跳至主要内容
临床试验/NCT02758899
NCT02758899终止不适用

The Effects of Diabetes and Glycosylation Profile on Outcomes in the Surgical Treatment of Cervical Spondylosis

Washington University School of Medicine1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2014年3月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
21
试验地点
1
主要终点
Absolute Disc Glycosylation Levels

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

结局指标

主要结局

Absolute Disc Glycosylation Levels

时间窗: 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.

次要结局

  • Neck Disability Index (NDI)(24 months)
  • Rates of Fusion(24 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验