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Hip Impingement - Understanding Cartilage Damage

Primary Purpose

Femoroacetabular Impingement

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
MRI
qCT
Motion Analysis
PET-MRI
Sponsored by
Ottawa Hospital Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Femoroacetabular Impingement

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Ottawa Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Controls

Symptomatics

Asymptomatic

Arm Description

Asymptomatic control subjects with no deformity. All patients will undergo all 3 interventions: MRI, qCT, and motion analysis.

Subjects with bilateral cam deformity and unilateral symptoms. All patients will undergo all 3 interventions: MRI, qCT, and motion analysis. Select patients will be asked to participate in a PET-MRI scan being conducted at The Royal Ottawa.

Asymptomatic subjects with cam deformity. All patients will undergo all 3 interventions: MRI, qCT, and motion analysis. Select patients will be asked to participate in a PET-MRI scan being conducted at The Royal Ottawa.

Outcomes

Primary Outcome Measures

Magnetic Resonance Imaging (MRI)
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 Outcome Measures

Quantitative Computed Tomography (qCT)
Patients will undergo a CT scan of the hip (qCT) that is sensitive to the mineral content within bone tissue, and can assess bone mineral density, a strong predictor of bone strength and stiffness, which can influence the health of the cartilage. This scan will take approximately 15 minutes.
Quantitative Motion Analysis to assess hip joint function
Hip joint kinematics and contact forces will be analyzed in the same subjects undergoing imaging analysis to better understand the role of joint function in the degeneration process. Patients will have 16 pairs of surface electromyography (EMG) electrodes placed on certain area of the skin. The kinematic and kinetic data will be recorded for all 3 groups. Data will be recorded during normal level walking and during completion of simulated daily tasks (uphill, downhill walking, stairs, squatting, sitting, rising from a chair).
Positron emission tomography-magnetic resonance imaging (PET-MRI)
Positron emission tomography combined with magnetic resonance imaging (PET-MRI) is a technology that will examine bone and cartilage at the molecular level.

Full Information

First Posted
August 19, 2010
Last Updated
February 11, 2020
Sponsor
Ottawa Hospital Research Institute
Collaborators
Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT01546493
Brief Title
Hip Impingement - Understanding Cartilage Damage
Official Title
Femoroacetabular Impingement: Correlating Hip Morphology to Changes in Cartilage and Subchondral Bone
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 4, 2010 (Actual)
Primary Completion Date
August 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ottawa Hospital Research Institute
Collaborators
Canadian Institutes of Health Research (CIHR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: 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. To determine whether subchondral bone changes occur before detectable cartilage degeneration by examining magnetic resonance images of asymptomatic subjects who have an identifiable deformity. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femoroacetabular Impingement

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Controls
Arm Type
Experimental
Arm Description
Asymptomatic control subjects with no deformity. All patients will undergo all 3 interventions: MRI, qCT, and motion analysis.
Arm Title
Symptomatics
Arm Type
Experimental
Arm Description
Subjects with bilateral cam deformity and unilateral symptoms. All patients will undergo all 3 interventions: MRI, qCT, and motion analysis. Select patients will be asked to participate in a PET-MRI scan being conducted at The Royal Ottawa.
Arm Title
Asymptomatic
Arm Type
Experimental
Arm Description
Asymptomatic subjects with cam deformity. All patients will undergo all 3 interventions: MRI, qCT, and motion analysis. Select patients will be asked to participate in a PET-MRI scan being conducted at The Royal Ottawa.
Intervention Type
Radiation
Intervention Name(s)
MRI
Intervention Description
MRI scan. 3.0 Tesla MRI scans of both hips using Tip(T1-rho) and ultra-short echo time (UTE) sequences.
Intervention Type
Radiation
Intervention Name(s)
qCT
Intervention Description
Quantitative computed tomography(QCT) scans using a CT phantom
Intervention Type
Other
Intervention Name(s)
Motion Analysis
Intervention Description
3D motion analysis to assess hip function.
Intervention Type
Radiation
Intervention Name(s)
PET-MRI
Other Intervention Name(s)
Positron emission tomography-magnetic resonance imaging
Intervention Description
Positron emission tomography combined with magnetic resonance imaging (PET-MRI) is a technology that will help us examine bone and cartilage at the molecular level.
Primary Outcome Measure Information:
Title
Magnetic Resonance Imaging (MRI)
Description
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.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Quantitative Computed Tomography (qCT)
Description
Patients will undergo a CT scan of the hip (qCT) that is sensitive to the mineral content within bone tissue, and can assess bone mineral density, a strong predictor of bone strength and stiffness, which can influence the health of the cartilage. This scan will take approximately 15 minutes.
Time Frame
24 months
Title
Quantitative Motion Analysis to assess hip joint function
Description
Hip joint kinematics and contact forces will be analyzed in the same subjects undergoing imaging analysis to better understand the role of joint function in the degeneration process. Patients will have 16 pairs of surface electromyography (EMG) electrodes placed on certain area of the skin. The kinematic and kinetic data will be recorded for all 3 groups. Data will be recorded during normal level walking and during completion of simulated daily tasks (uphill, downhill walking, stairs, squatting, sitting, rising from a chair).
Time Frame
24 months
Title
Positron emission tomography-magnetic resonance imaging (PET-MRI)
Description
Positron emission tomography combined with magnetic resonance imaging (PET-MRI) is a technology that will examine bone and cartilage at the molecular level.
Time Frame
24 months or greater after original enrolment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul E Beaule, MD, FRCSC
Organizational Affiliation
Ottawa Hospital Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ottawa Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada

12. IPD Sharing Statement

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Hip Impingement - Understanding Cartilage Damage

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