<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03265561</url>
  </required_header>
  <id_info>
    <org_study_id>OR15-005</org_study_id>
    <nct_id>NCT03265561</nct_id>
  </id_info>
  <brief_title>Spinal Infection Management With Structural Allograft</brief_title>
  <official_title>Spinal Infection Management With Structural Allograft</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad Autonoma de Nuevo Leon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad Autonoma de Nuevo Leon</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background. Bone infections can involve the vertebral column, intervertebral disc space,&#xD;
      spinal canal and soft tissues, can generate neurological deficit in addition to the&#xD;
      destruction of the bone that causes functional disability. Vertebral osteomyelitis is the&#xD;
      most frequent, affecting 2 to 7 patients per 100,000 habitants. Management is bone&#xD;
      debridement and bone reconstruction.&#xD;
&#xD;
      Objective. Demonstrate that the use of bone allograft is a functional method to stabilize the&#xD;
      spine after a bone spinal infection Material and methods. Patients with vertebral bone&#xD;
      destruction are included in two groups. Bone allograft group will receive bone structural&#xD;
      allograft; Auto and allograft group will receive bone structural allograft plus autograft.&#xD;
      The bone reconstruction will be performed in a one-time surgical procedure. Bone&#xD;
      consolidation, pain, functionality, and spine deformity will be evaluated.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Spinal bone infections can involve the bone vertebra, intervertebral disc space, spinal canal&#xD;
      and soft tissues. It generate neurological deficit in addition to the destruction of the bone&#xD;
      that causes functional disability and significant pain (Colmenero 1997). Spinal infections&#xD;
      include discitis, osteomyelitis, epidural abscesses, meningitis, subdural empyema, and&#xD;
      abscesses of the spinal cord (An, 2006). Only discitis and osteomyelitis can occur together&#xD;
      (Skaf, 2010). Vertebral osteomyelitis is the most frequent, affecting 2 to 7 patients per&#xD;
      100,000 habitants (Bhavan, 2010; Grammatico 2003).&#xD;
&#xD;
      Pathogenic organisms reach the column by hematogenous pathway, arterial pathways (Batson's&#xD;
      plexus) or by direct inoculation, due to a diagnostic or therapeutic intervention (Skaf,&#xD;
      2010). The natural history of pyogenic vertebral infections involves an infectious source or&#xD;
      an incident followed by a period of intense pain, with or without generalized significant&#xD;
      sepsis. Neurological deficit is caused by: [1] direct extension of the infection in the form&#xD;
      of an abscess or bacterial communication with the spinal canal to the neural elements or [2]&#xD;
      secondary compression of a pathological fracture as a result of bone softening. (Campbell´s,&#xD;
      2013).&#xD;
&#xD;
      Early diagnosis and treatment are essential for optimal outcomes (Weisz, 2000). The treatment&#xD;
      goals may include eradicating the infection, relieving pain, preserving or restoring&#xD;
      neurologic function, improving nutrition, and maintaining spinal stability (Tay, 2002). The&#xD;
      aim of this study is to demonstrate that the use of bone allograft is a functional method to&#xD;
      stabilize the spine after a bone spinal infection.&#xD;
&#xD;
      METHODS This study was approved by our Institutional Ethics and Research Committee. Patients&#xD;
      with vertebral bone destruction are randomized included in two groups. Inclusion criteria:&#xD;
      patients older than 18 years, any gender, pyogenic spinal infection with bone destruction and&#xD;
      kyphotic deformity, without previous treatment of any kind, and Informed Consent signature.&#xD;
      Exclusion criteria: patients with immunodeficiency, psychiatric disorders, patients with&#xD;
      severe malnutrition, morbid obesity. Elimination criteria: failure to comply with follow-up&#xD;
      time, patient's express request to leave the study. The bone reconstruction will be performed&#xD;
      in a one-step surgical procedure. All participants will undergo the same surgical procedure&#xD;
      consisting of open surgery, more debridement of infected and devitalized tissue, as well as&#xD;
      corresponding bone resection. For the identification of the microorganism, biopsies will be&#xD;
