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

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.

Study Overview

• Status: Recruiting
• Conditions: Developmental Dysplasia of the Hip
• Intervention / Treatment: Radiation: Magnetic Resonance Imaging (MRI)

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.

• Study Type: Observational
• Enrollment (Anticipated): 25

Contacts and Locations

• Study Contact: Name: Paul Beaule, MD, FRCSC; Phone Number: 73265 613-737-8899; Email: pbeaule@toh.ca
• Study Contact Backup: Name: Cheryl Kreviazuk; Phone Number: 613-737-8920; Email: ckreviazuk@ohri.ca

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1H8L6
      • Recruiting
      • Ottawa Hospital - General Campus
      • Principal Investigator: Paul Beaule, MD
      • Contact: Orthopaedic Research; Phone Number: 613-737-8920

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 98 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study group will consist of patients diagnosed with developmental dysplasia of the hip (DDH), and who are scheduled to undergo surgery to correct this.

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Ottawa Hospital Research Institute
• Collaborators: Zimmer Biomet; The Ottawa Hospital Academic Medical Association
• Investigators: Principal Investigator: Paul Beaule, MD, FRCSC, Ottawa Hospital Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2017
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: June 2, 2014
• First Submitted That Met QC Criteria: July 3, 2014
• First Posted (Estimate): July 9, 2014

Study Record Updates

• Last Update Posted (Actual): June 23, 2021
• Last Update Submitted That Met QC Criteria: June 22, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Developmental dysplasia of the hip; DDH; T1-rho MRI; dGEMRIC MRI
• Additional Relevant MeSH Terms: Pathologic Processes; Congenital Abnormalities; Joint Diseases; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Joint Dislocations; Hip Dislocation; Hyperplasia; Developmental Dysplasia of the Hip; Hip Dislocation, Congenital
• Other Study ID Numbers: 20140371-01H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No