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RecruitingNCT03181048Updated Sep 11, 2026

Clinical Trial of Concomitant Hip Arthroscopy During PAO

An interventional study of Periacetabular osteotomy and Periacetabular osteotomy with hip arthroscopy in Hip Dysplasia, sponsored by Mayo Clinic. Recruiting at 1 site in United States. Open to participants aged 15 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-09-11.

Sponsored by Mayo Clinic · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
106
Allocation
Randomized
Ages
15 Years to 55 Years
Sex
All
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Study summary

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.

Read the detailed description

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.

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Conditions studied

  • Hip Dysplasia

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Who can participate

Ages eligible
15 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
106 participants (estimated)

Study arms

  • Experimental
    Periacetabular osteotomy

    Standard periacetabular osteotomy on the day of surgery.

    Procedure: Periacetabular osteotomy

  • Active comparator
    Periacetabular osteotomy with hip arthroscopy

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

    Procedure: Periacetabular osteotomy with hip arthroscopy

Interventions

  • ProcedurePeriacetabular osteotomy

    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.

  • ProcedurePeriacetabular osteotomy with hip arthroscopy

    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.

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What researchers measure

Primary outcomes

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

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

    Time frame: 1 year follow-up time point

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

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

    Time frame: 1 year follow-up time point

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

    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.

    Time frame: 1 year follow-up time point

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

    Score is measured from 0-4.

    Time frame: 1 year follow-up time point

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Study locations

1 of 1 sites recruiting
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
    • Cody Wyles, MD · Contact · wyles.cody@mayo.edu · (507) 284-1175
    • Rafael Sierra, MD · Principal investigator
    Recruiting
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References and documents

Individual participant data

Plan to share: No — Only study personnel authorized by the investigator will collect data/enroll subjects. Data will be stored in electronic files and/or a cabinet, with access to study personnel as authorized by the investigator. The investigator will review the data on a regular basis (at least annually) to verify the validity of the data.

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Registry details

Key details

Study ID
NCT03181048
Lead sponsor
Mayo Clinic
Responsible party
Rafael J. Sierra, M.D. (Professor of Orthopedics, Mayo Clinic) — Principal investigator
First posted
Jun 8, 2017
Start date
Aug 23, 2017
Primary completion
Jun 2028 (estimated)
Completion
Jun 2028 (estimated)
Last update
Sep 11, 2026

Study contacts

Cody Wyles, MD
Contact
wyles.cody@mayo.edu
(507) 284-1175
Lauren Cole
Contact
cole.lauren@mayo.edu
507-266-1227
Rafael Sierra, MD
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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