p172. hydroxyapatite-coated pedicle screws for dynamic fixation significantly improve...
TRANSCRIPT
161SProceedings of the NASS 22nd Annual Meeting / The Spine Journal 7 (2007) 1S–163S
OUTCOME MEASURES: Reoperation rate was defined as any patient
requiring reoperation, revision, or supplemental fixation at the index level.
Heterotopic ossification (HO) was classified at the adjacent levels at 24
months using the criteria described by McAfee.
METHODS: Patients were assessed pre-operatively and post-operatively,
6 weeks, 3, 6, 12, 18 and 24 months.
RESULTS: Adjacent level SCDD was reported in one (1) patient in short-
term (!42–210 days) and in two (2) patients in long-term (!210 days)
follow-up in the ACDF group out to 24 months for an incidence rate of
2.8%. No patients in the ProDisc-C group were reported to have adjacent level
SCDD out to 24 months. Class I ossification was identified at the adjacent
level in ten (10) ACDF patients representing 10.9% (10/92). Class II ossifica-
tion was identified at the adjacent level in two (2) ACDF patients representing
2.2% (2/92) of the ACDF patients. Class III ossification was identified at the
adjacent level in one (1) ACDF patients representing 1.1% (1/92) of the ACDF
patients. Class IV ossification was identified at the adjacent level in one (1)
ACDF patients representing 1.1% (1/92) of the ACDF patients. Therefore,
ACDF patients had an overall adjacent level HO rate of 15.2%. Class II ossi-
fication was identified in one (1) ProDisc-C patient at 24 months representing
0.97% (1/103). No Class I, III, or IV level ossifications were found in the Pro-
Disc-C group at adjacent levels therefore the overall HO rate was 0.97% for
the ProDisc-C group. The reoperation rate at 24 months were statistically dif-
ferent between treatments (p50.04). In the ACDF group, the reoperation rate
was 9.4% (10/106) compared to the ProDisc-C group was 1.9%(2/103).
CONCLUSIONS: This study supports previously published rates of
SCDD after ACDF of 2.8% but cervical TDR does not exhibit the same
degeneration pathology. In addition, the ACDF group had significantly dif-
ferent adjacent level HO rates at 2 year follow-up in comparison to the Pro-
Disc-C group. Reoperation rates at the index level were statistically
different between treatments. ACDF has been the historical standard be-
cause it is viewed as very successful, however the high reoperation rate,
adjacent level symptomatic degeneration, and high prevalence of HO
clearly have a negative clinical and economic effect on the system. All
three issues are not present following TDR at 2 years post-operatively.
FDA DEVICE/DRUG STATUS: ProDisc-C: Investigational/ Not approved.
doi: 10.1016/j.spinee.2007.07.380
P171. Computer Assisted vs Manual Coding Of Surgical Procedures
in a Private Practice Setting
Paul Schwaegler, MD1; 1Orthopedics International, Seattle, WA, USA
BACKGROUND CONTEXT: Today coding for spinal surgical interven-
tion is dauntingly complex. That coding and the resulting reimbursement
are intimately tied together. As providers we perform work, determine
the most accurate coding to represent that work, and then send that coding
scenario to the third party carrier. Stereotypically, the insurers receive the
bill, and then run that coding scenario through a number of filters to deter-
mine the reimbursement they think is fair to pay. Those ‘‘filters’’ include
not only the contracted rate of reimbursement, but also a payer set of rules
which determines how and if work will be reimbursed.
PURPOSE: Advanced computer aided coding can be extremely helpful by
bringing these insurer ‘‘filters’’ to the surgeon as he is coding the claim. By
addressing the rule sets prospectively while coding, the likelihood that the
surgery will be appropriately reimbursed is greatly enhanced. Medicare is
the largest single insurer, and its rule set is over 200,000 long. We set out to
determine whether computer aided coding could be of value when coding
spine surgery claims with this large carrier.
STUDY DESIGN/SETTING: Two groups of Medicare surgical proce-
dure claims were retrospective analyzed. Group A consisted of consecutive
claims manually coded in the first half of 2005. Group B consisted of con-
secutive claims filed during a similar time frame in 2006 which were coded
with the assistance of a coding software program. The two groups were
evaluated for coding accuracy and resulting reimbursement.
