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Trials / Recruiting

RecruitingNCT03481010

Periacetabular Osteotomy With and Without Arthroscopic Management of Central Compartment Pathology

Periacetabular Osteotomy With and Without Arthroscopic Management of Central Compartment Pathology: A Multicenter Randomized Controlled Trial

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
204 (estimated)
Sponsor
Ottawa Hospital Research Institute · Academic / Other
Sex
All
Age
16 Years – 50 Years
Healthy volunteers
Not accepted

Summary

At present, it is not clear whether performing a hip arthroscopy at the same time as a PAO improves patient outcomes after surgery compared to a PAO alone. This research project will randomize patients to receive either a PAO alone, or a PAO and a hip arthroscopy at the same time.

Detailed description

Hip dysplasia is a developmental abnormality of the acetabulum (hip socket) that causes abnormal stresses inside the hip joint and leads to painful arthritis at a young age. Many patients develop painful symptoms in their hip before advanced arthritis occurs. The periacetabular osteotomy (PAO) is a surgical procedure that reorients the acetabulum to reduce the stresses inside the hip joint. The PAO is very effective at improving symptoms and quality of life. However, some patients may have residual symptoms. Frequently, people with hip dysplasia will have an MRI done before their surgery, which helps to identify other the abnormalities inside their hip joint (e.g., labral tears). These abnormalities inside the joint cannot easily be addressed through PAO alone, however they can be addressed with hip arthroscopy. Hip arthroscopy is a separate minimally invasive surgical procedure that allows the surgeon to access the inside of the hip joint with a small camera and address any abnormalities. At present, it is not clear whether performing a hip arthroscopy at the same time as a PAO improves patient outcomes after surgery compared to a PAO alone. This research project will randomize patients to receive either a PAO alone, or a PAO and a hip arthroscopy at the same time. Patients will be followed for 2 years after surgery. Symptomatic differences between the two patient groups will be assessed to determine added benefit of the hip arthroscopy.

Conditions

Interventions

TypeNameDescription
PROCEDUREPAO with hip arthroscopyParticipants who are randomized to the Scope-PAO group will receive central compartment hip arthroscopy in addition to the PAO.
PROCEDUREPAO without hip arthroscopyParticipants who are randomized to the "PAO-only" group will receive a Bernese Periacetabular Osteotomy (PAO) for treatment of hip dysplasia.

Timeline

Start date
2018-04-04
Primary completion
2030-07-31
Completion
2030-12-31
First posted
2018-03-29
Last updated
2025-12-30

Locations

7 sites across 2 countries: United States, Canada

Source: ClinicalTrials.gov record NCT03481010. Inclusion in this directory is not an endorsement.