PAO With vs Without Arthroscopy for Hip Dysplasia

Recruiting at 7 trial locations

Overseen By Geoffrey Wilkin, MD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Ottawa Hospital Research Institute

Disqualifiers: Arthritis, Connective tissue, Neuromuscular, others

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

Compensation: Varies

Number of Visits: 3

Duration: Intra-operative

204 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if adding hip arthroscopy (a procedure using a camera to examine the joint) to a PAO (a surgery to correct hip dysplasia) results in better outcomes than performing the PAO alone. Individuals with hip dysplasia who have been advised to undergo surgery and can have an MRI (a type of scan) before surgery might qualify. The trial will randomly assign participants to receive either only the PAO or both the PAO and hip arthroscopy. As an unphased trial, this study provides participants the chance to contribute to important research that could enhance surgical outcomes for future patients.

Do I need to stop my current medications for the trial?

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that combining PAO (periacetabular osteotomy) with hip arthroscopy is generally well-tolerated. Studies indicate that complications from PAO occur in 0% to 7.8% of cases, suggesting it is relatively safe for most patients.

One study examined results five years after combining hip arthroscopy with PAO and found the procedure effective, with patients reporting positive outcomes. However, 2% to 11% of patients might require another hip arthroscopy after the initial PAO.

Overall, these combined surgeries are manageable for most people, though some may need further treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for hip dysplasia because they explore different surgical approaches to improve patient outcomes. Periacetabular osteotomy (PAO) is a well-established procedure for this condition, but the addition of hip arthroscopy is a relatively new approach that might enhance surgical precision and address additional hip issues concurrently. The PAO with hip arthroscopy could potentially result in better joint preservation and less post-operative pain, as it allows for direct visual and surgical access inside the joint. By comparing PAO with and without hip arthroscopy, this research aims to refine treatment strategies and possibly offer a more comprehensive solution for patients with hip dysplasia.

What evidence suggests that this trial's treatments could be effective for hip dysplasia?

This trial will compare the outcomes of two surgical approaches for treating hip dysplasia: PAO with hip arthroscopy and PAO without hip arthroscopy. Research suggests that combining these procedures might offer long-term benefits. Specifically, studies have shown that patients who underwent both procedures reported symptom improvements lasting up to five years. However, other research did not find a significant difference in results when adding hip arthroscopy to PAO compared to PAO alone. Some experts believe that performing both procedures can relieve symptoms in certain cases of hip dysplasia. Overall, while evidence supports the effectiveness of combining these procedures, results can vary, and more research is needed to fully understand the benefits. ^{1 2 5 6 7}

Who Is on the Research Team?

Geoffrey Wilkin, MD

Principal Investigator

The Ottawa Hospital Research Institute

Are You a Good Fit for This Trial?

This trial is for individuals aged 16-50 who can consent to treatment, have mature skeletons, and are undergoing surgery for hip instability due to acetabular dysplasia. They must be able to attend all follow-ups and complete questionnaires. Those with advanced arthritis, cognitive impairments, previous hip surgeries or certain genetic disorders cannot participate.

Inclusion Criteria

I understand the details of the clinical trial and can agree to participate.

Pre-Operative MRI at 3T and/or gadolinium MR arthrogram

I am between 16 and 50 years old.

Exclusion Criteria

I have had hip replacement surgery before.

Patient unable/unwilling to complete all required follow-up visits

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either a periacetabular osteotomy (PAO) alone or a PAO with hip arthroscopy

Intra-operative

1 visit (in-person)

Post-operative Recovery

Participants recover from surgery and are monitored for adverse events and hospital length of stay

up to 1 month

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 6, 12, and 24 months

24 months

Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• PAO with hip arthroscopy
• PAO without hip arthroscopy

Trial Overview The study aims to determine if adding a hip arthroscopy procedure at the same time as a periacetabular osteotomy (PAO) leads to better outcomes than PAO alone. Patients will be randomly assigned to either just receive PAO or both PAO and hip arthroscopy.

How Is the Trial Designed?

Group I: PAO with hip arthroscopy Experimental Treatment 1 Intervention

Patient's in the "Scope PAO" group have been diagnosed with hip dysplasia and a decision has been made between the patient and the surgeon that the best way to treat the hip problems is with surgery. Patient's in the "Scope-PAO" group have been randomized to receive a periacetabular osteotomy with a hip arthroscopy.

Group II: PAO without hip arthroscopy Active Control 1 Intervention

Patient's in the "PAO-only" group have been diagnosed with hip dysplasia and a decision has been made between the patient and the surgeon that the best way to treat the hip problems is with surgery. Patient's in the "PAO-only" group have been randomized to receive a periacetabular osteotomy only.

Who Is Running the Clinical Trial?

Ottawa Hospital Research Institute

Lead Sponsor

Trials

585

Recruited

3,283,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11973426/

Comparing outcomes of hip arthroscopy and ... Both PAO and HA studies demonstrated significant improvement in PROs. Complication rates in PAO patients ranged from 0% to 7.8% compared to 0% ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2666061X25002160

Durable Mid-Term Outcomes and High Rates of Clinically ... Concomitant hip arthroscopy and PAO is an effective procedure with durable 5-year outcomes. Patients demonstrated sustained improvements and ...

3. arthroplastyjournal.org arthroplastyjournal.org/article/S0883-5403(24)00482-0/fulltext

The Otto Aufranc Award: Does Hip Arthroscopy at the Time ... This randomized controlled trial has failed to show any significant clinical benefit in performing hip arthroscopy at the time of the PAO at 1- ...

4. esskajournals.onlinelibrary.wiley.com esskajournals.onlinelibrary.wiley.com/doi/10.1002/jeo2.70311

Periacetabular osteotomy versus hip arthroscopy in patients ... Three systematic reviews evaluated outcomes of HAS and PAO for BDDH. Barton et al. [3] focused on hip arthroscopy outcomes in 505 patients, ...

5. arthroscopyjournal.org arthroscopyjournal.org/article/S0749-8063(25)00004-0/fulltext

Editorial Commentary: Indications for Performing Hip ... This study adds to the repository of data showing that scope/PAO is effective in alleviating symptoms in hip dysplasia. 4. Lee, M.S. ...

6. academic.oup.com academic.oup.com/jhps/article/11/3/198/7642287

Clinical outcomes after hip arthroscopy in acetabular ... The risk of additional hip arthroscopy after the PAO procedure has been reported between 2% and 11% [3–5]. Hartig-Andreasen et al. [6] ...

7. arthroscopyjournal.org arthroscopyjournal.org/article/S0749-8063(23)00197-4/abstract

Patient-Reported Outcomes Are Similar in the First 2 Years ... Staged hip arthroscopy and PAO for hip dysplasia leads to similar PROs at 12-24 months compared to combined procedures. This suggests that ...