P39. A synthetic absorbable anterior tension band improves interbody spine fusion outcome in an in...
1
Proceedings of the NASS 20th Annual Meeting / The Spine Journal 5 (2005) 1S–189S 128S central portion of the vertebral body, exposing the central vascular foramen. Microdissection techniques were then used to harvest the basivertebral nerves and associated vessels from within the basivertebral foramen. The tissue was fixed with glutaraldehyde, dehydrated, embedded and sectioned. Grids were stained with uranyl acetate and lead citrate. RESULTS: All of the specimens contained abundant nerve tissue. The nerves were noted to have both myelinated and non-myelinated axons. There was a preponderance of small, non-myelinated fibers. CONCLUSIONS: The innervation of bone has recently been proven to be important in the regulation of bone metabolism and bone density. A role for these nerves in nocioception has also been suggested. Vasoregulation is another likely function. The Electron microscopic structure of these nerves is consistent such multiple functions. The authors are not aware of any previous electron microscopic description of human vertebral intraos- seous nerves. The preponderance of small non-myelinated axons is con- sistent with the possibility that these nerves may play a role in some forms of clinical back and neck pain. A better understanding of these nerves may lead to new clinical treatment options for back pain and osteoporosis. DISCLOSURES: No disclosures. CONFLICT OF INTEREST: No conflicts. doi: 10.1016/j.spinee.2005.05.253 P39. A synthetic absorbable anterior tension band improves interbody spine fusion outcome in an in vivo caprine animal model Bryan Cunningham, MSC 1 , Michael Slivka, MSC 2 , Nianbin Hu, MD 1 , Hassan Serhan, PhD 2 ; 1 Union Memorial Hospital, Baltimore, MD, USA; 2 DePuy Spine, Raynham, MA, USA BACKGROUND CONTEXT: Current trends in spine fusion are moving towards minimally invasive techniques, which include smaller incisions, lower profile devices and temporary (bioabsorbable) materials to minimize clinical problems such as swallowing difficulties, imaging artifacts and revision complications. PURPOSE: This study evaluates the in vivo use of a low profile, bioabsorb- able, anterior tension band device for augmenting anterior cervical and lumbar interbody fusion. STUDY DESIGN/SETTING: Seven skeletally mature female crossbred goats were used as the animal model in this study. PATIENT SAMPLE: Treatments were applied in a random fashion but required that both treatments be applied in each region of each animal. OUTCOME MEASURES: Fusion was assessed using radiographic, bio- mechanical and histological techniques. Plain films were obtained following animal sacrifice. Biomechanical flexibility was measured in flexion/exten- sion (4Nm), lateral bending (4Nm), and torsion (4Nm). The spines were then processed using undecalcified techniques. For each treatment, one mid-sagittal histological section was evaluated for bridging bone and trabecular bone density was quantified using image analysis. Statistical comparisons of quantitative data were made using Student’s t test at a p value of 0.05. METHODS: Using the Smith-Robinson approach, each animal had surgical implantation procedures in two cervical (C3–C4 and C5–C6) and two lumbar (L2–L3 and L4–L5) motion segments. Two treatments were studied in each region, tricortical iliac crest autograft alone or with an absorbable tension band. The synthetic, absorbable tension band consisted of a braided fabric strap with radial expansion anchors attached at each end. All animals were sacrificed at four months. RESULTS: In the cervical spine, radiographic assessment showed that 5/ 7 fused with augmentation versus 0/7 in the control group. There was a strong trend towards reduced motion in the augmented cervical spine levels for all motions tested, but did not reach statistical significance. Histological analysis confirmed 2/7 fused with augmentation versus 0/7 in the control group. There was a trend of higher mean trabecular bone formation in the augmented group (15.2%) versus control levels (10.7%), but did not reach statistical significance. For the lumbar treatments, radiographic assessment showed that 3/7 fused with augmentation versus 1/7 in the control group. Range-of-motion results were not statistically different. Mean trabecular bone area percentage was not statistically different comparing augmented (22.3%) versus control levels (24.2%). CONCLUSIONS: Previous studies have shown that augmentation of cervi- cal interbody fusion in the very similar caprine and ovine models using plates, interference screws, and a non-absorbable tension band were able to provide a modest improvement to the fusion outcome. With a lower rigidity, lower profile augmentation, we were able to show a superior im- provement in fusion outcome compared with the previous studies. In the lumbar spine treatments, there was less of