Characterization of Proteoglycan Depletion in Femoroacetabular Impingement With T1ρ Magnetic Resonance Imaging (MRI)

MRI Clinical Trial

Official title:

Characterization of Proteoglycan Depletion in Femoroacetabular Impingement With T1ρ MRI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01578694
• Other study ID #: 2007231-01H
• Status: Completed
• Phase: N/A
• First received: August 19, 2010
• Last updated: March 23, 2018
• Start date: July 2007
• Est. completion date: December 2012

Study information

• Verified date: March 2018
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Magnetic resonance imaging (MRI) has proven to be one of the best ways to image articular cartilage. A tremendous amount of research has focused on cartilage imaging with an emphasis of early-osteoarthritis (OA) characterization. One of the techniques which has shown great promise is the imaging technique called T1ρ . The advantage of this pulse sequence is that it is sensitive to proteoglycans (PG), a major macromolecule degraded in OA. The study objective is to determine if T1ρ can acutely assess PG content in femoroacetabular impingement (FAI) which may allow physicians to differentiate between normal and early-OA cartilage states in FAI patients.

Description:

Magnetic resonance imaging (MRI) is one of the best ways to image articular cartilage. One of the techniques which has shown great promise is the imaging technique called T1ρ (T1-rho). T1ρ is a modified pulse sequence from the standard T1 sequence used in the clinical MRI. Because the initial phases of arthritis occur at the molecular level, the main advantage of the T1ρ pulse sequence is that it is sensitive to proteoglycan. Proteoglycan is a molecule that is important to cartilage structure, and is lost as osteoarthritis develops. If we can show that this non-invasive tool can accurately assess cartilage damage and levels of proteoglycan, the clinical applications are numerous. The results can potentially help determine optimal surgical techniques and timing of surgical intervention to halt or slow the progression of arthritis, and will assist in the study of the effects of FAI and the success of the surgery performed to correct FAI.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Group 1: Patient has been diagnosed by the surgeon as having femoro-acetabular impingement (FAI) of the hip)

• Group 1: Must meet all the following criteria: A) History and Physical Exam 1) Intermittent pain worse with activity 2) Positive impingement test (pain with flexion, adduction, and internal rotation of affected hip) B) X-ray 1) No signs of OA on plain radiological films (i.e. no osteophytes, no loss of joint space) 2) Non-spherical femoral head

• Group 2: Patient has not been diagnosed by the surgeon as having any hip problems.

Exclusion Criteria:

• Previous Hip Surgeries (Pelvic Osteotomies)

• Previous Hip Trauma

• History of Pediatric Hip Pathology: Slipped Capital Femoral Epiphysis or Hip Dysplasia

• Over the age of 40 years

Related Conditions & MeSH terms

• Cartilage, Articular
• Femoracetabular Impingement
• Femoroacetabular Impingement
• Hip Joint
• MRI

Intervention

Diagnostic Test:
• Magnetic Resonance Imaging (MRI)
T1 rho MRI is a modified pulse sequence from the standard T1 sequence used in the clinical MRI.

Locations

Country	Name	City	State
Canada	The Ottawa Hospital	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

References & Publications (3)

Anwander H, Rakhra KS, Melkus G, Beaulé PE. T1? Hip Cartilage Mapping in Assessing Patients With Cam Morphology: How Can We Optimize the Regions of Interest? Clin Orthop Relat Res. 2017 Apr;475(4):1066-1075. doi: 10.1007/s11999-016-5011-0. — View Citation

McGuffin WS, Melkus G, Rakhra KS, Beaulé PE. Is the contralateral hip at risk in patients with unilateral symptomatic cam femoroacetabular impingement? A quantitative T1? MRI study. Osteoarthritis Cartilage. 2015 Aug;23(8):1337-42. doi: 10.1016/j.joca.201 — View Citation

Rakhra KS, Lattanzio PJ, Cárdenas-Blanco A, Cameron IG, Beaulé PE. Can T1-rho MRI detect acetabular cartilage degeneration in femoroacetabular impingement?: a pilot study. J Bone Joint Surg Br. 2012 Sep;94(9):1187-92. doi: 10.1302/0301-620X.94B9.29981. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess articular cartilage using T1rho MRI	To provide a detailed quantitative assessment of the sensitivity of T1rho in the characterization of proteoglycan depletion in patients with or without femoroacetabular impingement.	Pre-op (within 6 weeks prior to surgery)