Measurement of Instability in Cervical Spine Disorders

颈椎疾病不稳定性的测量

• 批准号: 6791545
• 负责人: JOHN A HIPP
• 金额: $ 25.26万
• 依托单位: MEDICAL METRICS, INC.
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-04-01 至 2006-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6791545
• 关键词: actigraphy; biomechanics; body movement; clinical research; computer assisted diagnosis; computer program /software; data collection methodology /evaluation; diagnosis design /evaluation; human subject; image processing; intervertebral disk; musculoskeletal disorder diagnosis; patient care management; patient care planning; postoperative complications; radiography; spinal cord imaging /visualization; spine disorder; vertebrae

DESCRIPTION (provided by applicant): Characterization of the cervical spine as stable or unstable is frequently an important part of diagnosing and treating patients with cervical spine disorders. This characterization of the spine is particularly important in determining whether to treat the patient conservatively or with surgery, and for monitoring the success of the treatment. Over 800,000 flexion-extension x-rays are used each year to diagnose spine stability, despite the fact that numerous studies have shown substantial errors in the assessments made using these studies. Despite the accepted importance of spinal stability in many patients, there are no validated, reliable measurements of stability that clinicians can commonly use in their day-to-day practice. Software that provides quantitative measurements of cervical spine stability, which could be used in routine clinical practice, has been developed by the applicant company, independently validated, and approved by the FDA. During Phase I, a database describing normal motion was started, and data were collected that show that a much higher proportion of motion abnormalities in patients with cervical spine disorders. The data also suggest the focus of clinicians and researchers on intervertebral rotation may be ineffective, since other motion abnormalities are more common in patients. Although the basic technical development is largely completed, this innovative technology is not in widespread clinical practice. Proof of clinical efficacy is required before clinicians will adopt a new technology and before payors will routinely reimburse for its use. The specific aims of Phase II are to provide evidence that the measurements have clinical value and can be effectively delivered in routine clinical practice. These aims will be accomplished by collecting and analyzing cervical spine stability in 100 patients with specific cervical spine disorders. A trial implementation of the technology, delivered via a remote image processing laboratory, will also be completed and analyzed. Successful completion of these aims will yield data showing that quantitative measurements of intervertebral motion significantly improve inter- and intra-observer error, and that these measurements significantly change the treatments offered to patients. This would facilitate adoption of the new technology into routine clinical practice. A clinically efficacious method to quantify cervical spine stability could benefit hundreds of thousands of patients.

描述（由申请人提供）：将颈椎表征为稳定或不稳定，通常是诊断和治疗颈椎疾病患者的重要组成部分。脊柱的这种特征在确定是保守或手​​术治疗以及监测治疗成功的情况下尤其重要。尽管许多研究表明在使用这些研究进行的评估中表明，每年都使用超过800,000张屈伸X射线来诊断脊柱稳定性。尽管许多患者的脊柱稳定性公认的重要性，但临床医生通常可以在日常练习中使用经过验证，可靠的稳定性测量。申请人公司已开发了可用于常规临床实践的颈椎稳定性定量测量的软件，该软件已由FDA独立验证和批准。在第一阶段，启动了一个描述正常运动的数据库，并收集了数据，该数据表明，颈椎疾病患者的运动异常比例更高。数据还表明，临床医生和研究人员在椎间旋转方面的重点可能无效，因为其他运动异常在患者中更为常见。尽管基本的技术开发在很大程度上完成了，但这种创新技术并不是广泛的临床实践。在临床医生采用新技术之前，需要临床疗效证明，并且在付款人经常偿还其使用之前。第二阶段的具体目的是提供证据表明测量值具有临床价值，并且可以在常规临床实践中有效地提供。这些目标将通过收集和分析100例特定颈椎疾病患者的颈椎稳定性来实现。通过远程图像处理实验室提供的技术的试验实施也将完成和分析。这些目标的成功完成将产生数据表明椎间盘运动的定量测量可显着改善观察者内和观察者的错误，并且这些测量值显着改变了提供给患者的治疗方法。这将有助于将新技术采用常规临床实践。量化颈椎稳定性的临床有效方法可以使数十万患者受益。