Hip DysplasiaNCT03481010
Periacetabular Osteotomy With and Without Arthroscopic Management of Central Compartment Pathology
A study testing PAO with hip arthroscopy and PAO without hip arthroscopy in people with Hip Dysplasia, run by Ottawa Hospital Research Institute at 7 sites in 2 countries.
Trial summary
At present, it is not clear whether performing a hip arthroscopy at the same time as a PAO improves patient outcomes after surgery compared to a PAO alone. This research project will randomize patients to receive either a PAO alone, or a PAO and a hip arthroscopy at the same time. Read more about this study
- Who is it for?
- Ages 16 to 50 years
- Conditions the study is for
- Hip Dysplasia
- What is being tested?
- PAO with hip arthroscopy and PAO without hip arthroscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 4 Apr 2018to 31 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 16 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Skeletally mature patient undergoing Bernese periacetabular osteotomy for symptomatic acetabular dysplasia/hip instability
- Pre-Operative MRI at 3T and/or gadolinium MR arthrogram
- Age, 16-50 years old
- Patient capable of giving informed consent
Who cannot join
- Prior hip/pelvis surgery of any kind on the surgical side
- Prior hip arthroplasty surgery on either side
- Radiographic evidence of arthritis (i.e. Tönnis grade =2)
- Known connective tissue disorder (e.g. Ehlers-Danlos Syndrome, etc.)
- Known neuromuscular disorder (e.g. Cerebral Palsy, Spina bifida, etc.)
- Known skeletal dysplasia (e.g. Achondroplasia, Multiple Epiphyseal Dysplasia, etc.)
Show all 9Show fewer
- Cognitive impairment that prevents accurate completion of patient-reported outcome questionnaires.
- Patient unable/unwilling to complete all required follow-up visits
- Concurrent proximal femoral osteotomy and/or surgical hip dislocation
Trial locations and contacts
7 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 2 countries
United States4 sites, 4 recruiting
- Recruiting
Northwestern University
Chicago, Illinois, 60611
Michael Stover, MD
- Recruiting
Hospital for Special Surgery
New York, New York, 10021
Ernest Sink, MD
- Recruiting
William Beaumont Hospital
Royal Oak, Michigan, 48073
Ira Zaltz, MD
- Recruiting
The Washington University
St Louis, Missouri, 63130
John C. Clohisy, MD
Canada3 sites, 3 recruiting
- Recruiting
Children's Hospital of Eastern Ontario
Ottawa, Ontario, K1H 8L1
Kevin Smit, MD
- Recruiting
Ottawa Hospital Research Institute
Ottawa, Ontario, K1H8L6
Geoffrey Wilkin, MD, 613-737-8920
Research Team, 613-737-8920
- Recruiting
CHU de Québec - Université Laval
Québec, G1J 1Z4
Etienne Belzile, MD
About this study
Official title: Periacetabular Osteotomy With and Without Arthroscopic Management of Central Compartment Pathology: A Multicenter Randomized Controlled Trial
At present, it is not clear whether performing a hip arthroscopy at the same time as a PAO improves patient outcomes after surgery compared to a PAO alone.
This research project will randomize patients to receive either a PAO alone, or a PAO and a hip arthroscopy at the same time.
Read the detailed description
Hip dysplasia is a developmental abnormality of the acetabulum (hip socket) that causes abnormal stresses inside the hip joint and leads to painful arthritis at a young age. Many patients develop painful symptoms in their hip before advanced arthritis occurs.
The periacetabular osteotomy (PAO) is a surgical procedure that reorients the acetabulum to reduce the stresses inside the hip joint. The PAO is very effective at improving symptoms and quality of life. However, some patients may have residual symptoms.
Frequently, people with hip dysplasia will have an MRI done before their surgery, which helps to identify other the abnormalities inside their hip joint (e.g., labral tears). These abnormalities inside the joint cannot easily be addressed through PAO alone, however they can be addressed with hip arthroscopy. Hip arthroscopy is a separate minimally invasive surgical procedure that allows the surgeon to access the inside of the hip joint with a small camera and address any abnormalities.
At present, it is not clear whether performing a hip arthroscopy at the same time as a PAO improves patient outcomes after surgery compared to a PAO alone.
This research project will randomize patients to receive either a PAO alone, or a PAO and a hip arthroscopy at the same time. Patients will be followed for 2 years after surgery. Symptomatic differences between the two patient groups will be assessed to determine added benefit of the hip arthroscopy.
- Conditions
- Hip Dysplasia
- Being tested
- PAO with hip arthroscopy, PAO without 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.
PAO with hip arthroscopyProcedure or surgery
Participants who are randomized to the Scope-PAO group will receive central compartment hip arthroscopy in addition to the PAO.
