THA Kinematics and Sound for Subjects Implanted Using Various Surgical Approaches (THA)
2019年10月8日 更新者：Richard Komistek、The University of Tennessee, Knoxville
In Vivo Determination of THA Kinematics and Sound for Subject Implanted Using Various Surgical Approaches
In a previous study conducted within the Center for Musculoskeletal Research (CMR) on Total Hip Arthroplasties (THA), it was determined that the investigators could simultaneously capture in vivo sound and motion of the femoral head within the acetabular cup during weight-bearing activities for subjects implanted with either a metal-on-polyethylene (MOP), metal-on-metal (MOM) or ceramic-on-ceramic (COC) THA.
This was the first study to apply sound analysis as an impulse excitation technique for testing hip conditions and for measuring femoral head sliding in the acetabular component of human hip joints by acoustic means.
Unfortunately, no studies have been conducted to compare the in vivo kinematics and sound for subjects implanted using various surgical approaches.
It could be hypothesized that subjects having various surgical approaches could lead to an increase or reduction of in vivo hip separation.
Therefore, the objective of this study is to analyze a total of 30 subjects implanted with either an anterior (10 patients), anterior-lateral (10 patients), or posterior-lateral (10 patients) surgical approach to determine if any of these surgical approaches leads to less or more in vivo hip separation.
All subjects will be analyzed under in vivo weight-bearing conditions using video fluoroscopy to determine in vivo motion.
研究概览
研究类型
观察性的
注册 (实际的)
30
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。
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
40年 至 85年 (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 implanted with a direct-anterior surgical approach will be provided by Dr. William Barrett of Valley Orthopedic Associates in Renton, WA.
Patients implanted with an anterior-lateral surgical approach will be provided by Dr. of Steven J. MacDonald of the London Health Sciences Center, London, Ontario.
Patients implanted with a posterior-lateral approach will be provided by Dr. David F. Dalury of Towson Orthopaedic Associates, Inc. in Towson, MD.
描述
Inclusion Criteria:
- Post-operative clinical evaluation judged successful using Harris Hip Scoring (HHS) system (HHS>90)
- Body weight less than 270 lbs
- No evidence of post-operative hip subluxation or dislocation
- Do not walk with detectable limp
- Be able to actively abduct their operated hip against gravity without difficulty
- Must be willing to sign Informed Consent and Health Insurance Portability and Accountability (HIPAA) forms
Exclusion Criteria:
- Pregnant, lactating or females not using reliable form of birth control
- Patients that do not meet study requirements
- Patients unwilling to sign Informed Consent or HIPAA forms
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 |
|---|---|
|
THA using direct-anterior surgical approach
Patients will have undergone THA using a direct-anterior surgical approach and will undergo fluoroscopy surveillance while walking.
|
While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking.
其他名称：
|
|
THA using anterior-lateral approach
Patients will have undergone THA using an anterior-lateral surgical approach and will undergo fluoroscopy surveillance while walking.
|
While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking.
其他名称：
|
|
THA using posterior-lateral approach
Patients will have undergone THA using a posterior-lateral surgical approach and will undergo fluoroscopy surveillance while walking.
|
While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking.
其他名称：
|
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 |
|---|---|---|
|
Kinematics - Swing Phase Separation
大体时间：6 months post-operatively
|
Determine amount of in vivo swing phase hip separation present within implanted hip during weight-bearing level walking while under fluoroscopic surveillance.
|
6 months post-operatively
|
|
Kinematics - Stance Phase Separation
大体时间：6 months post-operative
|
Determine amount of stance phase hip separation present in vivo of implanted hip during level walking activity under fluoroscopic surveillance.
|
6 months post-operative
|
|
Kinematics - Overall Separation
大体时间：6 months post-operative
|
Determine overall hip separation present in vivo in implanted hip during level walking activity under fluoroscopic surveillance
|
6 months post-operative
|
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：Adrija Sharma, Ph D、The University of Tennessee
- 首席研究员：Richard D Komistek, Ph D、The University of Tennessee
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
2013年6月1日
初级完成 (实际的)
2014年9月1日
研究完成 (实际的)
2014年9月1日
研究注册日期
首次提交
2013年4月11日
首先提交符合 QC 标准的
2013年4月16日
首次发布 (估计)
2013年4月17日
研究记录更新
最后更新发布 (实际的)
2019年10月10日
上次提交的符合 QC 标准的更新
2019年10月8日
最后验证
2019年10月1日
更多信息
与本研究相关的术语
其他研究编号
- 12009
- R01 1373 452 (其他标识符：University of Tennessee)
- 13-0372 (其他标识符：University of Tennessee)
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