The Effect of Perthes' Disease on Hip Cartilage
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00958464 |
Recruitment Status
:
Recruiting
First Posted
: August 13, 2009
Last Update Posted
: January 10, 2018
|
Tracking Information | |||||||
---|---|---|---|---|---|---|---|
First Submitted Date | August 11, 2009 | ||||||
First Posted Date | August 13, 2009 | ||||||
Last Update Posted Date | January 10, 2018 | ||||||
Study Start Date | January 2008 | ||||||
Estimated Primary Completion Date | December 2019 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures |
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 ] | ||||||
Original Primary Outcome Measures | Same as current | ||||||
Change History | Complete list of historical versions of study NCT00958464 on ClinicalTrials.gov Archive Site | ||||||
Current Secondary Outcome Measures | Not Provided | ||||||
Original Secondary Outcome Measures | Not Provided | ||||||
Current Other Outcome Measures | Not Provided | ||||||
Original Other Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title | The Effect of Perthes' Disease on Hip Cartilage | ||||||
Official Title | 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. |
||||||
Study Type | Observational | ||||||
Study Design | Observational Model: Case-Only Time Perspective: Cross-Sectional |
||||||
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 | Perthes' Disease | ||||||
Intervention | 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. |
||||||
Study Groups/Cohorts | 1
MRI protocol on 2 separate occasions
Intervention: Procedure: MRI |
||||||
Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||
Recruitment Information | |||||||
Recruitment Status | Recruiting | ||||||
Estimated Enrollment |
20 | ||||||
Original Estimated Enrollment | Same as current | ||||||
Estimated Study Completion Date | December 2019 | ||||||
Estimated Primary Completion Date | December 2019 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
|
||||||
Sex/Gender |
|
||||||
Ages | 17 Years to 18 Years (Child, Adult) | ||||||
Accepts Healthy Volunteers | Yes | ||||||
Contacts |
|
||||||
Listed Location Countries | Canada | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number | NCT00958464 | ||||||
Other Study ID Numbers | H07-00930 | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement | Not Provided | ||||||
Responsible Party | Kishore Mulpuri, University of British Columbia | ||||||
Study Sponsor | University of British Columbia | ||||||
Collaborators | Not Provided | ||||||
Investigators |
|
||||||
PRS Account | University of British Columbia | ||||||
Verification Date | January 2018 |