicle screw fixation may address some limitations of
posterior lumbar interbody fusion or pedicle screw fixa-
tion in cases that are more complex mechanically.
Methods. This clinical study of posterior lumbar inter-
body fusion with pedicle screw fixation involved a pro-
spective group of 221 patients.
Results. Fusion success was achieved in 176 (98.9%) of
178 patients. In the management of degenerative disc
disease in patients with prior failed discectomy surgery,
clinical success was achieved in 79 (86%) of 92 patients,
and radiographic bony arthrodesis in 91 (100%) of 91
patients. Disc space height, averaging 7.9 mm before sur-
gery, was increased to 12.3 mm at surgery and main-
tained at 11.7 mm at 2 years. Fusion success was not
From South Texas Orthopaedic and Spinal Surgery Associates, San
Antonio, Texas.
Supported by DePuy-AcroMed Corporation, Raynham, Massachu-
setts. The Brantigan I/F Cage and the VSP Spinal Fixation System,
manufactured by DePuy-AcroMed Corporation, are approved by the
FDA for treatment of degenerative disc disease in the United States.
Dr. Brantigan has a financial interest in the Brantigan I/F Cage for PLIF.
Dr. Steffee has a financial interest in the VSP pedicle screw system. Ms.
Lewis and Dr. Persenaire were employees of the clinical affairs depart-
ment of DePuy-AcroMed Corporation during this study. Ms. Quinn is
an independent statistician affiliated with QED Industries and Cleve-
land State University. Dr. Brantigan’s work was done as Associate
Professor of Surgery at Creighton University, Omaha, Nebraska,
where IRB supervision was done.
Acknowledgment date: October 15, 1996.
First revision date: December 2, 1998.
Second revision date: March 17, 1999.
Acceptance date: July 23, 1999.
Device status category: 3.
Conflict of interest category: 17.
diminished over multiple fusion levels. These results
were significantly better than those reported in prior lit-
erature. Although significant surgical complications oc-
curred, those attributable to the implant devices occurred
less frequently and generally were minor.
Conclusions. The Brantigan I/F Cage for posterior lum-
bar interbody fusion and the Variable Screw Placement
System are safe and effective for the management of
degenerative disc disease. [Key words: cage, degenera-
tive disc disease, failed discectomy, interbody fusion or-
thosis, multiple-level fusion, pedicle screw, postsurgical
failed back, posterior lumbar interbody fusion, recurrent
disc disease] Spine 2000;25:1437–1446
Posterior lumbar interbody fusion (PLIF) was pioneered
by Cloward18 –21 in the 1940s to treat painful interverte-
bral discs damaged by herniation or degeneration. In the
PLIF operation, the entire nuclear portion of the disc is
removed and replaced with multiple blocks of transplant
bone. The PLIF procedure has had supporters over the
years,46 – 49,53,54 but it never has been accepted generally.92
More recently, pedicle screws and plates were intro-
duced to treat the same degenerative conditions.80 – 82 As
early as 1988, Steffee et al1,82 recommended that pedicle
screw fixation be combined with PLIF to restore load
sharing through the anterior column. However, prob-
lems have remained with the transplanted bone, includ-
ing insufficient mechanical strength and slow bony heal-
ing.7,8,29,66
The Brantigan I/F Cage for PLIF was designed to im-
prove the fusion success of interbody fusion by separat-
ing the mechanical and biologic functions of PLIF. The
cage implant provides an actual device designed to meet
the mechanical requirements of PLIF and replaces the
donor bone with autologous cancellous bone, the best
possible bone for healing. Previous studies have included
mechanical testing in cadaver spines,12 a 2-year implan-
tation study in the Spanish goat,10 and an initial patient
series.11 The purpose of this article is to report the results
of a multicentered prospective clinical study.
An investigational device exemption (IDE) study was
approved by the Food and Drug Administration (FDA)
in November 1991 to test the safety and efficacy of the I/F
Cage and pedicle screw/Variable Screw Placement Sys-
tem (VSP) for treatment of recurrent disc disease, spon-
dylolisthesis, and failed fusion. The study emphasized
1437
1438 Spine • Volume 25 • Number 11 • 2000
Figure 1. Photograph of two carbon cages.
treatment of patients with failed discectomy because this
diagnosis represents a prognostically distinct subset of
degenerative disc disease for which there is general con-
sensus that fusion surgery is indicated. The implants
were approved by the FDA in February 1999 for the
management of degenerative disc disease. This article
reports the results for the FDA-approved indication
along with the demographics and complications of the
entire study.
Methods
Description of the Brantigan I/F Cage. The Brantigan I/F
Cage (DePuy-AcroMed Corp., Raynham, MA), shown in Fig-
ure 1, is a hollow implant, rectangular in cross-section, made of
carbon fiber polymer composite. This cage is manufactured
from polyether ketone ether ketone ketone (PEKEKK) rein-
forced with carbon fibers. The cage has ridges or teeth to resist