PATIENT SAMPLE: Group A consisted of 41 claims manually coded in
the first half of 2005. Group B consisted of 36 claims filed in 2006 and
coded with the assistance of a coding software program.
OUTCOME MEASURES: Outcome measures consisted at comparing
inappropriately denied reimbursement for the two groups.
METHODS: Methods involved reviewing all coding and reimbursement
from the two groups. We took each claim individually and examined each code
and each modifier for accuracy. Using the Medicare rule set (including the
Correct Coding Edits), we were able to determine how the claims should have
been coded, and how the misscoding affected the potential reimbursement.
RESULTS: Group A: There were 41 claims submitted in the first six
months of 2005, representing almost $110,000.00 ($109,649.69) of ex-
pected reimbursement. In the review, it was determined that eight of these
41 claims or 20% were under-reimbursed. The lost revenue was just under
$15,000 ($14,966.51), or 14%. Group B: 36 claims submitted, representing
expected reimbursement of just over $114,000 ($114,123.29). Using
computer aided coding, only three of the 36 or 8% of the claims were
under-reimbursed. More impressively, the lost revenue for those three
under-reimbursed claims totaled just over $1,500 ($1,534.20) or about 1%.
CONCLUSIONS: Computer aided coding can provide the surgeon with
information at the time of coding that can assist him in coding correctly.
Capturing the expected revenue on the ‘‘first pass’’ is incredibly valuable,
as the dispute process with many carriers is a maze of multiple appeals, all
of which must be timely, and each with its own set of rules that must be
followed. The cost of these appeals often times erodes the value of any
re-captured reimbursement we might ultimately gain. This makes it all
the more crucial to code correctly the first time.
FDA DEVICE/DRUG STATUS: This abstract does not discuss or include
any applicable devices or drugs.
doi: 10.1016/j.spinee.2007.07.381
P172. Hydroxyapatite-Coated Pedicle Screws for Dynamic Fixation
Significantly Improve Osseointegration at the Bone-Screw Interface
in an Ovine Model
Kevin Foley, MD1, Henry Bonin, MS2, Eric Lange, MS2, A. Simon Turner,
BVSC, MS3, Michael Beck, PhD4, Amy Lyons, MS3, Howard Seim, III,
DVM, DIPL ACVS3; 1University of Tennessee, Memphis, TN, USA;2Medtronic, Inc., Memphis, TN, USA; 3Colorado State University, Fort
Collins, CO, USA; 4Medtronic, Inc., Minneapolis, MN, USA
BACKGROUND CONTEXT: Pedicle-based dynamic fixation systems
have been introduced in the recent past. The risk of screw loosening following
these procedures remains significant, especially in patients with poor bone
quality. Surface augmentation of orthopedic implants with bioactive coatings
like hydroxyapatite (HA) has been shown to promote osseointegration and
may reduce the risk of screw loosening in dynamic fixation procedures.
PURPOSE: The purpose of this study was to determine what, if any, differ-
ences in osseointegration occurred between HA-coated and non-HA-coated
titanium pedicle screws when used in conjunction with a dynamic fixator in
an ovine model.
STUDY DESIGN/SETTING: An in vivo ovine model was used to eval-
uate various parameters of osseointegration of lumbar pedicle screws used
in conjunction with a dynamic fixator.
PATIENT SAMPLE: Twelve skeletally mature ewes were studied.
OUTCOME MEASURES: Extraction torque, percent connectivity (per-
cent surface area contact), bone implant contact.
METHODS: Single-level, bilateral pedicle screws were inserted in the lum-
bar spines of 12 sheep (48 screws). Each ipsilateral screw pair was connected
with a dynamic fixation device. Standard anodized titanium screws (4.5mm
diameter, 30mm length) were used in 6 sheep (24 standard screws); similar
titanium screws with a plasma-sprayed HA coating on the threaded portion
were used in the 6 others (24 HA–coated screws). Plain AP and lateral lumbar
radiographs along with axial CT scans were obtained at 3, 6, 9, and 12 months
postoperatively. Half of the sheep were euthanized at 6 months and half at
one year. Forty-two of the screws were removed from the harvested spines
using a torque wrench with digital readout and minimum torque measure-
ment of 0.5Nm. Peak extraction torque was recorded using a constant effort.
