Cam Type FAI is a Cause of Hip Pain in the Young Adult and a Precursor to OA

NCT04080466 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2024-01-05

No results posted yet for this study

Summary

An abnormally formed hip joint (cam deformity) is a major cause of osteoarthritis (OA). Individuals may not experience any symptoms until OA is severe due to extensive cartilage loss and changes in underlying bone. A series of studies showed that the cam deformity can lead to the development of OA if left untreated, thus strongly suggesting a causal relationship. Currently, the cam deformity that causes pain is surgically removed to relieve the pain and treat the associated cartilage damage. Recent studies have demonstrated that surgical treatment leads to bone and cartilage changes that were related to improved function and reduced pain.

Conditions

Interventions

RADIATION

Low-dose CT Scan

Low dose computed tomography, also known as qCT, 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. Participants will undergo a low dose CT scan of both hips. Participants in the Cam Group will undergo this scan once as part of their standard of care. Participants in the Control Group will undergo this scan once as part of the study.

OTHER

Blood/Urine Collection

Collection of blood and urine allows the researchers to look for a biomarker in the blood and urine that might help to predict the evolution of disease/hip osteoarthritis. Identifying a marker in the blood and urine that could be used for early detection of individuals with cam deformity that are at-risk of hip degeneration could greatly improve patient care. Participants in the Cam Group will undergo the blood and urine collection twice; once before surgery and once 2-years post-operative. Participants in the Control Group will undergo a blood and urine collection once as part of the study.

OTHER

Patient Reported Questionnaires

The purpose of the questionnaires is to assess how much trouble the participant is having with their hip and how it affects their quality of life. Participants in the Cam Group will complete the questionnaires twice; once before surgery and once 2-years post-operative. Participants in the Control Group will complete the questionnaires once as part of the study.

RADIATION

EOS Scan

The EOS® uses a new imaging technique that allows precise measurement of the hip and pelvis geometry and structure. This innovative x-ray technique exposes participants to 2-10 times less radiation than a routine x-ray and can capture multiple images at once. Participants in the Cam Group will undergo the EOS scan twice; once before surgery and once 2-years post-operative. Participants in the Control Group will undergo the scan once as part of the study.

RADIATION

PET-MRI

Positron emission tomography combined with magnetic resonance imaging (PET-MRI) is a technology that allows physicians to examine bone and cartilage at the molecular level. Participants in the Cam Group will undergo the scan twice; once before surgery and once 2-years post-operative. Participants in the Control Group will undergo the scan once as part of the study.

OTHER

Motion Analysis

Motion analysis is the study of how joints move and which muscles fire during specific movements. In the lab, participants will be asked to perform movements that they might do during a typical day or when exercising. Participants in the Cam Group will undergo the Motion Analysis session twice; once before surgery and once 2-years post-operative. Participants in the Control Group will undergo the Motion Analysis session once as part of the study.

RADIATION

3T MRI

Participants will undergo a 3-Tesla (3T) Magnetic Resonance Imaging (MRI) of both hips. Participants in the Cam Group will undergo this scan once as part of their standard of care. Participants in the Control Group will undergo this scan once as part of the study.

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV
  • Ottawa Hospital Research Institute

    lead OTHER

Principal Investigators

  • Paul Beaule, MD, FRCSC · The Ottawa Hospital Research Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-20
Primary Completion
2025-01-31
Completion
2025-01-31

Countries

  • Canada

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04080466 on ClinicalTrials.gov