Biomechanical Assessment of Femoroacetabular Impingement (FAI)
Study Overview
Status
Status
Conditions
Conditions
Detailed Description
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.
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Contacts and Locations
Study Locations
-
-
Utah
-
Salt Lake City, Utah, United States, 84108
- University of Utah Orthopaedic Center
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Data Collection
Time Frame: Follow-up Visit
|
We will calculate hip joint kinematics.
Statistical analysis of the results will allow comparisons between normal and FAI subjects.
|
Follow-up Visit
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Andrew Anderson, Orthopedic Surgery Operations
Study record dates
Study Major Dates
Study Start
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Estimated)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 51053
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.