SPINE Volume 27, Number 24, pp E518E527
2002, Lippincott Williams & Wilkins, Inc.
Anterior Lumbar Interbody Fusion with Processed Sea
Coral (Coralline Hydroxyapatite) as Part of a
Circumferential Fusion
John S. Thalgott, MD,* Zendek Klezl, MD, Marcus Timlin, MD,* and
James M. Giuffre, BA*
Study Design. A retrospective review of 20 patients
undergoing circumferential lumbar fusion with coralline
hydroxyapatite blocks anteriorly and autograft with trans-
pedicular or translaminar facet screw fixation posteriorly.
Objectives. To examine the efficacy of coralline hy-
droxyapatite as a bone graft substitute for anterior lum-
bar interbody fusion.
Summary of Background Data. Autograft is the gold
standard for bone grafting in the anterior lumbar spine.
Harvesting bone from the iliac crest leads to significant
postoperative pain and morbidity. Femoral ring allograft
is a widely used alternative to autograft but has some
inherent problems. Coralline hydroxyapatite was shown
to be 100% successful for anterior cervical fusion when
combined with rigid plating.
Methods. A retrospective review of 20 patients with low
back pain and indicated for surgical intervention. A circum-
ferential instrumented fusion was performed with coralline
hydroxyapatite blocks anteriorly and transpedicular or
translaminar facet fixation and autograft posteriorly. All pa-
tients reached a minimum 3-year clinical and radiologic
follow-up.
Results. Radiographic follow-up yielded a solid arth-
rodesis rate of 93.8% by level (30 of 32 disc spaces) and
90% by patient (18 of 20). Clinical follow-up generated a
mean pain reduction of 61.8% with clinical success demon-
strated in 80% (16 of 20) of all patients who reported good or
excellent pain relief. Eight of 12 (66.7%) patients employed
before surgery returned to work in some capacity.
Conclusions. Coralline hydroxyapatite is a practicable
anterior lumbar interbody fusion alternative to autograft
and allograft as part of a circumferential fusion with rigid
posterior fixation. It is not recommended for stand-alone
From the *International Spinal Development & Research Foundation,
Las Vegas, the University of Nevada School of Medicine, Las Vegas,
Nevada, Military Medical Academy JP, Hradec Kralove, and the Cen-
tral Military Hospital Prague, Department of Orthopaedics and Trau-
matology, Prague, Czech Republic.
Research support provided by Interpore Cross International, Irvine,
California.
Acknowledgment date: March 14, 2001. First revision date: July 6,
2002. Second revision date: October 22, 2001. Acceptance date: May
20, 2002.
The device(s)/drug(s) that is/are the subject of this manuscript is/are not
FDA-approved for this indication and is/are commercially available in
the United States.
Corporate/Industry funds were received to support this work. Al-
though one or more of the author(s) has/have received or will receive
benefits for personal or professional use from a commercial party re-
lated directly or indirectly to the subject of this manuscript, benefits
will be directed solely to a research fund, foundation, educational in-
stitution, or other nonprofit organization which the author(s) has/have
been associated.
Address correspondence to John S. Thalgott, MD, International Spinal
Development & Research Foundation, 600 South Rancho Drive, Suite
101, Las Vegas, NV 89106, USA; E-mail: spine@spine-research.org
E518
anterior lumbar interbody fusion without further study.
[Key words: bone graft substitute, processed sea coral,
coralline hydroxyapatite, anterior lumbar interbody fu-
sion] Spine 2002;27:E518 E527
The problem of low back pain that is nonresponsive to
conservative treatment is a significant healthcare issue in
the 21st century. Patients with low back pain who fail con-
servative treatment are inevitably sent for diagnostic
workup and, subsequently, surgical consultation. How
these patients are treated surgically depends on many fac-
tors, including diagnosis, surgeon preference and philoso-
phy, surgeon experience, literature-supported therapies,
available experimental therapies, FDA approval or nonap-
proval, popular dogma, and insurance considerations.
