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NCT Number: NCT03181048

Clinical Trial of Concomitant Hip Arthroscopy During PAO

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.

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Key information

Conditions

Hip Dysplasia Hip Dislocation Hip Injuries Joint Diseases Joint Dislocations Musculoskeletal Diseases Wounds and Injuries

Age range

15 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Location contact

Cody Wyles, MD

CONTACT

[email protected]

507-284-1175

Rafael Sierra, MD

PRINCIPAL_INVESTIGATOR

About this study

There are currently no absolute indications for intraarticular assessment at the time of periacetabular osteotomy (PAO). Based on investigators' review of the literature and experience, patients who may benefit from intraarticular assessment are those with radiographic or MRI evidence of damage where an intraarticular inspection may help in determining whether a PAO is a reasonable procedure, those with mechanical symptoms likely related to labral pathology, round ligament or cartilage problems and those with hip dysplasia and cam deformities with limited range of motion that may benefit from femoral head neck junction osteochondroplasty. However, despite these relative indications today there is no clear evidence to suggest that these patients will do better than those that do not have intraarticular work done. Hence, the objective of this project is to determine whether intraarticular work at the time of PAO surgery leads to improved pain and function when compared to patients that do not undergo intraarticular work at the time of PAO.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of hip dysplasia (DDH) electing periacetabular osteotomy (PAO) for treatment
  • Skeletally mature
  • Age 15 - 55
  • Tonnis Grade 0 or 1 osteoarthritis (minimal or no arthritis)
  • Ability to receive a standard of care preoperative (magnetic resonance imaging) MRI arthrogram of the hip

Exclusion criteria

  • Pregnant women
  • Previous surgery about the hip
  • Patients receiving PAO for acetabular retroversion in the absence of DDH
  • Previous hip arthroscopy to address intra-articular pathology

Treatment and study plan

Periacetabular osteotomy

Procedure

The Bernese periacetabular osteotomy has become the osteotomy of choice in North America for correction of the dysplastic hip. The ability to position the acetabular component in a specifically desired position for each individual patient improves joint biomechanics, restores joint balance and stability, and offloads the structures at risk for damage such as the labrum and the adjacent articular cartilage.

Periacetabular osteotomy with hip arthroscopy

Procedure

An intraarticular assessment with hip arthroscopy (HA) at the time of periacetabular osteotomy allows the surgeon to assess and treat the associated labral and chondral pathology and allows the surgeon to treat abnormalities of the femoral head junction.

Primary outcomes

  1. Mean score of Hip Disability and Osteoarthritis Outcome (Hoos)

    Time frame: 1 year follow-up time point

    Score ranges from 0-100 with higher scores representing better function.

  2. Mean score of Western Ontario and McMaster Universities Arthritis Index (WOMAC)

    Time frame: 1 year follow-up time point

    The scores range from 0-4 in 24 different categories that are broken up into three subcategories: pain, stiffness and physical function.

  3. Mean score of University California Los Angeles (UCLA) activity assessment

    Time frame: 1 year follow-up time point

    Measured on a 1-10 scale: 1) wholly inactive, dependent on others; 2) mostly inactive, restricted to minimal activities of daily living; 3) sometimes participate in mild activities such as walking, limited housework, or shopping; 4) regularly participate in mild activities; 5) sometimes participate in moderate activities such as swimming and unlimited housework or shopping; 6) regularly participate in moderate activities; 7) regularly participate in active events such as bicycling; 8) regularly participate in very active events such as bowling or golf; 9) sometimes participate in impact sports such as jogging, tennis, or skiing, or heavy labor; and 10) regularly participate in impact sports.

  4. Mean score of the Marx Activity Scale (MARX)

    Time frame: 1 year follow-up time point

    Score is measured from 0-4.

Study contacts

Contact information is provided by the study sponsor or research team.

Cody Wyles, MD

CONTACT

[email protected]

(507) 284-1175

Lauren Cole

CONTACT

[email protected]

507-266-1227

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Single-Blind Randomized Clinical Trial of Concomitant Hip Arthroscopy During Periacetabular Osteotomy for the Management of Hip Dysplasia

Important dates

Study start
2017
Primary completion
2028
Study completion
2028
First posted
Jun 8, 2017
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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