      performed guided by computed tomography (CT scan) and/or by fluoroscopy. A culture and&#xD;
      antibiogram will be performed in case of not obtaining enough material for this, at the time&#xD;
      of the surgery samples will be sent to perform the same procedure. The investigators will use&#xD;
      the appropriate antibiotics, according to infecting microorganism and result of antibiogram,&#xD;
      and patients with infections with gram positive and negative microorganisms only will be&#xD;
      included. Bone consolidation, pain, functionality, and spinal deformity will be evaluated.&#xD;
&#xD;
      The investigators will perform evaluations at 8, 12, 16, 20 and 24 weeks, and a CT scan will&#xD;
      be realized, to evaluated the bone consolidation, defined as the presence of continuous&#xD;
      trabeculae between the bone graft and the vertebra, according to the next classification&#xD;
      system. Type 1 definitive fusion; Type 2 uncertain fusion; Type 3 definitive pseudoarthrosis.&#xD;
&#xD;
      Statistical analysis. The results will be reported in contingency tables, frequencies,&#xD;
      percentages, measures of central tendency and dispersion. Qualitative variables will be&#xD;
      analyzed with the chi-square statistic and quantitative variables with t-test for independent&#xD;
      samples with a significance level of 95% with their respective confidence intervals, or with&#xD;
      non-parametric statistics if necessary. Using a formula for hypothesis testing and difference&#xD;
      of two proportions or with the proportion of a reference value, with a value zα of 1.94 with&#xD;
      a level of significance of 95% for a queue, and a value zβ of 1.20 with a power of 80 %, With&#xD;
      a proportion for group 1 of 0.38 and for group 2 of 0.83 (Zdeblick, Ducker) a sample of 19&#xD;
      participants was obtained per group. Statistical analysis will be performed with IBM SPSS&#xD;
      version 20 (SPSS, Inc., Armon, NY).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 14, 2015</start_date>
  <completion_date type="Actual">November 15, 2019</completion_date>
  <primary_completion_date type="Actual">November 15, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Bone allograft group will receive bone structural allograft; Auto and allograft group will receive bone structural allograft plus spongy autograft.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Bone consolidation</measure>
    <time_frame>Twelve months</time_frame>
    <description>Radiography or CT scan will demonstrate bone graft consolidation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain scale</measure>
    <time_frame>Three months</time_frame>
    <description>Visual Analogue Scale minimum 0 value = no pain; maximum 10 value= unsupportable pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oswestry Scale</measure>
    <time_frame>Three months</time_frame>
    <description>Oswestry Lumbar Pain Disability Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Degree of spinal deformity</measure>
    <time_frame>Three months</time_frame>
    <description>Radiographic measurement of Cobbs angle</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">38</enrollment>
  <condition>Bone Diseases, Infectious</condition>
  <condition>Disease of Bone</condition>
  <condition>Syndrome</condition>
  <condition>Spine Infection</condition>
  <condition>Allografts</condition>
  <condition>Bone Graft; Complications, Fracture</condition>
  <arm_group>
    <arm_group_label>Bone allograft group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This participants will receive bone structural allograft management for vertebral reconstruction. All patients undergo surgical procedure to realize debridement of the lesion, and the application of allograft without autograft.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bone auto and allograft group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This participants will receive bone structural allograft plus spongy autograft management for vertebral reconstruction. All patients undergo surgical procedure.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Bone allograft</intervention_name>
    <description>All patients will undergo the same surgical procedure consisting of open surgery, more debridement of infected and devitalized tissue, as well as corresponding bone resection. For the identification of the microorganism, biopsies will be performed by puncture guided by CAT and / or fluoroscopy, and culture and antibiogram will be performed in case of not obtaining enough material for this, at the time of the surgery samples will be sent to perform the same procedure. We will use the appropriate antibiotics, according to infecting microorganism and result of antibiogram. We will include patients with infections with gram positive and negative microorganisms only. This patients will go stabilized with bone allograft only.</description>
    <arm_group_label>Bone allograft group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Bone auto and allograft group</intervention_name>
    <description>All patients will undergo the same surgical procedure consisting of open surgery, more debridement of infected and devitalized tissue, as well as corresponding bone resection. For the identification of the microorganism, biopsies will be performed by puncture guided by CAT and / or fluoroscopy, and culture and antibiogram will be performed in case of not obtaining enough material for this, at the time of the surgery samples will be sent to perform the same procedure. We will use the appropriate antibiotics, according to infecting microorganism and result of antibiogram. We will include patients with infections with gram positive and negative microorganisms only. This patients will go stabilized with bone autograft plus bone allograft</description>
    <arm_group_label>Bone auto and allograft group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  pyogenic spinal infection with bone destruction and spinal deformity, without previous&#xD;
             treatment of any kind and Informed Consent signature&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  immunodeficiency, psychiatric disorders, patients with severe malnutrition, morbid&#xD;
             obesity&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carlos Acosta-Olivo, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidad Autonoma de Nuevo Leon</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Universidad Autonoma de Nuevo Leon</name>
      <address>
        <city>Monterrey</city>
        <state>Nuevo Leon</state>
        <zip>66460</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
  <reference>
    <citation>Colmenero JD, Jimenez-Mejias ME, Sanchez-Lora FJ, Reguera JM, Palomino-Nicas J, Martos F, Garcia de las Heras J, Pachon J. Pyogenic, tuberculous, and brucellar vertebral osteomyelitis: a descriptive and comparative study of 219 cases. Ann Rheum Dis. 1997 Dec;56(12):709-15. doi: 10.1136/ard.56.12.709.</citation>
    <PMID>9496149</PMID>
  </reference>
  <reference>
    <citation>An HS, Seldomridge JA. Spinal infections: diagnostic tests and imaging studies. Clin Orthop Relat Res. 2006 Mar;444:27-33. doi: 10.1097/01.blo.0000203452.36522.97.</citation>
    <PMID>16523124</PMID>
  </reference>
  <reference>
    <citation>Skaf GS, Domloj NT, Fehlings MG, Bouclaous CH, Sabbagh AS, Kanafani ZA, Kanj SS. Pyogenic spondylodiscitis: an overview. J Infect Public Health. 2010;3(1):5-16. doi: 10.1016/j.jiph.2010.01.001. Epub 2010 Feb 19.</citation>
    <PMID>20701886</PMID>
  </reference>
  <reference>
    <citation>Bhavan KP, Marschall J, Olsen MA, Fraser VJ, Wright NM, Warren DK. The epidemiology of hematogenous vertebral osteomyelitis: a cohort study in a tertiary care hospital. BMC Infect Dis. 2010 Jun 7;10:158. doi: 10.1186/1471-2334-10-158.</citation>
    <PMID>20529294</PMID>
  </reference>
  <reference>
    <citation>Grammatico L, Baron S, Rusch E, Lepage B, Surer N, Desenclos JC, Besnier JM. Epidemiology of vertebral osteomyelitis (VO) in France: analysis of hospital-discharge data 2002-2003. Epidemiol Infect. 2008 May;136(5):653-60. doi: 10.1017/S0950268807008850. Epub 2007 Jun 14.</citation>
    <PMID>17568478</PMID>
  </reference>
  <reference>
    <citation>Govender S. Spinal infections. J Bone Joint Surg Br. 2005 Nov;87(11):1454-8. doi: 10.1302/0301-620X.87B11.16294. No abstract available.</citation>
    <PMID>16260656</PMID>
  </reference>
  <reference>
    <citation>Reihsaus E, Waldbaur H, Seeling W. Spinal epidural abscess: a meta-analysis of 915 patients. Neurosurg Rev. 2000 Dec;23(4):175-204; discussion 205. doi: 10.1007/pl00011954.</citation>
    <PMID>11153548</PMID>
  </reference>
  <reference>
    <citation>Tay BK, Deckey J, Hu SS. Spinal infections. J Am Acad Orthop Surg. 2002 May-Jun;10(3):188-97. doi: 10.5435/00124635-200205000-00005.</citation>
    <PMID>12041940</PMID>
  </reference>
  <reference>
