Hip Impingement - Understanding Cartilage Damage

NCT01546493 | Unknown

• 1 other identifier: 2009537
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Femoroacetabular Impingement

Outcome Measures

Primary Outcomes (1)

• 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.

  24 months

Secondary Outcomes (3)

• Quantitative Computed Tomography (qCT)

  24 months

• Quantitative Motion Analysis to assess hip joint function

  24 months

• Positron emission tomography-magnetic resonance imaging (PET-MRI)

  24 months or greater after original enrolment

Study Arms (3)

Controls

EXPERIMENTAL

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

Radiation: MRI; Radiation: qCT; Other: Motion Analysis

Symptomatics

EXPERIMENTAL

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.

Radiation: MRI; Radiation: qCT; Other: Motion Analysis; Radiation: PET-MRI

Asymptomatic

EXPERIMENTAL

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.

Radiation: MRI; Radiation: qCT; Other: Motion Analysis; Radiation: PET-MRI

Interventions

MRI RADIATION

MRI scan. 3.0 Tesla MRI scans of both hips using Tip(T1-rho) and ultra-short echo time (UTE) sequences.

Asymptomatic; Controls; Symptomatics

qCT RADIATION

Quantitative computed tomography(QCT) scans using a CT phantom

Asymptomatic; Controls; Symptomatics

Motion Analysis OTHER

3D motion analysis to assess hip function.

Asymptomatic; Controls; Symptomatics

PET-MRI RADIATION

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.

Also known as: Positron emission tomography-magnetic resonance imaging

Asymptomatic; Symptomatics

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Participants who do not meet the criteria above.

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

MeSH Terms

Conditions

Femoracetabular Impingement

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Paul E Beaule, MD, FRCSC

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2010
• First Posted: March 7, 2012
• Study Start: August 4, 2010
• Primary Completion: April 28, 2024
• Study Completion: April 28, 2024
• Last Updated: January 5, 2024

Record last verified: 2024-01

Locations

CA (1)