Back to resultsHip Arthroscopy Versus Total Hip Arthroplasty RCT
Primary Purpose
Hip Osteoarthritis
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Hip Arthroscopy
Total Hip Arthroplasty
Sponsored by
About this trial
This is an interventional treatment trial for Hip Osteoarthritis focused on measuring Hip Scope, Total Hip Replacement
Eligibility Criteria
Inclusion criteria:
- Between the ages of 40-60 years at the time of surgery.
- Radiographic evidence of mild to moderate hip OA (Tönnis Gr 0 with MRI chondral wear, Tönnis Gr 1 and 2).
- Patients must have completed ≥3 months of non-operative management with ongoing symptoms.
Exclusion criteria:
- Advanced OA, defined as <2 mm joint space (Tönnis Gr 3) or those with acetabular or femoral head cysts.
- Patients who are pregnant or may become pregnant around the time of surgery.
- Prior arthroplasty of the contralateral hip.
- Current or prior hip dysplasia (defined by a lateral centre edge angle of <20 degrees).
- Acetabular protrusio or coxa profunda, making arthroscopic access unsafe/unfeasible.
Sites / Locations
- Fowler Kennedy Sport Medicine Clinic and University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Hip Arthroscopy
Total Hip Arthroplasty
Arm Description
Patients in the Hip Arthroscopy group will undergo arthroscopy in the supine position under general anesthesia, with all procedures performed by two subspecialty-trained hip arthroscopists. An algorithmic surgical approach will be utilized to sequentially address pathology in the central and peripheral compartments of the hip based on both preoperative imaging findings and intraoperative findings. Emphasis will be placed on labral preservation and refixation, with osseous decompression under fluoroscopic guidance.
Patients randomized to the Total Hip Replacement (THR) group will undergo THR via a direct anterior approach. A slightly oblique skin incision measuring approximately 8 cm will be used, starting 3 cm distally and laterally to the anterosuperior iliac spine. The intervals between tensor fascia lata (TFL) and sartorius will be developed superficially, and between rectus femoris and gluteus minimus deeper. Capsulotomy will be performed. A double osteotomy of the femoral neck will be performed to facilitate removal of the head followed by traditional preparation of the acetabulum using an offset reamer and the acetabular component will be inserted. Next, the superior capsule will be released to elevate the femur to allow access to the femoral canal, followed by standard preparation by use of an offset broach and the stem will be implanted
Outcomes
Primary Outcome Measures
Change in Hip Dysfunction and Osteoarthritis Outcome Score (HOOS)
Subscales measuring Pain, Symptoms, Activity limitations daily living and Function in sport and recreation The outcome measure is transformed in a worst to best scale from 0 to 100, with 100 indicating no symptoms and 0 indicating extreme symptoms.
Secondary Outcome Measures
Change in International Hip Outcome Tool [iHOT]
The iHOT-33 is a validated, self-administered quality of life assessment tool for young, active patients with hip symptoms. Each question is scored from 0-100 and the average for all questions is calculated, where 100 represents the best possible outcome or highest level of function.
Change in Hip Outcome Score
Validated measure of hip function, includes subscale of ADL (activities of daily living) and Sport will be utilized. Each HOS subscale is calculated from 0 to 100, with 100 being the best score
Change in Modified Harris Hip Score
Min: 0 Max: 100
Scoring of mHHS:
Excellent: 90--100 Good: 80--89 Fair: 70--79 Poor: <70
Higher score indicates better hip functionally.
EQ-5D
Health-related quality of life tool to estimate utility scores for the economic analyses (mixed quantitative and qualitative tool with VAS score from 0-100, where 100 represents the 'best imaginable health state')
Cost Utilization
Record all procedural related costs for each intervention and any additional direct and indirect resource use over the study period
Magnetic Resonance Imaging (MRI)
To enable quantification of morphological features of the hip joint (alpha angle - measured on the axial images; lateral center edge angle measured on the coronal images) and chondral degeneration (Outerbridge classification 0-5)
Change in performance on 40 meter fast-paced walk test
Walk as quickly but as safely as possible, without running, along a 10 m (33 ft) walkway and then turn around a cone, return then repeat again for a total distance of 40 m (132 ft) (3 turns). Time is recorded to the nearest 100th second, and speed is then calculated as a value of meters/second.
Change in 6-minute Walk Test
Walking from end to end over a premeasured distance, covering as much ground as possible at a comfortable, safe pace. Distance covered in 6 minutes is recorded to the nearest 10th of a meter.
Change in Timed Up and Go Test
Starting in a seated position in a standard arm chair (height of 44 cm), the time it takes to stand up, walk 3 meters and return to a seated position. Time is recorded to the nearest 100th of a second.
