NCT01578694

Brief Summary

Magnetic resonance imaging (MRI) has proven to be one of the best ways to image articular cartilage. A tremendous amount of research has focused on cartilage imaging with an emphasis of early-osteoarthritis (OA) characterization. One of the techniques which has shown great promise is the imaging technique called T1ρ . The advantage of this pulse sequence is that it is sensitive to proteoglycans (PG), a major macromolecule degraded in OA. The study objective is to determine if T1ρ can acutely assess PG content in femoroacetabular impingement (FAI) which may allow physicians to differentiate between normal and early-OA cartilage states in FAI patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 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

July 1, 2007

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

August 19, 2010

Completed
1.7 years until next milestone

First Posted

Study publicly available on registry

April 17, 2012

Completed
8 months 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 27, 2018

Status Verified

March 1, 2018

Enrollment Period

5.4 years

First QC Date

August 19, 2010

Last Update Submit

March 23, 2018

Conditions

Femoroacetabular ImpingementCartilage, ArticularHip JointMRI

Outcome Measures

Primary Outcomes (1)

  • Assess articular cartilage using T1rho MRI

    To provide a detailed quantitative assessment of the sensitivity of T1rho in the characterization of proteoglycan depletion in patients with or without femoroacetabular impingement.

    Pre-op (within 6 weeks prior to surgery)

Study Arms (2)

Patient Group

OTHER

The patient group has been diagnosed by the surgeon as having femoro-acetabular impingement (FAI) of the hip and will undergo a magnetic resonance imaging (MRI) test, more specifically, T1-rho to examine articular cartilage.

Diagnostic Test: Magnetic Resonance Imaging (MRI)

Control healthy volunteers

OTHER

The control group has not been diagnosed with any hip problems, but will undergo a magnetic resonance imaging (MRI) test, more specifically, T1-rho to examine articular cartilage.

Diagnostic Test: Magnetic Resonance Imaging (MRI)

Interventions

Magnetic Resonance Imaging (MRI)DIAGNOSTIC_TEST

T1 rho MRI is a modified pulse sequence from the standard T1 sequence used in the clinical MRI.

Control healthy volunteersPatient Group

Eligibility Criteria

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

You may qualify if:

  • Group 1: Patient has been diagnosed by the surgeon as having femoro-acetabular impingement (FAI) of the hip)
  • Group 1: Must meet all the following criteria: A) History and Physical Exam 1) Intermittent pain worse with activity 2) Positive impingement test (pain with flexion, adduction, and internal rotation of affected hip) B) X-ray 1) No signs of OA on plain radiological films (i.e. no osteophytes, no loss of joint space) 2) Non-spherical femoral head
  • Group 2: Patient has not been diagnosed by the surgeon as having any hip problems.

You may not qualify if:

  • Previous Hip Surgeries (Pelvic Osteotomies)
  • Previous Hip Trauma
  • History of Pediatric Hip Pathology: Slipped Capital Femoral Epiphysis or Hip Dysplasia
  • Over the age of 40 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

Related Publications (3)

  • Rakhra KS, Lattanzio PJ, Cardenas-Blanco A, Cameron IG, Beaule PE. Can T1-rho MRI detect acetabular cartilage degeneration in femoroacetabular impingement?: a pilot study. J Bone Joint Surg Br. 2012 Sep;94(9):1187-92. doi: 10.1302/0301-620X.94B9.29981.

    PMID: 22933489RESULT

  • Anwander H, Rakhra KS, Melkus G, Beaule PE. T1rho Hip Cartilage Mapping in Assessing Patients With Cam Morphology: How Can We Optimize the Regions of Interest? Clin Orthop Relat Res. 2017 Apr;475(4):1066-1075. doi: 10.1007/s11999-016-5011-0.

    PMID: 27506970RESULT

  • McGuffin WS, Melkus G, Rakhra KS, Beaule PE. Is the contralateral hip at risk in patients with unilateral symptomatic cam femoroacetabular impingement? A quantitative T1rho MRI study. Osteoarthritis Cartilage. 2015 Aug;23(8):1337-42. doi: 10.1016/j.joca.2015.03.018. Epub 2015 Mar 25.

    PMID: 25819578RESULT

MeSH Terms

Conditions

Femoracetabular Impingement

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

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

August 19, 2010

First Posted

April 17, 2012

Study Start

July 1, 2007

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

March 27, 2018

Record last verified: 2018-03

Locations

CA(1)