    <citation>Weisz RD, Errico TJ. Spinal infections. Diagnosis and treatment. Bull Hosp Jt Dis. 2000;59(1):40-6.</citation>
    <PMID>10789037</PMID>
  </reference>
  <reference>
    <citation>Mann S, Schutze M, Sola S, Piek J. Nonspecific pyogenic spondylodiscitis: clinical manifestations, surgical treatment, and outcome in 24 patients. Neurosurg Focus. 2004 Dec 15;17(6):E3. doi: 10.3171/foc.2004.17.6.3.</citation>
    <PMID>15636573</PMID>
  </reference>
  <reference>
    <citation>Sapico FL, Montgomerie JZ. Vertebral osteomyelitis. Infect Dis Clin North Am. 1990 Sep;4(3):539-50.</citation>
    <PMID>2212605</PMID>
  </reference>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>August 24, 2017</study_first_submitted>
  <study_first_submitted_qc>August 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>November 15, 2019</last_update_submitted>
  <last_update_submitted_qc>November 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad Autonoma de Nuevo Leon</investigator_affiliation>
    <investigator_full_name>Carlos A Acosta-Olivo</investigator_full_name>
    <investigator_title>Prinicipal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Bone Diseases, Infectious</mesh_term>
    <mesh_term>Bone Diseases</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03265561
org study id: OR15-005
nct id: NCT03265561
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Background. Bone infections can involve the vertebral column, intervertebral disc space,
      spinal canal and soft tissues, can generate neurological deficit in addition to the
      destruction of the bone that causes functional disability. Vertebral osteomyelitis is the
      most frequent, affecting 2 to 7 patients per 100,000 habitants. Management is bone
      debridement and bone reconstruction.

      Objective. Demonstrate that the use of bone allograft is a functional method to stabilize the
      spine after a bone spinal infection Material and methods. Patients with vertebral bone
      destruction are included in two groups. Bone allograft group will receive bone structural
      allograft; Auto and allograft group will receive bone structural allograft plus autograft.
      The bone reconstruction will be performed in a one-time surgical procedure. Bone
      consolidation, pain, functionality, and spine deformity will be evaluated.
Spinal bone infections can involve the bone vertebra, intervertebral disc space, spinal canal
      and soft tissues. It generate neurological deficit in addition to the destruction of the bone
      that causes functional disability and significant pain (Colmenero 1997). Spinal infections
      include discitis, osteomyelitis, epidural abscesses, meningitis, subdural empyema, and
      abscesses of the spinal cord (An, 2006). Only discitis and osteomyelitis can occur together
      (Skaf, 2010). Vertebral osteomyelitis is the most frequent, affecting 2 to 7 patients per
      100,000 habitants (Bhavan, 2010; Grammatico 2003).

      Pathogenic organisms reach the column by hematogenous pathway, arterial pathways (Batson's
      plexus) or by direct inoculation, due to a diagnostic or therapeutic intervention (Skaf,
      2010). The natural history of pyogenic vertebral infections involves an infectious source or
      an incident followed by a period of intense pain, with or without generalized significant
      sepsis. Neurological deficit is caused by: [1] direct extension of the infection in the form
      of an abscess or bacterial communication with the spinal canal to the neural elements or [2]
      secondary compression of a pathological fracture as a result of bone softening. (Campbell´s,
      2013).

      Early diagnosis and treatment are essential for optimal outcomes (Weisz, 2000). The treatment
      goals may include eradicating the infection, relieving pain, preserving or restoring
      neurologic function, improving nutrition, and maintaining spinal stability (Tay, 2002). The
      aim of this study is to demonstrate that the use of bone allograft is a functional method to
      stabilize the spine after a bone spinal infection.

      METHODS This study was approved by our Institutional Ethics and Research Committee. Patients
      with vertebral bone destruction are randomized included in two groups. Inclusion criteria:
      patients older than 18 years, any gender, pyogenic spinal infection with bone destruction and
      kyphotic deformity, without previous treatment of any kind, and Informed Consent signature.
