NCT02260726

Brief Summary

Patients are being asked to participate in this study because a previous research MRI of their hips showed that the shape of the head of their thigh bone may indicate FAI of the hip. We have already collected cartilage imaging data and data on how the hip joint moves on people with painful/symptomatic FAI and people with normal hip function. We would now like to compare the motion of the hip joint to those with painful FAI using ultrasound.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2014

Typical duration for not_applicable

Status
withdrawn

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

October 1, 2014

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

October 6, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 9, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

April 17, 2018

Status Verified

April 1, 2018

Enrollment Period

1 year

First QC Date

October 6, 2014

Last Update Submit

April 13, 2018

Conditions

Keywords

femoroacetabular impingementmorphometrydynamicmagnetic resonance imagingultrasoundscreeningdiagnosis

Outcome Measures

Primary Outcomes (1)

  • Ultrasound grade

    Ultrasound grade evaluated on a four point scale following ultrasound imaging session

    Upon enrollment

Secondary Outcomes (2)

  • Ultrasound parameters

    Upon enrollment

  • MRI parameters

    Upon enrollment

Study Arms (2)

Surgical group

EXPERIMENTAL

Subjects already scheduled to undergo surgical correction of a symptomatic cam-type hip impingement deformity. Subjects will undergo magnetic resonance imaging (MRI) and ultrasound investigation prior to surgery.

Procedure: Magnetic resonance imagingProcedure: Ultrasound

Control

OTHER

Asymptomatic subjects with normal hip morphometry, as determined by MRI. Subjects will undergo magnetic resonance imaging (MRI) and ultrasound imaging.

Procedure: Magnetic resonance imagingProcedure: Ultrasound

Interventions

ControlSurgical group
UltrasoundPROCEDURE
ControlSurgical group

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Surgical group:
  • Hip pain longer than 6 months referred to the groin/lateral aspect of the hip
  • Positive Impingement Sign
  • Plain radiographs:
  • Absence of arthritis (Tonnis Grade 0 or 1)
  • Absence of dysplasia (center edge \>25 degrees) on anterior-posterior radiograph
  • α-angle greater than 60 degrees on MRI.

You may not qualify if:

  • Control group: subjects with hip pain or with alpha angle \> 50 degrees on MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Femoracetabular ImpingementDisease

Interventions

Magnetic Resonance SpectroscopyHigh-Energy Shock Waves

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative TechniquesUltrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Officials

  • Paul E Beaule, MD, FRCSC

    University of Ottawa / The Ottawa Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

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

Study Record Dates

First Submitted

October 6, 2014

First Posted

October 9, 2014

Study Start

October 1, 2014

Primary Completion

October 1, 2015

Study Completion

October 1, 2016

Last Updated

April 17, 2018

Record last verified: 2018-04