Clinical Trial of Concomitant Hip Arthroscopy During PAO

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hip Dysplasia
• Intervention / Treatment: Procedure: Periacetabular osteotomy; Procedure: Periacetabular osteotomy with hip arthroscopy

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.

• Study Type: Interventional
• Enrollment (Estimated): 106
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cody Wyles, MD; Phone Number: (507) 284-1175; Email: wyles.cody@mayo.edu
• Study Contact Backup: Name: Lauren Cole; Phone Number: 507-266-1227; Email: cole.lauren@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic
      • Contact: Cody Wyles, MD; Phone Number: 507-284-1175; Email: wyles.cody@mayo.edu
      • Principal Investigator: Rafael Sierra, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 55 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Periacetabular osteotomy; Standard periacetabular osteotomy on the day of surgery.	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.
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean score of Hip Disability and Osteoarthritis Outcome (Hoos)	Score ranges from 0-100 with higher scores representing better function.	1 year follow-up time point
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.	1 year follow-up time point
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.	1 year follow-up time point
Mean score of the Marx Activity Scale (MARX)	Score is measured from 0-4.	1 year follow-up time point

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Rafael Sierra, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2017
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: June 6, 2017
• First Submitted That Met QC Criteria: June 7, 2017
• First Posted (Actual): June 8, 2017

Study Record Updates

• Last Update Posted (Actual): August 29, 2023
• Last Update Submitted That Met QC Criteria: August 26, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Congenital Abnormalities; Joint Diseases; Musculoskeletal Diseases; Hip Injuries; Musculoskeletal Abnormalities; Joint Dislocations; Hip Dislocation; Developmental Dysplasia of the Hip; Hip Dislocation, Congenital
• Other Study ID Numbers: 17-001014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No