Treatment of Type II Odontoid Fractures Among the Elderly
2017年8月9日 更新者：AOSpine North America Research Network
Comparing Surgical to Conservative Management in the Treatment of Type II Odontoid Fractures Among the Elderly
The purpose of this study is to compare the safety and effectiveness of surgical versus conservative management of type II odontoid fractures among patients > 64 years of age.
Of secondary interest is to determine if there are differences in outcomes between anterior screw fixation and posterior fusion of these fractures.
研究概览
详细说明
Hypotheses are as follows:
- Patients receiving surgical management will exhibit better disease specific health and general health related quality of life measures compared to those managed conservatively.
- The rate of radiographic bony fusion will be greater among elderly patients receiving surgical fixation compared to patients receiving conservative management.
- The rate of non union will be greater in the conservative group compared to the surgical group.
- The complication rate will be higher in the surgical group due to the nature of the intervention though the rate of severe and serious complications will be low.
研究类型
观察性的
注册 (实际的)
159
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
-
-
Ontario
-
Toronto、Ontario、加拿大、M5T 258
- Toronto Western Hospital
-
-
-
-
Georgia
-
Atlanta、Georgia、美国、30329
- Emory University SOM: Orthopedics
-
-
Indiana
-
Indianapolis、Indiana、美国、46260
- Indiana Spine Group
-
-
Kansas
-
Kansas City、Kansas、美国、66160
- Kansas University Medical Center
-
-
Maryland
-
Baltimore、Maryland、美国、21287
- John Hopkins University
-
-
Massachusetts
-
Boston、Massachusetts、美国、02115
- Brigham and Women's Hospital
-
-
Minnesota
-
Rochester、Minnesota、美国、55905
- Mayo Clinic
-
-
New York
-
New York、New York、美国、10021
- Cornell Weill Medical College
-
-
Ohio
-
Cleveland、Ohio、美国
- Cleveland Clinic
-
-
Pennsylvania
-
Philadelphia、Pennsylvania、美国、19107
- Spinal Cord Injury Center Thomas Jefferson University and The Rothman Institute
-
-
Tennessee
-
Nashville、Tennessee、美国、37232
- Vanderbilt University
-
-
Utah
-
Salt Lake City、Utah、美国、84108
- University of Utah
-
-
Virginia
-
Charlottesville、Virginia、美国、22908
- University of Virginia
-
-
Washington
-
Seattle、Washington、美国、98104
- Harborview Medical Center
-
-
West Virginia
-
Morgantown、West Virginia、美国、26506
- West Virginia University
-
-
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
64年 及以上 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Subjects receiving care for acute Type II Odontoid Fracture in participating investigational sites
描述
Inclusion Criteria:
- All new type II odontoid fractures including those in which the fracture line crosses into the body of C2
- Age > 64
- Stable and unstable fractures
- < 3 months post-injury
- No previous treatment for an odontoid fracture
Exclusion Criteria:
- Pathological fractures unrelated to osteoporosis
- Severe dementia or severe mental health problems
- Participation in other trials or unlikely to attend follow-ups
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
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Surgical
Subjects receiving surgical treatment for Type II odontoid fracture per discretion of investigator (non-randomized allocation)
|
surgical treatment of odontoid fractures
|
|
Non-surgical
Subjects treated with non-operative treatment options
|
conservative stabilization of fractures
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Compare disease-specific health-related quality of life between the surgically and conservatively managed patients using the neck disability index
大体时间：12 months
|
12 months
|
|
Compare the proportion of patients with radiographic bony fusion between the surgically and conservatively managed patients
大体时间：12 months
|
12 months
|
|
Compare the rate of non-union between the surgically and conservatively managed patients
大体时间：12 months
|
12 months
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Compare the rate of complications
大体时间：12 months
|
12 months
|
|
Compare the cervical range of motion between patients receiving anterior screw fixation, posterior fusion, and conservative management
大体时间：12 months
|
12 months
|
|
Identify risk factors for a poor outcome, independent of treatment intervention
大体时间：12 months
|
12 months
|
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。
调查人员
- 首席研究员：Alexander R Vaccaro, MD、Thomas Jefferson University and The Rothman Institute
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Smith HE, Kerr SM, Maltenfort M, Chaudhry S, Norton R, Albert TJ, Harrop J, Hilibrand AS, Anderson DG, Kopjar B, Brodke DS, Wang JC, Fehlings MG, Chapman JR, Patel A, Arnold PM, Vaccaro AR. Early complications of surgical versus conservative treatment of isolated type II odontoid fractures in octogenarians: a retrospective cohort study. J Spinal Disord Tech. 2008 Dec;21(8):535-9. doi: 10.1097/BSD.0b013e318163570b.