Patients with lumbar discogenic pain caused by de-
generative disc disease or internal disc disruption are
managed with a variety of surgical interventions; many
involve the fusion of spinal segments. Prior investigators
have reported the use of posterior lumbar interbody fu-
sion (PLIF) with or without posterior instrumentation
for the treatment of lumbar discogenic pain. Multiple
reports utilizing the PLIF technique demonstrated good
results.1,7,15,16,36,40,44,45,56,64,65,74,75,78,92 Despite these
numerous studies, many believe that PLIF is too destruc-
tive to the posterior elements, the approach is wrought
with potential for complications, and access to the far
anterior disc is somewhat difficult.8,85
The number of anterior lumbar interbody fusions
(ALIF) has increased steadily over the past two decades.
Anterior lumbar interbody fusion has become a major
technique for addressing lumbar discogenic pain. Prior
authors have noted excellent initial clinical results for
stand-alone ALIF with screw-in titanium cages filled with
autograft.40,50,66 These results have not yet stood the test of
time, and reports of a number of revisions of stand-alone
ALIF with screw-in cages are increasing.10,13,17,30,49,55
Early reports of stand-alone ALIF with femoral ring allo-
graft contained some highly variable clinical and radiologic
results with no clear correlation between fusion success and
clinical success.4,12,28,29,37,41,67,72,73
The one surgical technique for lumbar discogenic pain
that has shown consistently good results in the literature is
circumferential instrumented fusion.2,24,25,26,27,31,39,46,47,52,
71,81,84,87,88
Supporters of circumferential lumbar fusion
note the high fusion rate and good clinical success re-
ported in multiple studies. Detractors note the technique
 ALIF With Processed Coralline Hydroxyapatite Thalgott et al E519

requires two surgical procedures, which may lead to

higher blood losses, increased complications, longer sur-
gical times, and longer hospital stays. Because the ap-
proach taken to perform a lumbar fusion is both sur-
geon- and patient-specific, the question of which
technique is better cannot be answered here. With any
fusion technique, an issue of major importance is the
choice of bone graft, or bone graft substitute.
Autograft, specifically autograft taken from the iliac
crest, is the gold standard in bone grafting for lumbar
fusion. Despite the high fusion rates with autograft, pain
and morbidity from iliac crest bone harvesting have been
reported to be as high as 25%.22,34,38,43,76,91 The au-
thors have encountered patients with significant graft site
pain as far out as 5 years after surgery. Although bone
graft site pain and morbidity are significant problems,
they are often seen as a necessary trade-off in the effort to
secure a solid arthrodesis.
As cited previously, allograft has produced widely
variable fusion rates in a stand-alone ALIF model. How-
ever, femoral ring allograft has been used successfully in
a circumferential fusion model.9,26,39,46,52,88 Allograft
has inherent problems that are often difficult to address.
Despite extensive processing, the small possibility of in-
fectious disease transmission is always present. With
comprehensive processing also comes increased expense.
Manufactured allograft in uniform shapes and sizes of-
ten costs three to four times more than bone bank allo-
graft. In many countries, allograft cannot be used for
religious reasons. An efficacious bone graft substitute for
Figure 1. A, The microstructure of Pro Osteon 200 coralline
the anterior lumbar spine would eliminate the inherent hydroxyapatite, similar to cortical bone. B, The microstructure of
problems with both iliac crest bone harvesting and ceramic hydroxyapatite.
allograft.