retropulsion, struts to support weight, and a hollow area to
allow packing of autologous bone graft. Filled with a patient’s
own bone at surgery, the cage is implanted in a horizontally
opposed transverse channel prepared in the disc space using a
PLIF Broach System (DePuy-AcroMed Corp.).
The carbon material has two properties that give it potential
advantage over implants made of titanium or other metal: The
carbon fiber composite is radiolucent so that normal radio-
graphic methods can demonstrate bony healing without the
obscuring shadows of metal materials, and the structure has a
modulus of elasticity virtually identical to that of cortical bone.
Table 1. Clinical Evaluation Scales
Pain Function
P1: Excruciating or unbearable F1: Total incapacity
pain
P2: Severe pain F2: Able to do activities in the
home
P3: Moderate pain F3: Able to do activities outside
the home with limitation of
moderate-demand activities
P4: Mild pain F4: Limitation of strenuous
activities or sports
P5: No pain F5: Able to do all activities
Pain ⫹ function ⫹ economic ⫹ medication scores are added to create a 4- to 20-point rating in which 4 to 8 points equals poor, 9 to 12 points equals fair, 13 to
16 points equals good, and 17 to 20 equals excellent clinical status. Data points can be abbreviated as P5–F4 –E4 –F5 to record all parameters quickly.
Compared with metals that are 10 times as stiff, the elasticity of
the carbon material minimizes stress shielding of the enclosed
graft and potentially decreases micromotion between bone and
implant during loading.
Description of the Variable Screw Placement System. The
VSP (DePuy-AcroMed Corp.) includes pedicle screws and
plates.81 The screw has a cancellous thread ending in an inte-
gral nut, above which a machine thread with tapered and lock-
ing nuts allows the screw to be anchored securely to the plate.
Screws are available in standard outer diameters of 5.5 to 8.5
mm and in cancellous thread lengths of 35 to 70 mm.
The VSP plate has a series of “nests,” into which the tapered
portion of the nut can be fixed securely. Because the position of
the screw can vary both along the length of the plate and in an
angular direction, it has been called the variable screw place-
ment plate. The VSP system includes plates of multiple slot
lengths, flat and tapered washers, and cross connectors.
Clinical Study Design. Inclusion criteria required all patients
to have disabling back and/or radicular pain refractory to at
least 6 weeks of conservative management after at least one
prior failed discectomy operation and moderate to severe de-
generative change in one, two, or three disc levels based on
magnetic resonance imaging (MRI) or discogram. Exclusion
criteria ruled out patients with more than three abnormal lev-
els, past or present infection in the disc or spine, tumor, past or
present abuse of illicit drugs, or current alcohol abuse. Prison-
ers and patients younger than 18 years or older than 89 years
also were excluded from this study. There was no upper limit to
the number of prior failed lumbar surgeries.
At the conclusion of the study, 221 patients were prospec-
tively treated with cages and pedicle screws at six study centers,
110 of whom were in the degenerative disc disease group. De-
mographic data were recorded including age, gender, height,
weight, employment, job category, compensation issues, neu-
rologic function, number of prior back surgeries, duration of
back and leg pain, and diagnosis at each lumbar level.
Patients were examined and data recorded before surgery,
at surgery, and at 1, 3, 6, 12, and 24 months after surgery.
Evaluations at each interval included ratings of pain, function,
economic status, and medication usage according to the
5-point Likert scales listed in Table 1. Patient satisfaction, sen-
sory and motor function, tension signs, reflexes, and radio-
graphic findings were recorded at each follow-up interval. Ad-
Economic Medication
E1: Unable to do tasks around the M1: 10 or more hydrocodone tablets or
home equivalent
E2: Able to do tasks around the M2: 6–9 hydrocodone tablets or
home but unable to work equivalent
E3: Able to work at light or M3: 3–5 hydrocodone tablets or
sedentary capacity equivalent
E4: Able to work at moderate M4: Regular nonsteroidal anti-
capacity inflammatory drugs (NSAIDs) and/or
occasional hydrocodone tablets
E5: Able to work at heavy M5: None or occasional NSAID or
capacity or previous occupation equivalent
 Carbon Fiber Implant for PLIF: FDA Clinical Trials • Brantigan et al 1439
ditional clinical data were recorded including surgery levels,
operative difficulties, complications, fusion status, and reop-
erations or revisions.
Fusion status was examined during any reoperation. Case
report forms were submitted to DePuy-AcroMed Corporation,
whose clinical monitor audited each site on a regular basis and
verified all reported data by reference to hospital and office
records. Objective clinical ratings were recorded by a data
manager at each study site using FDA-reviewed case report
forms. Independent statistical evaluations were conducted by
one of the authors (L.M.Q.).