PAO without hip arthroscopyProcedure or surgery
Participants who are randomized to the "PAO-only" group will receive a Bernese Periacetabular Osteotomy (PAO) for treatment of hip dysplasia.
| Study group | Role | What they receive |
|---|---|---|
| PAO with hip arthroscopy | Experimental | 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. Receives: Procedure: PAO with hip arthroscopy |
| PAO without hip arthroscopy | Active comparator | 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. Receives: Procedure: PAO without hip arthroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
iHOT-33
Patient-reported quality of life will be the primary outcome used for comparison between the two treatment groups as measured by the International Hip Outcome Tool (iHOT-33). The iHOT-33 is a validated, self-administered quality of life assessment tool for young, active patients with hip symptoms.
Measured: 24 months
Secondary outcomes (6)
HOOS
Hip-specific symptoms and functional impairment will be compared using the Hip Disability and Osteoarthritis Outcome Score (HOOS). This 40-item patient reported outcome tool has been validated for use in patients with and without hip osteoarthritis and has shown good responsiveness, reliability and reproducibility in this patient population.
Measured: before surgery, 6 months, 12 months, 24 months after surgery
PROMIS Global 10
Global Health assessment will be compared using the PROMIS Global 10 Score. This 10-item tool assesses general domains of health related quality of life in the domains of physical, mental, and social well-being.
Measured: before surgery, 6 months, 12 months, 24 months after surgery
Operative time
Total operative time is expected to be longer in the "Scope-PAO" treatment group, however the average increase in time will be valuable information for future research assessing cost-effectiveness of this treatment strategy. Total operative time will be measured from the time the patient enters the operating room to the time the patient is ready for transfer to post-anesthetic care unit (PACU). This time interval represents the best assessment of the overall time cost to the health care system associated with the surgical procedure while avoiding confounding due to delays in transfer to PACU.
Measured: intra-operative
Hospital Length of Stay
Length of stay, measured in days, will be assessed from date of admission to date of discharge up to one month.
Measured: up to one month
Adverse Events
Adverse events will be assessed prospectively at the first and second post-operative visits using Sink et al.'s classification system that grades the complications based on required treatment and long-term morbidity.
Measured: 2-4 weeks and 3 months after surgery
Cost-Effectiveness
The cost-effectiveness of the two study groups will be assessed prospectively using the Work Productivity and Activity Impairment Questionnaire. This 6-item validated questionnaire quantifies work impairments. Four scores are derived: percentage of absenteeism, percentage of presenteeism (reduced productivity while at work), an overall work impairment score that combines absenteeism and presenteeism and percentage of impairment in activities performed outside of work. Greater scores indicate greater impairment.
Measured: 6 months, 12 months, and 24 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start4 Apr 2018
- Primary completion31 Jul 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hip DysplasiaStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe 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
- None (open label)
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Geoffrey Wilkin, MD, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03481010
- Sponsor's protocol ID
- 20170796
- Status last verified
- Dec 2025
- First submitted
- 15 Mar 2018
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Beaule PE, Verhaegen JCF, Clohisy JC, Zaltz I, Stover MD, Belzile EL, Sink EL, Carsen S, Nepple JJ, Smit KM, Wilkin GP, Poitras S. The Otto Aufranc Award: Does Hip Arthroscopy at the Time of Periacetabular Osteotomy Improve the Clinical Outcome for the Treatment of Hip Dysplasia? A Multicenter Randomized Clinical Trial. J Arthroplasty. 2024 Sep;39(9 Suppl 1):S9-S16. doi: 10.1016/j.arth.2024.05.035. Epub 2024 May 18.
PubMed 38768770Wilkin GP, Poitras S, Clohisy J, Belzile E, Zaltz I, Grammatopoulos G, Melkus G, Rakhra K, Ramsay T, Thavorn K, Beaule PE. Periacetabular osteotomy with or without arthroscopic management in patients with hip dysplasia: study protocol for a multicenter randomized controlled trial. Trials. 2020 Aug 18;21(1):725. doi: 10.1186/s13063-020-04592-9.
PubMed 32811527
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Periacetabular Osteotomy With and Without Arthroscopic Management of Central Compartment Pathology: A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03481010
- Acronym / sponsor ID
- 20170796
- Conditions
- Hip Dysplasia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- 4 Apr 2018 (actual)
- Primary completion
- 31 Jul 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 29 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
At present, it is not clear whether performing a hip arthroscopy at the same time as a PAO improves patient outcomes after surgery compared to a PAO alone.
This research project will randomize patients to receive either a PAO alone, or a PAO and a hip arthroscopy at the same time.