Early bone graft substitutes such as synthetic hy-
droxyapatite,90 ceramics,62,89 and glass14 assisted in sta- microns () and a mean compressive strength of 10
bilizing the lumbar spine in an animal model, but these Mega Pascals (MPa) (measured in a dog metaphyseal
compounds did not show a propensity to illicit a solid defect model).70 The microstructure of Pro Osteon 200 is
fusion. This is primarily due to the fact that these com- similar to cortical bone but dissimilar to synthetic hy-
pounds are not nearly as osteoconductive as bone, and droxyapatite (Figure 1). The primary difference is that
subsequently, bony ingrowth did not occur. bony ingrowth can occur more easily through Pro Os-
An ideal bone graft substitute for spinal surgery teon due to its interconnected porosity than through syn-
would have the following characteristics: osteoinductiv- thetic hydroxyapatite (Figure 2). Synthetic hydroxyapa-
ity, osteoconductivity, rapid biologic incorporation, ap- tite was tested in a human ALIF model, and due to the
propriate structural integrity to load share, uniformity, noninterconnected porosity of the implant, it broke,
predictable structural elements, ability to be machined failed, and was deemed inadequate for human ALIF.61
into different sizes and shapes, ease in storage and han- Pro Osteon fulfills all of the criteria for an ideal bone
dling, a reasonably low cost, and international graft except for one. Pro Osteon is not osteoinductive.
availability. Pro Osteon has been used successfully as a bone graft
Coralline hydroxyapatite (Pro Osteon 200, Inter- substitute in a variety of surgical applications for ortho-
pore Cross International, Irvine, CA) is a bone graft sub- pedic (long bones),3,11,20,32,33,54,63,77 ophthalmolog-
stitute derived from sea coral. The coral, harvested from ic,19,35,48 orthognathic,18,51,83 and maxillofacial5,23 use.
the South Pacific Ocean, is primarily calcium carbonate. Boden et al6 showed Pro Osteon 500, with a larger pore
A patented process is applied to the coral that changes size, requires an osteoinductive compound such as autol-
the calcium carbonate to hydroxyapatite. Depryogena- ogous bone to initiate a solid fusion in a rabbit postero-
tion takes place during processing leaving the resulting lateral fusion model. In a human model, the authors
compound completely nonimmunogenic. Coral from the demonstrated Pro Osteon 500 was an effective bone graft
genera porities is utilized to manufacture Pro Osteon extender when combined with autograft for instru-
200, which has a pore diameter of approximately 200 mented posterolateral fusion.80 The authors also re-
E520 Spine Volume 27 Number 24 2002
Figure 2. A, Noninterconnected porosity. B, Interconnected
porosity.
ported that bony ingrowth occurs when Pro Osteon 200
is loaded in compression, by itself, in conjunction with
rigid internal fixation in a human anterior cervical fusion
model.82
Some may envision the cervical spine biomechanically
as a smaller version of the lumbar spine and vice versa.
This is not true. The forces on the lumbar spine are dif-
ferent in both magnitude and orientation when com-
pared to the cervical spine.57,58,59,60 A fusion technique
that is successful in the cervical spine does not necessarily
translate to success in the lumbar spine. With the knowl-
edge that Pro Osteon 200 is successful for anterior cer-
vical fusion with rigid anterior plating, the logical ques-
tion becomes, is Pro Osteon 200 successful for ALIF in a
rigid instrumented environment? The goal of this study
was to determine the efficacy of Pro Osteon 200 for ALIF
in an instrumented anteroposterior fusion model.
Methods
This series was comprised of 20 patients, 16 female and 4 male,
with a mean age of 43.5 years (range 26 68 years). Nine of the
20 were smokers. Twelve of the 20 worked within 6 months
before surgery. All patients had mechanical low back pain con-
sistent with discogenic pain symptomology. Each of the 20
patients showed loss of disc height and disc dehydration con-
sistent with degenerative disc disease on magnetic resonance
imaging (MRI). Secondary diagnoses included failed laminec-
tomy syndrome 8, posterior pseudarthrosis 7, and spondyloly-
sis 1.
Custom tombstone-shaped blocks of Pro Osteon 200 were
manufactured specifically for the senior authors (J.S.T.) use.
Because these blocks were custom devices, they were not
subject to FDA regulatory review. At the time of this study, Pro
Osteon 200 was FDA approved for orthopedic applications but
was not approved for spinal use. A resorbable version of Pro
Osteon 200 was developed later, and this version is FDA ap-
proved for spinal use.
Failing nonoperative treatment, all patients gave their writ-
ten informed consent for the use of custom Pro Osteon 200
blocks anteriorly and subsequently underwent successful cir-
cumferential instrumented fusion. Ten patients had both ante-
rior and posterior procedures on the same day, whereas 10
were staged procedures. The ALIF was performed first in all
cases. Surgeries were performed by the senior author (J.S.T.)
between May 1993 and April 1995. There were 10 one-level:
L3L4 (1), L4 L5 (6), L5S1 (3); 8 two-level: L3L5 (1),
L4 S1 (7); and 2 three-level: L2L5 (1), L31 (1) fusions. Pos-
teriorly, each patient was implanted with transpedicular (16)
or translaminar facet (4) fixation augmented with an autolo-
gous posterolateral fusion.
Anteriorly, a standard open anterior retroperitoneal ap-
proach was utilized in all cases. Following the successful ap-
proach, pin distractors were placed into the cranial and caudal
vertebrae to distract the appropriate disc space. A gross discec-
tomy was performed, and the disc space was further prepared
be removing all disc material with curettes and rongeurs. The
end plates were made as clean and as parallel as possible down
to bleeding bone. The disc space was sized with custom sizers,
and a custom, tombstone-shaped block (Figure 3) of Pro Os-
teon 200 was selected. The block was gently tamped into the
distracted disc space as far back to the posterior annulus as
possible.
Once the block was firmly inserted within the disc space,
perioperative radiographs were taken to verify the position of
the block and the absence of cracks or breakage within the
block. Although Pro Osteon 200 is extremely strong in com-
pression, it is weak when loaded in shear.77,83 Three blocks
were broken during insertion and had to be replaced periop-
eratively. All blocks were secured with a buttress locking plate
(Synthes USA, Paoli, PA).53 Distractors were removed, and
wound layers were closed in standard fashion. All patients were
placed in a TLSO brace for 3 months and entered into physical
therapy at 1 month. Patients advanced with activities as
tolerated.
Figure 3. A block of Pro Osteon 200, machined to a tombstone
shape.
 ALIF With Processed Coralline Hydroxyapatite Thalgott et al E521

Results
In patients undergoing both procedures on the same day,
the mean hospital stay was 5.9 days. In patients under-
going staged procedures, the mean combined hospital
stay was 12.5 days. Mean blood loss was 212 cc anteri-
orly and 202 cc posteriorly. There was one vessel lacer-
ation perioperatively that was repaired without sequelae.
After surgery, there was one deep vein thrombosis (un-
related to the vessel laceration) and one foot drop sec-
ondary to the posterior procedure.
Mean follow-up was 48 months with a range of 37 to
61 months. Patients were evaluated both clinically and
radiographically.

Clinical Results
Patients were evaluated after surgery at 3, 6, 12, and 24
months and annually thereafter. Patients were given Os-
westry Disability questionnaires before surgery and at
each follow-up after surgery. The mean preoperative
score was 64% disabled. The mean postoperative score
at latest follow-up was 35% disabled. Patients were
asked to rate their pain on a visual analog scale. Mean
preoperative pain was 8.9. Mean postoperative pain was
3.4 (a mean decrease of 61.8%). Clinical success was
demonstrated in 16 patients (80%) who reported pain
relief of 50% or greater. Of the 12 patients working
before surgery, 6 (50%) returned to full-time employ-
ment, 2 returned to part-time employment (16.7%), 1
took early retirement, and 3 were unable to return to
work.

Radiographic Results
Plain films were analyzed at the latest radiographic fol-
low-up available with a minimum of 36 months and a
maximum of 61 months. Anteroposterior and lateral
plain films were taken at each follow-up corresponding
with the clinical follow-up. Flexion and extension views
were taken at 36 months postop and at least annually
thereafter. Two patterns of incorporation were identi-
fied. The first, described as diffuse amalgamation is a
disappearance of the block shape of the implant. The
second, described as loss of lucency is a maintenance
of the block shape but a disappearance of radiolucent
lines in contact between the implant and vertebra.
