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临床试验/NCT06845293
NCT06845293尚未招募不适用

AO CSH Mainstream Study on Cervical Spine Degeneration

AO Innovation Translation Center0 个研究点目标入组 300 人开始时间: 2025年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
300
主要终点
Form a large patient cohort

研究概览

简要总结

Adult patients with cervical degenerative diseases undergoing primary anterior and/or posterior cervical fusion will be prospectively enrolled from participating sites.

Patients will be treated and followed up at the participating sites per local standard of care. Several variables related to the patient characteristics and fusion details will be collected. The mainstream study will not collect follow-up (FU) data.

The duration of this patient cohort is currently planned as open ended.

详细描述

Degeneration of the cervical spine is common and encompasses a wide range of pathologies including spondylosis, central canal and neuroforaminal stenosis, facet arthropathy, and ligamentous hypertrophy. Prevalence of MRI cervical degenerative increases with age. Degenerative changes of cervical intervertebral disc from C2 to C7, including loss of signal intensity, posterior and anterior disc protrusion, narrowing of the disc space, and foraminal stenosis, in 497 asymptomatic subjects using MRI; rates of degenerative changes were 17% in males and 12% in females in their 20s and 86% and 89% in males and females in their 60s, respectively. Ten years later, 223 of the 497 subjects were assessed again (FU rate: 44.9%), and the authors reported an overall rate of degenerative changes of 81%, and 34% of subjects developed clinical symptoms. In a 20-year FU of 193 of the 497 subjects (FU rate: 38.8%), the authors found that degenerative changes have progressed in 95% of the subjects, and gross structural failures like anterior compression of the dura/spinal cord and posterior disc protrusion started in half of the subjects in their 30s, gradually worsened with age, and were detected in > 80% of subjects ≥ 40 years of age.

Degeneration of the cervical spine develops over the time due to structural load, repetitive microtrauma, and age-related changes to the spinal axis. The process typically starts with the intervertebral disc physiology resulting in a loss of the supportive nature of the discs and osteophyte formation, which give rise to spinal canal stenosis and chronic compression of the spinal cord. The structural changes may also lead to hypermobility or spondylolisthesis, which, if unstable, will cause dynamic injuries and repetitive microtrauma to the neural elements. C5-C6 is the most affected level owing to its high mobility and increased weight load.

Patients with cervical degeneration may present with a spectrum of symptoms ranging from generalized neck pain, mechanical or axial neck pain, to debilitating neurologic symptoms such as radiculopathy and myelopathy. Degenerative cervical myelopathy is most worrisome presentation and is the most common nontraumatic spinal cord injury with a wide range of symptoms such as hand numbness and paresthesia, gait impairment, motor weakness of the upper and lower extremities, and bladder and bowel dysfunction. Annual incidence of cervical radiculopathy and myelopathy has been estimated as approximately 83 cases per 100,000 persons and 4 per 100,000 persons.

State of the art of the research field Various treatment algorithms have been proposed to manage cervical degeneration Nonsurgical care including analgesics, chronic pain management physical therapy, supervised exercise and manual therapy, acupuncture, and epidural glucocorticoid injections can provide sufficient relief of chronic neck pain and/or radiculopathy. Surgical treatments are indicated especially in the cases of progressive or significant neurologic symptoms and myelopathy. In the past decades, there is an increase of surgical treatments for cervical degenerative radiculopathy or myelopathy as a result of increased availability of MRI diagnostics, an ageing population, advances in surgical techniques, and easier access to specialist healthcare services.

Surgical approaches for treating cervical degenerative radiculopathy or myelopathy include anterior, posterior, and anteroposterior techniques. The goals of the surgery are to adequately decompress the nerve root or spinal cord and stabilize the spinal column while restoring or maintaining relatively normal spinal alignment. ACDF is a recognized and effective surgical treatment for cervical degenerative disease. In a randomized controlled trial of patients with single-level cervical radiculopathy, ACDF plus physiotherapy showed significant improvement in neck disability, demonstrated by a mean reduction of Neck Disability Index score of 21% (95% confidence interval [CI]: 14 - 28%) after 5 to 8 years, compared with 11% (95% CI: 4 - 18%) in the physiotherapy alone group (p = 0.03). Research is ongoing to identify factors predictive of a good or bad outcome of ACDF and techniques to improve the surgical outcomes.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age 18 years and older
  • •Undergoing primary surgical treatment for cervical degenerative disease
  • •Ability to provide informed consent according to the IRB/EC defined and approved procedures

排除标准

  • •Age under 18 years
  • •Patients with spinal infection
  • •Patients with spinal tumor
  • •Patients with acute spinal injuries/trauma within 1 year

结局指标

主要结局

Form a large patient cohort

时间窗: Baseline

The primary objective is to form a large prospective multicenter patient cohort with standardized data collection of key patient and treatment characteristics that will drive hypothesis generation in patients with cervical degenerative diseases.

次要结局

未报告次要终点

研究者

发起方
AO Innovation Translation Center
申办方类型
Other
责任方
Sponsor

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