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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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year follow-up time point

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 below

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I have hip dysplasia and am choosing surgery (PAO) for treatment.

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My arthritis is mild or nonexistent.

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My bones have stopped growing.

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I am between 15 and 55 years old.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year follow-up time point for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 more

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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,207 Previous Clinical Trials

3,766,754 Total Patients Enrolled

1 Trials studying Hip Dysplasia

Rafael Sierra, MDPrincipal InvestigatorMayo Clinic

Media Library

Periacetabular osteotomy Clinical Trial Eligibility Overview. Trial Name: NCT03181048 — N/A

Hip Dysplasia Research Study Groups: Periacetabular osteotomy with hip arthroscopy, Periacetabular osteotomy

Hip Dysplasia Clinical Trial 2023: Periacetabular osteotomy Highlights & Side Effects. Trial Name: NCT03181048 — N/A

Periacetabular osteotomy 2023 Treatment Timeline for Medical Study. Trial Name: NCT03181048 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment currently taking place for this research endeavor?

"Data from clinicaltrials.gov affirms that this research is in the process of recruiting suitable participants. The project was initially posted on August 23rd 2017 and last updated on August 22nd 2022."

Answered by AI

How many participants are being incorporated into this clinical trial?

"Affirmative. The clinicaltrials.gov website substantiates that this research is currently searching for participants, with a starting date of August 23rd 2017 and an updated listing on the 22nd of August 2022. 106 individuals need to be recruited from 1 centre."

Answered by AI

Is the age range for this study more expansive than 70 years old?

"This research initiative is currently recruiting participants between the ages of 15 and 55."

Answered by AI

Is participation in this trial open to me?

"This trial aims to enrol 106 patients aged 15-55 who suffer from hip dysplasia. In addition, prospective participants should be skeletally mature and meet the age criteria stipulated above."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Clinical Trial of Concomitant Hip Arthroscopy During PAO

Rafael J. Sierra, M.D. 2017. "Clinical Trial of Concomitant Hip Arthroscopy During PAO". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03181048.