Hip Arthroscopy with Periacetabular Osteotomy for Hip Dysplasia

Overseen By Lauren Cole

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Pregnancy, Previous hip surgery, others

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

Compensation: Varies

Number of Visits: 1

106 Participants Needed

Trial Summary

What is the purpose of this trial?

The study will assess the outcomes of patients treated with concomitant hip arthroscopy at the time of periacetabular osteotomy (PAO) for patients with hip dysplasia compared with patients treated with PAO alone.

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.

What data supports the effectiveness of the treatment Periacetabular osteotomy combined with hip arthroscopy for hip dysplasia?

Research shows that the Bernese periacetabular osteotomy (PAO) is effective for treating hip dysplasia by reorienting the hip socket, and combining it with hip arthroscopy can address additional hip joint issues. Studies have reported positive intermediate-term outcomes and patient satisfaction with this combined approach. ^{1 2 3 4 5}

Is hip arthroscopy with periacetabular osteotomy generally safe for humans?

Periacetabular osteotomy (PAO), including its combination with hip arthroscopy, is generally considered safe, but there are some risks. Studies have reported complications such as femoroacetabular impingement (a condition where bones in the hip joint rub against each other) and other surgical risks, which can vary based on the surgical approach used. ^{1 2 6 7 8}

How does the treatment of hip arthroscopy with periacetabular osteotomy for hip dysplasia differ from other treatments?

This treatment is unique because it combines hip arthroscopy (a minimally invasive procedure to look inside the joint) with periacetabular osteotomy (a surgery to correct the hip socket's position) to address both the bone structure and any joint issues in patients with hip dysplasia, offering a comprehensive approach to treatment. ^{1 3 4 5 9}

Research Team

Rafael Sierra, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for individuals aged 15-55 with hip dysplasia, specifically Developmental Dysplasia of the Hip (DDH), who are skeletally mature and have minimal or no arthritis. They must be able to undergo a preoperative MRI arthrogram of the hip. Pregnant women, those with previous hip surgeries, or patients treated for acetabular retroversion without DDH cannot participate.

Inclusion Criteria

I have hip dysplasia and am choosing surgery (PAO) for treatment.

My arthritis is mild or nonexistent.

My bones have stopped growing.

Exclusion Criteria

I am getting PAO surgery for hip socket misalignment without having developmental hip dysplasia.

I have had hip surgery to treat joint problems.

I have had surgery on my hip before.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo periacetabular osteotomy with or without hip arthroscopy

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after surgery

1 year

Multiple visits (in-person)

Treatment Details

Interventions

• Periacetabular osteotomy
• Periacetabular osteotomy with hip arthroscopy

Trial Overview The study compares two treatments for hip dysplasia: one group will receive Periacetabular Osteotomy (PAO) alone, while another group will get PAO combined with hip arthroscopy. The goal is to see which treatment leads to better outcomes in terms of joint function and pain relief.

Participant Groups

Group I: Periacetabular osteotomy Experimental Treatment 1 Intervention

Standard periacetabular osteotomy on the day of surgery.

Group II: Periacetabular osteotomy with hip arthroscopy Active Control 1 Intervention

Hip arthroscopy on the day of surgery, followed by a standard periacetabular osteotomy.

Periacetabular osteotomy is already approved in European Union, United States, Switzerland for the following indications:

Approved in European Union as PAO for:

• Hip dysplasia
• Developmental dysplasia of the hip (DDH)
• Femoroacetabular impingement (FAI)

Approved in United States as PAO for:

• Hip dysplasia
• DDH
• FAI
• Labral tears

Approved in Switzerland as PAO for:

• Hip dysplasia
• DDH
• FAI

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Findings from Research

In a review of 40 studies involving 4070 hips, Bernese periacetabular osteotomy (PAO) showed good to excellent outcomes in 82% of cases, with a lower complication rate of 7% compared to previous reports.

Minimally invasive surgical approaches, such as the modified Smith-Petersen and trans-sartorial techniques, were associated with significantly reduced rates of nerve injuries and major wound complications, making them preferable options for this procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications and outcome after periacetabular osteotomy - influence of surgical approach. Ali, M., Malviya, A.[2022]

The Bernese periacetabular osteotomy (PAO) showed a high hip survival rate of 92% at 15 years post-surgery, indicating its effectiveness as a treatment for symptomatic acetabular dysplasia in 154 hips evaluated after an average of 10.3 years.

Factors such as fair or poor preoperative joint congruency and excessive postoperative femoral head coverage increased the risk of failure, while performing a concurrent head-neck osteochondroplasty reduced this risk, highlighting important considerations for surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intermediate-Term Hip Survivorship and Patient-Reported Outcomes of Periacetabular Osteotomy: The Washington University Experience. Wells, J., Schoenecker, P., Duncan, S., et al.[2022]

In a study of 17 patients undergoing simultaneous hip arthroscopy and periacetabular osteotomy (PAO) for acetabular dysplasia, 82% achieved excellent outcomes with significant improvements in pain and function over an average follow-up of 2.4 years.

All patients had chondrolabral damage, which was treated during the procedure, and no patients required conversion to total hip arthroplasty or revision surgery, indicating that this combined approach is both effective and safe.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Concomitant Hip Arthroscopy and Periacetabular Osteotomy. Domb, BG., LaReau, JM., Hammarstedt, JE., et al.[2022]

The study presents a refined two-surgeon technique for performing combined hip arthroscopy and periacetabular osteotomy (PAO) to treat adults with acetabular dysplasia and intra-articular hip issues, emphasizing a muscle-sparing approach.

Intra-abdominal pressure monitoring during the procedure helps detect potential complications like abdominal compartment syndrome, enhancing patient safety during this complex surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined Surgical Approach to Young Adults with Hip Dysplasia and Concomitant Intra-Articular Pathology Using Intra-Abdominal Monitoring. Wetzel, RJ., Joseph, NM., Knapik, DM., et al.[2021]

In a systematic review of 775 patients undergoing periacetabular osteotomy (PAO), it was found that labral tears were significantly more prevalent when evaluated with arthroscopy (84%) compared to open arthrotomy (21%), highlighting the importance of using arthroscopy for better detection of intra-articular injuries.

The study also revealed a high prevalence of chondral injuries, with 73% of acetabular and 27% of femoral chondral injuries identified during arthroscopy, suggesting that addressing these injuries may be crucial for improving patient outcomes after PAO.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The prevalence of hip labral and chondral lesions identified by method of detection during periacetabular osteotomy: arthroscopy versus arthrotomy. Redmond, JM., Gupta, A., Stake, CE., et al.[2022]

In a study of 38 males who underwent 46 Bernese periacetabular osteotomies (PAO), the incidence of clinical signs of femoroacetabular impingement (FAI) increased postoperatively, with 47.8% of hips showing positive impingement signs after surgery compared to 41.3% preoperatively.

Despite improvements in radiographic parameters and WOMAC scores indicating better function and less pain, the high rate of postoperative FAI signs suggests that PAO may not fully resolve symptoms related to hip impingement in male patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bernese periacetabular osteotomy in males: is there an increased risk of femoroacetabular impingement (FAI) after Bernese periacetabular osteotomy? Ziebarth, K., Balakumar, J., Domayer, S., et al.[2021]

In a study of 66 hips from 59 patients who underwent Bernese periacetabular osteotomy (PAO) for developmental dysplasia of the hip (DDH), significant improvements in patient-reported outcomes were observed after an average follow-up of 3.01 years.

The study identified that a postoperative lateral center-edge angle (LCEA) greater than 38° increases the likelihood of adverse outcomes, while a Tönnis angle between -10° and 0° serves as a protective factor, highlighting the importance of precise surgical angles for optimal recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The association the patient-reported outcomes after periacetabular osteotomy with radiographic features: a short-term retrospective study. Fan, Y., Li, W., Wu, Y., et al.[2023]

Periacetabular osteotomy (PAO) for hip dysplasia has a 4% risk of major adverse events and a 14% risk of minor adverse events, with peroneal nerve dysfunction being the most common major complication.

Despite the risks, PAO significantly improves patient-reported hip pain and function, with benefits lasting at least 5 years post-surgery, exceeding the minimal clinically important differences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Periacetabular osteotomy to treat hip dysplasia: a systematic review of harms and benefits. Tønning, LU., O'Brien, M., Semciw, A., et al.[2023]

In a study of 16 patients (17 hips) with hip dysplasia undergoing periacetabular osteotomy (PAO) and arthroscopy, significant intraarticular pathology was found in all cases, including labral tears and chondral injuries.

The findings revealed that 14 hips had anterosuperior labral tears, 11 hips had femoral cam-type lesions, and 16 hips had articular chondral injuries, highlighting the importance of assessing intraarticular conditions before PAO.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is intraarticular pathology common in patients with hip dysplasia undergoing periacetabular osteotomy? Domb, BG., Lareau, JM., Baydoun, H., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Complications and outcome after periacetabular osteotomy - influence of surgical approach. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Intermediate-Term Hip Survivorship and Patient-Reported Outcomes of Periacetabular Osteotomy: The Washington University Experience. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Concomitant Hip Arthroscopy and Periacetabular Osteotomy. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Combined Surgical Approach to Young Adults with Hip Dysplasia and Concomitant Intra-Articular Pathology Using Intra-Abdominal Monitoring. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

The prevalence of hip labral and chondral lesions identified by method of detection during periacetabular osteotomy: arthroscopy versus arthrotomy. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Bernese periacetabular osteotomy in males: is there an increased risk of femoroacetabular impingement (FAI) after Bernese periacetabular osteotomy? [2021]

7. England pubmed.ncbi.nlm.nih.gov

The association the patient-reported outcomes after periacetabular osteotomy with radiographic features: a short-term retrospective study. [2023]

8. Germany pubmed.ncbi.nlm.nih.gov

Periacetabular osteotomy to treat hip dysplasia: a systematic review of harms and benefits. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Is intraarticular pathology common in patients with hip dysplasia undergoing periacetabular osteotomy? [2022]