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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT01578694
First received: August 19, 2010
Last updated: February 7, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Femoroacetabular Impingement
Cartilage, Articular
Hip Joint
MRI
Procedure: MRI

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Characterization of Proteoglycan Depletion in Femoroacetabular Impingement With T1ρ MRI

Resource links provided by NLM:


Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome Measures:
  • T1rho MRI [ Time Frame: Pre-op (within 6 weeks prior to surgery) ] [ Designated as safety issue: No ]

Enrollment: 26
Study Start Date: July 2007
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Patient Procedure: MRI
T1 rho MRI
Control Procedure: MRI
T1 rho MRI

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects:

Number

  1. N=10
  2. From: Dr. Paul Beaule's Practice, Ottawa General Hospital, Ottawa, ON

Inclusion Criteria (must meet all criteria listed below) A) History and Physical Exam

  1. Intermittent Pain worse with activity
  2. Positive Impingement test (Pain with flexion, adduction and internal rotation of effected hip)

B) X-ray

1. No signs of OA on plain radiological films (i.e. no osteophytes, no loss of joint space) 3. Non-spherical femoral head

Exclusion Criteria:

  1. Previous Hip Surgeries (Pelvic Osteotomies)
  2. Previous Hip Trauma
  3. Hx of Pediatric Hip Pathology: Slipped Capital Femoral Epiphysis or Hip Dysplasia
  4. Over the age of 40 years
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT01578694     History of Changes
Other Study ID Numbers: 2007231-01H
Study First Received: August 19, 2010
Last Updated: February 7, 2014
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Femoracetabular Impingement
Joint Diseases
Musculoskeletal Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 19, 2014