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PAO With vs Without Arthroscopy for Hip Dysplasia

N/A

Recruiting

Led By Geoffrey Wilkin, MD

Research Sponsored by Ottawa Hospital Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age, 16-50 years old

Skeletally mature patient undergoing Bernese periacetabular osteotomy for symptomatic acetabular dysplasia/hip instability

Must not have

Prior hip arthroplasty surgery on either side

Cognitive impairment that prevents accurate completion of patient-reported outcome questionnaires

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2-4 weeks and 3 months after surgery

Awards & highlights

No Placebo-Only Group

Summary

This trial will help determine if performing a hip arthroscopy at the same time as a PAO improves patient outcomes.

Who is the study for?

This trial is for individuals aged 16-50 who can consent to treatment, have mature skeletons, and are undergoing surgery for hip instability due to acetabular dysplasia. They must be able to attend all follow-ups and complete questionnaires. Those with advanced arthritis, cognitive impairments, previous hip surgeries or certain genetic disorders cannot participate.

What is being tested?

The study aims to determine if adding a hip arthroscopy procedure at the same time as a periacetabular osteotomy (PAO) leads to better outcomes than PAO alone. Patients will be randomly assigned to either just receive PAO or both PAO and hip arthroscopy.

What are the potential side effects?

While specific side effects are not listed here, common risks of surgical procedures like PAO may include pain, bleeding, infection risk post-surgery, possible damage to surrounding tissues or nerves during operation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 16 and 50 years old.

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I am an adult having surgery for hip dysplasia.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had hip replacement surgery before.

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I have difficulty understanding or filling out questionnaires due to cognitive issues.

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I am undergoing or have undergone surgery for hip joint issues.

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I have had hip or pelvis surgery on the side that needs treatment.

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I have a diagnosed bone growth disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to one month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to one month

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to one month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

iHOT-33

Secondary study objectives

Adverse Events

Cost-Effectiveness

HOOS

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: PAO with hip arthroscopyExperimental Treatment1 Intervention

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.

Group II: PAO without hip arthroscopyActive Control1 Intervention

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.

0 / 7Eligibility criteria met