Clinical trial NCT02758899: Diabetes and Glycosylation in Cervical Spondylosis
Official title: The Effects of Diabetes and Glycosylation Profile on Outcomes in the Surgical Treatment of Cervical Spondylosis
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Diabetes
Cervical Myelopathy
Cervical Spondylosis
Keywords: Anterior cervical discectomy
Anterior cervical fusion
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2016-05-03
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Absolute Disc Glycosylation Levels
timeFrame: One-time, measured at time of surgery
Secondary outcomes:
measure: Neck Disability Index (NDI)
timeFrame: 24 months
measure: Rates of Fusion
timeFrame: 24 months
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Wilson Z Ray, MD
role: PRINCIPAL_INVESTIGATOR
References: