Clinical trial NCT02185365: Evaluation of T1rho Magnetic Resonance Imaging for Diagnosis of Cartilage Lesions in Hips With Developmental Dysplasia
Official title: Evaluation of T1rho Magnetic Resonance Imaging for Diagnosis of Cartilage Lesions in Hips With Developmental Dysplasia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Developmental Dysplasia of the Hip
Keywords: T1-rho MRI
dGEMRIC MRI
DDH
Developmental dysplasia of the hip
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: Zimmer Biomet
name: The Ottawa Hospital Academic Medical Association
First posted: 2014-07-09
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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)

Primary outcomes:
measure: Assess proteoglycan amounts in hip cartilage
timeFrame: Within the 6 months prior to surgery
Secondary outcomes:
measure: Change in WOMAC Questionnaire
timeFrame: 12 months
measure: Change in iHOT 12 Questionnaire
timeFrame: 12 months
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Ottawa Hospital - General Campus
state: Ontario
Study officials:
affiliation: Ottawa Hospital Research Institute
name: Paul Beaule, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
References: