Neurosurg Focus 16 (3):Article 1, 2004, Click here to return to Table of Contents

The use of bioabsorbable implants in spine surgery

MATTHEW M. ROBBINS, B.A., ALEXANDER R. VACCARO, M.D., AND LUKE MADIGAN, M.D.
Department of Orthopaedic Surgery, Thomas Jefferson University Hospital, Rothman Institute,
Philadelphia, Pennsylvania

The use of bioabsorbable implants in spine surgery is expanding at a rapid pace. These implants are mimicking the
roles of traditional metallic devices and are demonstrating similar efficacy in terms of maintaining stability and acting
as carriers for grafting substances. Biomechanical studies have demonstrated their ability to stabilize effectively a de-
generative cervical and lumbar motion segment. In numerous animal models, researchers have illustrated the ability of
bioabsorbable implants to function satisfactorily as an interbody spacer and to achieve satisfactory bone fusion.
Investigators have explored various opportunities for these implants to replace their metallic counterparts in clinical
studies conducted in humans. The gradual resorption of these implants appears effectively to transfer gradual loads to
the grafting substances promoting the biological mechanisms of fusion.
Novel uses of bioabsorbable technology are constantly evolving. Their future as a carrier of biological agents such
as bone morphogenetic proteins and bone graft extenders, their radiolucency, and their eventual resorption make them
an ideal implant for use in spinal degenerative disease.

KEY WORDS • spinal surgery • bioabsorbable implant • polylactic acid •

polyglycolic acid

Since the first description of bioabsorbable technology
for clinical applications in the mid-1960s, the diversity
and potential for widespread applications of these poly-
mers continues to evolve.14 Bioabsorbable implants have
been used successfully in craniomaxillofacial, neurologi-
cal, general surgical, and orthopedic procedures.24 Their
use continues to increase in orthopedic subspecialties such
as sports medicine, foot and ankle surgery, shoulder sur-
gery, and in the specialty of spine surgery. The evolution
of bioabsorbable material has paralleled the development
of spinal instrumentation systems, and the merging of the
two technologies has expanded the surgical armamentari-
um of the practicing spine surgeon.
Alpha-polyesters are the bioabsorbable materials used
in current clinical applications. The two that have had the
most widespread use are polylactide and polyglycolide.
The breakdown products of these two materials, glycolic
acid and lactic acid, are familiar to the physiological mi-
lieu of the body. Polyglycolic acid, which was the first to
be widely studied, degrades at a faster rate than polylactic
acid.6,11,18,29 As a result, polyglycolide has demonstrated an
increased risk of aseptic inflammatory reaction compared
with polylactide. Different compositions of bioabsorbable
products alter the rates of degradation and strength of the
devices. Polylactide has been used in both a pure levo
form and in a levodextro copolymer form. A combination
of its stereoisomers has decreased the soft-tissue reaction
to the implant in animal studies (Fig. 1).
Bioabsorbable technology offers many distinct advan-
Abbreviations used in this paper: ABG = autologous bone graft;
DBM = demineralized bone matrix; MP = MacroPore; PDLLA =
poly-D,L-lactic acid; PLLA = poly-L-lactic acid.
tages over conventional metallic devices that are current-
ly being used in spine surgery. First, these implants allow
optimal postoperative radiographic evaluation because of
their radiolucency and the absence of artifacts associated
with similar metallic devices exposed to advanced imag-
ing modalities. Bioabsorbable implants also may offer ad-
vantages with respect to fusion healing because of their
unique biomechanical properties. With a modulus of elas-
ticity closer to that of bone and with its gradual resorptive
properties, bioabsorbable implants gradually decrease the
stress shielding seen with rigid metallic implant systems.
Flexible and less rigid bioabsorbable implants confer the
advantage of stabilizing the motion segments while, over
time, allowing a greater transfer of load to the host spine
during implant resorption, potentially minimizing junc-
tional degeneration. Although complications such as im-
plant migration, subsidence, and extrusion may still exist
with these implants, it obviously becomes less of a prob-
lem over time as the devices dissolve into their biochemi-
cal environment.
Biomechanical Studies of Bioabsorbable Implants Used
in Spine Surgery
Numerous studies of bioabsorbable implants have been
conducted to determine the unique biomechanical proper-
ties of these devices. Ideally these implants are intended to
mimic the biomechanical properties of their metallic and
tricortical allograft counterparts. These implants should be
able to stabilize the spine initially, allowing fusion healing
to occur prior to their resorption, while exposing the graft
substance they contain to continuous compressive loads in
the setting of an interbody implant.

