Periacetabular Osteotomy With and Without Arthroscopic Management of Central Compartment Pathology
1 other identifier
interventional
204
2 countries
7
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2018
Longer than P75 for not_applicable
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 15, 2018
CompletedFirst Posted
Study publicly available on registry
March 29, 2018
CompletedStudy Start
First participant enrolled
April 4, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2030
December 30, 2025
December 1, 2025
12.3 years
March 15, 2018
December 24, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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.
24 months
Secondary Outcomes (6)
HOOS
before surgery, 6 months, 12 months, 24 months after surgery
PROMIS Global 10
before surgery, 6 months, 12 months, 24 months after surgery
Operative time
intra-operative
Hospital Length of Stay
up to one month
Adverse Events
2-4 weeks and 3 months after surgery
- +1 more secondary outcomes
Study Arms (2)
PAO with hip arthroscopy
EXPERIMENTALPatient'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 COMPARATORPatient'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.
Interventions
Participants who are randomized to the Scope-PAO group will receive central compartment hip arthroscopy in addition to the PAO.
Participants who are randomized to the "PAO-only" group will receive a Bernese Periacetabular Osteotomy (PAO) for treatment of hip dysplasia.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.)
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Northwestern University
Chicago, Illinois, 60611, United States
William Beaumont Hospital
Royal Oak, Michigan, 48073, United States
The Washington University
St Louis, Missouri, 63130, United States
Hospital for Special Surgery
New York, New York, 10021, United States
Children's Hospital of Eastern Ontario
Ottawa, Ontario, K1H 8L1, Canada
Ottawa Hospital Research Institute
Ottawa, Ontario, K1H8L6, Canada
CHU de Québec - Université Laval
Québec, G1J 1Z4, Canada
Related Publications (1)
Wilkin 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.
PMID: 32811527DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Geoffrey Wilkin, MD
The Ottawa Hospital Research Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 15, 2018
First Posted
March 29, 2018
Study Start
April 4, 2018
Primary Completion (Estimated)
July 31, 2030
Study Completion (Estimated)
December 31, 2030
Last Updated
December 30, 2025
Record last verified: 2025-12