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Procedure

Surgical Treatment for Femoroacetabular Impingement

Phase 2
Recruiting
Led By Paul Beaule, MD, FRCSC
Research Sponsored by Ottawa Hospital Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Skeletally mature patient undergoing cam resection by hip arthroscopy with hip pain longer than 6 months
Absence of arthritis (Tonnis Grade 0 or 1)
Must not have
Cognitive impairment that prevents accurate completion of patient-reported outcome questionnaires
Prior joint replacement surgery in any lower-limb joint due to OA
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
No Placebo-Only Group

Summary

This trial found that the cam deformity leads to the development of osteoarthritis if left untreated and that surgical treatment can improve function and reduce pain.

Who is the study for?
Adults over 18 with hip pain from cam deformity, no severe arthritis or dysplasia, and an alpha angle >55°. Must be able to attend study visits and not have blood diseases, implanted devices, extreme claustrophobia, obesity (BMI >30), or recent metal exposure. Pregnant or breastfeeding individuals are excluded.
What is being tested?
The trial is studying the effects of surgically removing a cam deformity in the hip to reduce pain and improve function. It involves MRI scans, motion analysis tests, CT scans for detailed imaging, as well as collecting blood/urine samples and patient questionnaires.
What are the potential side effects?
Potential side effects may include discomfort from diagnostic procedures like MRI or CT scans; allergic reactions to contrast materials used in imaging; soreness from blood draws; privacy risks due to data collection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had hip pain for over 6 months and am scheduled for a specific hip surgery.
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I do not have severe arthritis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have difficulty understanding or filling out questionnaires due to cognitive issues.
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I had a joint replacement in my leg because of arthritis.
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I have had a lower-limb or back injury in the past year that affects my ability to move.
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I have not been exposed to high levels of radiation in the past year.
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I have been diagnosed with Parkinson's or have uncontrollable tremors.
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I cannot or do not want to attend all the follow-up visits.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Assessment of [18F]-NaF as a biomarker of hip degeneration
Secondary study objectives
Body Weight Changes
Change in EQ-5D-5L score
Change in Hip Disability and Osteoarthritis Outcome Score (HOOS) score
+11 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Cam GroupExperimental Treatment7 Interventions
This group will consist of patients that are scheduled for surgery to undergo cam resection by hip arthroscopy.
Group II: Control GroupActive Control7 Interventions
This group will consist of a matched cohort of control participants.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
3T MRI
2016
N/A
~190
PET-MRI
2018
N/A
~100

Find a Location

Who is running the clinical trial?

Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,388 Previous Clinical Trials
26,518,026 Total Patients Enrolled
Ottawa Hospital Research InstituteLead Sponsor
575 Previous Clinical Trials
3,094,842 Total Patients Enrolled
Paul Beaule, MD, FRCSCPrincipal InvestigatorThe Ottawa Hospital Research Institute
2 Previous Clinical Trials
120 Total Patients Enrolled

Media Library

Surgical Treatment (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04080466 — Phase 2
Femoroacetabular Impingement Research Study Groups: Cam Group, Control Group
Femoroacetabular Impingement Clinical Trial 2023: Surgical Treatment Highlights & Side Effects. Trial Name: NCT04080466 — Phase 2
Surgical Treatment (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04080466 — Phase 2
~1 spots leftby Jan 2025
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