Clinical success was defined according to literature param-
eters used over many years35,53,63,75,88 and modeled after an
expanded Prolo scale.68 The 5-point Likert scales for pain,
function, economic status, and medication usage given in Table
1 were added to a combined 4- and 20-point scale. This study
prospectively defined a patient’s result as a clinical success
when the 2-year rating was excellent (17 to 20 points) or good
(13 to 16 points), or fair (9 to 12 points) if the patient achieved
a minimum improvement of three points or more in the com-
bined 20-point score.
As outlined by the FDA in June 1997, clinical success is
improvement in pain, maintenance or improvement in func-
tion, and maintenance or improvement in neurologic function
in terms of motor strength. Calculations of clinical success were
made by the 10-point Prolo score, by the 20-point expanded
Prolo score, and by the FDA clinical success criteria. Because
the results from the three ratings did not differ statistically, the
FDA clinical success scores are emphasized in this article, as
they represent the data provided to the FDA for clinical ap-
proval of the aforementioned devices.
Fusion status was recorded for each surgically treated seg-
ment at each follow-up interval. The level was regarded as
fused if there was radiographic evidence of bone bridging the
disc space with no lucency. For patients undergoing multiple-
level fusion, all surgically treated segments needed to be fused
for the patient to be considered a fusion success. Overall suc-
cess was defined by FDA as fusion plus clinical success.
The primary determinations of safety and efficacy were
based on comparison with historical literature controls. A
Medline search was conducted, resulting in a detailed review of
300 published articles. Studies were accepted for statistical
comparison if they involved a consecutive series of patients, at
least 85% of whom were followed up for 2 years; if they had
evaluations by comparable criteria, and if they allowed specific
numbers of patients who were successes or failures to be
counted.
Statistical Methods. Demographics were compared among
sites using ␹2 analysis and analysis of variance (ANOVA) to
ensure that results could be pooled. Comparisons to the litera-
ture were made using ␹2 and Fisher’s exact test analyses. Com-
parisons between pre- and postoperative scores were made us-
ing paired t tests.
Results
Efficacy in Managing Degenerative Disc Disease
The demographics of the study patients are summarized
in Table 2, and surgical parameters are shown in Table 3.
Fusion success was achieved in 176 (98.9%) of 178 pa-
Table 2. Demographics of the Prospective Patient
Study Group
Total patients enrolled: 221
Men: 126
Women: 95
Age, yr: 44.3 ⫾ 11.7 (range 24–77)
Diagnosis
Recurrent disc disease: 110
Spondylolisthesis: 51
Failed fusion: 60
Physical characteristics
Height: 68.2 ⫾ 4.3 in
Weight: 188.6 ⫾ 42.7 lb
Work
Patients not working preoperatively: 145/221 (66%)
Patients “retired” preoperatively: 29/221 (13%)
Workers compensation: 87/221 (40%)
Litigation pending: 49/221 (22%)
Pain
Average duration of back pain: 8 yr
Average duration of leg pain: 5 yr
Smoking history
Positive smoking history 135/221 (62%)
Mean smoking history: 15.3 ⫾ 18.4 pack years
Prior lumbar surgeries
Total number of prior lumbar surgeries: 326
Spondylolisthesis cases without prior surgery: 51
Other cases had 326 prior surgeries in 170 patients, or 1.9 prior
lumbar surgeries per patient
tients who had 2-year radiographs. Follow-up rates for
the degenerative disc disease group were 100% (n ⫽
109) at 1 month, 99% (n ⫽ 106) at 3 months, 98% (n ⫽
107) at 6 months, 98% (n ⫽ 104) at 12 months, and
88% (n ⫽ 92) at 24 months. Also, 47 patients who had
reached the 48-month interval had 4-year data.
Outcome values over time for each parameter are pre-
sented in Table 4. At 24 months, clinical success by pro-
tocol definition was achieved in 79 (86%) of 92 patients,
and by FDA definition in 77 (83.7%) of 92 patients.
Fusion success was achieved in 91 of 91 patients (100%),
and FDA overall success was realized in 77 (85%) of 91
patients. At 24 months, 77 (85%) of 92 patients were
satisfied with their result and would undergo the proce-
dure again. At 48 months 95% of the patients were sat-
isfied.
Bivariate analysis indicated that the following factors
had no statistical effect on clinical or fusion success: gen-
der, numbers of levels treated surgically, previous sur-
gery, smoking history, and obesity. Obese patients (body
mass index exceeding 30 kg/m2) had a higher rate of
screw breakage. Patients receiving workers’ compensa-
tion had a statistically lower clinical success rate (37/56;
66%) than patients who were not receiving workers’
compensation (76/86; 88.3%). No difference was found
in fusion success rates for patients with workers’ com-
pensation. Patients with two or three previous surgeries
had significantly greater clinical success (P ⫽ 0.022) than
all other patients.
Safety
Complications were divided into device-related and
non– device-related complications and further defined as
1440 Spine • Volume 25 • Number 11 • 2000

Table 3. Surgical Parameters

All Patients 1 Level 2 Level 3–4 Levels

Blood loss (mL) 1577 ⫾ 1246 1066 ⫾ 600 1843 ⫾ 1442 2561 ⫾ 1410
(100–8200) (100–2500) (100–8200) (600–5000)
Surgical time (min) 297 ⫾ 82 261 ⫾ 68 311 ⫾ 70 396 ⫾ 107
(175–633) (175–500) (180–520) (257–633)
Cages used 3.3 ⫾ 1.3 2.0 ⫾ 0.2 3.9 ⫾ 0.4 6.2 ⫾ 0.7
(1–8) (1–2) (2–4) (6–8)
Screws used 5.8 ⫾ 1.6 4.4 ⫾ 1.0 6.4 ⫾ 1.0 8.4 ⫾ 0.9
(4–12) (4–8) (6–12) (8–10)
Days in hospital 6.6 ⫾ 2.9 6.4 ⫾ 3.4 6.6 ⫾ 2.7 7.4 ⫾ 1.5
(2–25) (2–25) (2–18) (6–10)
Levels treated
L2–L3 4 (4%) 0 (0%) 0 (0%) 4 (4%)
L3–L4 14 (13%) 0 (0%) 5 (9%) 9 (100%)
L4–L5 85 (77%) 21 (46%) 55 (100%) 9 (100%)
L5–S1 81 (74%) 25 (54%) 50 (91%) 6 (67%)
Blood loss significantly increases with the number of levels treated; P ⫽ 0.0002. Surgical time significantly increases with the number of levels treated; P ⫽
0.0001. Length of hospitalization is not significantly different as number of levels treated increases; P ⫽ 0.5924. Percentages of levels will not add up to 100%
because more than one level can be treated per patient.

major, minor, or insignificant. There were no major de-
vice-related complications and 30 minor device-related
complications in 221 patients (13.5%). Two cages were
cracked on insertion. The fractures were located around
the threaded hole for the insertion tool and occurred on
impaction into the disc space. One was replaced at the
primary surgery, and the other was left in place. It is
important to understand that the carbon fiber polymer
composite used in this study is directional in its strength
and can be broken with excessive leverage on the long
handle of the insertion tool. This is not a physiologic
failure mode, and no cages were identified as cracked,
broken, or displaced at patient follow-up assessment.
In 13 patients, 16 broken screws were found (5.9% of
the patients; 1.3% of the screws). Of these 13 patients, 6
required hardware removal. Clinical and fusion success
was achieved in 11 of the 13 patients. None of the mi-
grating screws caused a neurologic injury. All of the
loose screws were noted incidentally at elective device
removal. Retropulsion of the cage implant did not occur
in this study.
Non– device-related complications were listed as ma-
jor, minor, and insignificant. In 23 major non– device-
related complications (10.4%), there were six deaths.
Two deaths occurred intraoperatively, the one because
of excessive bleeding, and the other because of massive
myocardial infarction. Two deaths occurred after hospi-
tal discharge as a result of unrelated medical causes. Two
patients committed suicide. There were eight deep infec-
tions requiring reoperation: two cases of deep venous
thrombosis, three cases of reflex sympathetic dystrophe,
and three cases of increasing motor deficit after surgery,
one of which was permanent. One patient had a myocar-
dial infarction several days after surgery.
There were 29 minor non– device-related complica-
tions (13.2%) and 58 insignificant events (26.2%). Of
these, 41 were intraoperative dural penetrations repaired
at surgery, not requiring reoperation, not causing neuro-
logic injury, and not affecting the hospital course.
Further surgery was performed in 102 patients
(46.1%). Elective removal of pedicle screws and VSP
plates was done in 78 patients (35.2%). Seven surgeries
were performed to address new disc levels, six to repair
dural tears, and three to remove broken drains. Of 221
patients, 5 (2.2%) required revision of the pedicle screws
or cages of the original construct.

Table 4. Outcome Values Over Time

End Point Preoperation 1 mo 3 mo 6 mo 12 mo 24 mo 48 mo

Pain 2.0 ⫾ 0.7 3.3 ⫾ 0.8 3.7 ⫾ 0.8 3.7 ⫾ 0.8 3.7 ⫾ 0.9 3.8 ⫾ 0.9 4.1 ⫾ 0.9
Function 2.3 ⫾ 0.6 1.9 ⫾ 0.8 3.3 ⫾ 0.8 3.4 ⫾ 0.8 3.6 ⫾ 0.9 3.7 ⫾ 0.9 4.0 ⫾ 0.9
Medication 3.3 ⫾ 1.3 2.4 ⫾ 1.2 3.8 ⫾ 1.2 4.0 ⫾ 1.1 4.4 ⫾ 0.9 4.4 ⫾ 0.9 4.4 ⫾ 1.1
Economic status 2.2 ⫾ 0.7 1.7 ⫾ 0.7 2.4 ⫾ 0.8 2.9 ⫾ 0.8 3.4 ⫾ 1.1 3.6 ⫾ 1.1 4.0 ⫾ 1.2
20-point score 9.8 ⫾ 2.3 9.2 ⫾ 2.9 13.1 ⫾ 2.8 14.1 ⫾ 3.1 15.1 ⫾ 3.2 15.4 ⫾ 3.3 16.4 ⫾ 3.5
Excellent status 0% 2% 8% 17% 41% 47% 61%
Good status 8% 6% 53% 55% 39% 30% 25%
Fair status 64% 52% 32% 23% 15% 20% 14%
Poor status 28% 39% 7% 5% 4% 3% 0%
Clinical success NA 17 (16%) 76 (72%) 89 (83%) 91 (88%) 79 (86%) 39 (89%)
Satisfaction NA 71 (93%) 86 (97%) 82 (90%) 84 (82%) 77 (85%) 40 (95%)
Fusion NA 4 (5%) 40 (45%) 50 (55%) 88 (96%) 91 (100%) 40 (95%)
Disc height (mm) 7.9 ⫾ 2.3 12.3 ⫾ 3.7 12.2 ⫾ 2.0 11.9 ⫾ 1.9 11.7 ⫾ 2.0 11.8 ⫾ 1.9 11.7 ⫾ 1.9
 Carbon Fiber Implant for PLIF: FDA Clinical Trials • Brantigan et al 1441

Figure 2. A, Anteroposterior radiograph 6 months after cage posterior lumbar

interbody fusion. Bone density is demonstrated inside and between the
cages. The contrasting radiographic densities of bone and carbon cage strut
(arrow) allow a comparison of increased bone density with healing of the
fusion. There is no lucency between the bone and the vertebral endplates. B,
Lateral radiograph 6 months after cage posterior lumbar interbody fusion.
The shadow of the cage strut is shown by the white arrow.

