Clinical trial NCT03481010: Periacetabular Osteotomy With and Without Arthroscopic Management of Central Compartment Pathology
Official title: Periacetabular Osteotomy With and Without Arthroscopic Management of Central Compartment Pathology: A Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hip Dysplasia
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2018-03-29
Enrollment: 204
Sex: ALL
Minimum age (years): 16
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Skeletally mature patient undergoing Bernese periacetabular osteotomy for symptomatic acetabular dysplasia/hip instability
* Pre-Operative MRI at 3T and/or gadolinium MR arthrogram
* Age, 16-50 years old
* Patient capable of giving informed consent

Exclusion Criteria:

* Prior hip/pelvis surgery of any kind on the surgical side
* Prior hip arthroplasty surgery on either side
* Radiographic evidence of arthritis (i.e. Tönnis grade =2)
* Known connective tissue disorder (e.g. Ehlers-Danlos Syndrome, etc.)
* Known neuromuscular disorder (e.g. Cerebral Palsy, Spina bifida, etc.)
* Known skeletal dysplasia (e.g. Achondroplasia, Multiple Epiphyseal Dysplasia, etc.)
* Cognitive impairment that prevents accurate completion of patient-reported outcome questionnaires.
* Patient unable/unwilling to complete all required follow-up visits
* Concurrent proximal femoral osteotomy and/or surgical hip dislocation

Primary outcomes:
measure: iHOT-33
timeFrame: 24 months
Secondary outcomes:
measure: HOOS
timeFrame: before surgery, 6 months, 12 months, 24 months after surgery
measure: PROMIS Global 10
timeFrame: before surgery, 6 months, 12 months, 24 months after surgery
measure: Operative time
timeFrame: intra-operative
measure: Hospital Length of Stay
timeFrame: up to one month
measure: Adverse Events
timeFrame: 2-4 weeks and 3 months after surgery
measure: Cost-Effectiveness
timeFrame: 6 months, 12 months, and 24 months after surgery
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Saint Louis
country: United States
facility: The Washington University
state: Missouri
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
city: Ottawa
country: Canada
facility: Children's Hospital of Eastern Ontario
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hospital Research Institute
state: Ontario
city: Québec
country: Canada
facility: CHU de Québec - Université Laval
Study officials:
affiliation: The Ottawa Hospital Research Institute
name: Geoffrey Wilkin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wilkin GP, Poitras S, Clohisy J, Belzile E, Zaltz I, Grammatopoulos G, Melkus G, Rakhra K, Ramsay T, Thavorn K, Beaule PE. Periacetabular osteotomy with or without arthroscopic management in patients with hip dysplasia: study protocol for a multicenter randomized controlled trial. Trials. 2020 Aug 18;21(1):725. doi: 10.1186/s13063-020-04592-9.