Clinical Trial of Concomitant Hip Arthroscopy During PAO

NCT03181048 | Recruiting

• 1 other identifier: 17-001014
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip Dysplasia

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Periacetabular osteotomy

EXPERIMENTAL

Standard periacetabular osteotomy on the day of surgery.

Procedure: Periacetabular osteotomy

Periacetabular osteotomy with hip arthroscopy

ACTIVE COMPARATOR

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

Procedure: Periacetabular osteotomy with hip arthroscopy

Interventions

Periacetabular osteotomy PROCEDURE

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.

Periacetabular osteotomy

Periacetabular osteotomy with hip arthroscopy PROCEDURE

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.

Periacetabular osteotomy with hip arthroscopy

Eligibility Criteria

• Age: 15 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Hip Dislocation

Condition Hierarchy (Ancestors)

Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Hip Injuries

Study Officials

• Rafael Sierra, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cody Wyles, MD

CONTACT

(507) 284-1175; wyles.cody@mayo.edu

Lauren Cole

CONTACT

507-266-1227; cole.lauren@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients will be randomized in a 1:1 fashion. The first arm will be the "PAO alone" group who will receive a standard periacetabular osteotomy (PAO) on the day of surgery. The second arm will be the "PAO + HA" group who will receive a PAO and hip arthroscopy (HA) on the day of surgery. Any pathology if present that can be corrected with the arthroscope (cartilage and labral abnormalities) will be addressed. This will be followed by a standard PAO. Patients from both groups will have dressings placed in the location of hip arthroscopy portals to remain blinded to the treatment arm during the perioperative period. Only patients in the PAO + HA group will have incisions and sutures under these dressings. The dressings will come off for all patients after 2 weeks, which is standard of care. All other study team members will remain unblinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Orthopedics

Study Record Dates

• First Submitted: June 6, 2017
• First Posted: June 8, 2017
• Study Start: August 23, 2017
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: September 5, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)