Discussion and Swift in 1929,37 Cleveland et al in 1948,17 Prothero

et al in 1966,69 Stauffer and Coventry in 1972,79 Chow
Evaluation of Clinical Success
et al in 1980,16 Zinreich et al in 1990,95 and Brodsky et
Objective assessment of clinical status remains elusive.
al in 1991.13 The recent use of pedicle screw fixation has
Numerous studies have provided subjective descriptions
only added to the problem, because overlying shadows
of criteria for excellent, good, fair, and poor re-
of the implants have blocked radiographic visualization
sults22,35,53,55,63,68,77,91. Additionally, the Dallas Pain
of posterolateral fusion mass.22,81 Since the beginning of
Questionnaire,43 the Million score,60 the Disability
fusion surgery, the “gold standard” for determining fu-
Questionnaire,73 the McGill Pain Questionnaire,59 the
sion success has been surgical exploration.13,37,84 In this
Medical Outcomes Study 36-Item Short Form,58,88 the
study, the accuracy of radiographic fusion interpretation
Oswestry,50 and others44,71,87 have been described with-
of success was validated by surgical exploration.
out a consensus in the literature regarding optimum de-
During the course of this study, pedicle screws were
sign of a prospective surgical device study.
removed in 78 patients (115 levels) treated with I/F Cage
Prolo et al68 attempted to quantify the results of the
PLIF in whom the fusion was explored and for whom the
PLIF operation by creating a 10-point score that com-
the fusion interpretation was recorded in the operative
bined 5-point economic and functional scales to define
report. The radiologic evaluation at the last follow-up
excellent, good, fair, and poor clinical status. The Prolo
assessment before reexploration was compared with the
scales included consideration of pain, function, eco-
findings at reexploration. Of these levels, 104 (90%)
nomic status, and use of pain medication. In the current
were considered fused by exploration. Overall, compar-
study, each of these parameters was evaluated sepa-
isons of radiographic diagnosis and fusion success at ex-
rately. Because calculations of clinical success based on
ploration indicated a sensitivity of 97.1%, a positive pre-
the 10-point Prolo scale, the 20-point scale, and the FDA
dictive value of fusion of 94.4%, and an overall accuracy
clinical success criteria did not differ statistically, results
of 93%. These results indicate that the radiologic fusion
can be compared meaningfully to other studies using the
interpretation as defined in this study is sufficiently accu-
Prolo score, including the clinical studies of other inter-
rate to be used for the assessment of fusion status. Al-
body fusion devices.41,72
though this study did not include an independent radio-
Evaluation of Fusion Success graph review, the accuracy of radiographic observations
Removal of internal fixation after bony healing is consis- was confirmed by surgical exploration.
tent with principles established by the AO Group (Swiss The accuracy of radiographic interpretation was facil-
Association for the Study of Internal Fixation).62 The itated by the nature of the carbon copolymer material.
difficulty in determining fusion success by standard Because this material is radiolucent, bone densities and
roentgenographic methods was emphasized by Hibbs areas of resorption in the interbody fusion area can be
1442 Spine • Volume 25 • Number 11 • 2000
Figure 3. A 2-year postoperative radiograph demonstrates solid
bony healing of the cage posterior lumbar interbody fusion.
seen reliably on regular radiographs, and the radio-
graphic density of cage struts allows a constant against
which changes in fusion bone density can be compared.
Figures 2A and B show typical anteroposterior and
lateral radiographs 6 months after surgery. On the lat-
eral view, bone is observed in the interspace. The faint
radiolucent shadow of the struts is seen (arrow). On the
anteroposterior view, the cross-sectional pattern of four
square cage struts (arrow) clearly shows the position of
the cages. Continuous radio-dense bone is seen in the
center of the cages and between the cages bridging the
interspace, providing definite radiographic evidence of
fusion.
Figure 3 shows a cage fusion 2 years after surgery. In
this radiograph, the shadow of the struts is not visible.
Figure 4. Computed tomography
(CT) scan through the patient in
Figure 3 demonstrates that fusion
bone extends between and be-
side the cages to fill an esti-
mated 65% of the surface area of
the vertebral endplate.
The bone, having become more trabecular in appear-
ance, has extended to fill the disc space. Figure 4 shows a
computed tomography (CT) scan through the cage fu-
sion in the same patient as in Figure 3. Bone fills 65% of
the surface area of the vertebral endplate.
Fusion Over Multiple Levels
Combined literature statistics of Prothero et al,69 Gold-
ner et al,30 Chow et al,16 Loguidice et al,51 and Kuslich et
al41 have indicated one-level fusion success in 399
(92.3%) of 432 cases, two-level fusion success in 346
(76.4%) of 454 cases, and three-level fusion success in 19
(62.5%) of 31 cases. In comparison, cage fusion success
was achieved in 100% of two-, three-, and four-level
cases. Except for other pedicle screw studies,81 no prior
study has shown undiminished fusion success for treat-
ment of degenerative lumbar conditions over multiple
levels.
Changes in Disc Space Height
In each surgery, the disc space height was restored to
normal as part of the operative procedure. Disc height in
the cage levels was increased from an average of 7.9 mm
before surgery to an average of 12.3 mm after surgery,
losing an average of 0.6 mm during healing. Prior studies
of interbody fusion have reported significant loss of
disc space height during healing of interbody
grafts.8,20,38,40,76,83 Reporting this loss of disc space height
after anterior lumbar interbody fusion, Dennis et al23
stated, “One hundred percent of patients developed disc
space height decreases during the postoperative period,
with 46% of levels being narrower than their preopera-
tive height at last follow-up.”p876 In past reports, even
pedicle screw stabilization has not prevented this loss of
disc space height during the healing of interbody fu-
sion.8,38,74 Because loss of disc space height creates fo-
raminal narrowing and the potential for nerve root com-
pression, this maintenance of height during bony healing
may be an an advantage over other interbody fusion
constructs.
 Carbon Fiber Implant for PLIF: FDA Clinical Trials • Brantigan et al 1443

