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Diabetes and Glycosylation in Cervical Spondylosis

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ClinicalTrials.gov Identifier: NCT02758899
Recruitment Status : Unknown
Verified April 2016 by Wilson Z. Ray, Washington University School of Medicine.
Recruitment status was:  Recruiting
First Posted : May 3, 2016
Last Update Posted : May 3, 2016
Sponsor:
Information provided by (Responsible Party):
Wilson Z. Ray, Washington University School of Medicine

Brief Summary:

The purpose of this study is to determine the relevant significance of diabetes on cervical disc degeneration, and correlate diabetic control (HgbA1C) with disc glycosylation profile in patients undergoing anterior cervical discectomy and fusion for cervical spondylosis. Additionally, to compare the level of degenerative cervical disc glycosylation in patients with and without diabetes.

Hypothesis: Patients with diabetes and degenerative cervical disc disease have higher levels of disc tissue glycosylation, and higher levels of glycosylation are correlated with poor outcomes.


Condition or disease
Diabetes Cervical Myelopathy Cervical Spondylosis

Detailed Description:

Spine surgery has increased substantially in the U.S. during the past decade, with an estimated 100,000 patients undergoing cervical procedures annually. As the demographics of an aging population begin to increase their utilization of healthcare resources, surgeons will undoubtedly be faced with an increasing number of high-risk patients. A number of factors including smoking, obesity, and diabetes significantly contribute to surgical complications following spinal arthrodesis. Nicotine has a direct inhibitory effect on autologous cancellous bone graft revascularization, significantly increasing the rate of bony non-union. Similarly, obesity has been demonstrated to represent a significant risk factor for subsequent pseudoarthrosis and has been linked to nearly a 100% higher in-hospital complication rate. Spine instrumentation in the setting of diabetes has been linked to reduced incidence of bony fusion, increased surgical site infection9, and higher hospital costs.

Achieving solid bony fusion following cervical arthrodesis has long been considered the most important primary outcome measure and is highly correlated with patient reported outcome measures. Non-union or pseudoarthrosis following cervical instrumentation can lead to persistent neck pain and/or recurrence of myeloradiculopathy. The incidence of bony fusion is affected by both patient systemic factors and local biologic environment. Significant resources have been invested into studying local environment following spinal arthrodesis, with a particular focus on high-risk patients. Animal studies have suggested diabetes is a significant risk factor for disc degeneration, yet corresponding human studies are lacking. Understanding the mechanism by which diabetes contributes to disc degeneration is the first requisite step in designing therapies to prevent diabetes associated disc degeneration.


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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effects of Diabetes and Glycosylation Profile on Outcomes in the Surgical Treatment of Cervical Spondylosis
Study Start Date : March 2014
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : June 2018

Group/Cohort
Diabetic Patients
Patients with diagnosis of type I or type II diabetes, in addition to clinical diagnosis of cervical myelopathy or cervical spondylosis requiring anterior cervical discectomy and fusion.
Control Patients
Patients with no diagnosis of diabetes, with a clinical diagnosis of cervical myelopathy or cervical spondylosis requiring anterior cervical discectomy and fusion.



Primary Outcome Measures :
  1. Absolute disc glycosylation levels [ Time Frame: One-time, measured at time of surgery, compared to overall outcomes at 24months ]
    Instead of discarding the intervertebral disc material (as is the normal clinical practice), it will be collected and immediately sent in saline to the lab for glycosylation analysis and indentation mechanical testing.


Secondary Outcome Measures :
  1. Neck Disability Index (NDI) [ Time Frame: 24 months ]
    Questionnaire to determine how subject's neck pain has affected their ability to manage in everyday life.

  2. Rates of Fusion [ Time Frame: 24 months ]
    Rate of fusion will be assessed by flexion extension X-rays at routine follow-up, translation method (<2mm) and/or by computed tomography (CT) scan at 2 year post- operatively.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with a clinical diagnosis of cervical myelopathy or cervical spondylosis that require an anterior cervical discectomy and fusion.
Criteria

Inclusion Criteria:

  • Age 18-75
  • A diagnosis of type I or type II diabetes mellitus (diabetes cohort only)
  • Clinical diagnosis of cervical myelopathy or cervical spondylosis
  • Requiring anterior cervical discectomy and fusion
  • Able to cooperate in the completion of standardized outcome measures (NDI)
  • Willing and able to comply with study protocol
  • Control patients will fulfill all eligibility criteria with the exception of diagnosis of diabetes.

Exclusion Criteria:

  • Pre-existent neurologic disorder or mental disorder that would preclude accurate evaluation (psychiatric disease, Parkinson's disease, Alzheimer's disease)
  • History of previous anterior cervical fusion adjacent to the operative site
  • Osteoporosis
  • Rheumatoid arthritis
  • Pregnancy
  • Active malignancy
  • History of previous posterior cervical decompression

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): NCT02758899


Contacts
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Contact: Alaina Landstrom, BSN, RN 314-362-3114 landstroma@wudosis.wustl.edu

Locations
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United States, Missouri
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Contact: Alaina Landstrom, BSN, RN    314-362-3114    landstroma@wudosis.wustl.edu   
Principal Investigator: Wilson Z. Ray, MD         
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Wilson Z Ray, MD Washington University School of Medicine

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Responsible Party: Wilson Z. Ray, Assistant Professor, Neurosurgery, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02758899     History of Changes
Other Study ID Numbers: 201309048
First Posted: May 3, 2016    Key Record Dates
Last Update Posted: May 3, 2016
Last Verified: April 2016

Keywords provided by Wilson Z. Ray, Washington University School of Medicine:
Anterior cervical discectomy
Anterior cervical fusion

Additional relevant MeSH terms:
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Diabetes Mellitus
Spinal Cord Diseases
Spondylosis
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Central Nervous System Diseases
Nervous System Diseases
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases