Hip Impingement - Understanding Cartilage Damage
| Tracking Information | |||||
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| First Received Date ICMJE | August 19, 2010 | ||||
| Last Updated Date | March 1, 2012 | ||||
| Start Date ICMJE | September 2010 | ||||
| Estimated Primary Completion Date | September 2015 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Magnetic Resonance Imaging (MRI) [ Time Frame: Pre-op (within 6 weeks of surgery) ] [ Designated as safety issue: No ] MRI |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01546493 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Hip Impingement - Understanding Cartilage Damage | ||||
| Official Title ICMJE | 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label |
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| Condition ICMJE | Femoroacetabular Impingement | ||||
| Intervention ICMJE | Procedure: MRI, qCT, motion analysis
MRI, qCT, motion analysis
Other Name: non applicable |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 75 | ||||
| Estimated Completion Date | September 2015 | ||||
| Estimated Primary Completion Date | September 2015 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Plain radiographs:
Group II: asymptomatic subjects with cam deformity
Group III: asymptomatic control subjects with no deformity
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Not Provided | ||||
| Location Countries ICMJE | Canada | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01546493 | ||||
| Other Study ID Numbers ICMJE | OHREB 2009-537 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Ottawa Hospital Research Institute | ||||
| Study Sponsor ICMJE | Ottawa Hospital Research Institute | ||||
| Collaborators ICMJE | Canadian Institutes of Health Research (CIHR) | ||||
| Investigators ICMJE |
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| Information Provided By | Ottawa Hospital Research Institute | ||||
| Verification Date | March 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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