The Effect of Perthes' Disease on Hip Cartilage

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; (submitted: August 12, 2009)	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; (submitted: August 12, 2009)	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: Subjects must have reached the healed stage of unilateral Perthes' disease. -Subjects will be between 7 and 18 years of age.; Subjects must understand English. Exclusion Criteria: Subjects will be excluded if they have bilateral Perthes' disease or if they have not yet reached the healing stage of the disease.; Subjects will also be excluded if they do not meet the criteria to have an MRI (e.g., the subject has metal implants, is claustrophobic, has a metallic object in eye or a pacemaker).; A subject will be excluded if they have any of the precautions for the MR contrast agent, Magnevist, such as pregnancy, breast-feeding, respiratory allergies, asthma, thrombotic syndromes, history of grand mal seizures, impaired renal or hepatic function.
Sex/Gender	Sexes Eligible for Study: All
Ages	17 Years to 18 Years (Child, Adult)
Accepts Healthy Volunteers	Yes
Contacts	Contact: Eva Habib 604-875-2359 eva.habib@cw.bc.ca
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	Principal Investigator: Kishore Mulpuri, Dr. University of British Columbia Study Director: David Wilson, Dr. University of British Columbia
PRS Account	University of British Columbia
Verification Date	January 2018