1
183. Cervical Arthroplasty in Elderly: Prospective 6-Year Follow-up Leonardo Oliveira, BSc 1 , Luis Marchi, MSc 2 , Etevaldo Coutinho, MD 2 , Luiz Pimenta, MD, PhD 2 ; 1 Universidade Federal de Sa˜o Paulo, Sa˜o Paulo, Brazil; 2 Instituto de Patologia da Coluna, Sa˜o Paulo, Brazil BACKGROUND CONTEXT: Traditional treatment of cervical spon- dylosis and cervical herniated disc disease with neurological compres- sion is anterior spinal decompression followed by fusion. Total disc replacement has been reported to restore motion in the cervical spine decreasing adjacent level disease rate, but indicated for the young population. PURPOSE: The purpose of the present study is to evaluate the safety and effectiveness of the PCM artificial disc in the elderly segment. STUDY DESIGN/SETTING: Prospective non randomized clinical trial. PATIENT SAMPLE: Series of 14 patients, mean age 65.4 y/o (Range 60 - 80) with a total of 24 prostheses. OUTCOME MEASURES: The Neck Disability Index (NDI), Visual An- alog Scale (VAS) and TIGT questionnaires were used to assess pain and functional outcomes. METHODS: The neural decompression was performed in standard Smith- Robinson technique. Radiographic (AP, lateral and dynamics images) and clinical outcomes were collected preoperatively and postoperatively after 1 week, 1, 3, 6 months and annually. RESULTS: At 72 months follow-up, there were no deaths, no infections, and no cases of iatrogenic neurologic progression. The mean VAS and NDI improved in all periods when compared to preoperative follow-up. One patient (4.2%) presented facet degeneration grade III in Pimenta’s scale. Two prosthesis (8.3%) presented bone formation with no movement of the disc, and other two patients presented bone formation with decreas- ing of the range of motion, but with no worsening in their clinical outcomes. CONCLUSIONS: Following cervical arthroplasty with PCM prosthesis, radiographic and clinical outcome measurements were encouraging when compared to historical data of ACDF in elderly. Considering the aging population, cervical disc arthroplasty is a good treatment option for degen- erative disc disease and a viable alternative to fusion in the elderly segment of the society. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs. doi: 10.1016/j.spinee.2010.07.227 184. Facet Replacement: Three-Year Follow-up on a Multicenter Study Leonardo Oliveira, BSc 1 , Luis Marchi, Msc 2 , Etevaldo Coutinho, MD 2 , Luiz Pimenta, MD, PhD 2 ; 1 Universidade Federal de Sa˜o Paulo, Sa˜o Paulo, Brazil; 2 Instituto de Patologia da Coluna, Sa˜o Paulo, Brazil BACKGROUND CONTEXT: Fusion remains the gold standard by which mechanical low back pain from degenerative disc disease is treated. How- ever, arthrodesis can cause increased motion and stress in the segments ad- jacent to a fusion by means of load transfer. Artificial mechanical total disc replacement (TDR) has been successfully used as an alternate means of treatment that can also restore the interbody geometry while preserving segmental motion. Patients with significant spinal stenosis and facet ar- thropathy, however, are often excluded from having TDR as increased seg- mental motion can exacerbate dorsal spondylytic changes. For this large population of patients for whom TDR is contraindicated, the TOPS system offers a novel mechanism of total facet replacement (TFR) that allows for excellent dynamic, multiaxial, 3-column stabilization after complete neu- ral decompression via a standard posterior approach PURPOSE: The purpose of this study is to report our surgical data and clinical outcomes in patients treated with the TOPS Lumbar TFR system STUDY DESIGN/SETTING: Prospective, non-randomized, multicenter, prospective pilot study that was approved by each individual local institu- tional review board. PATIENT SAMPLE: Twenty patients were enrolled with a primary sur- gical indication of low back pain, neurological claudication, and/or radi- culopathy resulting from spinal stenosis at L4-5 due to facet arthropathy with no frank disc herniation and only a mild degree of degenerative disc disease. OUTCOME MEASURES: Radiographs and outcome measures such as Visual Analogue Scale for pain, Oswestry Disability index, SF-36 and Zur- ich Claudication Questionnaire were prospectively recorded before surgery and at 1, 3, 6, 12, and 18 months postoperatively. METHODS: Patients ranged from 50–70 years in age with no mitigating systemic diseases or osteopenia as demonstrated on dual X-ray absorpti- ometry. Patients with greater than 50% loss of height or more than 11-de- grees of motion on flexion-extension at L4-5 were excluded. Prior to instrumentation, a bilateral total facetectomy and laminectomy at L4-L5 levels was accomplished through a standard midline posterior approach. After decompression, the TOPS screws were inserted into the L4 and L5 pedicles to achieve maximal purchase via triangulating, bicortical trajecto- ries. An appropriately sized TOPS implant was then applied and secured in place. After completion of the arthroplasty procedure, standard closure with drain placement was performed. RESULTS: There were three intraoperative dural tears solved at the time of surgery. The mean surgical time was 160 min. All patients were mobi- lized early on after surgery. No postoperative infections occurred. Blood loss was less them 200 cc in each case. One patient shows segmental instability in L3-L4 due to much removal of superior L4 facet, All patients recovered uneventfully. On VAS, patients experienced a degree of post- operative pain similar to that of standard fusion patients and were dis- charged at an average of 2.5 days postop. VAS, SF-36, ODI, Zurich Clau- dication Questionnaire and Prolo scores improved post-operatively with all patients being overall satisfied with the procedure at early assessment. Flexion-extension films within our follow-up period demonstrated preser- vation of motion at L4-5, no evidence of screw loosening or device malfunction. CONCLUSIONS: The TOPS TFR system represents a dynamic, poste- rior arthroplasty device that provides multiaxial stability in flexion, ex- tension, rotation, and lateral bending after total facetectomy and neural decompression. Our surgical data demonstrates that it can be safely ap- plied through a traditional approach with low surgical morbidity and good functional and radiographic outcomes in patients with back pain and posterior disease. Additional long-term, randomized studies will be needed before conclusive statements can be made regarding the efficacy of the TOPS system. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs. doi: 10.1016/j.spinee.2010.07.228 185. Microsurgical Lumbar Laminoplasty: Bilateral Lumbar Microdecompression via Unilateral Laminotomy Amit K. Sharma, MD, Christopher K. Kepler, MD, Joon-Hyung Kim, BS, Russel C. Huang, MD; Hospital for Special Surgery, NY, New York, NY, USA BACKGROUND CONTEXT: Laminectomy is the standard procedure for lumbar spinal canal decompression. Microsurgical Lumbar Lamino- plasty (MLL) is a less disruptive technique for bilateral lumbar decompres- sion via a unilateral laminotomy. During MLL, the spinous process, supra-spinous ligaments, contralateral paraspinal muscles, and the majority of the lamina are preserved. The technique is intended to maximally pre- serve spinal stability whilst performing a complete decompression of the spinal canal and subarticular lateral recess. 85S Proceedings of the NASS 25th Annual Meeting / The Spine Journal 10 (2010) 1S–149S All referenced figures and tables will be available at the Annual Meeting and will be included with the post-meeting online content.

