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

Developmental Dysplasia of the Hip Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02185365
• Other study ID #: 20140371-01H
• Status: Recruiting
• Start date: July 25, 2017
• Est. completion date: December 2021

Study information

• Verified date: June 2021
• Source: Ottawa Hospital Research Institute
• Contact: Paul Beaule, MD, FRCSC
• Phone: 613-737-8899
• Email: pbeaule[@]toh.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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)

Related Conditions & MeSH terms

• Developmental Dysplasia of the Hip
• Hip Dislocation, Congenital
• Hyperplasia

Intervention

Radiation:
• 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.

Locations

Country	Name	City	State
Canada	Ottawa Hospital - General Campus	Ottawa	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute	The Ottawa Hospital Academic Medical Association, Zimmer Biomet

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess proteoglycan amounts in hip cartilage	Our aim is to correlate T1-rho with dGEMRIC values in painful hips with underlying DDH. To achieve this, we will assess whether T1-rho MRI values correlate with dGEMRIC MRI values in hips with DDH.	Within the 6 months prior to surgery
Secondary	Change in WOMAC Questionnaire	The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is widely used as a standard assessment of arthritis in the hip joint. The Index is self-administered and assesses the three dimensions of pain (5 items), joint stiffness (2 items), and Physical Function (17 items) in hip osteoarthritis using 24 questions. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme. These correspond to an ordinal scale of 0-4. Scores are summed with higher scores indicating worse pain, stiffness, and function.	12 months
Secondary	Change in iHOT 12 Questionnaire	The International Hip Outcome Tool (iHOT-12) is a questionnaire that has recently been validated in young active patients with early hip disease. The questionnaire is self-administered and assesses across 4 domains: symptoms and functional limitations; sport and recreational activities; job-related concerns; and social, emotional, and lifestyle concerns. Questions are answered by marking a visual analog scale between 2 anchor statements (100-mm scale). The total score is calculated as a simple mean of these responses ranging from 0 to 100, with 100 representing the best possible quality-of-life score.	12 months