p143. effects of 5-lipoxygenase inhibition on posterolateral lumbar spinal fusion in the rat model

2
also greater in TPS compared with Hybrid (66% vs 49%, p50.03). No dif- ferences were detected in number of fused levels, coronal balance, lordo- sis, sagittal balance, tilt angle, kyphosis, and scoliometer measurements at 2-year follow up. The lowest instrumented vertebrae (LIV) relative to the stable vertebrae was on average 1.4 levels higher in TPS compared with Hybrid (p50.02). No significant differences were detected in any of the SRS questionnaire outcomes, although both groups significantly improved from baseline (p50.0082). TPS had a trend towards increased EBL (852 vs 593, p50.06) but no differences were detected in cell saver, operative times, or length of stay. Vital capacity, but not peak flow, improved signif- icantly from baseline in both groups. At 2 years, TPS patients had signif- icantly higher peak flow measurements (p50.05). CONCLUSIONS: Potential advantages of TPS over Hybrid PSF include saving 1.4 distal levels, greater major thoracic and compensatory lumbar curve correction, and slightly greater peak flow at 2 years. No differences were detected in clinical outcomes. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs. doi:10.1016/j.spinee.2008.06.387 P141. Surgical Outcomes of Decompression, Decompression with Limited Fusion, and Decompression with Full Curve Fusion for Degenerative Scoliosis with Radiculopathy Raymond Topp, MD 1 , Ensor Transfeldt, MD 2 , Amir Mehbod, MD 2 , Robert Winter, MD 2 ; 1 San Antonio, TX, USA; 2 Minneapolis, MN, USA BACKGROUND CONTEXT: Degenerative scoliosis is a lateral devia- tion of the spine often associated with spinal stenosis. Surgical treatments involve decompression with or without instrumented fusions however no consensus for surgical management exists. PURPOSE: The purpose of this study is to report outcomes of surgery for degenerative scoliosis with radiculopathy treated by decompression with and without instrumented fusion. STUDY DESIGN/ SETTING: A retrospective chart review with patient recall was performed on all patients treated surgically over a seven year period. The patient population was obtained from a multisurgeon spine group centered in Minneapolis, Minnesota. PATIENT SAMPLE: 177 patients were identified as being surgically treated for degenerative scoliosis with radiculopathy from 1999 to 2005. Patients were followed for a minimum of 2 years postoperatively. OUTCOME MEASURES: SF-36, Oswestry Disability Index, and Roland-Morris data were collected pre- and postoperatively in the patient population. Additionally, satisfaction questionairres were collected postop- eratively. Radiographic outcomes were also compared to preop values. METHODS: A retrospective chart review with patient recall was per- formed on 177 patients surgically managed by a multisurgeon spine center over a seven year period. 148 patients met inclusion criteria and were ana- lyzed in three groups: decompression alone (D), decompression with lim- ited fusion (D-LF) and decompression with full curve fusion (D-FF). Successful outcomes were defined as O 25% improvement in ODI, as well as, the patients ´ report of success from a satisfaction questionairres. For each group, logistic regression analysis was then used to determine the probabil- ity of a successful outcome with regards to specific surgical variables. RESULTS: 104/148 (70.2%) patients were available for follow-up after surgery. Pre- and postoperative Cobb angles were similar in the D and D-LF groups and there was no significant change in pre- to postoperative magnitudes in these two groups. However, patients in the D-FF group had a higher mean preoperative angle of 39.4 degrees and a significant change was seen in this group to 19.4 degrees postoperatively. Mean blood loss in the D-FF group was 1538cc while the D-LF and D group mean blood loss were 450 and 107.5cc, respectively. The complication rate was highest in patients treated with fusions. After