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

Phase 2

Recruiting

• Conditions: Hip Dysplasia; Femoroacetabular Impingement; Osteoarthritis
• Interventions: 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

• Registration Number: NCT04080466
• Lead Sponsor: Ottawa Hospital Research Institute

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.

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.

Study Timeline

• Study First Submitted: 2019-08-22
• Study First Submitted QC: 2019-09-03
• Study First Posted: 2019-09-06
• Study Start: 2021-02-20
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-02
• Last Update Posted: 2024-01-05
• Primary Completion: 2025-01
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 58

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cam Group	Patient Reported Questionnaires	This group will consist of patients that are scheduled for surgery to undergo cam resection by hip arthroscopy.
Control Group	Low-dose CT Scan	This group will consist of a matched cohort of control participants.
Cam Group	EOS Scan	This group will consist of patients that are scheduled for surgery to undergo cam resection by hip arthroscopy.
Cam Group	Blood/Urine Collection	This group will consist of patients that are scheduled for surgery to undergo cam resection by hip arthroscopy.
Cam Group	Low-dose CT Scan	This group will consist of patients that are scheduled for surgery to undergo cam resection by hip arthroscopy.
Cam Group	Motion Analysis	This group will consist of patients that are scheduled for surgery to undergo cam resection by hip arthroscopy.
Control Group	Blood/Urine Collection	This group will consist of a matched cohort of control participants.
Cam Group	PET-MRI	This group will consist of patients that are scheduled for surgery to undergo cam resection by hip arthroscopy.
Control Group	PET-MRI	This group will consist of a matched cohort of control participants.
Control Group	Motion Analysis	This group will consist of a matched cohort of control participants.
Control Group	3T MRI	This group will consist of a matched cohort of control participants.
Cam Group	3T MRI	This group will consist of patients that are scheduled for surgery to undergo cam resection by hip arthroscopy.
Control Group	Patient Reported Questionnaires	This group will consist of a matched cohort of control participants.
Control Group	EOS Scan	This group will consist of a matched cohort of control participants.

Primary Outcome Measures

Name	Time	Method
Assessment of [18F]-NaF as a biomarker of hip degeneration	24 months	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.

Secondary Outcome Measures

Name	Time	Method
Change in N-terminal cross-linking telopeptide of type I collagen (NTX-1)	24 months	Determine the change in bone turnover plasma biomarker levels (N-terminal cross-linking telopeptide of type I collagen (NTX-1)) two years after surgical correction of a symptomatic cam deformity.
Change in N-terminal pro-peptide of type I procollagen (PINP)	24 months	Determine the change in bone turnover serum biomarker levels (N-terminal pro-peptide of type I procollagen (PINP)), measured by the ELISA kit, two years after surgical correction of a symptomatic cam deformity.
Change in cartilage oligomeric matrix protein (COMP)	24 months	Determine the change in serum biomarker levels (cartilage oligomeric matrix protein (COMP)), measured by the ELISA kit, two years after surgical correction of a symptomatic cam deformity.
Muscle Activity	24 months	Retro-reflective markers will be placed on each participant in a laboratory setting. Electromyography (EMG) electrodes will be placed over the following muscles: rectus femoris, vastus medialis, vastus lateralis, tensor fascia latea, biceps femoris, semitendinosus, gluteus medius and gluteus maximus. Muscle activity will be measured using EMG signal recorded during maximum voluntary isometric contraction.
Change in iHot-33 score	24 months	The International Hip Outcome Tool (iHOT-33 is a questionnaire that evaluates young active patients with early hip disease. The questionnaire is self-administered and assesses across 4 domains: symptoms and functional limitations; sport and recreational activities; job-related concerns; and social, emotional, and lifestyle concerns. Questions are answered by marking a visual analog scale between 2 anchor statements (100-mm scale). The total score is calculated as a simple mean of these responses ranging from 0 to 100, with 100 representing the best possible quality-of-life score.
Change in EQ-5D-5L score	24 months	This questionnaire assesses generic health status. Each question is scored from 1-5, with 1 being no problems and 5 being severe problems. These scores are not aggregated. There are 5 domains: mobility, self-care, usual activities, pain and anxiety. The final question is asking the participant to self score their health that day out of 100 (0 being the worst health and 100 being the best health).
Change in PET-MRI (SUV/T1Rho)	24 months	Determine the change in PET-MRI (SUV/T1Rho) two years after surgical correction of a symptomatic cam deformity to discern disease state.
qCT (Low Dose Computed Tomography)	Within 2 months after recruitment	Used to measure bone mineral density (mass of mineral per volume of bone) in the subchondral bone. Negative scores indicate lower bone density, and positive scores indicate higher.
Change in C-reactive protein (CRP)	24 months	Determine the change in serum biomarker levels (C-reactive protein (CRP)), measured by the ELISA kit, two years after surgical correction of a symptomatic cam deformity.
Change in carboxy-terminal collagen crosslinks (CTx)	24 months	Determine the change in bone turnover plasma biomarker levels (carboxy-terminal collagen crosslinks (CTx)), measured by the ELISA kit, two years after surgical correction of a symptomatic cam deformity.
Change in Hip Disability and Osteoarthritis Outcome Score (HOOS) score	24 months	Hip-specific symptoms and functional impairment will be compared using the Hip Disability and Osteoarthritis Outcome Score (HOOS). This 40-item patient reported outcome tool has 5 categories: pain, symptoms, daily living, quality of life, sports and recreational activities. Each category is scored on 100 points, 0 being the worse outcome and 100 the best outcome.
Joint Kinematics to predict hip contact forces	24 months	Retro-reflective markers will be placed on each participant in a laboratory setting. Joint kinematics will be reconstructed from marker trajectories recorded by a 10- camera system (Vicon Vantage \& Vicon Vero, Oxford, UK; frequency 200 Hz). Together, with joint kinetics, the investigators will predict hip contact forces.
Change in type II collagen telopeptide (CTX-II)	24 months	Determine the change in urine biomarker levels (type II collagen telopeptide (CTX-II), measured by the ELISA kit, two years after surgical correction of a symptomatic cam deformity.
Joint kinetics to predict hip contact forces	24 months	Retro-reflective markers will be placed on each participant in a laboratory setting. Force platforms will record kinetic data. Together, with joint kinetics, the investigators will predict hip contact forces.

Trial Locations

Locations (1)

The Ottawa Hospital; 🇨🇦 Ottawa, Ontario, Canada