Spinal Infection Management With Structural Allograft

November 15, 2019 updated by: Carlos A Acosta-Olivo, Universidad Autonoma de Nuevo Leon

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico, 66460
        • Universidad Autonoma de Nuevo Leon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • pyogenic spinal infection with bone destruction and spinal deformity, without previous treatment of any kind and Informed Consent signature

Exclusion Criteria:

  • immunodeficiency, psychiatric disorders, patients with severe malnutrition, morbid obesity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bone allograft group
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.
Device: Bone allograft
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.
Active Comparator: Bone auto and allograft group
This participants will receive bone structural allograft plus spongy autograft management for vertebral reconstruction. All patients undergo surgical procedure.
Device: Bone auto and allograft group
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone consolidation
Time Frame: Twelve months
Radiography or CT scan will demonstrate bone graft consolidation
Twelve months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain scale
Time Frame: Three months
Visual Analogue Scale minimum 0 value = no pain; maximum 10 value= unsupportable pain
Three months
Oswestry Scale
Time Frame: Three months
Oswestry Lumbar Pain Disability Scale
Three months
Degree of spinal deformity
Time Frame: Three months
Radiographic measurement of Cobbs angle
Three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Autonoma de Nuevo Leon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 14, 2015

Primary Completion (Actual)

November 15, 2019

Study Completion (Actual)

November 15, 2019

Study Registration Dates

First Submitted

August 24, 2017

First Submitted That Met QC Criteria

August 25, 2017

First Posted (Actual)

August 29, 2017

Study Record Updates

Last Update Posted (Actual)

November 18, 2019

Last Update Submitted That Met QC Criteria

November 15, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OR15-005

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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