SF 36 analysis, significant z score changes were seen in the MCS for the three groups while PCS did not change significantly from pre- to postoperative values. Disability indices improved significantly in the D group by 7.9% and in the D-LF group by 7.6%. No significant change in ODI was noted in the D-FF group. With regards to success, 75% of patients in the D-FF felt the surgery was suc- cessful while 73.9% and 63.6% felt the same in the D-LF and D groups, respectively. After regression analysis, the probability of surgical success was significantly decreased with sacral to apical limited fusions and with postoperative positive sagittal balance greater than 4 cm. CONCLUSIONS: The treatment for degenerative scoliosis with radicul- opathy remains a challenge for the spine surgeon. Effective treatment can be achieved with either decompression alone, decompression with lim- ited fusion or decompression with full curve fusion. The choice of the pro- cedure depends most notably on the levels requiring decompression as they relate to the apex of the curve, segmental instability and sagittal balance. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs. doi:10.1016/j.spinee.2008.06.388 P142. CT Scan Analysis of Pedicle Screw Placement: Measurement of Breach is Not Reliable Randal Betz, MD 1 , Amer Samdani 1 , John Gaughan 2 , Stewart Bailey, MD 3 , Courtney Brown, MD 4 , Jahangir Asghar, MD 1 , Patrick Cahill, MD 1 , D’Andrea Linda, MD 5 , Maurice Bourlion 6 ; 1 Shriners Hospital for Children, Philadelphia, PA, USA; 2 Temple University, Philadelphia, PA, USA; 3 University of Western Ontario, London, Ontario, Canada; 4 Panorama Orthopedics & Spine Center, Golden, CO, USA; 5 Brandywine Institute of Orthopaedics, Pottstown, PA, USA; 6 San Francisco, CA, USA BACKGROUND CONTEXT: Recent experience with the measurement of pedicle screw breach by CT scan as an outcome measure in a multicenter clinical trial has led us to question the previously reported reliability. PURPOSE: We sought to evaluate the inter-rater agreement of individual measurements of pedicle screw breach and its potential clinical significance. STUDY DESIGN/ SETTING: Interrater analysis. PATIENT SAMPLE: Post-op CT scans of 11 patients with degenerative disease who had titanium or stainless steel screws placed at T12 and below. OUTCOME MEASURES: Degree of breach on post-op CT scan. METHODS: To determine accuracy and agreement, we measured the breach of pedicle screws using six experienced spine surgeons to read post-op CT scans of 11 patients with degenerative disease who had titanium or stainless steel screws placed at T12 and below. Raters scored each screw as: in, out less than 2mm or out greater than or equal to 2 mm. Multiple evaluations of 113 screws (44 titanium and 69 stainless steel) were used to calculate the chance-adjusted kappa statistic as an indicator of inter-rater agreement. RESULTS: Of 597 screw evaluations, 69 (11.6%) were found to have breach greater than or equal to 2mm, 165 (27.6%) were found to have breach less than 2mm, and 363 (60.8%) were found to have no breach. The calculated kappa sta- tistics were 0.115 (95%CI .054, .176) for titanium screws and 0.184 (95%CI .125, .243) for stainless steel screws, indicating poor agreement among raters. CONCLUSIONS: Our results indicate that the evaluation of pedicle screw breach on CT by a single surgeon is highly variable and care should be taken in using individual CT evaluations of mm of breech as a basis for screw removal. FDA DEVICE/DRUG STATUS: Pedicle screws: Approved for this indication. doi:10.1016/j.spinee.2008.06.389 P143. Effects of 5-Lipoxygenase Inhibition on Posterolateral Lumbar Spinal Fusion in the Rat Model Colin Harris, MD 1 , Mitchell Reiter, MD 2 , J. Patrick O’Connor, PhD 3 , Michael Vives, MD 3 , Michael Loeven, BA 4 , Praveen Yalamanchili, MD 3 ; 1 University of Medicine and Dentistry of New Jersey, Hoboken, NJ, USA; 169S Proceedings of the NASS 23rd Annual Meeting / The Spine Journal 8 (2008) 1S–191S