Neurosurg. Focus / Volume 16 / March, 2004 1


Fig. 1. Photograph showing bioabsorbable implants that have
potential applications throughout the spine.
Van Dijk, et al.,26 evaluated the compression strength
and mechanical properties of titanium lumbar interbody
cages compared with resorbable PLLA cages. The authors
postulated that bioabsorbable implants had a potential
advantage over metallic implants because their modulus
of elasticity is closer to that of vertebral bone. Therefore,
if the compressive strength of these implants were suffi-
cient, their use would be more beneficial than traditional
metallic implants, which have a significantly higher mod-
ulus of elasticity and thus a greater potential for implant
subsidence. In this investigation, 21 goats underwent a
single-level lumbar interbody fusion with either a metallic
cage implant or a stiff or flexible PLLA cage. At harvest-
ing, the bioabsorbable cages proved to be mechanically
satisfactory for interbody use. Compression strength of
the motion segments did not differ between the stiff and
flexible PLLA cages. Interestingly, the toothed titanium
cages filled with bone graft showed significantly less
compression strength compared with the stiff PLLA cages
and bone graft. This finding was not observed in the group
treated with smooth (nontoothed) titanium cages. The
authors concluded that PLLA is an effective polymer for
use in lumbar interbody fusion because it stabilizes the
motion segment and facilitates an adequate fusion re-
sponse (Fig. 2).
Fig. 2. Left: Photograph showing an example of an anterior
lumbar bioabsorbable interbody spacer. Right: Photograph
showing an example of an anterior lumbar bioabsorbable interbody
spacer and vertebral body replacement implant.
2 Neurosurg. Focus / Volume 16 / March, 2004
M. M. Robbins, A. R. Vaccaro, and L. Madigan
In a biomechanical study in which human cadaveric
specimens were used, DiAngelo, et al.,9 evaluated the use
of a bioabsorbable anterior lumbar plate combined with a
traditional metallic cage in anterior lumbar interbody fu-
sions. The goal of their study was to determine if the addi-
tion of an anterior bioabsorbable plate improved the bio-
mechanical stability of the fusion construct. The addition
of a bioabsorbable plate was found to decrease interspace
motion in extension, flexion, and right lateral bending
over the intact nonfused (no cage) specimens. The speci-
mens with anterior plates demonstrated significantly de-
creased extension motion compared with nonplate-treated
specimens stabilized with cage implantation. The investi-
gators suggested that the increased stability afforded by
the addition of an anterior absorbable plate should in-
crease the fusion rate over nonplate-treated cage fusions.
Also, with the recreation of the anterior tension band (the
anterior longitudinal ligament is largely sacrificed with
this approach), the need to augment this surgery with pos-
terior instrumentation may be diminished in certain clin-
ical situations. Additionally, the use of a bioabsorbable
plate at the L5–S1 anterior interspace, in proximity to the
great vessels, may lessen the risk for vessel erosion caused
by late implant migration.12
Evaluation of Bioabsorbable Implants in Animal Trials
Many of the biomechanical and fusion studies of bioab-
sorbable implants have been conducted in animal models.
In particular, sheep and goats have been most widely used
as test subjects for bioabsorbable products in trials to dis-
cern their effectiveness and safety (Fig. 3). Studies have
shown that the biomechanical environment of axial load-
ing of the sheep and goat spine is comparable to that of the
human spine.8,20,21,32,33
Cervical Spine Studies. Bioabsorbable implants have
been developed to mimic the roles of traditional cervical
spine implants such as anterior cervical plates and inter-
body cages (Fig. 4). Cahill, et al.,4 evaluated the effica-
cy of a bioabsorbable anterior cervical cage compared
with ABG for anterior cervical fusion in an animal model.
Twelve goats underwent a two-level anterior cervical dis-
cectomy and fusion. Of the 12, eight underwent fusion
with an 85:15 polylactide/polyglycolide bioabsorbable
cage packed with ABG, and the remaining four underwent
Fig. 3. Photograph showing an example of a bioabsorbable
anterior thoracolumbar graft containment device.
The use of bioabsorbable implants in spine surgery
Fig. 4. Plain x-ray film showing a bioabsorbable anterior cervi-
cal graft containment mesh implant covering the anterior cervical
interspace in a goat.
fusions with autologous bone grafting alone. The goats
were evaluated 12 weeks postoperatively. Stable inter-
body fusions were obtained in only three (19%) of 16 in
the group treated with the bioabsorbable device and in one
(14%) of seven in the group treated with ABG. Although
the group treated with bioabsorbable cages had a higher
fusion success rate than the animals that received ABG,
the authors cited three potential reasons for such low fu-
sion rates in both groups. The first problem posited was
that the time period of 12 weeks might not have been
enough time to judge if a union is stable in a goat model.
