Skip to main content
Clinical Trials/NCT01546493
NCT01546493
Active, not recruiting
Not Applicable

Femoroacetabular Impingement: Correlating Hip Morphology to Changes in Cartilage and Subchondral Bone

Ottawa Hospital Research Institute1 site in 1 country70 target enrollmentAugust 4, 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Femoroacetabular Impingement
Sponsor
Ottawa Hospital Research Institute
Enrollment
70
Locations
1
Primary Endpoint
Magnetic Resonance Imaging (MRI)
Status
Active, not recruiting
Last Updated
2 years ago

Overview

Brief Summary

Femoro-acetabular impingement (FAI) is a known cause of hip pain and possibly a major cause of adult hip osteoarthritis. The relationship between cam-type FAI deformity characteristics and joint degradation to better identify 'at-risk' patients requiring corrective surgery will be scrutinized to gain a better understanding of the condition's natural history. The influence of certain morphologies (e.g. size and location of the deformity) will be analyzed to determine if this leads to aberrant loading of regions of the cartilage and subchondral bone, resulting in cartilage damage and joint degradation. Additionally, this research will determine if changes in the subchondral bone precede cartilage degeneration.

The methodology for establishing the morphology/cartilage degeneration relationship includes Magnetic Resonance Image (MRI) analysis, three-dimensional motion analysis and computer simulation/finite element analysis.

The outcomes of this research may lead to a reduction in total hip replacement cases by as much as 70%, saving many Canadians from a painful and debilitating condition and reducing costs to the Canadian health care system by as much as $290 million annually.

Detailed Description

The research objectives are: 1. To determine the factors of cam deformities, including morphological, functional and bone quality, that are associated with cartilage degeneration through shape analysis, kinematic analysis, MRI imaging and bone densitometry. 2. To determine whether subchondral bone changes occur before detectable cartilage degeneration by examining magnetic resonance images of asymptomatic subjects who have an identifiable deformity. 3. To use 3D motion and finite element analysis to examine differences in mechanical stimuli in the subchondral bone and cartilage that are associated with FAI, thus expanding our understanding of the pathomechanisms of associated degeneration. Three subject cohorts will be recruited: subjects with bilateral cam deformity and unilateral symptoms (Group I, 'active cartilage damage stage'), asymptomatic subjects with cam deformity (Group II, 'early stage') and asymptomatic control subjects with no deformity (Group III).

Registry
clinicaltrials.gov
Start Date
August 4, 2010
End Date
April 28, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Group I: Subjects with bilateral cam deformity and unilateral symptoms; Hip pain longer than 6 months referred to the groin/lateral aspect of hip; Positive impingement sign (determined by the surgeon); Plain radiographs: absence of arthritis (Tonnis Grade 0 or 1), absence of dysplasia (center edge \>25 degrees) on AP radiograph, α-angle greater than 55 degrees on the Dunn view.
  • Group II: Asymptomatic subjects with cam deformity; These patients will be recruited from our prevalence study (2006.813) with 200 asymptomatic individuals using MRI with radial sequences.
  • Group III: Asymptomatic control subjects with no deformity; These patients will be recruited from our prevalence study (2006.813) which established their hip joint as having a normal femoral head neck contour. These subjects will be age-matched to Group I.

Exclusion Criteria

  • Participants who do not meet the criteria above.

Outcomes

Primary Outcomes

Magnetic Resonance Imaging (MRI)

Time Frame: 24 months

Patients will undergo MRI modalities which are sensitive to biochemical markers (T1-rho) and bone porosity (ultra-short echo time \[UTE\]) to evaluate joint cartilage. The T1-rho imaging is used to detect early molecular and biochemical alterations to cartilage while the UTE imaging is used to assess bone porosity. MRI scans will be completely pre-operatively and at a minimum of 24 months post-operatively.

Secondary Outcomes

  • Positron emission tomography-magnetic resonance imaging (PET-MRI)(24 months or greater after original enrolment)
  • Quantitative Motion Analysis to assess hip joint function(24 months)
  • Quantitative Computed Tomography (qCT)(24 months)

Study Sites (1)

Loading locations...

Similar Trials