The other six screws were carefully harvested to capture approximately 5mm
of bone surrounding the screws. These 6 samples were analyzed using
162S Proceedings of the NASS 22nd Annual Meeting / The Spine Journal 7 (2007) 1S–163S
micro-CT and un-decalcified histology. Radiographs from 12-month sheep
following screw removal were analyzed for micro-fractures. Contact area
at the bone-screw interface was calculated using virtual volume subtraction
of the 3D reconstructed micro-CT scans. Stained, un-decalcified histology
was used to complement the micro-CT data.
RESULTS: Mean extraction torque for non-HA coated screws at 6 and
12 months postoperative was 1.64þ/�0.15 Nm and 1.49þ/�2.68 Nm,
respectively. Mean extraction torque for HA-coated screws at 6 and 12
months postoperative was 7.28þ/�1.41 Nm and 7.20þ/�0.97 Nm. Radio-
lucent zones (defined as greater than 1 mm in width) were not found on any
of the plain films or axial CTs. Micro-fractures were not found in radio-
graphs of vertebral bodies where screws were removed. Both 6 and
12-month HA-coated screws demonstrated 96.6% virtual connectivity on
micro-CT, whereas the 12-month non-HA-coated screws showed only
57.5% virtual connectivity. Measurements of bone-to-implant apposition
obtained with standard un-decalcified histology matched the micro-CT data.
CONCLUSIONS: In this study, HA coating significantly improved os-
seointegration at the bone-screw interface, as measured by peak extraction
torque, micro-CT analysis, and histology, in an ovine model of pedicle–
based lumbar dynamic fixation.
FDA DEVICE/DRUG STATUS: CD HORIZON Spinal System: Ap-
proved for this indication.
doi: 10.1016/j.spinee.2007.07.382
P173. Lumbar Degenerative Spondylolisthesis: MRI Accuracy
Christian Fras, MD1, Michael Fras, MD2; 1Department of Orthopaedic
Surgery, University of Pennsylvania, Philadelphia, PA, USA; 2Allegheny
General Hospital, Pittsburgh, PA, USA
BACKGROUND CONTEXT: Degenerative spondylolisthesis and steno-
sis of the lumbar spine is a common condition affecting the elderly. Surgi-
cally treatment frequently includes lumbar decompression and fusion.
Patients often present pre-operatively with only MRI studies of their lum-
bar spine, and no x-rays. It is unclear how often the MRI films accurately
diagnose the presence of the degenerative spondylolisthesis.
PURPOSE: The purpose of this study was to evaluate how frequently
MRI studies correctly diagnosed the presence of degenerative spondylolis-
thesis as established by x-rays.
STUDY DESIGN/SETTING: Retrospective review of all x-rays and
MRI’s of patients undergoing surgery for spinal stenosis and degenerative
spondylolisthesis.
PATIENT SAMPLE: All patients undergoing surgery for lumbar spinal
stenosis and degenerative spondylolisthesis.
OUTCOME MEASURES: Accuracy of MRI films in diagnosing the
presence of the degenerative spondylolisthesis.
METHODS: 25 consecutive patients who underwent lumbar decompres-
sion and fusion for L4-5 lumbar stenosis and spondylolisthesis were iden-
tified; all had Grade I degenerative spondylolisthesis on pre-operative
x-rays. The pre-operative MRI studies were then evaluated independently
of the x-rays for the presence of spondylolisthesis. The frequency with
which the MRI studies correctly identified the deformity noted on x-ray
was then determined.
RESULTS: Fourteen women and 11 men were identified; mean age was
66 (range: 47–78). All patients had degenerative Grade I spondylolisthesis
on x-ray. Review of MRI films revealed 6 of 25 patients to have no evi-
dence of spondylolisthesis apparent. The MRI report of 2 patients specif-
ically indicated that no spondylolisthesis was present, although direct
examination of these films revealed a clear deformity.
