Spinal Infection Management With Structural Allograft
Condition: Bone Diseases, Infectious; Disease of Bone; Syndrome; Spine Infection; Allografts; Bone Graft; Complications, Fracture
MeSH terms: Infections; Communicable Diseases; Bone Diseases, Infectious; Bone Diseases
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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).
    

Intervention name(s): Bone allograft; Bone auto and allograft group
Intervention type(s): Device; Device
Intervention description(s): 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.; 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
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.
Masking: None (Open Label)
Primary purpose: Treatment