The second, as has been seen in retrospective analysis of
human applications of interbody cages, is that multilevel
stand-alone constructs often have an unacceptably high
failure rate in the absence of adjunctive anterior plate fix-
ation, especially in animals that are impossible to immo-
bilize postoperatively. The third is that resorbable poly-
mers containing polyglycolides typically have a much
faster resorption time; because of this, the implants may
not have had sufficient mechanical strength during the
critical healing period in the cervical spine.
Histological analysis of the fusion sites demonstrated a
primary fibrous union in the group treated with bioab-
sorbable devices; along with a 50% foreign body granulo-
ma reaction to the 85:15 polylactide/polyglycolide poly-
mer. These researchers postulated that the granulomatous
response may be a factor of the time course of degradation
of the implant and not of properties of the material itself.
It was asserted that a longer degradation halflife (chang-
ing the stereoisomer ratio) may provide increased biome-
chanical stability and decrease the histologically observed
granulomatous response.
Lumbar Spine Studies. Poynton, et al.,19 assessed the
efficacy of a bioresorbable graft containment device in
protecting and enhancing a posterolateral fusion mass.
Twenty rabbits underwent a one-level posterolateral lum-
bar spinal fusion with either ABG alone, ABG covered
with an MP (MacroPore Biosurgery, Inc., San Diego, CA)
containment device (ABG
MP), DBM alone, or DBM
covered with an MP containment device (DBM
MP).
The animals were assessed 6 weeks postsurgery with
volumetric helical computerized tomography scans and
Faxitron high-resolution radiographs. Fusion mass scores
Neurosurg. Focus / Volume 16 / March, 2004
were significantly increased in both the ABG
MP and
the DBM
MP groups compared with the ABG or DBM
groups treated without the containment device. Inter-
estingly, the rates of fusion, as judged from radiograph-
ic findings, were not significantly different among the
groups.
One of the inherent properties of all bioabsorbable im-
plants is their gradual degradation in the human body
when exposed to body fluids. To elucidate the degradation
process of PLLA spinal interbody fusion cages, van Dijk,
et al.,28 studied the in vitro and in vivo degradation pro-
cesses in a goat model. In the in vitro condition, PLLA
cages were placed in a phosphate-buffered saline solution.
In the in vivo assessment, 18 goats underwent a single-
level lumbar fusion with either stiff or flexible PLLA
cages, both containing autologous bone graft. The animals
were killed at 3, 6, or 12 months.
No radiographic differences or alterations in cage con-
figuration were seen between the stiff and the flexible
cages at the 3-, 6-, and 12-month time points. After 6
months, both sets of cages were still intact and maintained
their original 10-mm height. Mechanical strength of the
cages was not maintained at 12 months in both settings.
Radiographic studies confirmed a successful fusion at 6
months in four of six of the animals killed at that time. No
differences existed between the stiff and flexible cages
with regard to fusion. Overall, at the 1-year follow-up
review, fusion was present in four of the six specimens in
the presence of the degraded interbody cages. Comparison
of the in vivo and in vitro groups demonstrated an
increased degradation rate in the in vivo group. The
authors concluded that compressive cyclic loads acting on
the in vivo cages are most likely responsible for the
increased rate of degradation. This trend has also been
seen in other studies.5,16,17
Toth, et al.,23 evaluated the combination of 70% L-lac-
tide and 30% D,L-lactide copolymer (brand name HY-
DROSORB) as an interbody fusion cage in a sheep model.
In a short-term follow-up period of 3 months, fusion was
present in one (25%) of four sheep treated with the
HYDROSORB cages. In histological analyses performed
at 6 months, fusion was noted in 50% of the sheep.
Stiffness increased and radiographically and histologi-
cally confirmed fusion was progressive from the 3- to
24-month time points. In particular, at the 24-month time
point, significant implant degradation was observed, ac-
companied by bone replacement of the space formerly
occupied by the polymer and normal staining (trichrome
stain) of the bone mineralization immediately adjacent
to the remnants of the polymer device. A mild-to-moder-
ate chronic inflammatory response was noted at planned
death in all animals; however, no adverse clinical events
were noted and no osteolysis was found in periimplant tis-
sues. These authors suggested that the HYDROSORB
polymer combination may be a viable alternative to metal-
lic implants.
Bioabsorbable interbody cages composed of PLLA and
metallic cages were studied by Wuisman, et al.,34 in a goat
model. The PLLA cages (two types: stiff and flexible) as
well as titanium cages were placed in a retroperitoneal
fashion at a single interbody level. The goats were fol-
lowed up for 3 to 30 months. At 6 months, four (80%) of
3
 M. M. Robbins, A. R. Vaccaro, and L. Madigan