      Exclusion criteria: patients with immunodeficiency, psychiatric disorders, patients with
      severe malnutrition, morbid obesity. Elimination criteria: failure to comply with follow-up
      time, patient's express request to leave the study. The bone reconstruction will be performed
      in a one-step surgical procedure. All participants will undergo the same surgical procedure
      consisting of open surgery, more debridement of infected and devitalized tissue, as well as
      corresponding bone resection. For the identification of the microorganism, biopsies will be
      performed guided by computed tomography (CT scan) and/or by fluoroscopy. A culture and
      antibiogram will be performed in case of not obtaining enough material for this, at the time
      of the surgery samples will be sent to perform the same procedure. The investigators will use
      the appropriate antibiotics, according to infecting microorganism and result of antibiogram,
      and patients with infections with gram positive and negative microorganisms only will be
      included. Bone consolidation, pain, functionality, and spinal deformity will be evaluated.

      The investigators will perform evaluations at 8, 12, 16, 20 and 24 weeks, and a CT scan will
      be realized, to evaluated the bone consolidation, defined as the presence of continuous
      trabeculae between the bone graft and the vertebra, according to the next classification
      system. Type 1 definitive fusion; Type 2 uncertain fusion; Type 3 definitive pseudoarthrosis.

      Statistical analysis. The results will be reported in contingency tables, frequencies,
      percentages, measures of central tendency and dispersion. Qualitative variables will be
      analyzed with the chi-square statistic and quantitative variables with t-test for independent
      samples with a significance level of 95% with their respective confidence intervals, or with
      non-parametric statistics if necessary. Using a formula for hypothesis testing and difference
      of two proportions or with the proportion of a reference value, with a value zα of 1.94 with
      a level of significance of 95% for a queue, and a value zβ of 1.20 with a power of 80 %, With
      a proportion for group 1 of 0.38 and for group 2 of 0.83 (Zdeblick, Ducker) a sample of 19
      participants was obtained per group. Statistical analysis will be performed with IBM SPSS
      version 20 (SPSS, Inc., Armon, NY).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Bone allograft group will receive bone structural allograft; Auto and allograft group will receive bone structural allograft plus spongy autograft.
primary purpose: Treatment
masking: None (Open Label)
measure: Bone consolidation
time frame: Twelve months
description: Radiography or CT scan will demonstrate bone graft consolidation
measure: Pain scale
time frame: Three months
description: Visual Analogue Scale minimum 0 value = no pain; maximum 10 value= unsupportable pain
measure: Oswestry Scale
time frame: Three months
description: Oswestry Lumbar Pain Disability Scale
measure: Degree of spinal deformity
time frame: Three months
description: Radiographic measurement of Cobbs angle
arm group label: Bone allograft group
arm group type: Experimental
description: This participants will receive bone structural allograft management for vertebral reconstruction. All patients undergo surgical procedure to realize debridement of the lesion, and the application of allograft without autograft.
arm group label: Bone auto and allograft group
arm group type: Active Comparator
description: This participants will receive bone structural allograft plus spongy autograft management for vertebral reconstruction. All patients undergo surgical procedure.
intervention type: Device
intervention name: Bone allograft
description: All patients will undergo the same surgical procedure consisting of open surgery, more debridement of infected and devitalized tissue, as well as corresponding bone resection. For the identification of the microorganism, biopsies will be performed by puncture guided by CAT and / or fluoroscopy, and culture and antibiogram will be performed in case of not obtaining enough material for this, at the time of the surgery samples will be sent to perform the same procedure. We will use the appropriate antibiotics, according to infecting microorganism and result of antibiogram. We will include patients with infections with gram positive and negative microorganisms only. This patients will go stabilized with bone allograft only.