Facet Replacement: Three-Year Follow-up on a Multicenter Study

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85SProceedings of the NASS 25th Annual Meeting / The Spine Journal 10 (2010) 1S–149S

183. Cervical Arthroplasty in Elderly: Prospective 6-Year

Follow-up

Leonardo Oliveira, BSc1, Luis Marchi, MSc2, Etevaldo Coutinho, MD2,

Luiz Pimenta, MD, PhD2; 1Universidade Federal de Sao Paulo, Sao Paulo,

Brazil; 2Instituto de Patologia da Coluna, Sao Paulo, Brazil

BACKGROUND CONTEXT: Traditional treatment of cervical spon-

dylosis and cervical herniated disc disease with neurological compres-

sion is anterior spinal decompression followed by fusion. Total disc

replacement has been reported to restore motion in the cervical spine

decreasing adjacent level disease rate, but indicated for the young

population.

PURPOSE: The purpose of the present study is to evaluate the safety and

effectiveness of the PCM artificial disc in the elderly segment.

STUDY DESIGN/SETTING: Prospective non randomized clinical trial.

PATIENT SAMPLE: Series of 14 patients, mean age 65.4 y/o (Range 60 -

80) with a total of 24 prostheses.

OUTCOME MEASURES: The Neck Disability Index (NDI), Visual An-

alog Scale (VAS) and TIGT questionnaires were used to assess pain and

functional outcomes.

METHODS: The neural decompression was performed in standard Smith-

Robinson technique. Radiographic (AP, lateral and dynamics images) and

clinical outcomes were collected preoperatively and postoperatively after 1

week, 1, 3, 6 months and annually.

RESULTS: At 72 months follow-up, there were no deaths, no infections,

and no cases of iatrogenic neurologic progression. The mean VAS and

NDI improved in all periods when compared to preoperative follow-up.

One patient (4.2%) presented facet degeneration grade III in Pimenta’s

scale. Two prosthesis (8.3%) presented bone formation with no movement

of the disc, and other two patients presented bone formation with decreas-

ing of the range of motion, but with no worsening in their clinical

outcomes.

CONCLUSIONS: Following cervical arthroplasty with PCM prosthesis,

radiographic and clinical outcome measurements were encouraging when

compared to historical data of ACDF in elderly. Considering the aging

population, cervical disc arthroplasty is a good treatment option for degen-

erative disc disease and a viable alternative to fusion in the elderly segment

of the society.