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Page 1: P143. Effects of 5-Lipoxygenase Inhibition on Posterolateral Lumbar Spinal Fusion in the Rat Model

169SProceedings of the NASS 23rd Annual Meeting / The Spine Journal 8 (2008) 1S–191S

also greater in TPS compared with Hybrid (66% vs 49%, p50.03). No dif-

ferences were detected in number of fused levels, coronal balance, lordo-

sis, sagittal balance, tilt angle, kyphosis, and scoliometer measurements at

2-year follow up. The lowest instrumented vertebrae (LIV) relative to the

stable vertebrae was on average 1.4 levels higher in TPS compared with

Hybrid (p50.02). No significant differences were detected in any of the

SRS questionnaire outcomes, although both groups significantly improved

from baseline (p50.0082). TPS had a trend towards increased EBL (852 vs

593, p50.06) but no differences were detected in cell saver, operative

times, or length of stay. Vital capacity, but not peak flow, improved signif-

icantly from baseline in both groups. At 2 years, TPS patients had signif-

icantly higher peak flow measurements (p50.05).

CONCLUSIONS: Potential advantages of TPS over Hybrid PSF include

saving 1.4 distal levels, greater major thoracic and compensatory lumbar

curve correction, and slightly greater peak flow at 2 years. No differences

were detected in clinical outcomes.

FDA DEVICE/DRUG STATUS: This abstract does not discuss or include

any applicable devices or drugs.

doi:10.1016/j.spinee.2008.06.387

P141. Surgical Outcomes of Decompression, Decompression with

Limited Fusion, and Decompression with Full Curve Fusion for

Degenerative Scoliosis with Radiculopathy

Raymond Topp, MD1, Ensor Transfeldt, MD2, Amir Mehbod, MD2,

Robert Winter, MD2; 1San Antonio, TX, USA; 2Minneapolis, MN, USA

BACKGROUND CONTEXT: Degenerative scoliosis is a lateral devia-

tion of the spine often associated with spinal stenosis. Surgical treatments

involve decompression with or without instrumented fusions however no

consensus for surgical management exists.

PURPOSE: The purpose of this study is to report outcomes of surgery for

degenerative scoliosis with radiculopathy treated by decompression with

and without instrumented fusion.

STUDY DESIGN/ SETTING: A retrospective chart review with patient

recall was performed on all patients treated surgically over a seven year

period. The patient population was obtained from a multisurgeon spine

group centered in Minneapolis, Minnesota.

PATIENT SAMPLE: 177 patients were identified as being surgically

treated for degenerative scoliosis with radiculopathy from 1999 to 2005.

Patients were followed for a minimum of 2 years postoperatively.

OUTCOME MEASURES: SF-36, Oswestry Disability Index, and

Roland-Morris data were collected pre- and postoperatively in the patient

population. Additionally, satisfaction questionairres were collected postop-

eratively. Radiographic outcomes were also compared to preop values.

METHODS: A retrospective chart review with patient recall was per-

formed on 177 patients surgically managed by a multisurgeon spine center

over a seven year period. 148 patients met inclusion criteria and were ana-

lyzed in three groups: decompression alone (D), decompression with lim-

ited fusion (D-LF) and decompression with full curve fusion (D-FF).

Successful outcomes were defined as O25% improvement in ODI, as well

as, the patients report of success from a satisfaction questionairres. For each

group, logistic regression analysis was then used to determine the probabil-

ity of a successful outcome with regards to specific surgical variables.

RESULTS: 104/148 (70.2%) patients were available for follow-up after

surgery. Pre- and postoperative Cobb angles were similar in the D and

D-LF groups and there was no significant change in pre- to postoperative

magnitudes in these two groups. However, patients in the D-FF group had

a higher mean preoperative angle of 39.4 degrees and a significant change

was seen in this group to 19.4 degrees postoperatively. Mean blood loss in

the D-FF group was 1538cc while the D-LF and D group mean blood loss

were 450 and 107.5cc, respectively. The complication rate was highest in

patients treated with fusions. After SF 36 analysis, significant z score

changes were seen in the MCS for the three groups while PCS did not

change significantly from pre- to postoperative values. Disability indices

improved significantly in the D group by 7.9% and in the D-LF group

by 7.6%. No significant change in ODI was noted in the D-FF group. With

regards to success, 75% of patients in the D-FF felt the surgery was suc-

cessful while 73.9% and 63.6% felt the same in the D-LF and D groups,

respectively. After regression analysis, the probability of surgical success

was significantly decreased with sacral to apical limited fusions and with

postoperative positive sagittal balance greater than 4 cm.

