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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the best way to treat hip dysplasia, a condition where the hip joint doesn't fit snugly in its socket. Researchers are comparing two treatments: one group will receive a standard surgery called periacetabular osteotomy (PAO), while the other group will undergo an additional procedure called hip arthroscopy during the PAO surgery. The goal is to determine if adding hip arthroscopy leads to better outcomes. Individuals diagnosed with hip dysplasia and planning to have PAO surgery could be a good fit for this trial, especially if they have minimal or no arthritis and haven't had previous hip surgeries. As an unphased trial, this study offers a unique opportunity to contribute to understanding and improving treatment options for hip dysplasia.

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 prior data suggests that these surgical techniques are safe for treating hip dysplasia?

Research has shown that periacetabular osteotomy (PAO) is generally safe and can significantly improve hip function. One study found that the Harris Hip Score, which measures hip function, increased from 48 before surgery to 96 six months after. Approximately 5.11% of patients experienced complications, but only a few required additional treatment.

For PAO combined with hip arthroscopy, studies indicate it is also well-tolerated. Complication rates range from 0% to 7.8%, similar to PAO alone. This combined procedure has demonstrated lasting improvements in hip function over five years.

Overall, both treatments are considered relatively safe and lead to positive outcomes for most patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about combining hip arthroscopy with periacetabular osteotomy (PAO) for treating hip dysplasia because of its potential to address both joint issues and bone alignment in a single procedure. While standard treatments often focus solely on realigning the hip socket, this combination approach also allows for the direct treatment of soft tissue problems within the joint during the same surgery. This dual-action method could lead to better overall outcomes and quicker recovery times for patients by tackling multiple sources of pain and dysfunction at once.

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

Research has shown that periacetabular osteotomy (PAO) effectively treats hip dysplasia. It can help prevent hip arthritis and improve hip function. In one study, patients' hip health scores improved significantly, from 48 to 96, just six months after surgery.

This trial will compare two treatment approaches: one group will receive the standard PAO, while another group will undergo PAO combined with hip arthroscopy. Previous studies have shown good results when adding hip arthroscopy, a procedure to examine the joint, to PAO. These studies found that patients experienced better outcomes with the combined procedures and encountered few complications. Both treatments have shown promising results for people with hip dysplasia. ^{1 2 3 6 7}

Who Is on the Research Team?

Rafael Sierra, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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 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]

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 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 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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10614309/

The favorable outcome of Bernese periacetabular osteotomy ... Currently, the Bernese PAO has been recognized as an effective surgery to prevent secondary hip osteoarthritis in patients with hip dysplasia.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0011384025002102

Clinical Outcomes of 3D-Guided Ganz Periacetabular ... Mean preoperative Harris Hip Score (HHS) was 48, increasing to 92 at 3 months and 96 at 6 months postoperatively. At postoperative 6 months, 13 ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38407597/

Functional and radiological outcomes of periacetabular ... Minimally invasive periacetabular osteotomy is a safe procedure that provides significant functional outcome improvements following surgery at six months which ...

4. academic.oup.com academic.oup.com/jhps/advance-article/doi/10.1093/jhps/hnaf050/8240620

Short term-outcomes of periacetabular osteotomy in the ... In this cohort there was stable reduction of the hip in all but two patients (three hips), and effective pain management for this challenging ...

5. arthroplastyjournal.org arthroplastyjournal.org/article/S0883-5403(24)01088-X/abstract

What Are the Indications for Reconstructive Pelvic ... Complications and short-term patient outcomes of periacetabular osteotomy for symptomatic mild hip dysplasia. Hip Int. 2017; 27:42-48.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7260271/

Outcomes of computer-assisted peri-acetabular osteotomy ... Computer-assisted PAO not only improved accuracy and safety but also achieved sufficient anterior and lateral displacement to prevent the progression of DDH.

7. link.springer.com link.springer.com/article/10.1007/s00264-024-06094-8

Functional and radiological outcomes of periacetabular ... A total of 5.11% of patients developed post-operative complications, with four requiring posterior column fixation. Four patients (1.12%) needed ...