Clinical Trial Finder

Biomechanical Assessment of Femoroacetabular Impingement

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational
Eligible Ages 18 Years - 35 Years
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT01575964
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 University of Utah
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Andrew Anderson
Principal Investigator Affiliation Orthopedic Surgery Operations
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Enrolling by invitation
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Femoro Acetabular Impingement
Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Utah Orthopaedic Center, Salt Lake, Utah

Status

Address

University of Utah Orthopaedic Center

Salt Lake, Utah, 84108

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