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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I have had hip pain for over 6 months and am scheduled for a specific hip surgery.
Select...
I do not have severe arthritis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Assessment of [18F]-NaF as a biomarker of hip degeneration
Secondary outcome measures
Body Weight Changes
Change in EQ-5D-5L score
Change in Hip Disability and Osteoarthritis Outcome Score (HOOS) score
+11 moreTrial 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
1,344 Previous Clinical Trials
26,453,359 Total Patients Enrolled
Ottawa Hospital Research InstituteLead Sponsor
561 Previous Clinical Trials
2,785,633 Total Patients Enrolled
Paul Beaule, MD, FRCSCPrincipal InvestigatorThe Ottawa Hospital Research Institute
2 Previous Clinical Trials
120 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have difficulty understanding or filling out questionnaires due to cognitive issues.You have had metal or metal fragments in your eye.I am willing and able to attend all study visits and do the required tests.I had a joint replacement in my leg because of arthritis.I am over 18 years old.I have had a lower-limb or back injury in the past year that affects my ability to move.I have had hip pain for over 6 months and am scheduled for a specific hip surgery.I have not been exposed to high levels of radiation in the past year.My immediate family has a history of early onset arthritis.You have extreme fear or anxiety in small, enclosed spaces.I have been diagnosed with Parkinson's or have uncontrollable tremors.You have a metal implant in your body.I cannot or do not want to attend all the follow-up visits.I do not have severe arthritis.
Research Study Groups:
This trial has the following groups:- Group 1: Cam Group
- Group 2: Control Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the cap of participants in this research endeavor?
"Affirmative. Clinicaltrials.gov records show that this medical experiment, first posted on February 20th 2021, is presently recruiting participants. A total of 58 patients are needed from one site for the trial to be successful."
Answered by AI
Are recruiting efforts still underway for this clinical research?
"Confirmed. According to clinicaltrials.gov, the enrolment process for this experiment is still in progress after being initially published on February 20th 2021 and last modifiedon June 22nd 2021. 58 participants are needed from a single centre."
Answered by AI
What hazards, if any, are associated with PET-MRI tests?
"Our team has assigned PET-MRI a safety rating of 2 on our scale due to the lack of evidence for efficacy, though there is some existing data indicating its secure use."
Answered by AI
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