Evaluation of T1rho Magnetic Resonance Imaging for Diagnosis of Cartilage Lesions in Hips With Developmental Dysplasia

NCT ID: NCT02185365

Last Updated: 2021-06-23

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 25 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-07-25
• Study Completion Date: 2021-12-31

Brief Summary

One of the leading causes of hip arthritis is developmental dysplasia of the hip (DDH). DDH can lead to major damage in the hip joint and may result in hip arthritis later in life. Patients recruited into this study will be undergoing corrective hip surgery within the next 6 months with a goal of preventing further hip problems down the road. This study is being done to see how well a newer type of Magnetic Resonance Imaging (MRI) detects hip cartilage damage compared to an older but well validated MRI method.

Detailed Description

The start of arthritis can first be detected in certain molecules in the joint. Proteoglycan is a molecule that is important to cartilage structure, and is lost as arthritis develops. Magnetic resonance imaging (MRI) is one of the best ways to image cartilage, and an investigational MRI technique that has shown great promise in detecting proteoglycan amounts is called T1-rho.

In this study, patients with hip dysplasia will undergo this investigational MRI in addition to a well validated MRI method (called dGEMRIC) to see if T1-rho is as good as dGEMRIC at detecting cartilage damage. The dGEMRIC MRI requires an injection of a contrast agent, while the T1-rho MRI does not. If the T1-rho is shown to be as useful as the dGEMRIC method it can then be used to look at cartilage damage in the hip without having to have an injection.

Conditions

Developmental Dysplasia of the Hip

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Developmental dysplasia of the hip (DDH)

Patients will complete 2 magnetic resonance imaging (MRI): T1-rho and dGEMRIC. The T1-rho MRI does not require the injection of a contrast agent, while the dGEMRIC MRI requires a gadolinium injection to visualize cartilage in the hip.

Magnetic Resonance Imaging (MRI)

Intervention Type: RADIATION

Patients will undergo 2 different MRIs of the affected hip. Both MRIs assess hip cartilage degeneration. A contrast agent, Gadolinium, will be used to visualize cartilage during the MRI. The contrast agent is injected through an intravenous (a small plastic tube inserted into a vein in the patients' arm) before the MRI.

Interventions

Magnetic Resonance Imaging (MRI)

Patients will undergo 2 different MRIs of the affected hip. Both MRIs assess hip cartilage degeneration. A contrast agent, Gadolinium, will be used to visualize cartilage during the MRI. The contrast agent is injected through an intravenous (a small plastic tube inserted into a vein in the patients' arm) before the MRI.

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• patients with a diagnosis of developmental dysplasia of the hip (DDH)

Exclusion Criteria

• patients under the age of 18
• pregnancy and/or lactation
• non-MRI compatible implants (stents, electronic devices, cardiac pacers or wires)
• severe claustrophobia
• prior contrast allergic reaction
• kidney impairment
• previous hip surgery
• osteoarthritis on conventional radiographs (Tönnis Grade>0)
• additional underlying hip diseases such as posttraumatic arthritis, Legg-Calvé-Perthes-Disease (LCPD), or slipped capital femoral epiphysis (SCFE)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zimmer Biomet

INDUSTRY

Sponsor Role: collaborator

The Ottawa Hospital Academic Medical Association

OTHER

Sponsor Role: collaborator

Ottawa Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul Beaule, MD, FRCSC

Role: PRINCIPAL_INVESTIGATOR

Ottawa Hospital Research Institute

Locations

Ottawa Hospital - General Campus

Ottawa, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Paul Beaule, MD, FRCSC

Role: CONTACT

pbeaule@toh.ca

613-737-8899 ext. 73265

Cheryl Kreviazuk

Role: CONTACT

ckreviazuk@ohri.ca

613-737-8920

Facility Contacts

Orthopaedic Research

Role: primary

613-737-8920

Other Identifiers

20140371-01H

Identifier Type: -

Identifier Source: org_study_id