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

NCT04080466 | Unknown Phase 2

• 1 other identifier: 20190456
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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

Keywords

Hip; Cam deformity

Outcome Measures

Primary Outcomes (1)

• Assessment of [18F]-NaF as a biomarker of hip degeneration

  This study will assess \[18F\]-NaF uptake in PET-MRI as a novel biomarker of hip degeneration. This will be done by evaluating the presence of active bone turnover.

  24 months

Secondary Outcomes (14)

• Change in PET-MRI (SUV/T1Rho)

  24 months

• qCT (Low Dose Computed Tomography)

  Within 2 months after recruitment

• Change in type II collagen telopeptide (CTX-II)

  24 months

• Change in cartilage oligomeric matrix protein (COMP)

  24 months

• Change in C-reactive protein (CRP)

  24 months

Study Arms (2)

Cam Group

EXPERIMENTAL

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

Radiation: Low-dose CT Scan; Other: Blood/Urine Collection; Other: Patient Reported Questionnaires; Radiation: EOS Scan; Radiation: PET-MRI; Other: Motion Analysis; Radiation: 3T MRI

Control Group

ACTIVE COMPARATOR

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

Radiation: Low-dose CT Scan; Other: Blood/Urine Collection; Other: Patient Reported Questionnaires; Radiation: EOS Scan; Radiation: PET-MRI; Other: Motion Analysis; Radiation: 3T MRI

Interventions

Low-dose CT Scan RADIATION

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.

Cam Group; Control Group

Blood/Urine Collection OTHER

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.

Cam Group; Control Group

Patient Reported Questionnaires OTHER

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.

Cam Group; Control Group

EOS Scan RADIATION

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.

Cam Group; Control Group

PET-MRI RADIATION

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.

Cam Group; Control Group

Motion Analysis OTHER

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.

Cam Group; Control Group

3T MRI RADIATION

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.

Cam Group; Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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)

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

RECRUITING

MeSH Terms

Conditions

Hip Dislocation; Femoracetabular Impingement; Osteoarthritis

Interventions

Blood Specimen Collection; Urine Specimen Collection

Condition Hierarchy (Ancestors)

Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Hip Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arthritis; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Paul Beaule, MD, FRCSC

  The Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paul Beaule, MD, FRCSC

CONTACT

613-737-8920; pbeaule@toh.ca

Cheryl Kreviazuk, BA

CONTACT

613-737-8920; ckreviazuk@ohri.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Non-randomized, single centre trial with 2 parallel groups

Study Record Dates

• First Submitted: August 22, 2019
• First Posted: September 6, 2019
• Study Start: February 20, 2021
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: January 5, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)