Periacetabular Osteotomy With and Without Arthroscopic Management of Central Compartment Pathology

Hip Dysplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03481010
• Other study ID #: 20170796
• Status: Recruiting
• Phase: N/A
• Start date: April 4, 2018
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: Ottawa Hospital Research Institute
• Contact: Geoffrey Wilkin, MD
• Phone: 613-798-5555
• Email: gwilkin[@]toh.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 204
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Canada	Children's Hospital of Eastern Ontario	Ottawa	Ontario
Canada	Ottawa Hospital Research Institute	Ottawa	Ontario
Canada	CHU de Québec - Université Laval	Québec
United States	Northwestern University	Chicago	Illinois
United States	Hospital for Special Surgery	New York	New York
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	The Washington University	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	iHOT-33	Patient-reported quality of life will be the primary outcome used for comparison between the two treatment groups as measured by the International Hip Outcome Tool (iHOT-33). The iHOT-33 is a validated, self-administered quality of life assessment tool for young, active patients with hip symptoms.	24 months
Secondary	HOOS	Hip-specific symptoms and functional impairment will be compared using the Hip Disability and Osteoarthritis Outcome Score (HOOS). This 40-item patient reported outcome tool has been validated for use in patients with and without hip osteoarthritis and has shown good responsiveness, reliability and reproducibility in this patient population.	before surgery, 6 months, 12 months, 24 months after surgery
Secondary	PROMIS Global 10	Global Health assessment will be compared using the PROMIS Global 10 Score. This 10-item tool assesses general domains of health related quality of life in the domains of physical, mental, and social well-being.	before surgery, 6 months, 12 months, 24 months after surgery
Secondary	Operative time	Total operative time is expected to be longer in the "Scope-PAO" treatment group, however the average increase in time will be valuable information for future research assessing cost-effectiveness of this treatment strategy. Total operative time will be measured from the time the patient enters the operating room to the time the patient is ready for transfer to post-anesthetic care unit (PACU). This time interval represents the best assessment of the overall time cost to the health care system associated with the surgical procedure while avoiding confounding due to delays in transfer to PACU.	intra-operative
Secondary	Hospital Length of Stay	Length of stay, measured in days, will be assessed from date of admission to date of discharge up to one month.	up to one month
Secondary	Adverse Events	Adverse events will be assessed prospectively at the first and second post-operative visits using Sink et al.'s classification system that grades the complications based on required treatment and long-term morbidity.	2-4 weeks and 3 months after surgery
Secondary	Cost-Effectiveness	The cost-effectiveness of the two study groups will be assessed prospectively using the Work Productivity and Activity Impairment Questionnaire. This 6-item validated questionnaire quantifies work impairments. Four scores are derived: percentage of absenteeism, percentage of presenteeism (reduced productivity while at work), an overall work impairment score that combines absenteeism and presenteeism and percentage of impairment in activities performed outside of work. Greater scores indicate greater impairment.	6 months, 12 months, and 24 months after surgery