Disc spaces were graded using a slightly modified scale
as described in our previous research with Pro Osteon 200
the cervical spine:82 Grade I: no incorporation (0%), lucent
lines still present; Grade II: partial incorporation (0% and
75%); Grade III: near-total incorporation (75% and
100%); Grade IVa: total incorporation (100%), loss of
lucency; Grade IVb: total incorporation (100%), diffuse
amalgamation; Grade V (radiographic subgrade): pseudar-
throsis by direct exploration; Grade VI (radiographic sub-
grade): solid fusion by direct exploration.
For the 32 disc spaces, the evaluation was as follows:
Grade I: 0; Grade II: 0; Grade III: 3; Grade IVa: 19
(Figure 4); Grade IVb: 4 (Figure 5); Grade V (radio-
Figure 4. A, Lateral radiograph at 9 months postop of a 46-year-old
female presenting with degenerative disc disease and internal
disc disruption at L3L4 and L4 L5. B, Lateral radiograph of the
same patient at 3 years postop showing Grade IVa incorporation at
both disc spaces as well as a bridging osteophyte at L4 L5. The
patient had a 75% reduction in pain.
graphic subgrade II): 2; Grade VI (radiographic subgrade
IVa): 4.
Maintenance of interspace height was achieved at all
32 interspace levels. Initial settling of 1 mm was noted in
23 of 32 interspaces, but no further settling or interspace
collapse was found throughout the follow-up period in-
cluding the latest radiographic follow-up. The posterior
fusion was graded in tandem with the anterior fusion. If
solid, consolidated bone, with no clefts, was present on
both the left and the right side with resorption no greater
than a total of 25%, the level was considered fused pos-
E522 Spine Volume 27 Number 24 2002

moval had a solid two-level fusion (Grade IVa). The di-

rect exploration fusion rate was 4 of 6 (66.7%) by level
and 1 of 3 (33.3%) by patient. When added together, the
solid fusion rate by level was 30 out of 32 (93.8%) and
90% (18 out of 20) by patient.
Two nonpropagating cracks (Figure 6) were identified
that did not affect incorporation. These cracks were
found on early postoperative radiographs but were not
evident perioperatively. None of the blocks migrated.
Discussion
Application of an instrumented circumferential fusion
technique versus a stand-alone ALIF technique is based
largely on surgeon philosophy. The debate over which
approach is better and under what circumstances may
never be settled, and it will not be settled here.
A fusion rate of 93.8% by level and 90.0% by patient
and the clinical success reported in this series indicate the
use of Pro Osteon 200 for ALIF as part of an instru-
mented circumferential fusion is similar to results cited
previously with autograft or allograft in the same model.

Figure 5. A, Lateral radiograph at 2 months postop of a 27-year-old

female presenting with failed lumbar laminectomy syndrome and
internal disc disruption at L4 L5 and L5S1. B, Lateral radiograph
at 6 years postop showing Grade IVa incorporation at L4 L5 and
Grade IVb incorporation at L5S1. The patient returned to work at
9 months postop and had a 90% reduction in pain.

teriorly. All disc spaces evaluated as Grade III, IVa, and

IVb anteriorly were subsequently found to be fused pos-
teriorly. The radiographic fusion rate was 26 of 26
(100%) by level and 17 of 17 (100%) by patient.
Three patients had their posterior hardware removed
at 24 months postop or later, secondary to residual leg
pain in 2 patients, and patient choice in the third patient.
The patients with residual leg pain were both two-level
fusions. One level in each patient was solidly fused Figure 6. A, A nonpropagating crack identified at 4 months postop
(Grade IVa) and one level in each patient was a pseudar- on lateral radiograph. B, Lateral radiograph at 5 years postop of
throsis (Grade V). The other patient with hardware re- the same patient with the crack filled in by new bone growth.
 ALIF With Processed Coralline Hydroxyapatite Thalgott et al E523
We believe this is an important finding in the anterior
column. But the fact remains that autograft was used
posteriorly with transpedicular fixation to augment the
ALIF.