five in the PLLA group demonstrated radiographic evi-

dence of interbody fusion. The rate of bone formation was
decreased in the titanium compared with the PLLA group,
a finding the authors believed was the result of metallic
stress shielding. Considering all specimens, the rate of
fusion was significantly higher in the PLLA group than in
the titanium group. Bone remodeling was found to be
complete in the group treated with bioabsorbable cages at
the 2-year follow-up evaluation. At the 3-year follow up,
the degradation of the PLLA cages was found to be almost
complete. During the absorption of PLLA, a mild inflam-
matory reaction was noted.
The histological characteristics of fusion maturation in
the setting of a bioabsorbable containment device were
assessed by Smit, et al.,22 in a goat model. Using speci- Fig. 5. Photograph showing an example of a recent design for
mens from another study, these investigators compared an anterior cervical bioabsorbable plate used for graft containment.
the histological characteristics of the fusion mass in goats
that received PLLA cages with those treated with titanium
cages. The PLLA cages consisted of more “mature” bone, At more than 6 months of follow up, radiographically con-
characterized as coarser and more homogeneous than the firmed fusion was present in seven (77%) of the nine pa-
bone sampled in the titanium cages. The authors believed tients. The two patients in whom fusion was not achieved
the decreased stiffness of the PLLA cages was responsible manifested no clinical symptoms of nonunion. No patient
for such superior bone formation. in this study had evidence of soft-tissue complications or
plate dislodgment manifested as swallowing difficulties in
Long-Term Animal Studies the follow-up period. At present, bioabsorbable interbody
Van Dijk, et al.,27 reported on the long-term results of spacers are being used clinically as carriers for bone graft
the use of PLLA cages for lumbar interbody fusion in a or bone morphogenetic protein in anterior cervical fusions
goat model. A total of 36 goats underwent an inter-body (Figs. 7 and 8).
fusion at L3–4; 30 goats received PLLA cages and six Lumbar Spine. Austin, et al.,2 evaluated the use of a
received titanium cages. Similar to the previously cited bioabsorbable interbody spacer in the treatment of lumbar
studies, interbody fusion occurred at approximately 6 degenerative disease and deformity. In their study, 12 pa-
months in the PLLA group, whereas fusion was compara- tients underwent a multilevel posterior lumbar interbody
tively delayed in the titanium group. At 36-month follow fusion with bilaterally placed bioabsorbable spacers aug-
up, the PLLA cage fusion rate was 86% (19 of 22) com- mented with pedicle screw fixation. At the 1-year follow-
pared with 33% (two of six) in the goats that underwent up visit, all patients were found to have attained a suc-
fusion with titanium cages. By 12 months postoperatively, cessful clinical outcome with radiographically confirmed
the PLLA cages were demonstrating progressive degrada- fusion. The only complication noted was delayed wound
tion, and 50% of them were completely absorbed at 36 healing, which occurred in one patient (Fig. 9).
months.
The authors then assessed the flexibility of the bioab- Bioabsorbable Implants Used in the Delivery of
sorbable cages in terms of their effect on bone healing Biological Agents
biology and biomechanics. The stiff and flexible cages A logical extension of the utility of bioabsorbable im-
yielded similar results with respect to fusion, local tissue plants is for delivery of biological agents to a targeted site.
response, bone volume, activity of bone formation, and
motion segment subsidence. The flexible cages increased
the amount of lamellar bone formation, however, when
compared with stiff cages.
In this long-term study, PLLA cages demonstrated a
more rapid and complete rate of bone formation compared
with the titanium cages. Investigators attributed this find-
ing to increased stress shielding provided by titanium
cages. In vitro histomorphometric testing allowed confir-
mation of a decrease in bone volume and bone formation
rate associated with titanium cages.
Recent Trials of Bioabsorbable Implants in Humans
Cervical Spine. Vaccaro, et al.,25 demonstrated the ef-
fective use of a bioabsorbable anterior cervical graft con-
tainment plate (Fig. 5) for the treatment of symptomatic
degenerative and traumatic disc herniations (Fig. 6). Nine Fig. 6. Lateral plain x-ray film obtained at a follow-up interval
patients underwent an allograft interbody fusion followed of 202 days after an anterior cervical allograft fusion and place-
by application of a HYDROSORB anterior cervical plate. ment of a bioabsorbable graft containment device.

