NCT01575964Enrolling By Invitation不适用
Biomechanical Assessment of Femoroacetabular Impingement
适应症
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Data Collection
研究概览
简要总结
The purpose of this study is to determine the influence of FAI abnormalities on hip joint biomechanics.
详细描述
The purpose of this study is to quantify hip biomechanics of subjects with and without FAI.
The results of this study will advance our understanding of how the FAI alters the biomechanics of the hip joint, improving diagnosis and directing treatment strategies.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who present with hip pain subsequently diagnosed as femoroacetabular impingement
- •Subjects who meet the following radiographic criterion of cam or pincer FAI, will be given the opportunity to volunteer in this study.
- •Subjects that demonstrate a cross-over-sign or a lateral center edge angle (LCEA) without an alpha angle, will be classified as having pincer FAI.
- •Subjects with an alpha angle, without a cross-over sign or LCEA, will be categorized as having cam type FAI.
- •Finally, with at least one cam (alpha angle) and pincer sign "cross-over-sign or a lateral center edge angle (LCEA)" will be classified as mixed FAI.
- •Control Population Inclusion Criteria:
- •12 controls will consist of volunteers in the same age range as the subject groups (18-35 years).
- •Control hips will be screened with a standard AP radiograph. Normal volunteers who have radiographic evidence of FAI, dysplasia or other joint deformities will be excluded.
排除标准
- •Subjects who have radiographic evidence of osteoarthritis (Tonnis Grade III or IV) will be excluded as this study focuses on the mechanics of hips before prominent cartilage damage.
- •Subjects who have had prior procedures to correct FAI or other hip conditions will be excluded (exploratory procedures will be included).
- •Minors (under age 18), mentally disabled, persons incarcerated, on parole, probation awaiting trial, or pregnant women are excluded from this study.
- •A human Chorionic Gondaotropin (hCG) urine pregnancy test will be performed on all women prior to the study.
- •To limit the annual radiation exposure to any participating volunteers, we will exclude anyone who has had a CT scan or participated in a research study involving ionizing radiation in the past 12 months.
- •Motion Capture Exclusion Criteria:
- •Subjects who are unwilling or unable to perform the proposed activities of daily living or undergo the clinical exams will be dismissed.
- •Subjects with a BMI less than 30 (www.nhlbisupport.com/bmi/) or those with dense hip musculature/wide hips (maximum of 42 cm of circumferential hip length) will be excluded.
- •CT Exclusion Criteria:
- •Subjects who are unwilling or unable to remain still.
- •Subjects who are allergic to contrast agent and/or lidocaine will be dismissed.
结局指标
主要结局
Data Collection
时间窗: Follow-up Visit
We will calculate hip joint kinematics. Statistical analysis of the results will allow comparisons between normal and FAI subjects.
次要结局
未报告次要终点
研究者
Andrew Anderson
Associate Professor
University of Utah
研究点 (1)
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