Clinical Trial of Concomitant Hip Arthroscopy During PAO

Hip Dysplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03181048
• Other study ID #: 17-001014
• Status: Recruiting
• Phase: N/A
• Start date: August 23, 2017
• Est. completion date: June 2024

Study information

• Verified date: August 2023
• Source: Mayo Clinic
• Contact: Cody Wyles, MD
• Phone: (507) 284-1175
• Email: wyles.cody[@]mayo.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 106
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Developmental Dysplasia of the Hip
• Hip Dislocation
• Hip Dislocation, Congenital
• Hip Dysplasia

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Mean score of the Marx Activity Scale (MARX)	Score is measured from 0-4.	1 year follow-up time point

External Links

•   Mayo Clinic Clinical Trials