4 Neurosurg. Focus / Volume 16 / March, 2004

The use of bioabsorbable implants in spine surgery
Fig. 7. Photograph showing an example of an anterior cervical
bioabsorbable interbody spacer.
The carrier or cage would function initially as a stabiliz-
ing device until the contained biological agent has begun
its healing function. The bioabsorbable carrier would then
gradually degrade, leaving behind the degradation end
products and the effects of the passively delivered carrier,
that is, bone healing. Kandziora, et al.,13 specifically eval-
uated the efficacy of PDLLA-coated titanium cages im-
pregnated with insulin-like growth factor–I and trans-
forming growth factor–1 to enhance interbody fusion in
an animal model. In their study, an anterior cervical disc-
ectomy and fusion at C3–4 was performed in 32 sheep.
The sheep were divided into four different groups: 1) iliac
crest bone graft; 2) titanium cage; 3) titanium cage coated
with a PDLLA carrier; and 4) titanium cage coated with a
PDLLA carrier, insulin-like growth factor–I, and trans-
forming growth factor–1. The titanium cage coated with
the PDLLA and growth factor combination had, on his-
tological inspection, a significantly higher level of bone
mineral content, bony callus volume, and bone mineral
density than the other cages. Biomechanically, the
PDLLA and bone growth factor group displayed a greater
mean stiffness in rotation and bending than the other
groups.
Fig. 8. Lateral plain x-ray film obtained after an anterior cervi-
cal fusion with a bioabsorbable interbody spacer graft and place-
ment of an anterior cervical plate.
Neurosurg. Focus / Volume 16 / March, 2004
Fig. 9. Photographs showing examples of posterior lumbar bi-
oabsorbable interbody spacers. Left: The Telamon device, in
which two cages are designed to be inserted in the lumbar inter-
body spacer. Note: the resorbable HYDROSORB Telamon is
approved in Europe for interbody spacer indications. Right: The
Boomerang device, in which a single implant is designed to be
inserted in the lumbar interbody space.
Bioabsorbable Implants as a Protective and Permissive
Barrier
Iliac Crest Harvest Site Reconstruction. Complications
relating to bone graft harvesting commonly include pain
and cosmetic deformity, the possibility of herniation of
abdominal contents through the harvest site, hematoma
requiring surgical intervention, and fracture of the anteri-
or superior iliac spine.1,35 Bioabsorbable membranes have
demonstrated the ability to act as a barrier to prevent
fibrous and scar tissue permeation of grafting agents while
allowing access to blood and vital nutrients in the sur-
rounding environment. To facilitate controlled bone re-
growth in a defined anatomical location, bioabsorbable
sheets have been used successfully to cover the iliac crest
after bone graft harvesting.
Cornwall, et al.,7 evaluated the use of resorbable sheets
(MacroPore Biosurgery, Inc.) in iliac crest reconstruction
after bone graft harvesting. In this study, sheep were di-
vided into a control group with no crest coverage and an
experimental group in which polylactic acid sheets were
used to cover the iliac crest defect. In the nonprotected
control group, 10.7% of the defect was filled with new
