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Spinal Infection Management With Structural Allograft

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ClinicalTrials.gov Identifier: NCT03265561
Recruitment Status : Recruiting
First Posted : August 29, 2017
Last Update Posted : August 29, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.


Condition or disease Intervention/treatment
Bone Diseases, Infectious Disease of Bone Syndrome Spine Infection Allografts Bone Graft; Complications, Fracture Device: Bone allograft Device: Bone auto and allograft group

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
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
Official Title: Spinal Infection Management With Structural Allograft
Actual Study Start Date : May 14, 2015
Estimated Primary Completion Date : April 4, 2019
Estimated Study Completion Date : August 4, 2019
Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Bone consolidation [ Time Frame: Twelve months ]
    Radiography or CT scan will demonstrate bone graft consolidation


Secondary Outcome Measures :
  1. Pain scale [ Time Frame: Three months ]
    Visual Analogue Scale minimum 0 value = no pain; maximum 10 value= unsupportable pain

  2. Oswestry Scale [ Time Frame: Three months ]
    Oswestry Lumbar Pain Disability Scale

  3. Degree of spinal deformity [ Time Frame: Three months ]
    Radiographic measurement of Cobbs angle


Eligibility Criteria

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03265561


Contacts
Contact: Carlos Acosta-Olivo, PhD dr.carlosacosta@gmail.com
Contact: Yadira Tamez-Mata, MD dra.yadiratamez@gmail.com

Locations
Mexico
Universidad Autonoma de Nuevo Leon Recruiting
Monterrey, Nuevo Leon, Mexico, 66460
Contact: Carlos Acosta-Olivo, PhD       dr.carlosacosta@gmail.com   
Contact: Yadira Tamez-Mata, MD       dra.yadiratamez@gmail.com   
Sponsors and Collaborators
Universidad Autonoma de Nuevo Leon
Investigators
Principal Investigator: Carlos Acosta-Olivo, PhD Universidad Autonoma de Nuevo Leon
More Information

Publications:

Responsible Party: Carlos A Acosta-Olivo, Prinicipal Investigator, Universidad Autonoma de Nuevo Leon
ClinicalTrials.gov Identifier: NCT03265561     History of Changes
Other Study ID Numbers: OR15-005
First Posted: August 29, 2017    Key Record Dates
Last Update Posted: August 29, 2017
Last Verified: August 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Infection
Communicable Diseases
Bone Diseases
Bone Diseases, Infectious
Musculoskeletal Diseases