NCT01575964

Brief Summary

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
31mo left

Started Jan 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Jan 2012Dec 2028

Study Start

First participant enrolled

January 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 12, 2012

Completed
16.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

January 9, 2026

Status Verified

January 1, 2026

Enrollment Period

16.9 years

First QC Date

March 6, 2012

Last Update Submit

January 7, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Data Collection

    We will calculate hip joint kinematics. Statistical analysis of the results will allow comparisons between normal and FAI subjects.

    Follow-up Visit

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Normal subjects and subjects with femoroacetabular impingement.

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • 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.
  • 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.
  • Subjects who are unwilling or unable to remain still.
  • Subjects who are allergic to contrast agent and/or lidocaine will be dismissed.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah Orthopaedic Center

Salt Lake City, Utah, 84108, United States

Location

MeSH Terms

Conditions

Femoracetabular Impingement

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Andrew Anderson

    Orthopedic Surgery Operations

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 6, 2012

First Posted

April 12, 2012

Study Start

January 1, 2012

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

January 9, 2026

Record last verified: 2026-01

Locations