CONCLUSIONS: The treatment for degenerative scoliosis with radicul-

opathy remains a challenge for the spine surgeon. Effective treatment

can be achieved with either decompression alone, decompression with lim-

ited fusion or decompression with full curve fusion. The choice of the pro-

cedure depends most notably on the levels requiring decompression as they

relate to the apex of the curve, segmental instability and sagittal balance.

FDA DEVICE/DRUG STATUS: This abstract does not discuss or include

any applicable devices or drugs.

doi:10.1016/j.spinee.2008.06.388

P142. CT Scan Analysis of Pedicle Screw Placement: Measurement

of Breach is Not Reliable

Randal Betz, MD1, Amer Samdani1, John Gaughan2, Stewart Bailey, MD3,

Courtney Brown, MD4, Jahangir Asghar, MD1, Patrick Cahill, MD1,

D’Andrea Linda, MD5, Maurice Bourlion6; 1Shriners Hospital for

Children, Philadelphia, PA, USA; 2Temple University, Philadelphia, PA,

USA; 3University of Western Ontario, London, Ontario, Canada;4Panorama Orthopedics & Spine Center, Golden, CO, USA; 5Brandywine

Institute of Orthopaedics, Pottstown, PA, USA; 6San Francisco, CA, USA

BACKGROUND CONTEXT: Recent experience with the measurement

of pedicle screw breach by CT scan as an outcome measure in a multicenter

clinical trial has led us to question the previously reported reliability.

PURPOSE: We sought to evaluate the inter-rater agreement of individual

measurements of pedicle screw breach and its potential clinical significance.

STUDY DESIGN/ SETTING: Interrater analysis.

PATIENT SAMPLE: Post-op CT scans of 11 patients with degenerative

disease who had titanium or stainless steel screws placed at T12 and below.

OUTCOME MEASURES: Degree of breach on post-op CT scan.

METHODS: To determine accuracy and agreement, we measured the breach

of pedicle screws using six experienced spine surgeons to read post-op CT

scans of 11 patients with degenerative disease who had titanium or stainless

steel screws placed at T12 and below. Raters scored each screw as: in, out less

than 2mm or out greater than or equal to 2 mm. Multiple evaluations of 113

screws (44 titanium and 69 stainless steel) were used to calculate the

chance-adjusted kappa statistic as an indicator of inter-rater agreement.

RESULTS: Of 597 screw evaluations, 69 (11.6%) were found to have breach

greater than or equal to 2mm, 165 (27.6%) were found to have breach less than

2mm, and 363 (60.8%) were found to have no breach. The calculated kappa sta-

tistics were 0.115 (95%CI .054, .176) for titanium screws and 0.184 (95%CI

.125, .243) for stainless steel screws, indicating poor agreement among raters.

CONCLUSIONS: Our results indicate that the evaluation of pedicle screw

breach on CT by a single surgeon is highly variable and care should be

taken in using individual CT evaluations of mm of breech as a basis for

screw removal.

FDA DEVICE/DRUG STATUS: Pedicle screws: Approved for this

indication.

doi:10.1016/j.spinee.2008.06.389

P143. Effects of 5-Lipoxygenase Inhibition on Posterolateral Lumbar

Spinal Fusion in the Rat Model

Colin Harris, MD1, Mitchell Reiter, MD2, J. Patrick O’Connor, PhD3,

Michael Vives, MD3, Michael Loeven, BA4, Praveen Yalamanchili, MD3;1University of Medicine and Dentistry of New Jersey, Hoboken, NJ, USA;