Table 5. Literature Comparison of Percentage of Specific Complications

Yuan-D-Spondylo Esses–Pedicle Screw
Hall/Asher West Pihajamski
I/F Cage/ Degen Disc O’Sullivan Repeat Pedicle First Pedicle Pedicle
Complications VSP Screw Isola Discectomy Screw Noninstrumented Operation PSFB Screw Screw
(n ⫽ 221) (n ⫽ 120) (n ⫽ 76) (n ⫽ 2117) (n ⫽ 507) (n ⫽ 398) (n ⫽ 219) (n ⫽ 124) (n ⫽ 102)

Surgical death 0.90 0.83 0 0.5 0.7 — — 1.6 0

Device comp. 9.0* 8.33† — 5.1 — 16.4‡ 27 14.8 38.2
Cord injury 0 0.83 1.28 0.3 0.2 — — — 0
Root injury 1.35 5 2.6 6.3 4.9 5.3 9 6.3 2.9
Deep infection 2.71 3.33 5.12 2.6§ 2.4 4.2 7 1.6 2
Major cardiac 0.45 3.33 — — — — — — —
Vascular 0 0.83㛳 — 0.4 0.2 0.16 0 — 0
DVT/PE 0.90 0 — — — — — 1.6 —
RSD 1.36 1.66 — — — — — — —
Reoperation dural tear 1.80 0 5.12 0.5 0.7 1.9 3 0 —
* 5 fractured pedicles, 2 migrating screws, 13 broken screws.
† 6 fractured pedicles, 4 malpositioned screws.
‡ Aorto-iliac thrombosis.
§ Nerve root injury or new radicular pain or deficit.
㛳 Screw malposition, breakage, loosening, cutout, pedicle fracture, prominent hardware.
VSP ⫽ Variable Screw Placement; PSFB ⫽ postsurgical failed back; device comp. ⫽ device-related complication; DVT/PE ⫽ deep venous thrombosis/pulmonary
embolus; RSD ⫽ reflex sympathetic dystrophe.