Angular motion on lateral flexion and extension ra-
diographs was measured for all patients at the latest fol-
low-up available. Larsen et al42 reported that measure-
ment of angular motion was not relevant in assessing
solid fusion versus pseudarthrosis radiographically in the
presence of pedicle screws. Because 16 of the 20 patients
had transpedicular fixation, these measurements were
deemed to be insufficient criteria to judge solid fusion
radiographically.
The major drawback to the use of Pro Osteon in spi-
nal fusion is the fact that it has no osteoinductive prop-
erties. The implant is osteoconductive, so it requires a
large interface directly with bone or fusion will not
occur.
Pro Osteon cannot be used as the sole grafting mate-
rial in a posterolateral fusion model because it has no
inherent osteoinductive properties. Our prior investiga-
tion80 showed Pro Osteon 500, with a structure similar
to cancellous bone, to be an effective bone graft extender
for instrumented posterolateral fusion when mixed with
autograft. But Pro Osteon 200 cannot be used in this
manner because its structure is similar to cortical bone,
not cancellous bone. Pro Osteon 200 is strongest when
loaded in compression,79,86 which is why it is a reason-
able bone graft substitute for the anterior lumbar spine.
Current investigations are evaluating recombinant and
synthetic bone morphogenetic protein (BMP) technology
and other growth factors for use in spinal surgery. It is
not out of the realm of possibility to combine Pro Osteon
with an osteoinductive molecule to facilitate a solid fu-
sion without using bone graft. This is a topic of future
study.
The difference in incorporation patterns is inexplica-
ble. There are no discernible reasons why 20 blocks in-
corporated through the loss of lucency pattern of in-
corporation and 4 incorporated through the diffuse
amalgamation pattern of incorporation. The ratio of
loss of lucency to diffuse amalgamation in this study was
5 to 1. In our clinical study of Pro Osteon 200 in the
cervical spine,82 it was approximately 2 to 1. There may
be physiochemical or biomechanical reasons for this dif-
ference between the cervical spine and the lumbar spine
that would require further study.
The propensity of the implant to crack during implan-
tation is a concern, but the use of perioperative radio-
graphs is recommended to verify that the implant re-
mains intact and is seated properly. With regards to the
two nonpropagating, postoperative cracks that oc-
curred, they did not affect incorporation of the implant.
The potential for cracking or breakage of the implant can
be reduced with proper end plate preparation and
distraction.
The version of Pro Osteon 200 utilized in this study
resorbs at an extremely slow rate, approaching 100%
resorption in 1520 years. This makes it somewhat dif-
ficult if not impossible to see new bony ingrowth within
the blocks on radiographs at 3 to 5 years after surgery.
Because of this fact, we recognize the possibility of a
locked pseudarthrosis occurring, as championed by
Fagan et al.21 Despite the fact that we have no histologic
results from this particular study population, there have
been studies performed in animals that have correlated
radiographic and histologic results concerning bony in-
growth through coralline hydroxyapatite.
Sartoris et al,69 utilizing a dog metaphyseal defect
model with harvesting at 6 months, reported, In con-
trast to autografts, incorporation of coralline implants
was characterized by predictable osseous growth and ap-
position with preservation of intrinsic architecture.
Greater percent increase in radiographic density and
higher ultimate compressive strength were documented
advantages of coralline hydroxyapatite over autogenous
graft.
A second study preformed by Sartoris et al68 com-
pared coralline hydroxyapatite blocks to iliac cortico-
cancellous autograft in a dog diaphyseal defect model
out to 48 months. They commented: A remarkable
mean percent bone ingrowth of 51.2% was documented
for the 14 dogs. . .and represents the probable obligate
minimum required for vascular nutrition. Histometric
analysis of implant specimens revealed satisfactory
union and native osseous ingrowth at all time intervals.
A locked pseudarthrosis hypothesis is a possible out-
come in this series. However, based on the two animal
studies previously cited, maintenance of the interspace
height over time, no failure of the implant as with syn-
thetic hydroxyapatite, the solid fusion attained in four of
the six segments that were manually explored, and the
good clinical outcomes, we believe bony ingrowth has
occurred in these nonexplored segments and that they
are in fact solidly fused.
We acknowledge that there is no imaging technology
currently available that will discern the amount of new
bone growth within the block because the implant is so
radio opaque, even to computed tomography scan. We
also acknowledge that the three segments classified as
Grade III: near-total incorporation (75% and 100%)
may be viewed as not a solid fusion in some circles. We
believe these three segments had a slight mechanical mis-
match between the implant and the endplate on implant
insertion. If the apposition of the implant is not within 1
mm of the endplate, bone will not grow across the divide.
Because the remaining cranial and caudal interfaces are
completely incorporated, and the interspaces met all of
the other criteria listed above, these three Grade III in-
terspaces were graded as solidly fused.
A faster-resorbing version of Pro Osteon is currently
available and FDA approved for spinal use. This resorb-
able version (Pro Osteon 500R) completely resorbs in
1224 months. Pro Osteon 200R is currently in develop-
ment and should be studied in this model to ascertain
whether our results are reproducible.
E524 Spine Volume 27 Number 24 2002
Pro Osteon 200 coralline hydroxyapatite is an effec-
tive bone graft substitute for ALIF under the following
conditions:
1. The ALIF must be combined with rigid posterior
fixation and posterolateral fusion.
2. Special care must be taken to prepare the end plates
to be as clean and as parallel as possible.
3. The implant must be inserted using distraction.
4. Perioperative radiographs should be taken to en-
sure the implant has not cracked or broken.
5. The implant must fit snugly within the disc space
with a large implant/bone interface
6. The implant should not be used for corpectomy.
7. The implant should not be used in a stand-alone
ALIF without further study using that model.
8. Buttress plate fixation is recommended to prevent
possible migration of the implant.
Key Points
Coralline hydroxyapatite performed similarly to
autograft and allograft as the anterior component
in an instrumented circumferential lumbar fusion
model.
Coralline hydroxyapatite blocks are extremely
strong when loaded in compression, but weak
when loaded in shear.
Coralline hydroxyapatite is an excellent osteo-
conductive matrix for bony ingrowth but has no
osteoinductive properties.
Coralline hydroxyapatite is not for stand-alone
ALIF or corpectomy use.
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E526 Spine Volume 27 Number 24 2002
Point of View
John W. Brantigan, MD
I congratulate Dr. Thalgott and his colleagues on a fas-
cinating study of the use of coralline hydroxyapatite for
instrumented anterior lumbar interbody fusion (ALIF).
My only concern with this report is the age-old question
of whether the authors have used valid criteria for fusion
success. A result should not be referred to as fusion
unless there is scientific evidence that continuous living
bone bridges the space between the vertebral bodies.
Others have provided animal studies in which radio-
graph evidence was compared with actual histology.1
Such correlation is particularly important when a higher
density implant material blocks normal radiographic vi-
sualization of bone. I believe that the present paper has
demonstrated bone growing into the edges of the im-
plants from adjacent vertebral bodies similar to the tita-
nium fiber mesh interbody implants used in the past in
China. In a review of 28 patients receiving a fiber mesh
implant, Leong et al2 reported that 25% had experienced
long-term mechanical failures of the mesh device. With-
out valid scientific evidence of continuous bridging bone,
the results should be referred to as a locked pseudar-
throsis, as described by Robert Fraser for other con-
From the South Texas Orthopedic and Spinal Surgery Associates, San
Antonio, Texas.
The device(s)/drug(s) that is/are the subject of this manuscript is/are not
FDA-approved for this indication and is/are commercially available in
the United States.
No funds were received in support of this work. One or more of the
author(s) has/have received or will receive benefits for personal or pro-
fessional use from a commercial party related directly or indirectly to
the subject of this manuscript: e.g., royalties, stocks, stock options,
decision making position.