Page 2: P143. Effects of 5-Lipoxygenase Inhibition on Posterolateral Lumbar Spinal Fusion in the Rat Model

170S Proceedings of the NASS 23rd Annual Meeting / The Spine Journal 8 (2008) 1S–191S

2New Jersey Medical School, Newark, NJ, USA; 3University of Medicine

and Dentistry of New Jersey, Newark, NJ, USA; 4Weill Medical College of

Cornell University, New York, NY, USA

BACKGROUND CONTEXT: The process of osteogenesis after spinal

arthrodesis is similar to that which occurs during fracture healing and het-

erotopic ossification. Previous work with fracture healing models has dem-

onstrated increased healing rates with 5-lipoxygenase inhibition, which

increases the cyclooxygenase pathway leading to increased prostaglandin

formation. Although arachidonic acid metabolism has been shown to play

a central role in fracture healing, little is known about the effects of mod-

ulation of the arachidonic acid pathway on spinal fusion healing.

PURPOSE: The purpose of this study was to compare the rate of spinal

fusion in the rat model using autograft iliac crest bone and calcium sulfate

carrier alone versus iliac crest autograft bone with 5-lipoxygenase inhibitor

added locally to the fusion bed.

STUDY DESIGN/ SETTING: An animal study utilizing rat lumbar

spines (L4-L5).

PATIENT SAMPLE: Fourteen adult male Sprague-Dawley rats weighing

approximately 600 grams each were used in this study.

OUTCOME MEASURES: The lumbar fusion masses in this study were

evaluated with manual palpation testing of the intact specimens, radio-

graphic comparison of AP radiographs and MicroCt images, and qualita-

tive histologic testing using standard staining techniques.

METHODS: Fourteen adult male Sprague-Dawley rats weighing approx-

imately 600 grams each underwent posterolateral intertransverse lumbar

fusions from L4-L5 utilizing a Wiltse-type approach. After exposure of

the transverse processes and high-speed burr decortication, illiac crest au-

tograft with 5-lipoxygenase inhibitor (AA861) and calcium sulfate carrier

(experimental group), or iliac crest and calcium sulfate carrier alone

(control group) were implanted in the fusion beds. Spines were harvested

en bloc on postoperative day 28 and underwent manual palpation testing,

radiographic comparison, and histologic testing.

RESULTS: All 7 control animals and 6 out of 7 animals in the experimen-

tal group survived to study completion. Manual palpation of the specimens

revealed 5 of the control spines to be unfused, 1 partially fused, and 1 fully

fused. Palpation of the experimental group specimens revealed no unfused

spines, 2 partially fused, and 4 fully fused. Radiographic review of the con-

trol spines revealed 3 grade B spines, 3 grade C spines, and 1 grade D spine

according to the Lenke criteria (A5solid fusion mass, B5unilateral fusion

mass, C5small fusion masses bilaterally, D5graft resorption). Review of

the spines in the experimental group spines revealed 4 grade A spines, 1

grade B spine, and 1 spine that was graded B by one observer and C by

the other observer. Overall, this difference was significant (p!0.008).

CONCLUSIONS: This study shows that the arachidonic acid pathway

may play an important role in the early, inflammatory phase of spinal fu-

sion healing and that 5-lipoxygenase inhibitor applied locally to the spinal

fusion bed increases healing compared to controls in the rat model. While

the optimal dosages and methods of delivery of this medication are not yet

known, early results are promising and demonstrate that further investiga-

tions with these compounds are needed.

FDA DEVICE/DRUG STATUS: AA861: Investigational/Not approved.

doi:10.1016/j.spinee.2008.06.390

P144. Patient Reported Outcomes of Neck Pain Following Anterior

Cervical Discectomy and Fusion: Effect of Subjective Qualitative

and Quantitative Description of Neck Pain

Ian Rodway, MD1, Louis Jenis, MD2, Matthew Hwang, MD1,

Marc Parham, PhD2, Cheryl Frank, RN2; 1New England Baptist Hospital,

Boston, MA, USA; 2Boston Spine Group, Boston, MA, USA

BACKGROUND CONTEXT: Anterior cervical discectomy and fusion

(ACDF) is a commonly performed spinal procedure. Studies focusing on

pain intensity have shown that ACDF provides excellent results for the

treatment of radicular upper extremity pain, but the effect on neck pain

is less clear and variable. This variability in reported improvement follow-

ing arthrodesis may be related to several factors including the lack of dis-

tinguishing the subjective quality and location of axial symptoms.

