Recruiting

Phase 2

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

Sponsor:

Ottawa Hospital Research Institute

Code:

NCT04080466

Conditions

Hip Dysplasia

Femoroacetabular Impingement

Osteoarthritis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Low-dose CT Scan

Blood/Urine Collection

Patient Reported Questionnaires

EOS Scan

PET-MRI

Study Details

Brief 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

Hip Dysplasia

Femoroacetabular Impingement

Osteoarthritis

Study ID

NCT04080466

Start date

Feb 20, 2021

Status verified date

Jan, 2024

Completion date

Jan, 2025

Anticipated

Primary completion date

Jan, 2025

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

Skeletally mature patient undergoing cam resection by hip arthroscopy with hip pain longer than 6 months
Absence of arthritis (Tonnis Grade 0 or 1)
Absence of dysplasia (LCEA > 25°) or overcoverage (LCEA > 39°)
Alpha angle greater than 55° on multiplanar imaging
Subject is over the age of 18 years old at time of enrollment
Subject is willing and able to complete required study visits and assessments
Subject is willing to sign the approved Informed Consent Form

Group 2 Inclusion Criteria:

Normal femoral head neck contour and no evidence of dysplasia
Subject is over the age of 18 years old at time of enrollment
Subject is willing and able to complete required study visits and assessments
Subject is willing to sign the approved Informed Consent Form

Exclusion Criteria:

Prior joint replacement surgery in any lower-limb joint due to OA
History of lower-limb joint or back injury in the last year that impairs mobility
Metallic prosthesis
Worked with metal, metal fragments in the eye
Blood transmittable disease(s)
In vivo devices (Aneurysm clip(s), Pacemaker, ICD, Implanted hearing device)
Extreme claustrophobia
Overweight or obese (BMI > 30) and/or waist circumference >102cm in men and >88cm in women
Diagnosis of Parkinson's or uncontrollable tremors
Known history of early OA in the immediate family
Pregnant, Breastfeeding, or planning to get pregnant
Cognitive impairment that prevents accurate completion of patient-reported outcome questionnaires
Patient unable/unwilling to complete all required follow-up visits
Participants who have been exposed to other sources of radiation within the last year (Bringing radiation exposure above annual maximum)

Study Design

Enrollment

58 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Cam Group

This group will consist of patients that are scheduled for surgery to undergo cam resection by hip arthroscopy.

active comparator: Control Group

This group will consist of a matched cohort of control participants.

Interventions

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.

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.

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.

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.

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.

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.

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.

Primary outcome measure

Assessment of [18F]-NaF as a biomarker of hip degeneration [ Time Frame: 24 months ]

Central Contacts and Locations

Central contacts

Paul Beaule, MD, FRCSC

613-737-8920 pbeaule@toh.ca

Cheryl Kreviazuk, BA

613-737-8920 ckreviazuk@ohri.ca

Locations

The Ottawa Hospital

Recruiting

Ottawa, Ontario, Canada, K1H 8L6

Contacts

Cheryl Kreviazuk, BA

613-737-8920 ckreviazuk@ohri.ca

Principal Investigator:

Paul E Beaule, MD, FRCSC

More Information

Sponsor

Ottawa Hospital Research Institute

Last update posted

Jan 5, 2024

Last verified

Jan, 2024

Keywords

Hip
Cam deformity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Ottawa Hospital Research Institute on 2024-01-05.