arm group label: Bone allograft group
intervention type: Device
intervention name: Bone auto and allograft group
description: All patients will undergo the same surgical procedure consisting of open surgery, more debridement of infected and devitalized tissue, as well as corresponding bone resection. For the identification of the microorganism, biopsies will be performed by puncture guided by CAT and / or fluoroscopy, and culture and antibiogram will be performed in case of not obtaining enough material for this, at the time of the surgery samples will be sent to perform the same procedure. We will use the appropriate antibiotics, according to infecting microorganism and result of antibiogram. We will include patients with infections with gram positive and negative microorganisms only. This patients will go stabilized with bone autograft plus bone allograft
arm group label: Bone auto and allograft group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Carlos Acosta-Olivo, PhD
role: Principal Investigator
affiliation: Universidad Autonoma de Nuevo Leon
facility: 
country: Mexico
citation: Colmenero JD, Jimenez-Mejias ME, Sanchez-Lora FJ, Reguera JM, Palomino-Nicas J, Martos F, Garcia de las Heras J, Pachon J. Pyogenic, tuberculous, and brucellar vertebral osteomyelitis: a descriptive and comparative study of 219 cases. Ann Rheum Dis. 1997 Dec;56(12):709-15. doi: 10.1136/ard.56.12.709.
PMID: 9496149
citation: An HS, Seldomridge JA. Spinal infections: diagnostic tests and imaging studies. Clin Orthop Relat Res. 2006 Mar;444:27-33. doi: 10.1097/01.blo.0000203452.36522.97.
PMID: 16523124
citation: Skaf GS, Domloj NT, Fehlings MG, Bouclaous CH, Sabbagh AS, Kanafani ZA, Kanj SS. Pyogenic spondylodiscitis: an overview. J Infect Public Health. 2010;3(1):5-16. doi: 10.1016/j.jiph.2010.01.001. Epub 2010 Feb 19.
PMID: 20701886
citation: Bhavan KP, Marschall J, Olsen MA, Fraser VJ, Wright NM, Warren DK. The epidemiology of hematogenous vertebral osteomyelitis: a cohort study in a tertiary care hospital. BMC Infect Dis. 2010 Jun 7;10:158. doi: 10.1186/1471-2334-10-158.
PMID: 20529294
citation: Grammatico L, Baron S, Rusch E, Lepage B, Surer N, Desenclos JC, Besnier JM. Epidemiology of vertebral osteomyelitis (VO) in France: analysis of hospital-discharge data 2002-2003. Epidemiol Infect. 2008 May;136(5):653-60. doi: 10.1017/S0950268807008850. Epub 2007 Jun 14.
PMID: 17568478
citation: Govender S. Spinal infections. J Bone Joint Surg Br. 2005 Nov;87(11):1454-8. doi: 10.1302/0301-620X.87B11.16294. No abstract available.
PMID: 16260656
citation: Reihsaus E, Waldbaur H, Seeling W. Spinal epidural abscess: a meta-analysis of 915 patients. Neurosurg Rev. 2000 Dec;23(4):175-204; discussion 205. doi: 10.1007/pl00011954.
PMID: 11153548
citation: Tay BK, Deckey J, Hu SS. Spinal infections. J Am Acad Orthop Surg. 2002 May-Jun;10(3):188-97. doi: 10.5435/00124635-200205000-00005.
PMID: 12041940
citation: Weisz RD, Errico TJ. Spinal infections. Diagnosis and treatment. Bull Hosp Jt Dis. 2000;59(1):40-6.
PMID: 10789037
citation: Mann S, Schutze M, Sola S, Piek J. Nonspecific pyogenic spondylodiscitis: clinical manifestations, surgical treatment, and outcome in 24 patients. Neurosurg Focus. 2004 Dec 15;17(6):E3. doi: 10.3171/foc.2004.17.6.3.
PMID: 15636573
citation: Sapico FL, Montgomerie JZ. Vertebral osteomyelitis. Infect Dis Clin North Am. 1990 Sep;4(3):539-50.
PMID: 2212605
responsible party type: Principal Investigator
investigator affiliation: Universidad Autonoma de Nuevo Leon
investigator full name: Carlos A Acosta-Olivo
investigator title: Prinicipal Investigator
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Bone Diseases, Infectious
mesh term: Bone Diseases