NCT00606047

Brief Summary

Femoroacetabular hip impingement syndrome is a newly recognized cause of early arthritis of the hip. In this condition a variation in the shape of the upper thigh bone causes it to repeatedly come in contact with the hip socket leading to cartilage damage and arthritis. The purpose of this study is to investigate whether patients without hip pain have variations at the hip joint such as those seen in hip impingement syndrome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

August 1, 2007

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 1, 2008

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 13, 2017

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

March 27, 2020

Completed
Last Updated

March 27, 2020

Status Verified

March 1, 2020

Enrollment Period

9.5 years

First QC Date

January 21, 2008

Results QC Date

March 6, 2020

Last Update Submit

March 25, 2020

Conditions

Femoroacetabular Hip Impingement Syndrome

Keywords

femoroacetabular impingement

Outcome Measures

Primary Outcomes (1)

  • Prevalence of Femoroacetabular Impingement (FAI)

    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).

    Pre-operative on Day of MRI

Study Arms (1)

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).

Radiation: Magnetic resonance imaging (MRI)

Interventions

Magnetic resonance imaging (MRI)RADIATION

Participation in this study will involve patients coming to the hospital after regular work hours for an MRI of the hip joints.

Asymptomatic patients

Eligibility Criteria

AgeUp to 50 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Healthy volunteers

You may qualify if:

  • No hip problems
  • No containdications to MRI

You may not qualify if:

  • \- Patient does not meet above criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ottawa Hospital Research Institute

Ottawa, Ontario, K1Y4E9, Canada

Location

Related Publications (2)

  • Khanna V, Caragianis A, Diprimio G, Rakhra K, Beaule PE. Incidence of hip pain in a prospective cohort of asymptomatic volunteers: is the cam deformity a risk factor for hip pain? Am J Sports Med. 2014 Apr;42(4):793-7. doi: 10.1177/0363546513518417. Epub 2014 Jan 30.

    PMID: 24481825RESULT

  • Hack K, Di Primio G, Rakhra K, Beaule PE. Prevalence of cam-type femoroacetabular impingement morphology in asymptomatic volunteers. J Bone Joint Surg Am. 2010 Oct 20;92(14):2436-44. doi: 10.2106/JBJS.J.01280.

    PMID: 20962194RESULT

MeSH Terms

Conditions

Femoracetabular Impingement

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Limitations and Caveats

A limitation of our study sample is that it may not truly represent the normal population as it was based in a hospital setting. However, the hospital where this study was conducted employs over 13,000 individuals with a varied work force.

Results Point of Contact

Title
Dr Paul Beaule
Organization
The Ottawa Hospital Research Institute
pbeaule@toh.ca
613-737-8920

Study Officials

  • Paul Beaulé, MD, FRCSC

    Ottawa Hospital Research Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2008

First Posted

February 1, 2008

Study Start

August 1, 2007

Primary Completion

February 1, 2017

Study Completion

February 13, 2017

Last Updated

March 27, 2020

Results First Posted

March 27, 2020

Record last verified: 2020-03

Locations

CA(1)