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

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ClinicalTrials.gov Identifier: NCT01578694
Recruitment Status : Completed
First Posted : April 17, 2012
Last Update Posted : March 27, 2018
Sponsor:
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

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.

Condition or disease Intervention/treatment Phase
Femoroacetabular Impingement Cartilage, Articular Hip Joint MRI Diagnostic Test: Magnetic Resonance Imaging (MRI) Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Characterization of Proteoglycan Depletion in Femoroacetabular Impingement With T1ρ MRI
Actual Study Start Date : July 2007
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

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U.S. FDA Resources

Arm Intervention/treatment
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.
Diagnostic Test: Magnetic Resonance Imaging (MRI)
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.
Diagnostic Test: Magnetic Resonance Imaging (MRI)
T1 rho MRI is a modified pulse sequence from the standard T1 sequence used in the clinical MRI.



Primary Outcome Measures :
  1. Assess articular cartilage using T1rho MRI [ Time Frame: Pre-op (within 6 weeks prior to surgery) ]
    To provide a detailed quantitative assessment of the sensitivity of T1rho in the characterization of proteoglycan depletion in patients with or without femoroacetabular impingement.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01578694


Locations
Canada, Ontario
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6
Sponsors and Collaborators
Ottawa Hospital Research Institute
Investigators
Principal Investigator: Paul E Beaule, MD, FRCSC University of Ottawa / The Ottawa Hospital