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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
Sponsor:
Information provided by (Responsible Party):
Kishore Mulpuri, University of British Columbia

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.

Condition or disease Intervention/treatment
Perthes' Disease Procedure: MRI

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
Estimated Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
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


Group/Cohort Intervention/treatment
1
MRI protocol on 2 separate occasions
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.




Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   17 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Volunteers with healed unilateral Perthes' disease between the ages of 7-18 years
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.

Information from the National Library of Medicine

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


Contacts
Contact: Eva Habib 604-875-2359 eva.habib@cw.bc.ca

Locations
Canada, British Columbia
BC Children's Hospital, Department of Orthopaedics Recruiting
Vancouver, British Columbia, Canada
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Kishore Mulpuri, Dr. University of British Columbia
Study Director: David Wilson, Dr. University of British Columbia

Responsible Party: Kishore Mulpuri, Principle Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT00958464     History of Changes
Other Study ID Numbers: H07-00930
First Posted: August 13, 2009    Key Record Dates
Last Update Posted: January 10, 2018
Last Verified: January 2018

Keywords provided by Kishore Mulpuri, University of British Columbia:
MRI
Perthes'disease
hip
cartilage

Additional relevant MeSH terms:
Legg-Calve-Perthes Disease
Femur Head Necrosis
Osteonecrosis
Bone Diseases
Musculoskeletal Diseases