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Clinical Trials/NCT03181048
NCT03181048
Recruiting
Not Applicable

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

Mayo Clinic1 site in 1 country106 target enrollmentAugust 23, 2017
ConditionsHip Dysplasia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hip Dysplasia
Sponsor
Mayo Clinic
Enrollment
106
Locations
1
Primary Endpoint
Mean score of University California Los Angeles (UCLA) activity assessment
Status
Recruiting
Last Updated
7 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 23, 2017
End Date
June 1, 2028
Last Updated
7 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Rafael J. Sierra, M.D.

Professor of Orthopedics

Mayo Clinic

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

Outcomes

Primary Outcomes

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.

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.

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.

Mean score of the Marx Activity Scale (MARX)

Time Frame: 1 year follow-up time point

Score is measured from 0-4.

Study Sites (1)

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