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Hip Impingement - Understanding Cartilage Damage

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT01546493
First received: August 19, 2010
Last updated: August 4, 2016
Last verified: August 2016
  Purpose

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.


Condition Intervention
Femoroacetabular Impingement
Procedure: MRI, qCT, motion analysis

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Femoroacetabular Impingement: Correlating Hip Morphology to Changes in Cartilage and Subchondral Bone

Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome Measures:
  • Magnetic Resonance Imaging (MRI) [ Time Frame: Pre-op (within 6 weeks of surgery) ] [ Designated as safety issue: No ]
    MRI


Secondary Outcome Measures:
  • Quantitative Computed Tomography (qCT) [ Time Frame: pre-op (within 6 weeks of surgery) ] [ Designated as safety issue: No ]
    qCT

  • Quantitative Motion Analysis [ Time Frame: pre-op (within 6 weeks of surgery) ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 75
Study Start Date: September 2010
Estimated Study Completion Date: September 2017
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Controls
MRI, qCT, motion analysis
Procedure: MRI, qCT, motion analysis
MRI scan, quantitative computed tomography(QCT), 3D motion analysis after imaging
Other Name: non applicable
Experimental: Symptomatics
MRI, qCT, motion analysis
Procedure: MRI, qCT, motion analysis
MRI scan, quantitative computed tomography(QCT), 3D motion analysis after imaging
Other Name: non applicable
Experimental: Asymptomatic
MRI, qCT, motion analysis
Procedure: MRI, qCT, motion analysis
MRI scan, quantitative computed tomography(QCT), 3D motion analysis after imaging
Other Name: non applicable

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).

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01546493

Locations
Canada, Ontario
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6
Sponsors and Collaborators
Ottawa Hospital Research Institute
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Paul E Beaule, MD, FRCSC University of Ottawa / The Ottawa Hospital
  More Information

Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT01546493     History of Changes
Other Study ID Numbers: OHREB 2009-537 
Study First Received: August 19, 2010
Last Updated: August 4, 2016
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Femoracetabular Impingement
Joint Diseases
Musculoskeletal Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on December 07, 2016