NCT00605969

Brief Summary

One of the leading causes of hip arthritis is femoro-acetabular impingement which means the hip joint is deformed such that the hip joint jams in the front when the hip is bent all the way forward. This can lead to significant damage to the hip joint and may result in the need for a total hip replacement. However, if detected early, this deformity can be treated surgically by reshaping the hip joint. If the hip joint could be better visualized before surgery, then surgeons would be able to develop less invasive surgical techniques to correct this deformity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2007

Longer than P75 for not_applicable

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

May 1, 2007

Completed
9 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
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

March 10, 2020

Status Verified

March 1, 2020

Enrollment Period

5.6 years

First QC Date

January 21, 2008

Last Update Submit

March 6, 2020

Conditions

Keywords

femoroacetabular, impingement

Outcome Measures

Primary Outcomes (1)

  • Validation of kinematic model of hip joint

    Development of a kinematical model of the hip joint to simulate virtual joint motion. This will be done by using automatic segmentation using the CT data to generate models.

    Within 6 months of recruitment

Secondary Outcomes (2)

  • Joint Kinetics

    24 months

  • Muscle Activity

    24 months

Study Arms (2)

FAI patients

ACTIVE COMPARATOR

This group consists of participants diagnosed with femoroacetabular impingement that are undergoing surgical correction.

Procedure: Motion analysisDiagnostic Test: Computed Tomography

Control

PLACEBO COMPARATOR

This group consists of healthy control participants with no hip problems.

Procedure: Motion analysisDiagnostic Test: Computed Tomography

Interventions

Participants will undergo a motion analysis procedure: a dynamic assessment of the movement in their hip.

ControlFAI patients
Computed TomographyDIAGNOSTIC_TEST

Participants will undergo computed tomography (CT) scan of their hip.

ControlFAI patients

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • All participants (patients and controls) must be between the ages of 18 and 55, with a BMI less than 35.
  • The patients must have a probable diagnosis of femoro-acetabular impingement (FAI). Their hip pain must have been ongoing for at least 3 months. The controls must have a normal hip as defined by AP pelvis radiographs.

You may not qualify if:

  • Participants (patients and controls) will be excluded if they are pregnant, have a knee injury or replacement, or history of childhood hip disease. Patients will be excluded if have they have arthritis, previous fracture or trauma to the hip, previous hip surgery, dysplasia, or avascular necrosis. Controls will be excluded if they have hip pain.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

Related Publications (5)

  • Ng KC, Lamontagne M, Adamczyk AP, Rakhra KS, Beaule PE. Patient-specific anatomical and functional parameters provide new insights into the pathomechanism of cam FAI. Clin Orthop Relat Res. 2015 Apr;473(4):1289-96. doi: 10.1007/s11999-014-3797-1.

  • Kennedy MJ, Lamontagne M, Beaule PE. Femoroacetabular impingement alters hip and pelvic biomechanics during gait Walking biomechanics of FAI. Gait Posture. 2009 Jul;30(1):41-4. doi: 10.1016/j.gaitpost.2009.02.008.

  • Lamontagne M, Kennedy MJ, Beaule PE. The effect of cam FAI on hip and pelvic motion during maximum squat. Clin Orthop Relat Res. 2009 Mar;467(3):645-50. doi: 10.1007/s11999-008-0620-x. Epub 2008 Nov 26.

  • Lamontagne M, Brisson N, Kennedy MJ, Beaule PE. Preoperative and postoperative lower-extremity joint and pelvic kinematics during maximal squatting of patients with cam femoro-acetabular impingement. J Bone Joint Surg Am. 2011 May;93 Suppl 2:40-5. doi: 10.2106/JBJS.J.01809.

  • Brisson N, Lamontagne M, Kennedy MJ, Beaule PE. The effects of cam femoroacetabular impingement corrective surgery on lower-extremity gait biomechanics. Gait Posture. 2013 Feb;37(2):258-63. doi: 10.1016/j.gaitpost.2012.07.016. Epub 2012 Aug 28.

MeSH Terms

Conditions

Femoracetabular Impingement

Interventions

Tomography, X-Ray Computed

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisRadiographic Image EnhancementImage EnhancementPhotographyRadiographyTomography, X-RayTomography

Study Officials

  • Paul E Beaule, MD, FRCSC

    University of Ottawa / The Ottawa Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2008

First Posted

February 1, 2008

Study Start

May 1, 2007

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

March 10, 2020

Record last verified: 2020-03

Locations