Characterization of Proteoglycan Depletion in Femoroacetabular Impingement With T1ρ Magnetic Resonance Imaging (MRI)

NCT ID: NCT01578694

Last Updated: 2018-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2012-12-31

Brief Summary

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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.

Detailed Description

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Magnetic resonance imaging (MRI) is one of the best ways to image articular cartilage. One of the techniques which has shown great promise is the imaging technique called T1ρ (T1-rho). T1ρ is a modified pulse sequence from the standard T1 sequence used in the clinical MRI. Because the initial phases of arthritis occur at the molecular level, the main advantage of the T1ρ pulse sequence is that it is sensitive to proteoglycan. Proteoglycan is a molecule that is important to cartilage structure, and is lost as osteoarthritis develops. If we can show that this non-invasive tool can accurately assess cartilage damage and levels of proteoglycan, the clinical applications are numerous. The results can potentially help determine optimal surgical techniques and timing of surgical intervention to halt or slow the progression of arthritis, and will assist in the study of the effects of FAI and the success of the surgery performed to correct FAI.

Conditions

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Femoroacetabular Impingement Cartilage, Articular Hip Joint MRI

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Patient Group

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.

Group Type OTHER

Magnetic Resonance Imaging (MRI)

Intervention Type DIAGNOSTIC_TEST

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

Control healthy volunteers

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.

Group Type OTHER

Magnetic Resonance Imaging (MRI)

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Magnetic Resonance Imaging (MRI)

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ottawa Hospital Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paul E Beaule, MD, FRCSC

Role: PRINCIPAL_INVESTIGATOR

University of Ottawa / The Ottawa Hospital

Locations

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The Ottawa Hospital

Ottawa, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type RESULT
PMID: 22933489 (View on PubMed)

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.

Reference Type RESULT
PMID: 27506970 (View on PubMed)

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.

Reference Type RESULT
PMID: 25819578 (View on PubMed)

Other Identifiers

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2007231-01H

Identifier Type: -

Identifier Source: org_study_id

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