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Biomechanical Assessment of Femoroacetabular Impingement (FAI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01575964
Recruitment Status : Active, not recruiting
First Posted : April 12, 2012
Last Update Posted : January 15, 2021
Sponsor:
Information provided by (Responsible Party):
Andrew Anderson, University of Utah

Brief Summary:
The purpose of this study is to determine the influence of FAI abnormalities on hip joint biomechanics.

Condition or disease
Femoro Acetabular Impingement

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.

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Study Type : Observational
Estimated Enrollment : 36 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Biomechanical Assessment of Femoroacetabular Impingement
Study Start Date : January 2012
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Normal subjects and subjects with femoroacetabular impingement.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01575964


Locations
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United States, Utah
University of Utah Orthopaedic Center
Salt Lake City, Utah, United States, 84108
Sponsors and Collaborators
University of Utah
Investigators
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Principal Investigator: Andrew Anderson Orthopedic Surgery Operations
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Responsible Party: Andrew Anderson, Associate Professor, University of Utah
ClinicalTrials.gov Identifier: NCT01575964    
Other Study ID Numbers: 51053
First Posted: April 12, 2012    Key Record Dates
Last Update Posted: January 15, 2021
Last Verified: January 2021
Additional relevant MeSH terms:
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Femoracetabular Impingement
Joint Diseases
Musculoskeletal Diseases
Pathologic Processes