an improvement with augmen- tation, potentially due to the less rigorous mechanical environment. DISCLOSURES: FDA device/drug: Absorbable anterior tension band. Status: Not approved for this indication. CONFLICT OF INTEREST: Author (BC) Consultant: DePuy Spine; Authors (BC, HS, MS) Stockholder: Johnson & Johnson, parent company for DePuy Spine; Authors (BC, NH) Other: Author was paid to perform study by DePuy Spine.; Authors (MS, HS) Other: Author is an employee of DePuy Spine. doi: 10.1016/j.spinee.2005.05.254 P40. Examining the utility of preexisting hospital records as a data source for a quality of care study of lumbar surgeries Richard L. Skolasky, MA 1 , Zubin Daruwalla 2 , David Cohen, MD, MPH 1 , Khaled Kebaish, MD 1 , Ziya Gokaslan, MD, FACS 2 , Donlin Long 1 , Lee Riley, III, MD 1 ; 1 Johns Hopkins University, Baltimore, MD, USA; 2 Baltimore, MD, USA BACKGROUND CONTEXT: Developing and implementing a valid system for assessing quality of care is a prerequisite for the efficient opera- tion of a health care system. Many of the measures currently used to assess quality have proven inadequate because they measure only a limited dimension of quality, rely heavily on administrative data, or fail to have scientific rationale. PURPOSE: To determine whether pre-existing hospital records of thoraco- lumbar cases could serve as the primary data source for a quality of care study. STUDY DESIGN/SETTING: A retrospective study was conducted to examine pre-existing hospital records of thoraco-lumbar surgery cases. PATIENT SAMPLE: During the twelve months from March 2003 through February 2004, fifteen cases were chosen from each surgeon. These 75 cases were predominantly White (84.0%) and late middle age (median age 59.9 years, IQR: 47.4, 72.1, range: 30–87). The group was evenly distributed with respect to gender (46.7% male). There were no differences on these factors across the five surgeons. OUTCOME MEASURES: The primary outcome for the study was the inter- and intra-rater reliability of the standard data collection form as applied to hospital records of individuals presenting for lumbar spine surgi- cal care. The secondary outcome for the study was the amount of data that could be collected from existing hospital records using a standard data collection form. METHODS: Thoraco-lumbar surgery cases were identified from the op- erating room billing records from five surgeons (three orthopedists and two neurosurgeons specializing in spine surgery) between March 2003 and February 2004 inclusive. A total of 15 cases were chosen from each surgeon distributed evenly throughout the twelve month period of observation. Hospital records were abstracted independently by two observers using a standard data collection tool. The data collection tool was based on the NASS recommendations and medical literature. Inter-rater and intra-rater reliability were assessed using intra-class correlation (ICC) based on the availability of information and key aspects of hospital care. Descriptive in- formation on the participating surgeons and the hospital encounters (patient and procedure information) were collected to inform further research. RESULTS: A total of 75 cases were selected from five surgeons. Existing hospital records were available on 74/75 (98.7%) cases. The use of a standard data collection tool allowed for reliable abstraction of hospital
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Transcript of P39. A synthetic absorbable anterior tension band improves interbody spine fusion outcome in an in...
Proceedings of the NASS 20th Annual Meeting / The Spine Journal 5 (2005) 1S–189S128S
central portion of the vertebral body, exposing the central vascular foramen.Microdissection techniques were then used to harvest the basivertebralnerves and associated vessels from within the basivertebral foramen. Thetissue was fixed with glutaraldehyde, dehydrated, embedded and sectioned.Grids were stained with uranyl acetate and lead citrate.RESULTS: All of the specimens contained abundant nerve tissue. Thenerves were noted to have both myelinated and non-myelinated axons.There was a preponderance of small, non-myelinated fibers.CONCLUSIONS: The innervation of bone has recently been proven tobe important in the regulation of bone metabolism and bone density. A rolefor these nerves in nocioception has also been suggested. Vasoregulationis another likely function. The Electron microscopic structure of thesenerves is consistent such multiple functions. The authors are not aware ofany previous electron microscopic description of human vertebral intraos-seous nerves. The preponderance of small non-myelinated axons is con-sistent with the possibility that these nerves may play a role in some formsof clinical back and neck pain. A better understanding of these nerves maylead to new clinical treatment options for back pain and osteoporosis.DISCLOSURES: No disclosures.CONFLICT OF INTEREST: No conflicts.
