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Hip Arthroscopy with Periacetabular Osteotomy for Hip Dysplasia
N/A
Recruiting
Led By Rafael Sierra, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of hip dysplasia (DDH) electing periacetabular osteotomy (PAO) for treatment
Tonnis Grade 0 or 1 osteoarthritis (minimal or no arthritis)
Must not have
Patients receiving PAO for acetabular retroversion in the absence of DDH
Previous hip arthroscopy to address intra-articular pathology
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year follow-up time point
Awards & highlights
No Placebo-Only Group
Summary
This trial will compare the outcomes of patients with hip dysplasia who have hip arthroscopy along with their periacetabular osteotomy, to those who have the osteotomy alone.
Who is the study for?
This trial is for individuals aged 15-55 with hip dysplasia, specifically Developmental Dysplasia of the Hip (DDH), who are skeletally mature and have minimal or no arthritis. They must be able to undergo a preoperative MRI arthrogram of the hip. Pregnant women, those with previous hip surgeries, or patients treated for acetabular retroversion without DDH cannot participate.
What is being tested?
The study compares two treatments for hip dysplasia: one group will receive Periacetabular Osteotomy (PAO) alone, while another group will get PAO combined with hip arthroscopy. The goal is to see which treatment leads to better outcomes in terms of joint function and pain relief.
What are the potential side effects?
Potential side effects may include pain at the surgery site, infection risk from surgical intervention, possible damage to surrounding nerves or tissues during operation, and complications related to anesthesia.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have hip dysplasia and am choosing surgery (PAO) for treatment.
Select...
My arthritis is mild or nonexistent.
Select...
My bones have stopped growing.
Select...
I am between 15 and 55 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am getting PAO surgery for hip socket misalignment without having developmental hip dysplasia.
Select...
I have had hip surgery to treat joint problems.
Select...
I have had surgery on my hip before.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year follow-up time point
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year follow-up time point
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Mean score of Hip Disability and Osteoarthritis Outcome (Hoos)
Mean score of University California Los Angeles (UCLA) activity assessment
Mean score of Western Ontario and McMaster Universities Arthritis Index (WOMAC)
+1 moreAwards & 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: Periacetabular osteotomyExperimental Treatment1 Intervention
Standard periacetabular osteotomy on the day of surgery.
Group II: Periacetabular osteotomy with hip arthroscopyActive Control1 Intervention
Hip arthroscopy on the day of surgery, followed by a standard periacetabular osteotomy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Periacetabular osteotomy
2004
N/A
~20
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,362 Previous Clinical Trials
3,065,900 Total Patients Enrolled
Rafael Sierra, MDPrincipal InvestigatorMayo Clinic
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have hip dysplasia and am choosing surgery (PAO) for treatment.My arthritis is mild or nonexistent.My bones have stopped growing.I am getting PAO surgery for hip socket misalignment without having developmental hip dysplasia.I can undergo a standard MRI scan of the hip with contrast.I have had hip surgery to treat joint problems.I have had surgery on my hip before.I am between 15 and 55 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Periacetabular osteotomy with hip arthroscopy
- Group 2: Periacetabular osteotomy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.