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

NCT02185365 | Unknown

• 1 other identifier: 20140371-01H
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Developmental Dysplasia of the Hip

Keywords

T1-rho MRI; dGEMRIC MRI; DDH; Developmental dysplasia of the hip

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in WOMAC Questionnaire

  12 months

• Change in iHOT 12 Questionnaire

  12 months

Study Arms (1)

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)

Interventions

Magnetic Resonance Imaging (MRI) 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.

Developmental dysplasia of the hip (DDH)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• Zimmer Biomet: collaborator
• The Ottawa Hospital Academic Medical Association: collaborator

Study Sites (1)

Ottawa Hospital - General Campus

Ottawa, Ontario, K1H8L6, Canada

RECRUITING

MeSH Terms

Conditions

Developmental Dysplasia of the Hip

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Hip Dislocation; Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Paul Beaule, MD, FRCSC

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paul Beaule, MD, FRCSC

CONTACT

613-737-8899; pbeaule@toh.ca

Cheryl Kreviazuk

CONTACT

613-737-8920; ckreviazuk@ohri.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2014
• First Posted: July 9, 2014
• Study Start: July 25, 2017
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: June 23, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)