Clinical Trial: Hip Impingement - Understanding Cartilage Damage

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

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 Summary:

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).


Sponsor: Ottawa Hospital Research Institute

Current Primary Outcome: Magnetic Resonance Imaging (MRI) [ Time Frame: Pre-op (within 6 weeks of surgery) ]

MRI


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Quantitative Computed Tomography (qCT) [ Time Frame: pre-op (within 6 weeks of surgery) ]
    qCT
  • Quantitative Motion Analysis [ Time Frame: pre-op (within 6 weeks of surgery) ]
    Quantitative motion analysis recording and quantifying kinetic and kinematic data occuring at the hip joint. Data recorded during normal level walking and during completion of simulated daily tasks (uphill, downhill walking, stairs, squatting, sitting, rising from a chair).


Original Secondary Outcome: Same as current

Information By: Ottawa Hospital Research Institute

Dates:
Date Received: August 19, 2010
Date Started: September 2010
Date Completion: September 2017
Last Updated: August 4, 2016
Last Verified: August 2016