CONCLUSIONS: Lumbar stenosis with spondylolisthesis has been
shown by some studies to be better treated surgically by lumbar laminec-
tomy and fusion than by laminectomy alone. In this study, 24% of patients
treated surgically for lumbar stenosis and spondylolisthesis would have
had their spondylolisthesis missed if radiographic evaluation were limited
to MRI alone, and could consequently have had suboptimal surgical care
rendered. An additional 8% of patients who did have spondylolisthesis
visible on MRI had an accompanying radiology report failing to recognize
the deformity. The need for x-ray as well as MRI evaluation of the patient
with spinal stenosis is therefore emphasized, as is the need for the treating
surgeon to personally review all studies.
FDA DEVICE/DRUG STATUS: This abstract does not discuss or include
any applicable devices or drugs.
doi: 10.1016/j.spinee.2007.07.383
P174. Anterior Cervical Fusion with Bone-Morphogenic Protein-7
(OP-1) A Prospective Study of its Effects on Postoperative Laryngeal
Swelling
Jack Chen, MD1; 1Orthopaedic Specialty Institute, Orange, CA, USA
BACKGROUND CONTEXT: Recombinant human bone-mophogenic
protein-7 (trademark OP-1, Stryker) has shown clinical efficacy in induc-
ing posterolateral fusions in the lumbar spine. Its use in anterior cervical
spine surgery, however, has not been described.
PURPOSE: The purpose of this study is to evaluate the safety of its use in
terms of postoperative prevertebral soft-tissue swelling and complications
related to airway and swallowing difficulty.
STUDY DESIGN/SETTING: Prospective study. Tertiary referral center.
PATIENT SAMPLE: 44 consecutive patients were treated with anterior
cervical decompression and fusion. All patients were treated with allograft
rings packed with OP-1 and stabilized with anterior instrumentation.
OUTCOME MEASURES: Radiographic measurements of soft tissue
swelling. Clinical evaluation of laryngeal swelling.
METHODS: Lateral radiographs of the cervical spine were taken preoper-
atively, on postoperative day 2, and on postoperative day 7. We recorded the
day of when patients were able to tolerate regular diet. Adverse events related
to soft-tissue swelling, including prolonged hospitalization (greater than
48 hours), hospital readmission, or prolonged dysphagia were also recorded.
RESULTS: Nine patients had a 1-level fusion, 20 patients had 2-level fu-
sions, 11 patients had 3-level fusions, and 3 patients had 4-level fusions.
The average preoperative prevertebral soft tissue swelling measured 5.1
mm at C3 and 15.5 mm at C6. On postoperative day 2, the average mea-
surements were 11.6 mm at C3 and 18.3 mm at C6. This was compared to
previously published control measurements of 12.7 mm and 17.3 mm. On
postoperative day 7, the average swelling measured 10.7 mm and 20.4 mm,
respectively, at C3 and C6. Reported historical controls are 9 mm and 18
mm. Forty-three patients (97%) tolerated soft diet on postoperative day 2.
There were no hospital readmissions. One patient required reintubation and
evacuation of a postoperative hematoma.
CONCLUSIONS: Our series show that the incidence of soft-tissue swell-
ing complications with the use of rhBMP-7 is low. Furthermore, our mea-
surements of prevertebral swelling after surgery show trends comparable to
those reported after anterior fusion with tricortical iliac crest autogenous
graft and plate fixation.
FDA DEVICE/DRUG STATUS: OP-1 (Stryker): Not approved for this
indication.
doi: 10.1016/j.spinee.2007.07.384
P175. A Comparison of Two Retroperitoneal Surgical Approaches
for Total Disc Arthroplasty of the Lumbar Spine
John Bendo, MD1, Martin Quirno, MD1, Thomas Errico, MD1,
Jeffrey Spivak, MD1, Jeffrey Goldstein, MD1; 1NYU Hospital for Joint
Diseases, New York, NY, USA
BACKGROUND CONTEXT: The theoretical advantages of disc arthro-
plasty are motion preservation and improved clinical outcome, with a corre-
sponding decrease in the incidence of adjacent level disease. A number of
studies have demonstrated comparable clinical outcomes between TDA and
lumbar fusion recipients. Surgical technique has evolved to allow for proper
placement of various interbody implants and to avoid immediate and long-
term complications. Little is known about the impact of varying surgical
approaches on lumbar artificial disc implant position and clinical outcome.