PURPOSE: The purpose of this study is to further define the effect of

ACDF in respect to neck pain by patient-reported outcomes.

STUDY DESIGN/ SETTING: A retrospective chart review of patients

undergoing ACDF with at least one-year follow-up was completed.

PATIENT SAMPLE: A total of 76 patients (38 F: 38 M) (47.8 +/-11.4

age) who underwent ACDF for radicular or myelopathic indications were

reviewed. Inclusion criteria were a history of preoperative neck pain and at

least one-year follow-up.

OUTCOME MEASURES: Pre-operative and post-operative subjective

quantitative and qualitative pain responses were recorded by visual ana-

logue scores (0- least - 10-most) as well as the site of preoperative pain

based on an anatomic neck / shoulder diagram. All ACDF procedures were

performed at one institution by a single surgeon.

METHODS: 76 patients with a pre-operative complaint of midaxial (M),

supratrapezial (S), interscapular (I), or combinations of these self-reported

neck pain sites who underwent ACDF with or without corpectomy were

reviewed. Pre and post-operative neck and arm pain VAS scores were re-

corded, in addition to preoperative diagnosis, duration of symptoms, oper-

ative procedure, and workmans compensation status.

RESULTS: 36 patients underwent single level ACDF, 27 two level ACDF,

and 13 three level ACDF of which 3 also underwent corpectomy. Overall,

all ACDF patients showed a statistically significant reduction in post-oper-

ative neck pain (6.5+/-2.4 to 2.2+/-2.4) p50.001). All neck pain locations

and combinations showed significant post-operative reduction of pain al-

though patients with diffuse (M/S/I) pain in combination with radicular

arm pain experienced less relief. In the absence of any self-reported local-

ized midaxial neck pain symptoms, improvement of perceived neck is also

greater. There was no significant difference in pre and post-operative neck

pain VAS scores between these WC (11 patients) and nonWC.

CONCLUSIONS: To our knowledge, this is the first study to evaluate the

detailed description of neck pain symptoms in an attempt to further define

patient expectations for neck pain relief following surgical intervention.

The outcomes of ACDF in this study confirm the reduction of neck pain

seen in other investigations and is not affected by number of levels fused.

The results also confirm the wide variability of patient depiction of neck

pain presentation as well as the intensity of pain symptoms. It appears that

patients who describe their neck pain in the superior trapezial or interscap-

ular areas as opposed to more localized midaxial or widely diffuse axial

discomfort experience slightly better pain improvement with ACDF. The

results of this study will allow for further counseling of patients and prep-

aration of their expectations with surgery.

FDA DEVICE/DRUG STATUS: This abstract does not discuss or include

any applicable devices or drugs.

doi:10.1016/j.spinee.2008.06.391

P145. Surgeons’ Perceptions of Spinal Navigation

Alexander Choo, Choll Kim, MD, PhD; University of California, San

Diego, San Diego, CA, USA

BACKGROUND CONTEXT: Computer-assisted spinal navigation al-

lows for real time localization of surgical instruments in multiple views.

Its use decreases radiation exposure, eliminates the need for cumbersome

protective gowns and clears the surgical field of the C-arm fluoroscope.

Despite these advantages spinal navigation has yet to gain general accep-

tance among spine surgeons.

PURPOSE: The purpose of this study is to survey spine surgeons about

their use of spinal navigation, as well as their opinions on the strengths

and weaknesses of spinal navigation.

STUDY DESIGN/ SETTING: We constructed a survey regarding sur-

geon’s beliefs regarding the strengths and weaknesses of spinal navigation.