Detailed description
Hip dysplasia is a developmental abnormality of the acetabulum (hip socket) that causes abnormal stresses inside the hip joint and leads to painful arthritis at a young age. Many patients develop painful symptoms in their hip before advanced arthritis occurs.
The periacetabular osteotomy (PAO) is a surgical procedure that reorients the acetabulum to reduce the stresses inside the hip joint. The PAO is very effective at improving symptoms and quality of life. However, some patients may have residual symptoms.
Frequently, people with hip dysplasia will have an MRI done before their surgery, which helps to identify other the abnormalities inside their hip joint (e.g., labral tears). These abnormalities inside the joint cannot easily be addressed through PAO alone, however they can be addressed with hip arthroscopy. Hip arthroscopy is a separate minimally invasive surgical procedure that allows the surgeon to access the inside of the hip joint with a small camera and address any abnormalities.
At present, it is not clear whether performing a hip arthroscopy at the same time as a PAO improves patient outcomes after surgery compared to a PAO alone.
This research project will randomize patients to receive either a PAO alone, or a PAO and a hip arthroscopy at the same time. Patients will be followed for 2 years after surgery. Symptomatic differences between the two patient groups will be assessed to determine added benefit of the hip arthroscopy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PAO with hip arthroscopy | Experimental | Procedure: PAO with hip arthroscopyPatient'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. |
| PAO without hip arthroscopy | Active comparator | Procedure: PAO without hip arthroscopyPatient'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. |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Skeletally mature patient undergoing Bernese periacetabular osteotomy for symptomatic acetabular dysplasia/hip instability
- Pre-Operative MRI at 3T and/or gadolinium MR arthrogram
- Age, 16-50 years old
- Patient capable of giving informed consent
Key exclusion criteria (9 listed)
- Prior hip/pelvis surgery of any kind on the surgical side
- Prior hip arthroplasty surgery on either side
- Radiographic evidence of arthritis (i.e. Tönnis grade =2)
- Known connective tissue disorder (e.g. Ehlers-Danlos Syndrome, etc.)
- Known neuromuscular disorder (e.g. Cerebral Palsy, Spina bifida, etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PAO with hip arthroscopyParticipants who are randomized to the Scope-PAO group will receive central compartment hip arthroscopy in addition to the PAO. | Procedure or surgery | PAO with hip arthroscopy |
| PAO without hip arthroscopyParticipants who are randomized to the "PAO-only" group will receive a Bernese Periacetabular Osteotomy (PAO) for treatment of hip dysplasia. | Procedure or surgery | PAO without hip arthroscopy |
Primary outcome
iHOT-33
Time frame: 24 months
Patient-reported quality of life will be the primary outcome used for comparison between the two treatment groups as measured by the International Hip Outcome Tool (iHOT-33). The iHOT-33 is a validated, self-administered quality of life assessment tool for young, active patients with hip symptoms.
6 secondary outcomes
HOOS
Time frame: before surgery, 6 months, 12 months, 24 months after surgery
PROMIS Global 10
Time frame: before surgery, 6 months, 12 months, 24 months after surgery
Operative time
Time frame: intra-operative
Hospital Length of Stay
Time frame: up to one month
Adverse Events
Time frame: 2-4 weeks and 3 months after surgery
Cost-Effectiveness
Time frame: 6 months, 12 months, and 24 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
- Derived from this study: PubMed 38768770Beaule PE, Verhaegen JCF, Clohisy JC, Zaltz I, Stover MD, Belzile EL, Sink EL, Carsen S, Nepple JJ, Smit KM, Wilkin GP, Poitras S. The Otto Aufranc Award: Does Hip Arthroscopy at the Time of Periacetabular Osteotomy Improve the Clinical Outcome for the Treatment of Hip Dysplasia? A Multicenter Randomized Clinical Trial. J Arthroplasty. 2024 Sep;39(9 Suppl 1):S9-S16. doi: 10.1016/j.arth.2024.05.035. Epub 2024 May 18.
- Derived from this study: PubMed 32811527Wilkin GP, Poitras S, Clohisy J, Belzile E, Zaltz I, Grammatopoulos G, Melkus G, Rakhra K, Ramsay T, Thavorn K, Beaule PE. Periacetabular osteotomy with or without arthroscopic management in patients with hip dysplasia: study protocol for a multicenter randomized controlled trial. Trials. 2020 Aug 18;21(1):725. doi: 10.1186/s13063-020-04592-9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Geoffrey Wilkin, MD principal investigator
Ottawa Hospital Research Institute
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PAO with hip arthroscopy and PAO without hip arthroscopy in people with Hip Dysplasia, run by Ottawa Hospital Research Institute at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Geoffrey Wilkin, MD (613-798-5555 ext. 10347, gwilkin@toh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
iHOT-33 (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03481010, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2025.