doi: 10.1016/j.spinee.2005.05.253
P40. Examining the utility of preexisting hospital records as a datasource for a quality of care study of lumbar surgeriesRichard L. Skolasky, MA1, Zubin Daruwalla2, David Cohen, MD, MPH1,Khaled Kebaish, MD1, Ziya Gokaslan, MD, FACS2, Donlin Long1,Lee Riley, III, MD1; 1Johns Hopkins University, Baltimore, MD, USA;2Baltimore, MD, USA
BACKGROUND CONTEXT: Developing and implementing a validsystem for assessing quality of care is a prerequisite for the efficient opera-tion of a health care system. Many of the measures currently used toassess quality have proven inadequate because they measure only a limiteddimension of quality, rely heavily on administrative data, or fail to havescientific rationale.PURPOSE: To determine whether pre-existing hospital records of thoraco-lumbar cases could serve as the primary data source for a quality of carestudy.STUDY DESIGN/SETTING: A retrospective study was conducted toexamine pre-existing hospital records of thoraco-lumbar surgery cases.PATIENT SAMPLE: During the twelve months from March 2003 throughFebruary 2004, fifteen cases were chosen from each surgeon. These 75cases were predominantly White (84.0%) and late middle age (median age59.9 years, IQR: 47.4, 72.1, range: 30–87). The group was evenly distributedwith respect to gender (46.7% male). There were no differences on thesefactors across the five surgeons.OUTCOME MEASURES: The primary outcome for the study was theinter- and intra-rater reliability of the standard data collection form asapplied to hospital records of individuals presenting for lumbar spine surgi-cal care. The secondary outcome for the study was the amount of datathat could be collected from existing hospital records using a standarddata collection form.METHODS: Thoraco-lumbar surgery cases were identified from the op-erating room billing records from five surgeons (three orthopedists and twoneurosurgeons specializing in spine surgery) between March 2003 andFebruary 2004 inclusive. A total of 15 cases were chosen from each surgeondistributed evenly throughout the twelve month period of observation.Hospital records were abstracted independently by two observers using astandard data collection tool. The data collection tool was based on theNASS recommendations and medical literature. Inter-rater and intra-raterreliability were assessed using intra-class correlation (ICC) based on theavailability of information and key aspects of hospital care. Descriptive in-formation on the participating surgeons and the hospital encounters (patientand procedure information) were collected to inform further research.RESULTS: A total of 75 cases were selected from five surgeons. Existinghospital records were available on 74/75 (98.7%) cases. The use of astandard data collection tool allowed for reliable abstraction of hospital
P39. A synthetic absorbable anterior tension band improvesinterbody spine fusion outcome in an in vivo caprine animal modelBryan Cunningham, MSC1, Michael Slivka, MSC2, Nianbin Hu, MD1,Hassan Serhan, PhD2; 1Union Memorial Hospital, Baltimore, MD,USA; 2DePuy Spine, Raynham, MA, USA
BACKGROUND CONTEXT: Current trends in spine fusion are movingtowards minimally invasive techniques, which include smaller incisions,lower profile devices and temporary (bioabsorbable) materials to minimizeclinical problems such as swallowing difficulties, imaging artifacts andrevision complications.PURPOSE: This study evaluates the in vivo use of a low profile, bioabsorb-able, anterior tension band device for augmenting anterior cervical andlumbar interbody fusion.STUDY DESIGN/SETTING: Seven skeletally mature female crossbredgoats were used as the animal model in this study.PATIENT SAMPLE: Treatments were applied in a random fashion butrequired that both treatments be applied in each region of each animal.OUTCOME MEASURES: Fusion was assessed using radiographic, bio-mechanical and histological techniques. Plain films were obtained followinganimal sacrifice. Biomechanical flexibility was measured in flexion/exten-sion (�4Nm), lateral bending (�4Nm), and torsion (�4Nm). The spineswere then processed using undecalcified techniques. For each treatment,one mid-sagittal histological section was evaluated for bridging bone andtrabecular bone density was quantified using image analysis. Statisticalcomparisons of quantitative data were made using Student’s t test at a pvalue of 0.05.METHODS: Using the Smith-Robinson approach, each animal had surgicalimplantation procedures in two cervical (C3–C4 and C5–C6) and twolumbar (L2–L3 and L4–L5) motion segments. Two treatments were studiedin each region, tricortical iliac crest autograft alone or with an absorbabletension band. The synthetic, absorbable tension band consisted of a braidedfabric strap with radial expansion anchors attached at each end. All animalswere sacrificed at four months.RESULTS: In the cervical spine, radiographic assessment showed that 5/7 fused with augmentation versus 0/7 in the control group. There was astrong trend towards reduced motion in the augmented cervical spine levelsfor all motions tested, but did not reach statistical significance. Histologicalanalysis confirmed 2/7 fused with augmentation versus 0/7 in the controlgroup. There was a trend of higher mean trabecular bone formation in theaugmented group (15.2%) versus control levels (10.7%), but did not reachstatistical significance. For the lumbar treatments, radiographic assessmentshowed that 3/7 fused with augmentation versus 1/7 in the control group.
Range-of-motion results were not statistically different. Mean trabecularbone area percentage was not statistically different comparing augmented(22.3%) versus control levels (24.2%).CONCLUSIONS: Previous studies have shown that augmentation of cervi-cal interbody fusion in the very similar caprine and ovine models usingplates, interference screws, and a non-absorbable tension band were ableto provide a modest improvement to the fusion outcome. With a lowerrigidity, lower profile augmentation, we were able to show a superior im-provement in fusion outcome compared with the previous studies. In thelumbar spine treatments, there was less of an improvement with augmen-tation, potentially due to the less rigorous mechanical environment.DISCLOSURES: FDA device/drug: Absorbable anterior tension band.Status: Not approved for this indication.CONFLICT OF INTEREST: Author (BC) Consultant: DePuy Spine;Authors (BC, HS, MS) Stockholder: Johnson & Johnson, parent companyfor DePuy Spine; Authors (BC, NH) Other: Author was paid to performstudy by DePuy Spine.; Authors (MS, HS) Other: Author is an employeeof DePuy Spine.
doi: 10.1016/j.spinee.2005.05.254
