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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a surgical treatment for individuals with hip pain caused by a cam deformity, which can lead to osteoarthritis (OA). The trial aims to determine if surgically removing the cam deformity improves hip function and reduces pain. Participants in the experimental group will undergo surgery, while the control group will not. Ideal participants have experienced hip pain for more than six months but do not yet have arthritis. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to potentially improve their hip function and reduce pain.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this surgical treatment is safe for femoroacetabular impingement?

Research shows that surgery for femoroacetabular impingement, a condition where the hip joint is not shaped correctly, is generally safe. Studies have found a low risk of major problems during or after the surgery. For instance, one study found that complications were rare, indicating that most people handle the surgery well.

Patients who have undergone arthroscopic surgery, a less invasive procedure using small cuts and a camera, reported significant improvements in hip function and daily activities. This suggests the surgery is not only safe but also enhances mobility and well-being.

Overall, past patients experienced good results, with improved symptoms and few serious issues. This indicates that the surgery is both effective and relatively safe. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about the surgical treatment for femoroacetabular impingement (FAI) because it focuses on cam resection through hip arthroscopy, which can offer a more precise and less invasive option compared to traditional open surgery. This technique allows surgeons to shave down the bony growths causing the impingement with minimal damage to surrounding tissues, potentially leading to quicker recovery times and less post-operative pain. Unlike standard treatments that might involve more invasive procedures or rely on physical therapy alone, this arthroscopic approach aims to directly address the structural cause of FAI, providing relief and improving joint function more effectively.

What evidence suggests that surgical treatment might be an effective treatment for osteoarthritis?

Research has shown that surgery for femoroacetabular impingement (FAI) can greatly improve hip function and reduce pain. One study found that this surgery successfully preserved the hip joint in 90.4% of patients over ten years. Patients who underwent the surgery experienced significant improvements in daily activities and sports, with their scores increasing by 27.57 and 14.79 points, respectively. In this trial, participants in the Cam Group will undergo cam resection by hip arthroscopy, a minimally invasive approach that usually leads to fewer complications and faster recovery. These findings suggest that removing the cam deformity through surgery can effectively address problems caused by FAI and may help prevent osteoarthritis. ^{1 2 3 6 7}

Who Is on the Research Team?

Paul Beaule, MD, FRCSC

Principal Investigator

The Ottawa Hospital Research Institute

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9626869/

Ten-year outcome following surgical treatment of ... Conclusion. FAI surgery provides lasting improvement in function and a joint preservation rate of 90.4% at ten years. The evolution of practice ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2806979/

Surgical Treatment of Femoroacetabular Impingement Studies with clinical outcome data and minimum two year followup were analyzed. Eleven studies met our criteria for inclusion. Nine were Level IV and two were ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2059775424002098

Clinical outcomes of arthroscopic surgical intervention in ... The results showed that patients who received arthroscopic surgical intervention had a significant improvement of 27.57 and14.79 in HOS-SS and HOS-ADL scores, ...

4. bmcmusculoskeletdisord.biomedcentral.com bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/s12891-025-08299-3

A meta-analysis of the effectiveness and side effects of hip ... The results showed that the arthroscopic approach had fewer complications and a faster recovery rate. Recently, some controlled clinical trials ...

5. jospt.org jospt.org/doi/10.2519/jospt.2016.0605

Femoroacetabular Impingement Surgery Is on the Rise— ... Surgical treatment for FAI has produced some early promising results. ... However, the evidence from these studies is mostly level 4 (low level), ...

6. bcbsm.com bcbsm.com/amslibs/content/dam/public/mpr/mprsearch/pdf/2018254.pdf

MEDICAL POLICY The objective of surgical treatment of femoroacetabular impingement is to provide symptom relief and reduce further joint damage. Comparators.

7. aetna.com aetna.com/cpb/medical/data/700_799/0736.html

Femoro-Acetabular Surgery for Hip Impingement Syndrome At a minimum follow-up of 1.3 years (average, 2.3 years; range, 1.3 to 4.1 years), all clinical outcome measures improved. Nine patients (8.6%) underwent total ...