Surgical Treatment for Femoroacetabular Impingement

Overseen By Paul Beaule, MD, FRCSC

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Ottawa Hospital Research Institute

Disqualifiers: Joint replacement, Obesity, Parkinson's, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 24 months

58 Participants Needed

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.

Research Team

Paul Beaule, MD, FRCSC

Principal Investigator

The Ottawa Hospital Research Institute

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.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo surgical correction of symptomatic cam deformity and are assessed using PET-MRI and biomarkers

24 months

Regular visits for assessments and biomarker measurements

Follow-up

Participants are monitored for changes in biomarkers and joint health post-surgery

24 months

Treatment Details

Interventions

• Surgical Treatment

Trial Overview 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.

Participant Groups

Group I: Cam Group Experimental Treatment 7 Interventions

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

Group II: Control Group Active Control 7 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:

• Recurrent glioblastoma
• Brain tumors
• Neurological conditions

Approved in United States as Surgery for:

• Recurrent glioblastoma
• Brain tumors
• Neurological conditions

Approved in Canada as Surgery for:

• Recurrent glioblastoma
• Brain tumors
• Neurological conditions

Approved in Japan as Surgery for:

• Recurrent glioblastoma
• Brain tumors
• Neurological conditions

Approved in China as Surgery for:

• Recurrent glioblastoma
• Brain tumors
• Neurological conditions

Approved in Switzerland as Surgery for:

• Recurrent glioblastoma
• Brain tumors
• Neurological conditions

Who Is Running the Clinical Trial?

Ottawa Hospital Research Institute

Lead Sponsor

Trials

585

Recruited

3,283,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+