NCT04080466

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

Cam Type Femoroacetabular Impingement (FAI) is a Cause of Hip Pain in the Young Adult and a Precursor to Osteoarthritis (OA)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 58 (estimated)
• Sponsor: Ottawa Hospital Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

This study will allow the investigators to gain a better understanding of the relationship between cartilage and bone changes. The investigators will examine adult participants in the disease state that require surgical correction and compare to age-matched controls. The investigators will look at the impact of surgical intervention through joint-specific biomarkers of OA, specifically the PET-MRI and blood/urine biomarkers, which will allow them to simultaneously query cartilage and bone activity. The investigators propose that the use of PET-MRI will give more sensitive and hip-specific information about the joint health compared to the blood/urine biomarkers in patients with symptomatic cam morphology. Participants will undergo motion analysis and 3D modeling to help the investigators better understand the disease process during the performance of specific activities and define joint contact mechanics as they relate to the PET-MRI imaging, validating a biomarker for early joint degeneration. This diagnostic tool will be extremely useful for younger individuals with a cam deformity who have not yet developed symptoms. In the future the investigators could use this to detect early degeneration in adolescents to prevent and mitigate development of OA later on. This will also help the investigators develop activity guidelines for people with smaller cam deformities in order to avoid surgery and prevent degeneration.

Conditions

• Hip Dysplasia
• Femoroacetabular Impingement
• Osteoarthritis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-02-20
• Primary completion: 2025-01-01
• Completion: 2025-01-01
• First posted: 2019-09-06
• Last updated: 2024-01-05

Locations

1 site across 1 country: Canada