跳至主要内容
临床试验/NCT01833481
NCT01833481已完成不适用

In Vivo Determination of THA Kinematics and Sound for Subject Implanted Using Various Surgical Approaches

The University of Tennessee, Knoxville3 个研究点 分布在 2 个国家目标入组 30 人开始时间: 2013年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
3
主要终点
Kinematics - Swing Phase Separation

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
40 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Kinematics - Swing Phase Separation

时间窗: 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.

Kinematics - Stance Phase Separation

时间窗: 6 months post-operative

Determine amount of stance phase hip separation present in vivo of implanted hip during level walking activity under fluoroscopic surveillance.

Kinematics - Overall Separation

时间窗: 6 months post-operative

Determine overall hip separation present in vivo in implanted hip during level walking activity under fluoroscopic surveillance

次要结局

未报告次要终点

研究者

发起方
The University of Tennessee, Knoxville
申办方类型
Other
责任方
Principal Investigator
主要研究者

Richard Komistek

Principal Investigator

The University of Tennessee, Knoxville

研究点 (3)

Loading locations...

相似试验

THA Kinematics and Sound for Subjects Implanted... | 临床试验