bone, whereas in the resorbable sheet–protected group,
25.9% of the defect was filled with new bone. Wang, et
al.,30 reported that patients whose defects were recon-
structed with MP protective sheeting had significantly less
pain than control patients in whom no iliac crest recon-
struction was performed. In a separate clinical series, Ep-
stein and Hollingsworth10 found no difference in postoper-
ative pain when comparing patients with reconstructed
iliac crests and control patients in whom no reconstruction
was performed. Nevertheless, the authors did note that the
protected and reconstructed iliac crest yielded new bone
growth as assessed on computerized tomography scans.10
Epidural Membrane Scar Barrier. It is a well-known
fact that any form of invasive manipulation leads to soft-
tissue trauma and scar formation. Resorbable films have
been developed that are intended to function as a barrier to
epidural scar or fibrous tissue deposition on the neural ele-
ments3,15,36 (Fig. 10). Welch, et al.,31 evaluated the effec-
tiveness of a polylactide resorbable film (MacroPore Bio-
surgery, Inc.) in preventing the formation of fibrosis after
5

Fig. 10. Left: Photograph showing a bioabsorbable membrane barrier designed to limit epidural scar formation.
Right: Drawing showing placement of a bioabsorbable membrane barrier designed to limit epidural scar formation.
spine surgery in ovine and canine models. Two different
thicknesses (0.02 and 0.2 mm) of bioabsorbable films
were compared. When no film was used, a dense posteri-
or scar adhering to the dura mater at the laminotomy win-
dow was observed. Both film sizes were found to create a
plane for dissection on subsequent surgical exposures and
reduced the amount of tissue adherence to the dura.
Future Research
Several new experimental bioabsorbable devices are in
the process of consideration as spinal implants. These in-
clude a myriad of posterior lumbar interbody fusion de-
vices, anterior spinal plates, and a variety of screw and
mesh designs (Fig. 11). In more than 16,000 patients in
whom more than 300,000 absorbable devices have been
implanted clinically, there has only been a 0.07% inci-
dence of sterile sinus formation reported.
CONCLUSIONS
As bioabsorbable technology continues to evolve, its
application in spine surgery will continue to expand. Fu-
ture design considerations will include a better under-
Fig. 11. Photograph showing an example of a bioabsorbable
plate and pedicle screw, washer implant assembly.
6 Neurosurg. Focus / Volume 16 / March, 2004
M. M. Robbins, A. R. Vaccaro, and L. Madigan
standing of implant stiffness and its effect on bone heal-
ing, and optimization of the mechanical characteristics
of implant materials in order to expand the range of appli-
cations and ultimately to eliminate the need for metal
hardware.
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Manuscript received December 22, 2003.
Accepted in final form February 10, 2004.
Address reprint requests to: Alexander R. Vaccaro, M.D., De-
partment of Orthopaedic Surgery, 925 Chestnut Street, 5th Floor,
Philadelphia, Pennsylvania19107. email: Alexvaccaro3@aol.com.
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