Surgical Treatment for Femoroacetabular Impingement

Recruiting in Palo Alto (17 mi)

Overseen byPaul Beaule, MD, FRCSC

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Ottawa Hospital Research Institute

No Placebo Group

Prior Safety Data

Approved in 6 Jurisdictions

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

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.

Inclusion Criteria

I am willing and able to attend all study visits and do the required tests.

I am over 18 years old.

I have had hip pain for over 6 months and am scheduled for a specific hip surgery.

+4 more

Exclusion Criteria

I have difficulty understanding or filling out questionnaires due to cognitive issues.

You have had metal or metal fragments in your eye.

I had a joint replacement in my leg because of arthritis.

+11 more

Participant Groups

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.

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.

Surgical Treatment is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

🇪🇺 Approved in European Union as Surgery for: