Clinical Trial of Concomitant Hip Arthroscopy During PAO

Study Purpose

The study will assess the outcomes of patients treated with concomitant hip arthroscopy at the time of periacetabular osteotomy (PAO) for patients with hip dysplasia compared with patients treated with PAO alone.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	15 Years - 55 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Diagnosis of hip dysplasia (DDH) electing periacetabular osteotomy (PAO) for treatment.

- Skeletally mature.

- Age 15 - 55.

- Tonnis Grade 0 or 1 osteoarthritis (minimal or no arthritis) - Ability to receive a standard of care preoperative (magnetic resonance imaging) MRI arthrogram of the hip.

Exclusion Criteria:

- Pregnant women.

- Previous surgery about the hip.

- Patients receiving PAO for acetabular retroversion in the absence of DDH.

- Previous hip arthroscopy to address intra-articular pathology

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03181048
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Mayo Clinic
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Rafael Sierra, MD
Principal Investigator Affiliation	Mayo Clinic
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Hip Dysplasia
Study Website:	View Trial Website

Additional Details

There are currently no absolute indications for intraarticular assessment at the time of periacetabular osteotomy (PAO). Based on investigators' review of the literature and experience, patients who may benefit from intraarticular assessment are those with radiographic or MRI evidence of damage where an intraarticular inspection may help in determining whether a PAO is a reasonable procedure, those with mechanical symptoms likely related to labral pathology, round ligament or cartilage problems and those with hip dysplasia and cam deformities with limited range of motion that may benefit from femoral head neck junction osteochondroplasty. However, despite these relative indications today there is no clear evidence to suggest that these patients will do better than those that do not have intraarticular work done. Hence, the objective of this project is to determine whether intraarticular work at the time of PAO surgery leads to improved pain and function when compared to patients that do not undergo intraarticular work at the time of PAO.

Arms & Interventions

Arms

Experimental: Periacetabular osteotomy

Standard periacetabular osteotomy on the day of surgery.

Active Comparator: Periacetabular osteotomy with hip arthroscopy

Hip arthroscopy on the day of surgery, followed by a standard periacetabular osteotomy.

Interventions

Procedure: - Periacetabular osteotomy

The Bernese periacetabular osteotomy has become the osteotomy of choice in North America for correction of the dysplastic hip. The ability to position the acetabular component in a specifically desired position for each individual patient improves joint biomechanics, restores joint balance and stability, and offloads the structures at risk for damage such as the labrum and the adjacent articular cartilage.

Procedure: - Periacetabular osteotomy with hip arthroscopy

An intraarticular assessment with hip arthroscopy (HA) at the time of periacetabular osteotomy allows the surgeon to assess and treat the associated labral and chondral pathology and allows the surgeon to treat abnormalities of the femoral head junction.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Mayo Clinic, Rochester, Minnesota

Status

Recruiting

Address

Mayo Clinic

Rochester, Minnesota, 55905

Site Contact

Cody Wyles, MD

[email protected]

507-284-1175

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