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Clinical Trial of Concomitant Hip Arthroscopy During PAO

Not Applicable
Recruiting
Conditions
Hip Dysplasia
Interventions
Procedure: Periacetabular osteotomy with hip arthroscopy
Procedure: Periacetabular osteotomy
Registration Number
NCT03181048
Lead Sponsor
Mayo Clinic
Brief 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.

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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
106
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Periacetabular osteotomy with hip arthroscopyPeriacetabular osteotomy with hip arthroscopyHip arthroscopy on the day of surgery, followed by a standard periacetabular osteotomy.
Periacetabular osteotomyPeriacetabular osteotomyStandard periacetabular osteotomy on the day of surgery.
Primary Outcome Measures
NameTimeMethod
Mean score of University California Los Angeles (UCLA) activity assessment1 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.

Mean score of Hip Disability and Osteoarthritis Outcome (Hoos)1 year follow-up time point

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

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

Mean score of the Marx Activity Scale (MARX)1 year follow-up time point

Score is measured from 0-4.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Mayo Clinic

🇺🇸

Rochester, Minnesota, United States

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