Diabetes and Glycosylation in Cervical Spondylosis

NCT ID: NCT02758899

Last Updated: 2021-02-10

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 21 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2016-08-31

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.

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.

Conditions

Diabetes; Cervical Myelopathy; Cervical Spondylosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

Control Patients

Patients with no diagnosis of diabetes, with a clinical diagnosis of cervical myelopathy or cervical spondylosis requiring anterior cervical discectomy and fusion.

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wilson Z Ray, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University School of Medicine

St Louis, Missouri, United States

Countries

United States

Other Identifiers

201309048

Identifier Type: -

Identifier Source: org_study_id