Diabetes and Glycosylation in Cervical Spondylosis
关键词
抽象
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.
日期
最后验证: | 03/31/2016 |
首次提交: | 04/25/2016 |
提交的预估入学人数: | 04/26/2016 |
首次发布: | 05/02/2016 |
上次提交的更新: | 04/26/2016 |
最近更新发布: | 05/02/2016 |
实际学习开始日期: | 02/28/2014 |
预计主要完成日期: | 05/31/2016 |
预计完成日期: | 05/31/2018 |
状况或疾病
相
手臂组
臂 | 干预/治疗 |
---|---|
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. |
资格标准
有资格学习的年龄 | 18 Years 至 18 Years |
有资格学习的性别 | All |
取样方式 | Non-Probability Sample |
接受健康志愿者 | 是 |
标准 | 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 |
结果
主要结果指标
1. Absolute disc glycosylation levels [One-time, measured at time of surgery, compared to overall outcomes at 24months]
次要成果指标
1. Neck Disability Index (NDI) [24 months]
2. Rates of Fusion [24 months]