- Smith HE, Vaccaro AR, Maltenfort M, Albert TJ, Hilibrand AS, Anderson DG, Harrop J, Fehlings MG, Kopjar B, Brodke DS, Arnold PM, Shaffrey CI. Trends in surgical management for type II odontoid fracture: 20 years of experience at a regional spinal cord injury center. Orthopedics. 2008 Jul;31(7):650.
- Vaccaro AR, Kepler CK, Kopjar B, Chapman J, Shaffrey C, Arnold P, Gokaslan Z, Brodke D, France J, Dekutoski M, Sasso R, Yoon ST, Bono C, Harrop J, Fehlings MG. Functional and quality-of-life outcomes in geriatric patients with type-II dens fracture. J Bone Joint Surg Am. 2013 Apr 17;95(8):729-35. doi: 10.2106/JBJS.K.01636.
- Fehlings MG, Arun R, Vaccaro AR, Arnold PM, Chapman JR, Kopjar B. Predictors of treatment outcomes in geriatric patients with odontoid fractures: AOSpine North America multi-centre prospective GOF study. Spine (Phila Pa 1976). 2013 May 15;38(11):881-6. doi: 10.1097/BRS.0b013e31828314ee.
- Chapman J, Smith JS, Kopjar B, Vaccaro AR, Arnold P, Shaffrey CI, Fehlings MG. The AOSpine North America Geriatric Odontoid Fracture Mortality Study: a retrospective review of mortality outcomes for operative versus nonoperative treatment of 322 patients with long-term follow-up. Spine (Phila Pa 1976). 2013 Jun 1;38(13):1098-104. doi: 10.1097/BRS.0b013e318286f0cf.
- Smith HE, Kerr SM, Fehlings MG, Chapman J, Maltenfort M, Zavlasky J, Harris E, Albert TJ, Harrop J, Hilibrand AS, Anderson DG, Vaccaro AR. Trends in epidemiology and management of type II odontoid fractures: 20-year experience at a model system spine injury tertiary referral center. J Spinal Disord Tech. 2010 Dec;23(8):501-5. doi: 10.1097/BSD.0b013e3181cc43c7.
- Smith JS, Kepler CK, Kopjar B, Harrop JS, Arnold P, Chapman JR, Fehlings MG, Vaccaro AR, Shaffrey CI. Effect of type II odontoid fracture nonunion on outcome among elderly patients treated without surgery: based on the AOSpine North America geriatric odontoid fracture study. Spine (Phila Pa 1976). 2013 Dec 15;38(26):2240-6. doi: 10.1097/BRS.0000000000000009.
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
2005年12月1日
初级完成 (实际的)
2010年5月1日
研究完成 (实际的)
2010年5月1日
研究注册日期
首次提交
2005年12月19日
首先提交符合 QC 标准的
2005年12月19日
首次发布 (估计)
2005年12月20日
研究记录更新
最后更新发布 (实际的)
2017年8月11日
上次提交的符合 QC 标准的更新
2017年8月9日
最后验证
2017年8月1日
更多信息
与本研究相关的术语
其他研究编号
- 07-GOF-05
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
surgical的临床试验
-
Corporacion Parc TauliDepartment of Health, Generalitat de Catalunya; Fundació Parc Taulí完全的