In Vivo Determination of THA Kinematics and Sound for Subject Implanted Using Various Surgical Approaches
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
- 否
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
Richard Komistek
Principal Investigator
The University of Tennessee, Knoxville
