Periacetabular Osteotomy With and Without Arthroscopic Management of Central Compartment Pathology

ConditionHip Dysplasia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-50
SponsorOttawa Hospital Research Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.)

Trial design

Design model

Parallel

Treatments tested in this trial

  • PAO with hip arthroscopy

    Procedure/Surgery

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

  • PAO without hip arthroscopy

    Procedure/Surgery

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

Treatment groups

204 Participants
are divided into 2 treatment groups
Group A: PAO with hip arthroscopyExperimental treatment 1 intervention
Group B: PAO without hip arthroscopyActive comparator 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

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