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

any applicable devices or drugs.

doi: 10.1016/j.spinee.2010.07.227

184. Facet Replacement: Three-Year Follow-up on a Multicenter

Study

Leonardo Oliveira, BSc1, Luis Marchi, Msc2, Etevaldo Coutinho, MD2,

Luiz Pimenta, MD, PhD2; 1Universidade Federal de Sao Paulo, Sao Paulo,

Brazil; 2Instituto de Patologia da Coluna, Sao Paulo, Brazil

BACKGROUND CONTEXT: Fusion remains the gold standard by which

mechanical low back pain from degenerative disc disease is treated. How-

ever, arthrodesis can cause increased motion and stress in the segments ad-

jacent to a fusion by means of load transfer. Artificial mechanical total disc

replacement (TDR) has been successfully used as an alternate means of

treatment that can also restore the interbody geometry while preserving

segmental motion. Patients with significant spinal stenosis and facet ar-

thropathy, however, are often excluded from having TDR as increased seg-

mental motion can exacerbate dorsal spondylytic changes. For this large

population of patients for whom TDR is contraindicated, the TOPS system

offers a novel mechanism of total facet replacement (TFR) that allows for

excellent dynamic, multiaxial, 3-column stabilization after complete neu-

ral decompression via a standard posterior approach

PURPOSE: The purpose of this study is to report our surgical data and

clinical outcomes in patients treated with the TOPS Lumbar TFR system

All referenced figures and tables will be available at the Annual Mee

STUDY DESIGN/SETTING: Prospective, non-randomized, multicenter,

prospective pilot study that was approved by each individual local institu-

tional review board.

PATIENT SAMPLE: Twenty patients were enrolled with a primary sur-

gical indication of low back pain, neurological claudication, and/or radi-

culopathy resulting from spinal stenosis at L4-5 due to facet arthropathy

with no frank disc herniation and only a mild degree of degenerative disc

disease.

OUTCOME MEASURES: Radiographs and outcome measures such as

Visual Analogue Scale for pain, Oswestry Disability index, SF-36 and Zur-

ich Claudication Questionnaire were prospectively recorded before surgery

and at 1, 3, 6, 12, and 18 months postoperatively.

METHODS: Patients ranged from 50–70 years in age with no mitigating

systemic diseases or osteopenia as demonstrated on dual X-ray absorpti-

ometry. Patients with greater than 50% loss of height or more than 11-de-

grees of motion on flexion-extension at L4-5 were excluded. Prior to

instrumentation, a bilateral total facetectomy and laminectomy at L4-L5

levels was accomplished through a standard midline posterior approach.

After decompression, the TOPS screws were inserted into the L4 and L5

pedicles to achieve maximal purchase via triangulating, bicortical trajecto-

ries. An appropriately sized TOPS implant was then applied and secured in

place. After completion of the arthroplasty procedure, standard closure

with drain placement was performed.

RESULTS: There were three intraoperative dural tears solved at the time

of surgery. The mean surgical time was 160 min. All patients were mobi-

lized early on after surgery. No postoperative infections occurred. Blood

loss was less them 200 cc in each case. One patient shows segmental

instability in L3-L4 due to much removal of superior L4 facet, All patients

recovered uneventfully. On VAS, patients experienced a degree of post-

operative pain similar to that of standard fusion patients and were dis-

charged at an average of 2.5 days postop. VAS, SF-36, ODI, Zurich Clau-

dication Questionnaire and Prolo scores improved post-operatively with all

patients being overall satisfied with the procedure at early assessment.

Flexion-extension films within our follow-up period demonstrated preser-

vation of motion at L4-5, no evidence of screw loosening or device

malfunction.

CONCLUSIONS: The TOPS TFR system represents a dynamic, poste-

rior arthroplasty device that provides multiaxial stability in flexion, ex-

tension, rotation, and lateral bending after total facetectomy and neural

decompression. Our surgical data demonstrates that it can be safely ap-

plied through a traditional approach with low surgical morbidity and

good functional and radiographic outcomes in patients with back pain

and posterior disease. Additional long-term, randomized studies will be

needed before conclusive statements can be made regarding the efficacy

of the TOPS system.

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

any applicable devices or drugs.

doi: 10.1016/j.spinee.2010.07.228

185. Microsurgical Lumbar Laminoplasty: Bilateral Lumbar

Microdecompression via Unilateral Laminotomy

Amit K. Sharma, MD, Christopher K. Kepler, MD, Joon-Hyung Kim, BS,

Russel C. Huang, MD; Hospital for Special Surgery, NY, New York,

NY, USA

BACKGROUND CONTEXT: Laminectomy is the standard procedure

for lumbar spinal canal decompression. Microsurgical Lumbar Lamino-

plasty (MLL) is a less disruptive technique for bilateral lumbar decompres-

sion via a unilateral laminotomy. During MLL, the spinous process,

supra-spinous ligaments, contralateral paraspinal muscles, and the majority

of the lamina are preserved. The technique is intended to maximally pre-

serve spinal stability whilst performing a complete decompression of the

spinal canal and subarticular lateral recess.

ting and will be included with the post-meeting online content.