Diabetes and Glycosylation in Cervical Spondylosis

Terminated

• Conditions: Cervical Spondylosis; Diabetes; Cervical Myelopathy

• Registration Number: NCT02758899
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2016-04-26
• Study First Submitted QC: 2016-04-27
• Study First Posted: 2016-05-03
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Results First Submitted: 2019-04-23
• Results First Submitted QC: 2020-08-03
• Results First Posted: 2020-08-18
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-08
• Last Update Posted: 2021-02-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 21

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.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Absolute Disc Glycosylation Levels	One-time, measured at time of surgery	After extraction during surgery, the intervertebral disc will be sent in saline to the lab for glycosylation analysis. Glycosylation refers to the chemical bonds of blood glucose to the red blood cells. Normally, only a small percentage of blood glucose, usually between 4.5%- 6%, is covalently linked to the red blood cells in hemoglobin of the non diabetes population.

Secondary Outcome Measures

Name	Time	Method
Neck Disability Index (NDI)	24 months	Questionnaire to determine how subject's neck pain has affected their ability to manage in everyday life. Scores are calculated. Low scores indicate less pain/less disability. High scores indicate more pain/more disability. Scores range from 0-100.
Rates of Fusion	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.

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States