CClinicalTrials.gg
RecruitingNCT03481010Updated Dec 30, 2025

Periacetabular Osteotomy With and Without Arthroscopic Management of Central Compartment Pathology

An interventional study of PAO with hip arthroscopy and PAO without hip arthroscopy in Hip Dysplasia, sponsored by Ottawa Hospital Research Institute. Recruiting at 7 sites in 2 countries. Open to participants aged 16 Years to 50 Years. Per ClinicalTrials.gov, last updated 2025-12-30.

Sponsored by Ottawa Hospital Research Institute · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
204
Allocation
Randomized
Ages
16 Years to 50 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Hip Dysplasia

Browse trials for

03

Who can participate

Ages eligible
16 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
204 participants (estimated)

Study arms

  • Experimental
    PAO with hip arthroscopy

    Patient's in the "Scope PAO" group have been diagnosed with hip dysplasia and a decision has been made between the patient and the surgeon that the best way to treat the hip problems is with surgery. Patient's in the "Scope-PAO" group have been randomized to receive a periacetabular osteotomy with a hip arthroscopy.

    Procedure: PAO with hip arthroscopy

  • Active comparator
    PAO without hip arthroscopy

    Patient's in the "PAO-only" group have been diagnosed with hip dysplasia and a decision has been made between the patient and the surgeon that the best way to treat the hip problems is with surgery. Patient's in the "PAO-only" group have been randomized to receive a periacetabular osteotomy only.

    Procedure: PAO without hip arthroscopy

Interventions

  • ProcedurePAO with hip arthroscopy

    Participants who are randomized to the Scope-PAO group will receive central compartment hip arthroscopy in addition to the PAO.

  • ProcedurePAO without hip arthroscopy

    Participants who are randomized to the "PAO-only" group will receive a Bernese Periacetabular Osteotomy (PAO) for treatment of hip dysplasia.

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 24 months

Secondary outcomes

  1. 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.

    Time frame: before surgery, 6 months, 12 months, 24 months after surgery

  2. 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.

    Time frame: before surgery, 6 months, 12 months, 24 months after surgery

  3. 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.

    Time frame: intra-operative

  4. 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.

    Time frame: up to one month

  5. 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.

    Time frame: 2-4 weeks and 3 months after surgery

  6. 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.

    Time frame: 6 months, 12 months, and 24 months after surgery

06

Study locations

7 of 7 sites recruiting
  • Northwestern University
    Chicago, Illinois 60611, United States
    • Michael Stover, MD · Contact
    Recruiting
  • William Beaumont Hospital
    Royal Oak, Michigan 48073, United States
    • Ira Zaltz, MD · Contact
    Recruiting
  • The Washington University
    St Louis, Missouri 63130, United States
    • John C. Clohisy, MD · Contact
    Recruiting
  • Hospital for Special Surgery
    New York, New York 10021, United States
    • Ernest Sink, MD · Contact
    Recruiting
  • Children's Hospital of Eastern Ontario
    Ottawa, Ontario K1H 8L1, Canada
    • Kevin Smit, MD · Contact
    Recruiting
  • Ottawa Hospital Research Institute
    Ottawa, Ontario K1H8L6, Canada
    • Geoffrey Wilkin, MD · Contact · 613-737-8920
    • Research Team · Contact · 613-737-8920
    Recruiting
  • CHU de Québec - Université Laval
    Québec, G1J 1Z4, Canada
    • Etienne Belzile, MD · Contact
    Recruiting
07

References and documents

Publications

  • Beaule PE, Verhaegen JCF, Clohisy JC, Zaltz I, Stover MD, Belzile EL, Sink EL, Carsen S, Nepple JJ, Smit KM, Wilkin GP, Poitras S. The Otto Aufranc Award: Does Hip Arthroscopy at the Time of Periacetabular Osteotomy Improve the Clinical Outcome for the Treatment of Hip Dysplasia? A Multicenter Randomized Clinical Trial. J Arthroplasty. 2024 Sep;39(9 Suppl 1):S9-S16. doi: 10.1016/j.arth.2024.05.035. Epub 2024 May 18. PubMed 38768770 ↗
  • 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. PubMed 32811527 ↗
08

Registry details

Key details

Study ID
NCT03481010
Lead sponsor
Ottawa Hospital Research Institute
Responsible party
Sponsor
First posted
Mar 29, 2018
Start date
Apr 4, 2018
Primary completion
Jul 31, 2030 (estimated)
Completion
Dec 31, 2030 (estimated)
Last update
Dec 30, 2025

Study contacts

Geoffrey Wilkin, MD
Contact
gwilkin@toh.ca
613-798-5555 ext. 10347
Cheryl Kreviazuk
Contact
ckreviazuk@ohri.ca
613-737-8920
Geoffrey Wilkin, MD
principal investigator · Ottawa Hospital Research Institute

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion