The Effect of Perthes' Disease on Hip Cartilage

This study has suspended participant recruitment.
(The engineers are working on a new scanning protocol that would allow us to image both hips simultaneously instead of having the subject come in on two days)
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00958464
First received: August 11, 2009
Last updated: June 20, 2014
Last verified: June 2014
  Purpose

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 Intervention
Perthes' Disease
Procedure: MRI

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: The Effect of Perthes' Disease on Hip Cartilage

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: January 2008
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   17 Years to 18 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00958464

Locations
Canada, British Columbia
BC Children's Hospital, Department of Orthopaedics
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
Study Director: Burkhard Maedler, Dr. University of British Columbia
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT00958464     History of Changes
Other Study ID Numbers: H07-00930
Study First Received: August 11, 2009
Last Updated: June 20, 2014
Health Authority: Canada: Health Canada

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

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

ClinicalTrials.gov processed this record on July 20, 2014