The Effect of Perthes' Disease on Hip Cartilage
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| First Received Date ICMJE | August 11, 2009 | |||||||||
| Last Updated Date | November 30, 2015 | |||||||||
| Start Date ICMJE | January 2008 | |||||||||
| Estimated Primary Completion Date | August 2016 (final data collection date for primary outcome measure) | |||||||||
| Current Primary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: No ] | |||||||||
| Original Primary Outcome Measures ICMJE | Same as current | |||||||||
| Change History | Complete list of historical versions of study NCT00958464 on ClinicalTrials.gov Archive Site | |||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | |||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | |||||||||
| Current Other Outcome Measures ICMJE | Not Provided | |||||||||
| Original Other Outcome Measures ICMJE | Not Provided | |||||||||
| Descriptive Information | ||||||||||
| Brief Title ICMJE | The Effect of Perthes' Disease on Hip Cartilage | |||||||||
| Official Title ICMJE | The Effect of Perthes' Disease on Hip Cartilage | |||||||||
| Brief Summary | The purpose of this study is to determine whether Perthes' disease has caused detectable hip cartilage damage in young people who have reached the healed stage of the disease. | |||||||||
| Detailed Description | 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. |
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| Study Type ICMJE | Observational | |||||||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Cross-Sectional |
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| Target Follow-Up Duration | Not Provided | |||||||||
| Biospecimen | Not Provided | |||||||||
| Sampling Method | Non-Probability Sample | |||||||||
| Study Population | Volunteers with healed unilateral Perthes' disease between the ages of 7-18 years | |||||||||
| Condition ICMJE | Perthes' Disease | |||||||||
| Intervention ICMJE | Procedure: MRI
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. |
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| Study Group/Cohort (s) | 1
MRI protocol on 2 separate occasions
Intervention: Procedure: MRI |
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| Publications * | Not Provided | |||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||
| Recruitment Status ICMJE | Suspended | |||||||||
| Estimated Enrollment ICMJE | 20 | |||||||||
| Estimated Completion Date | August 2016 | |||||||||
| Estimated Primary Completion Date | August 2016 (final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | |||||||||
| Ages | 17 Years to 18 Years (Child, Adult) | |||||||||
| Accepts Healthy Volunteers | Yes | |||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||
| Listed Location Countries ICMJE | Canada | |||||||||
| Removed Location Countries | ||||||||||
| Administrative Information | ||||||||||
| NCT Number ICMJE | NCT00958464 | |||||||||
| Other Study ID Numbers ICMJE | H07-00930 | |||||||||
| Has Data Monitoring Committee | No | |||||||||
| Plan to Share Data | Not Provided | |||||||||
| IPD Description | Not Provided | |||||||||
| Responsible Party | University of British Columbia | |||||||||
| Study Sponsor ICMJE | University of British Columbia | |||||||||
| Collaborators ICMJE | Not Provided | |||||||||
| Investigators ICMJE |
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| Information Provided By | University of British Columbia | |||||||||
| Verification Date | November 2015 | |||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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