Change in performance on 30-second Chair Stand Test
From the sitting position, stand up completely so hips and knees are fully extended, then completely back down, so that the bottom fully touches the seat. This is repeated as many times as possible in 30 seconds. Score is the total number of completed repetitions.
3-dimensional gait analysis to provide walking characteristics (gait velocity, step length, stride length), kinematics (hip joint angles, pelvic tilt, lateral trunk lean) and kinetics (hip joint moments)
12-camera, motion capture system, and a synchronized floor-mounted force platform will be used. Passive-reflective markers are placed on patients using a 22-marker, modified Helen Hayes marker set. Patients will be instructed to walk barefoot across an 8-m walkway at their typical self-selected walking speed, until at least five successful force plates strikes are collected for each limb. Three-dimensional joint angles and moments are calculated from the kinematic and kinetic data using commercial software (Orthotrak 6.6; Motion Analysis Corporation, Santa Rosa, CA) and custom post processing and data reduction techniques
Full Information
NCT ID
NCT04166227
First Posted
November 12, 2019
Last Updated
April 25, 2023
Sponsor
Western University, Canada
1. Study Identification
Unique Protocol Identification Number
NCT04166227
Brief Title
Hip Arthroscopy Versus Total Hip Arthroplasty RCT
Official Title
Clinical and Cost-effectiveness of Hip Arthroscopy Versus Definitive Total Hip Arthroplasty in 40-60 Year Olds With Early Hip Osteoarthritis: A Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
January 31, 2027 (Anticipated)
Study Completion Date
January 31, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Western University, Canada
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of the proposed study is to perform a comparative pilot, randomized controlled trial of hip arthroscopy versus definitive total hip arthroplasty (THA) for the treatment of early hip osteoarthritis (Tönnis Grade 1-2) in patients between the ages of 40-60 years.
Detailed Description
The purpose of this study is to conduct a randomized trial to compare hip arthroscopy to THR and estimate the long-term cost-effectiveness. Specifically, we aim to:
Estimate the magnitude of the between-groups difference in the primary outcome (Hip Dysfunction and Osteoarthritis Outcome Score - HOOS);
Evaluate the clinical and cost-effectiveness of early definitive THA compared to arthroscopy for early-stage hip OA at 1-year postoperative;
Estimate the lifetime cost-effectiveness of arthroscopy vs THA using a Markov model; and
Identify imaging and biomechanical predictors of outcomes following hip arthroscopy
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Osteoarthritis
Keywords
Hip Scope, Total Hip Replacement
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hip Arthroscopy
Arm Type
Active Comparator
Arm Description
Patients in the Hip Arthroscopy group will undergo arthroscopy in the supine position under general anesthesia, with all procedures performed by two subspecialty-trained hip arthroscopists. An algorithmic surgical approach will be utilized to sequentially address pathology in the central and peripheral compartments of the hip based on both preoperative imaging findings and intraoperative findings. Emphasis will be placed on labral preservation and refixation, with osseous decompression under fluoroscopic guidance.
Arm Title
Total Hip Arthroplasty
Arm Type
Active Comparator
Arm Description
Patients randomized to the Total Hip Replacement (THR) group will undergo THR via a direct anterior approach. A slightly oblique skin incision measuring approximately 8 cm will be used, starting 3 cm distally and laterally to the anterosuperior iliac spine. The intervals between tensor fascia lata (TFL) and sartorius will be developed superficially, and between rectus femoris and gluteus minimus deeper. Capsulotomy will be performed. A double osteotomy of the femoral neck will be performed to facilitate removal of the head followed by traditional preparation of the acetabulum using an offset reamer and the acetabular component will be inserted. Next, the superior capsule will be released to elevate the femur to allow access to the femoral canal, followed by standard preparation by use of an offset broach and the stem will be implanted
Intervention Type
Procedure
Intervention Name(s)
Hip Arthroscopy
Intervention Description
Patients in the Hip Arthroscopy group will undergo arthroscopy in the supine position under general anesthesia, with all procedures performed by two subspecialty-trained hip arthroscopists. An algorithmic surgical approach will be utilized to sequentially address pathology in the central and peripheral compartments of the hip based on both preoperative imaging findings and intraoperative findings. Emphasis will be placed on labral preservation and refixation, with osseous decompression under fluoroscopic guidance.
