Overview

This trial is active, not recruiting.

Condition femoroacetabular impingement
Treatments mri, qct, motion analysis
Sponsor Ottawa Hospital Research Institute
Collaborator Canadian Institutes of Health Research (CIHR)
Start date September 2010
End date September 2015
Trial size 75 participants
Trial identifier NCT01546493, OHREB 2009-537

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model parallel assignment
Masking open label
Arm
(Experimental)
MRI, qCT, motion analysis
mri, qct, motion analysis non applicable
MRI scan, quantitative computed tomography(QCT), 3D motion analysis after imaging
(Experimental)
MRI, qCT, motion analysis
mri, qct, motion analysis non applicable
MRI scan, quantitative computed tomography(QCT), 3D motion analysis after imaging
(Experimental)
MRI, qCT, motion analysis
mri, qct, motion analysis non applicable
MRI scan, quantitative computed tomography(QCT), 3D motion analysis after imaging

Primary Outcomes

Measure
Magnetic Resonance Imaging (MRI)
time frame: Pre-op (within 6 weeks of surgery)

Secondary Outcomes

Measure
Quantitative Computed Tomography (qCT)
time frame: pre-op (within 6 weeks of surgery)
Quantitative Motion Analysis
time frame: pre-op (within 6 weeks of surgery)

Eligibility Criteria

Male or female participants at least 18 years old.

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 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.

Additional Information

Official title Femoroacetabular Impingement: Correlating Hip Morphology to Changes in Cartilage and Subchondral Bone
Principal investigator Paul E Beaule, MD, FRCSC
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).
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Ottawa Hospital Research Institute.