Posterior Lumbar Interbody Fusion Success
Reports of PLIF fusion success in previous
studies20,39,46,47,53,61,72,74,85 include 1626 patients in whom
fusion success was achieved in 1394 (85.7%) cases. When
these results are compared with those of the current study,
fusion success using the carbon cage for interbody fusion with
pedicle screw fixation was greater than in prior historical stud-
ies of PLIF (P ⫽ 0.001).
Treatment of Failed Discectomy
Previous studies on the management of failed discecto-
my5,24,25,28,39,45,49,65,70,78,79,86 reported clinical success
in 791 (63.5%) of 1246 patients and fusion success in
499 (77.6%) of 643 patients. When these literature re-
sults are compared with the results from the current
study using the ␹2 statistic, success rates using the carbon
cage for interbody fusion with pedicle screw fixation
were significantly higher than the rates in the literature
for clinical success (␹2 ⫽ 16.090; P ⬍ 0.0001) and for
fusion success (␹2 ⫽ 14.546; P ⬍ 0.0001).
Alternate Interbody Fusion Cages
Alternate interbody fusion cages without the use of pos-
terior fixation have been evaluated in FDA studies.41,72
Independent reports have repeated the current recom-
mendation that results are improved by routine use of
posterior fixation.64 In contrast to other techniques, the
I/F Cage procedure follows established principles of
complete discectomy and bone grafting of the in-
terspace4,19,40,46 – 48,53,54.
Complications
Comparison of complication rates with literature reports
is problematic. Most published studies are retrospective
in design, tending to underreport complications as com-
pared with prospective studies. Many published studies
that have carefully analyzed fusion and clinical success
have omitted descriptions of complications entire-
ly.2,27,28,45,61 Table 5 lists complications of the current
study along with those reported by Hall et al32 for de-
generative disc disease treated with the Isola pedicle
screw system, O’Sullivan et al65 for recurrent discec-
tomy, Yuan et al93 for pedicle screw and nonpedicle
screw treatment of spondylolisthesis, West et al89 and
Pihajamski67 for pedicle screw studies. Complication
rates are similar in these studies and in the McDonnell et
al56 for combined anterior and posterior surgery. Each of
these reports represents a reasonably complete effort to
list complications, and the Hall et al32 article reports a
prospective study.
Bivariate Analysis
In the current study, patients receiving workers’ compensation
had significantly poorer results than patients who were not
receiving compensation. This relation has been reported fre-
quently in previous literature.26,28,31,33,34,36,42,78,79
Many previous studies have reported that smoking
results in a higher rate of fusion failure.3,6,14,34,51,52,57,94
Hanley and Shapiro34 reported that a smoking history of
more than 15 pack years predisposed patients to dis-
abling low back pain after discectomy. These authors
postulated that nicotine causes a generalized negative
metabolic effect, making intervertebral discs more sus-
ceptible to mechanical difficulties. In their study, 62% of
the patients had a positive smoking history and an aver-
age cigarette use of 15.3 pack years. Although a decrease
in fusion success for smokers was not observed in the
present study of the I/F Cage, the possible contribution of
smoking history to adjacent segment degeneration and
late recurrence of pain was not assessed.
Mechanical Considerations
Carson et al15 presented finite element analysis of load
distribution and bending moments in an instrumented
1444 Spine • Volume 25 • Number 11 • 2000
spine, concluding that anterior load sharing through ei-
ther a structurally intact disc or an interbody fusion de-
vice such as the carbon cage significantly improves the
fatigue life of pedicle fixation. This analysis was vali-
dated in a case series wherein failed or broken pedicle
screw constructs were repaired using the carbon cage
and new pedicle screws of the same type that had failed
previously.9 In these cases, the failures were not caused
by any defect in the screws or their technique of inser-
tion, but by the lack of load sharing through the anterior
column.
Surgical Complexity
Screws and cages are inherently simple devices whose
mechanical function has been reliable, and whose direct
complication rate has been low. The surgery to implant
these devices is not simple. Posterior lumbar interbody
fusion with pedicle screw fixation is a technically difficult
operation that can be unforgiving of errors in judgment
or performance. When performed by an inexperienced
surgeon, this procedure can have serious and frequent
complications. Placement of pedicle screws can be dan-
gerous for untrained surgeons. Exploration of the spinal
canal and posterior manipulation of the anterior column
increase the duration of surgery, the blood loss, and the
risk of nerve damage, particularly in the presence of scar
tissue from prior surgery. Failure of a PLIF operation can
cause a worse clinical situation than failures of less ex-
tensive spinal procedures.90
Because the rate of significant device-related compli-
cations has been low, the rate of non– device-related
complications has been within historical standards, and
the fusion and clinical success rates have been higher
than in previous studies, the current study has shown
that the Brantigan I/F Cage and the VSP pedicle screw
system are safe and effective devices when used by expe-
rienced surgeons for the treatment of degenerative disc
disease, even in patients with multiple prior failed sur-
geries. The I/F Cage with VSP spinal fixation was ap-
proved by the FDA on February 2, 1999 for the treat-
ment of degenerative disc disease.
Conclusions
1. Patients with one or more prior failed surgeries
treated for recurrent disc disease at one to three levels
achieved clinical success in 79 (86%) of 92 cases and
fusion success in 91 (100%) of 91 cases.
2. Results from treatment of degenerative disc disease
with prior failed discectomy were significantly better
than those reported in the literature for clinical suc-
cess (P ⬍ 0.0001) and for fusion success (P ⬍
0.0001).
3. On the average, disc space height in the cage treat-
ment group was increased by 4.3 mm at surgery and
maintained at 24-month follow-up assessment.
4. Fusion success was statistically greater than in prior
literature reports for PLIF (P ⫽ 0.001).
5. Fusion success was not diminished over multiple fu-
sion levels.
6. Fusion success was significantly greater for cage PLIF
than reported in prior PLIF literature (P ⫽ 0.001).
Key Points
● A carbon fiber cage implant for posterior lumbar
interbody fusion allows visualization of bony heal-
ing by normal radiographic methods.
● Established surgical principles of complete disc-
ectomy, complete grafting, and rigid stabilization
of the interspace are important for biologic success
of cage fusion.
● The use of pedicle screw fixation is required to
achieve nearly 100% fusion success with the use of
an interbody fusion cage.
● Clinical results in the management of failed disc-
ectomy using established surgical principles and
the described implants were better than in prior
studies.
Acknowledgment
The authors thank the following surgeon investigators
who contributed patients to this prospective IDE study:
R. S. Biscup, J. M. Cochran, S. H. Davne, I. P. Enker, J. S.
Fulghum, B. B. Hall, L. Keppler, W. F. Lestini, D. H.
McCord, S. D. Miller, D. L. Myers, A. Neidre, and L. A.
Whitehurst.
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