The Effect of Perthes' Disease on Hip Cartilage
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|ClinicalTrials.gov Identifier: NCT00958464|
Recruitment Status : Recruiting
First Posted : August 13, 2009
Last Update Posted : January 10, 2018
|Condition or disease||Intervention/treatment|
|Perthes' Disease||Procedure: MRI|
We will recruit 20 subjects from our healed Perthes' population. We will use dGEMRIC imaging to identify regions of cartilage degeneration in the femur and acetabulum. Both hips will be imaged so that we can use the unaffected side as a control. We will apply dGEMRIC imaging, which allows the composition of cartilage (specifically, the concentration of glycosaminoglycans [GAGs], important structural proteins in the cartilage) to be assessed.
The MRI protocol consists of intravenous injection of 0.4 ml/kg dose of gadopentetate dimeglumine 2- [Gd-DTPA2-] contrast agent (Magnevist, Bayer) 90 minutes prior to imaging. Due to the need to image within a relatively narrow window of time, each hip of each subject must be imaged on separate days. The subject will be asked to walk for 10 minutes after receiving the contrast agent injection to facilitate equilibration of contrast agent into the hip joint.
The scans will be performed at UBC's High Field Imaging Centre on the 3T Phillips Intera scanner. Dr. Wilson has access to this scanner for his research. The scanning protocol is as follows: 3D IR-TFE sequence with TR/TE/Flip of 4.7 ms/1.6 ms/30 o and seven inversion times; 1600, 1200, 800, 400, 200, 300, and 100 ms. In-plane resolution is 0.7 mm with a slice thickness of 3 mm. Total imaging time is approximately 1 hour (at each visit). The T1 calculated image will be obtained using validated, custom written software (IGOR). The resulting image provides a map approximating glycosaminoglycan concentration and, consequently, cartilage degeneration.
The MRI will not be done under sedation. MRIs are performed under sedation at BCCH for children under age seven. Subjects in this study will be between the ages of 7 and 18. The contrast agent, Gd-DTPA2- is routinely used in children in the clinical setting.
Radiographs used for comparison are obtained as part of standard of care follow-up protocol.
|Study Type :||Observational|
|Estimated Enrollment :||20 participants|
|Official Title:||The Effect of Perthes' Disease on Hip Cartilage|
|Study Start Date :||January 2008|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
MRI protocol on 2 separate occasions
MRI protocol consists of intravenous injection of 0.4 ml/kg dose of gadopentetate dimeglumine 2- [Gd-DTPA2-] contrast agent (Magnevist, Bayer) 90 minutes prior to imaging.
- Whether Perthes' disease has caused detectable hip cartilage damage in young people who have reached the healed stage of the disease. [ Time Frame: 2 days ]
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): NCT00958464
|Contact: Eva Habibfirstname.lastname@example.org|
|Canada, British Columbia|
|BC Children's Hospital, Department of Orthopaedics||Recruiting|
|Vancouver, British Columbia, Canada|
|Principal Investigator:||Kishore Mulpuri, Dr.||University of British Columbia|
|Study Director:||David Wilson, Dr.||University of British Columbia|