Trial Outcomes & Findings for Prevalence of Femoroacetabular Impingement in Asymptomatic Patients (NCT NCT00606047)

NCT ID: NCT00606047

Last Updated: 2020-03-27

Results Overview

Prevalence of femoroacetabular impingement (FAI), a newly recognized cause of early arthritis of the hip, will be investigated by means of hip MRI to evaluate for abnormal morphology of the anterior head-neck junction of the femur. Participant MRIs were reviewed by two independent radiologists. The prevalence of FAI was calculated as determined by an abnormal alpha angle (greater than 50.5 degrees).

Recruitment status

COMPLETED

Target enrollment

200 participants

Primary outcome timeframe

Pre-operative on Day of MRI

Results posted on

2020-03-27

Participant Flow

Participant milestones

Participant milestones
Measure
Asymptomatic Patients
Asymptomatic, healthy patients (without hip pain or prior hip disease) will be recruited. Patients will undergo a magnetic resonance imaging (MRI) of the hip joints to evaluate for the prevalence of femoroacetabular impingement (FAI). Magnetic resonance imaging (MRI): Participation in this study will involve patients coming to the hospital after regular work hours for an MRI of the hip joints.
Overall Study
STARTED
200
Overall Study
COMPLETED
200
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Prevalence of Femoroacetabular Impingement in Asymptomatic Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Asymptomatic Patients
n=200 Participants
Asymptomatic, healthy patients (without hip pain or prior hip disease) will be recruited. Patients will undergo a magnetic resonance imaging (MRI) of the hip joints to evaluate for the prevalence of femoroacetabular impingement (FAI). Magnetic resonance imaging (MRI): Participation in this study will involve patients coming to the hospital after regular work hours for an MRI of the hip joints.
Age, Continuous
29.4 years
n=5 Participants
Sex: Female, Male
Female
111 Participants
n=5 Participants
Sex: Female, Male
Male
89 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
3 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
197 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Region of Enrollment
Canada
200 Participants
n=5 Participants
Body Mass Index
25.49 kg/m^2
STANDARD_DEVIATION 3.18 • n=5 Participants
Handedness
Left-handedness
12 Participants
n=5 Participants
Handedness
Right-handedness
188 Participants
n=5 Participants
Family History of Hip Osteoarthritis
None
184 Participants
n=5 Participants
Family History of Hip Osteoarthritis
Family History of Hip Osteoarthritis
16 Participants
n=5 Participants
Personal History of Childhood Hip Problems
None
200 Participants
n=5 Participants
Personal History of Childhood Hip Problems
Personal History of Childhood Hip Problems
0 Participants
n=5 Participants

PRIMARY outcome

Timeframe: Pre-operative on Day of MRI

Prevalence of femoroacetabular impingement (FAI), a newly recognized cause of early arthritis of the hip, will be investigated by means of hip MRI to evaluate for abnormal morphology of the anterior head-neck junction of the femur. Participant MRIs were reviewed by two independent radiologists. The prevalence of FAI was calculated as determined by an abnormal alpha angle (greater than 50.5 degrees).

Outcome measures

Outcome measures
Measure
Asymptomatic Patients
n=200 Participants
Asymptomatic, healthy patients (without hip pain or prior hip disease) will be recruited. Patients will undergo a magnetic resonance imaging (MRI) of the hip joints to evaluate for the prevalence of femoroacetabular impingement (FAI). Magnetic resonance imaging (MRI): Participation in this study will involve patients coming to the hospital after regular work hours for an MRI of the hip joints.
Prevalence of Femoroacetabular Impingement (FAI)
Prevalence of Cam-Type FAI
28 Participants
Prevalence of Femoroacetabular Impingement (FAI)
No prevalence
172 Participants

Adverse Events

Asymptomatic Patients

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Paul Beaule

The Ottawa Hospital Research Institute

Phone: 613-737-8920

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place