Hip DysplasiaNCT03181048
Clinical Trial of Concomitant Hip Arthroscopy During PAO
A study testing Periacetabular osteotomy and Periacetabular osteotomy with hip arthroscopy in people with Hip Dysplasia, run by Mayo Clinic at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 15 to 55 years
- Conditions the study is for
- Hip Dysplasia
- What is being tested?
- Periacetabular osteotomy and Periacetabular osteotomy with hip arthroscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Aug 2017to Jun 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Cody Wyles, MD, (507) 284-1175, wyles.cody@mayo.edu
Rafael Sierra, MD
About this study
Official title: Single-Blind Randomized Clinical Trial of Concomitant Hip Arthroscopy During Periacetabular Osteotomy for the Management of Hip Dysplasia
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.
Read the detailed description
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.
- Conditions
- Hip Dysplasia
- Being tested
- Periacetabular osteotomy, Periacetabular osteotomy with hip arthroscopy
- Medical subject headings
- Hip Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periacetabular osteotomyProcedure or surgery
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.
Periacetabular osteotomy with hip arthroscopyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Periacetabular osteotomy | Experimental | Standard periacetabular osteotomy on the day of surgery. Receives: Procedure: Periacetabular osteotomy |
| Periacetabular osteotomy with hip arthroscopy | Active comparator | Hip arthroscopy on the day of surgery, followed by a standard periacetabular osteotomy. Receives: Procedure: Periacetabular osteotomy with hip arthroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean score of Hip Disability and Osteoarthritis Outcome (Hoos)
Score ranges from 0-100 with higher scores representing better function.
Measured: 1 year follow-up time point
Mean score of Western Ontario and McMaster Universities Arthritis Index (WOMAC)
The scores range from 0-4 in 24 different categories that are broken up into three subcategories: pain, stiffness and physical function.
Measured: 1 year follow-up time point
Mean score of University California Los Angeles (UCLA) activity assessment
Measured on a 1-10 scale: 1) wholly inactive, dependent on others; 2) mostly inactive, restricted to minimal activities of daily living; 3) sometimes participate in mild activities such as walking, limited housework, or shopping; 4) regularly participate in mild activities; 5) sometimes participate in moderate activities such as swimming and unlimited housework or shopping; 6) regularly participate in moderate activities; 7) regularly participate in active events such as bicycling; 8) regularly participate in very active events such as bowling or golf; 9) sometimes participate in impact sports such as jogging, tennis, or skiing, or heavy labor; and 10) regularly participate in impact sports.
Measured: 1 year follow-up time point
Mean score of the Marx Activity Scale (MARX)
Score is measured from 0-4.
Measured: 1 year follow-up time point
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2017
- Study start23 Aug 2017
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip DysplasiaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rafael J. Sierra, M.D., Mayo Clinic
- Investigators
- Rafael Sierra, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03181048
- Sponsor's protocol ID
- 17-001014
- Status last verified
- Sep 2026
- First submitted
- 6 Jun 2017
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only study personnel authorized by the investigator will collect data/enroll subjects. Data will be stored in electronic files and/or a cabinet, with access to study personnel as authorized by the investigator. The investigator will review the data on a regular basis (at least annually) to verify the validity of the data.