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Periacetabular Osteotomy With and Without Arthroscopic Management of Central Compartment Pathology

Primary Purpose

Hip Dysplasia

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
PAO with hip arthroscopy
PAO without hip arthroscopy
Sponsored by
Ottawa Hospital Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Dysplasia

Eligibility Criteria

16 Years - 50 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Northwestern UniversityRecruiting
  • William Beaumont HospitalRecruiting
  • The Washington UniversityRecruiting
  • Hospital for Special SurgeryRecruiting
  • Children's Hospital of Eastern OntarioRecruiting
  • Ottawa Hospital Research InstituteRecruiting
  • CHU de Québec - Université LavalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PAO with hip arthroscopy

PAO without hip arthroscopy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.

Full Information

First Posted
March 15, 2018
Last Updated
September 22, 2022
Sponsor
Ottawa Hospital Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03481010
Brief Title
Periacetabular Osteotomy With and Without Arthroscopic Management of Central Compartment Pathology
Official Title
Periacetabular Osteotomy With and Without Arthroscopic Management of Central Compartment Pathology: A Multicenter Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 4, 2018 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ottawa Hospital Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Dysplasia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
188 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PAO with hip arthroscopy
Arm Type
Experimental
Arm Description
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.
Arm Title
PAO without hip arthroscopy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
PAO with hip arthroscopy
Intervention Description
Participants who are randomized to the Scope-PAO group will receive central compartment hip arthroscopy in addition to the PAO.
Intervention Type
Procedure
Intervention Name(s)
PAO without hip arthroscopy
Intervention Description
Participants who are randomized to the "PAO-only" group will receive a Bernese Periacetabular Osteotomy (PAO) for treatment of hip dysplasia.
Primary Outcome Measure Information:
Title
iHOT-33
Description
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.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
HOOS
Description
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.
Time Frame
before surgery, 6 months, 12 months, 24 months after surgery
Title
PROMIS Global 10
Description
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.
Time Frame
before surgery, 6 months, 12 months, 24 months after surgery
Title
Operative time
Description
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.
Time Frame
intra-operative
Title
Hospital Length of Stay
Description
Length of stay, measured in days, will be assessed from date of admission to date of discharge up to one month.
Time Frame
up to one month
Title
Adverse Events
Description
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.
Time Frame
2-4 weeks and 3 months after surgery
Title
Cost-Effectiveness
Description
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.
Time Frame
6 months, 12 months, and 24 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Geoffrey Wilkin, MD
Phone
613-798-5555
Ext
10347
Email
gwilkin@toh.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Cheryl Kreviazuk
Phone
613-737-8920
Email
ckreviazuk@ohri.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geoffrey Wilkin, MD
Organizational Affiliation
The Ottawa Hospital Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Stover, MD
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ira Zaltz, MD
Facility Name
The Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63130
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John C. Clohisy, MD
Facility Name
Hospital for Special Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ernest Sink, MD
Facility Name
Children's Hospital of Eastern Ontario
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kevin Smit, MD
Facility Name
Ottawa Hospital Research Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H8L6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Geoffrey Wilkin, MD
Phone
613-737-8920
First Name & Middle Initial & Last Name & Degree
Research Team
Phone
613-737-8920
Facility Name
CHU de Québec - Université Laval
City
Québec
ZIP/Postal Code
G1J 1Z4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Etienne Belzile, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
32811527
Citation
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.
Results Reference
derived

Learn more about this trial

Periacetabular Osteotomy With and Without Arthroscopic Management of Central Compartment Pathology

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