Address correspondence to John W. Brantigan, MD, South Texas Or-
thopedic and Spinal Surgery Associates, 9150 Huebner Road Suite
350, San Antonio, TX 78240, USA; E-mail: johnwb@wans.net
Response to Point of View
John S. Thalgott, MD
We thank Dr. Brantigan for his thoughtful comments
regarding our research. However, we believe he is incor-
From the International Spinal Development & Research Foundation,
Las Vegas, Nevada.
The device(s)/drug(s) that is/are the subject of this manuscript is/are not
FDA-approved for this indication and is/are commercially available in
the United States.
Corporate/Industry funds were received to support this work. Al-
though one or more of the author(s) has/have received or will receive
benefits for personal or professional use from a commercial party re-
lated directly or indirectly to the subject of this manuscript, benefits
will be directed solely to a research fund, foundation, educational in-
stitution, or other nonprofit organization which the author(s) has/have
been associated.
structs. If a device has a long-term mechanical device
function, there will be unknown long-term mechanical
failure modes.
I disagree with a fusion grading that combines radio-
graphic results with those of surgical exploration. These
outcome measures should be reported separately and
their results compared statistically. Six levels were surgi-
cally explored in three patients. In these cases, fusion
success was achieved in 66% of the levels, but only 33%
of patients had fusion success in all levels. The authors
have not described the radiograph appearance of those
levels that were explored. Did the surgical exploration
results tend to confirm or contradict the radiographic
interpretations?
There are a number of published papers describing use
of hydroxyapetite in fusion studies, often with con-
flicting results. This study describes a proprietary mate-
rial called Pro Osteon 200. A faster resorbing version
called Pro Osteon 200R is described as being under de-
velopment. Although the quicker resorption sounds like
an improvement, it might become a disadvantage if the
material fails mechanically before solid fusion is
achieved. This work is interesting and potentially very
valuable. I encourage the authors and their sponsors to
study interbody fusion in an animal model using these
same materials so that the important questions of fusion
interpretation can be answered.
References
1. Brantigan JW, McAfee PC, Cunningham BW, et al. Interbody lumbar fusion
using a carbon fiber cage implant versus allograft bone: an investigational
study in the Spanish goat. Spine 1994;19:1436 44.
2. Leong JC, Chow SP, Yau AC. Titanium-mesh block replacement of the inter-
vertebral disk. Clin Orthop 1994;300:52 63.
rect in comparing a porous ceramic to a metal implant.1
The biomechanical properties of the coral implant are
not equivalent to metal. If incorporation does not occur
in the long-term, the coralline hydroxyapatite will most
certainly fail. We believe a minimum follow-up of 36
months with a mean of 48 months is sufficient to be
considered long-term follow-up for a lumbar fusion
series.
Address correspondence to John S. Thalgott, MD, International Spinal
Development & Research Foundation, 600 South Rancho Drive, Suite
101, Las Vegas, NV 89106, USA; E-mail: spine@spine-research.org
 ALIF With Processed Coralline Hydroxyapatite Thalgott et al E527
The biology of bony incorporation is also different
when compared to autologous bone in a metal or carbon
fiber cage environment. We believe a comparison of ef-
ficacy between our research and past research is entirely
appropriate. However, equivalency of the biomechanics
and biology of healing is not.
Dr. Brantigan points out the solid fusion rate in pa-
tients who were explored surgically was 66% by level
and 33% by patient. Surgical exploration was only per-
formed on patients who had a suspected pseudarthrosis
before the exploration. Naturally, one would expect a
low rate of solid fusion in the small number of patients
who were surgically explored if they were suspected of
having a pseudarthrosis before the exploration.
Finally, we wish to point out that the surgically ex-
plored levels were in fact graded radiographically and
are noted as radiographic subgrades within our classifi-
cation system.
Reference
1. Leong JC, Chow SP, Yau AC. Titanium-mesh block replacement of the inter-
vertebral disk. Clin Orthop 1994;300:52 63.