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PRESTIGE Observational Study

2016年1月26日更新者：Medtronic Spinal and Biologics

Prestige artificial disc replacement is an alternative treatment option with 16 years of experience addressing the unmet needs of surgical fusion interventions. Previous studies on the PRESTIGE® cervical disc have proven the safety and effectiveness of artificial disc surgery with level I evidence.

The PRESTIGE Observational Study is intended to collect prospectively observational data primarily on the Quality of Life (QoL).

研究概览

地位

完全的

条件

退行性颈椎间盘疾病

详细说明

Degenerative cervical disc disease is associated with a very high burden to the patient and the society. If conservative treatment options fail, surgical interventions are the last treatment option.

Symptomatic disc degeneration leads to neck pain, which can radiate to the scapula and arm, with dumbness and tingling, and sometimes grasping and walking difficulties. At an advanced stage, muscle weakness can be observed in the nerve territory.

The quality of life and functionality of patients with therapy-resistant (conservatively treated) severe degeneration of the disc is greatly impaired, as they suffer from intense pain and thus disability. Patients of working age were significantly more impacted by their symptoms than older patients. They are no longer able to fully participate in everyday activities.

Cervical neck pain resulting from degenerative disc disease is associated with a major economic burden for payers.

Traditional cervical surgical decompressions and fusions are currently the most common treatment option. Despite good treatment success rates, fusions are associated with a negative impact on the normal kinematics of the spine, long recuperation times and long absence from work. Prestige artificial disc replacement is an alternative treatment option.

The PRESTIGE Observational Study is intended to collect information on Quality of Life (QoL) prior and after PRESTIGE® Cervical Disc surgery; data on pain prior of participation to the study, drug regiment and X-ray evaluation throughout the course of the study will be obtained. In addition adverse events and economic data will be documented.

研究类型

观察性的

注册 (实际的)

194

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

匈牙利
- - Budapest、匈牙利
    - National Center for Spinal Disorders
  - Budapest、匈牙利、1126
    - National Center for Spinal Disorders
塞尔维亚
- - Belgrade、塞尔维亚、11000
    - Neurosurgical Clinic KCS
  - Belgrade、塞尔维亚
    - Neurosurgical Clinic KCS
  - Nis、塞尔维亚、18000
    - Clinical Center Nis Neurosurgical Clinic
  - Niš、塞尔维亚
    - Clinical Center Nis
  - Novi Sad、塞尔维亚
    - Clinical Center of Vojvodina
  - Novi Sad、塞尔维亚、21000
    - Clinical Center of Vojvodina Neurosurgical Clinic
希腊
- - Athens、希腊
    - Agia Olga Hospital
捷克共和国
- - Plzen、捷克共和国、32318
    - Hospital Plzen - Lochotin
  - Plzen、捷克共和国
    - Hospital Plzen - Lochotin
  - Prague、捷克共和国
    - University Clinic Motol
斯洛伐克
- - Nové Zamky、斯洛伐克
    - NsP Nové Zámky Hospital
沙特阿拉伯
- - Jeddah、沙特阿拉伯
    - King Faisal Specialist Hospital & Research Center
波兰
- - Konstancin、波兰、05-510
    - Centrum Ksztalcenia I Rehabilitcji
  - Konstancin、波兰
    - Centrum Ksztalcenia I Rehabilitcji
  - Konstancin、波兰
    - Centrum Rehabilitacji im.prof. M.Weissa "STOCER"
  - Konstancin-Jeziorna、波兰、05-510
    - Centrum Rehabilitacji im.prof.M.Weissa "STOCER"
  - Opole、波兰、45-418
    - State Hospital- Wojewodzkie Centrum
  - Szczecin、波兰、70-891
    - Specialist Hospital Prof. Alfreda Sokolowskiego
  - Szczecin、波兰
    - Specialist Hospital Prof. Alfreda Sokolowskiego
  - Zakopane、波兰、34-500
    - Orthopaedic University Hospital in Zakopane
  - Zakopane、波兰
    - Orthopaedic University Hospital in Zakopane
  - Zielona Gora、波兰、65-046
    - State Hospital- Szpital Wojewodzki
科威特
- - Kuwait、科威特
    - Al-Salam International Hospital
  - Kuwait City、科威特
    - Al-Salam International Hospital
  - Kuwait City、科威特
    - Razi Hospital for Orthopedic Surgery

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Patients with degenerative disc disease (DDD) who are scheduled to receive a cervical arthroplasty.

描述

Inclusion Criteria:

Patient must be willing to sign a Patient Data Release Form.
Patient with degenerative disc disease (DDD) who is scheduled to receive a PRESTIGE® Cervical Disc and fulfills the indications according to the product description.

Exclusion Criteria:

Patient fulfills any contraindication according to the product description.
Patient has not reached the age of legal consent according to local laws.
Patient has diabetes.
Patient has Body Mass Index (BMI) > 35.
Patient has affected disc not between C3/C4 and C6/C7.
Patient with instability of cervical spine.
Patients who will receive extensive decompression.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
EQ-5D 大体时间：2 years	The primary objective is the documentation of QoL before and after cervical disc surgery using the PRESTIGE® Cervical Disc System. The QoL will be determined using the EQ-5D questionnaire and the Neck Disability Index (NDI). EQ-5D is an instrument for measuring health outcome and consists of five dimensions: mobility, selfcare, usual activities, pain/discomfort, and anxiety/depression and a Visual Analog Scale that can be used as a quantitative measure of health as judged by the patient. Each dimension has 3 levels (no problems = 1, some problems = 2, and extreme problems = 3). The EQ-5D index has an upper limit of 1 that indicates full health (indicated by "no problem" in all domains), whereas 0 represents death. Scores worst than 0 are possible, implying that some health states may be worse than death.	2 years
Neck Disability Index (NDI) Score 大体时间：2 years	The primary objective is the documentation of QoL before and after cervical disc surgery using the PRESTIGE® Cervical Disc System. The QoL will be determined using the EQ-5D questionnaire and the Neck Disability Index (NDI). The NDI is a self-reported questionnaire designed to provide information on how neck pain affects the patient's ability to manage in everyday life. It contains questions on 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation. NDI results can be presented as a raw score or as a percent. When presenting it as a raw score, each section is scored on a 0 to 5 rating scale and the result is summarized to a total score with a maximum score of 50. This raw score can also be doubled and expressed as a percentage. Zero points or 0% means no activity limitations and 50 points or 100% means complete activity limitation.	2 years

次要结果测量

结果测量	措施说明	大体时间
Duration of Pain Prior to Enrollment 大体时间：Baseline visit	Documentation of duration of pain prior to enrollment	Baseline visit
Intervertebral Disc Space 大体时间：2 years		2 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Medtronic Spinal and Biologics

调查人员

首席研究员：Jan Štulik, MUDr、University Clinic Motol

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2008年4月1日

初级完成 (实际的)

2013年11月1日

研究完成 (实际的)

2013年11月1日

研究注册日期

首次提交

2009年4月1日

首先提交符合 QC 标准的

2009年4月2日

首次发布 (估计)

2009年4月3日

研究记录更新

最后更新发布 (估计)

2016年1月28日

上次提交的符合 QC 标准的更新

2016年1月26日

最后验证

2016年1月1日