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Recruiting NCT03181048

Clinical Trial of Concomitant Hip Arthroscopy During PAO

No phase Interventional Hip Dysplasia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Periacetabular osteotomy, Periacetabular osteotomy with hip arthroscopy.
Who it may be relevant to
Registry conditions: Hip Dysplasia. Basic parameters: 15 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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.

Interventions

  • Procedure Periacetabular 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.
  • Procedure Periacetabular 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.

Primary outcome measures

  • Mean score of Hip Disability and Osteoarthritis Outcome (Hoos) [Time frame: 1 year follow-up time point]
  • Mean score of Western Ontario and McMaster Universities Arthritis Index (WOMAC) [Time frame: 1 year follow-up time point]
  • Mean score of University California Los Angeles (UCLA) activity assessment [Time frame: 1 year follow-up time point]
  • Mean score of the Marx Activity Scale (MARX) [Time frame: 1 year follow-up time point]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Mayo Clinic — Rochester

Identifiers

NCT: NCT03181048 · 17-001014

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