Intervention Type
Procedure
Intervention Name(s)
Total Hip Arthroplasty
Intervention Description
Patients randomized to the Total Hip Replacement (THR) group will undergo THR via a direct anterior approach. A slightly oblique skin incision measuring approximately 8 cm will be used, starting 3 cm distally and laterally to the anterosuperior iliac spine. The intervals between tensor fascia lata (TFL) and sartorius will be developed superficially, and between rectus femoris and gluteus minimus deeper. Capsulotomy will be performed. A double osteotomy of the femoral neck will be performed to facilitate removal of the head followed by traditional preparation of the acetabulum using an offset reamer and the acetabular component will be inserted. Next, the superior capsule will be released to elevate the femur to allow access to the femoral canal, followed by standard preparation by use of an offset broach and the stem will be implanted
Primary Outcome Measure Information:
Title
Change in Hip Dysfunction and Osteoarthritis Outcome Score (HOOS)
Description
Subscales measuring Pain, Symptoms, Activity limitations daily living and Function in sport and recreation The outcome measure is transformed in a worst to best scale from 0 to 100, with 100 indicating no symptoms and 0 indicating extreme symptoms.
Time Frame
6 weeks, 3, 6 and 12 months
Secondary Outcome Measure Information:
Title
Change in International Hip Outcome Tool [iHOT]
Description
The iHOT-33 is a validated, self-administered quality of life assessment tool for young, active patients with hip symptoms. Each question is scored from 0-100 and the average for all questions is calculated, where 100 represents the best possible outcome or highest level of function.
Time Frame
6 weeks, 3, 6 and 12 months
Title
Change in Hip Outcome Score
Description
Validated measure of hip function, includes subscale of ADL (activities of daily living) and Sport will be utilized. Each HOS subscale is calculated from 0 to 100, with 100 being the best score
Time Frame
6 weeks, 3, 6 and 12 months
Title
Change in Modified Harris Hip Score
Description
Min: 0 Max: 100
Scoring of mHHS:
Excellent: 90--100 Good: 80--89 Fair: 70--79 Poor: <70
Higher score indicates better hip functionally.
Time Frame
6 weeks, 3, 6 and 12 months
Title
EQ-5D
Description
Health-related quality of life tool to estimate utility scores for the economic analyses (mixed quantitative and qualitative tool with VAS score from 0-100, where 100 represents the 'best imaginable health state')
Time Frame
6 weeks, 3, 6 and 12 months
Title
Cost Utilization
Description
Record all procedural related costs for each intervention and any additional direct and indirect resource use over the study period
Time Frame
6 weeks, 3, 6 and 12 months
Title
Magnetic Resonance Imaging (MRI)
Description
To enable quantification of morphological features of the hip joint (alpha angle - measured on the axial images; lateral center edge angle measured on the coronal images) and chondral degeneration (Outerbridge classification 0-5)
Time Frame
Baseline and 12 months
Title
Change in performance on 40 meter fast-paced walk test
Description
Walk as quickly but as safely as possible, without running, along a 10 m (33 ft) walkway and then turn around a cone, return then repeat again for a total distance of 40 m (132 ft) (3 turns). Time is recorded to the nearest 100th second, and speed is then calculated as a value of meters/second.
Time Frame
6 weeks, 3, 6 and 12 months
Title
Change in 6-minute Walk Test
Description
Walking from end to end over a premeasured distance, covering as much ground as possible at a comfortable, safe pace. Distance covered in 6 minutes is recorded to the nearest 10th of a meter.
Time Frame
6 weeks, 3, 6 and 12 months
Title
Change in Timed Up and Go Test
Description
Starting in a seated position in a standard arm chair (height of 44 cm), the time it takes to stand up, walk 3 meters and return to a seated position. Time is recorded to the nearest 100th of a second.
Time Frame
6 weeks, 3, 6 and 12 months
Title
Change in performance on 30-second Chair Stand Test
Description
From the sitting position, stand up completely so hips and knees are fully extended, then completely back down, so that the bottom fully touches the seat. This is repeated as many times as possible in 30 seconds. Score is the total number of completed repetitions.
Time Frame
6 weeks, 3, 6 and 12 months
Title
3-dimensional gait analysis to provide walking characteristics (gait velocity, step length, stride length), kinematics (hip joint angles, pelvic tilt, lateral trunk lean) and kinetics (hip joint moments)
Description
12-camera, motion capture system, and a synchronized floor-mounted force platform will be used. Passive-reflective markers are placed on patients using a 22-marker, modified Helen Hayes marker set. Patients will be instructed to walk barefoot across an 8-m walkway at their typical self-selected walking speed, until at least five successful force plates strikes are collected for each limb. Three-dimensional joint angles and moments are calculated from the kinematic and kinetic data using commercial software (Orthotrak 6.6; Motion Analysis Corporation, Santa Rosa, CA) and custom post processing and data reduction techniques
Time Frame
6 weeks, 3, 6 and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Between the ages of 40-60 years at the time of surgery.
Radiographic evidence of mild to moderate hip OA (Tönnis Gr 0 with MRI chondral wear, Tönnis Gr 1 and 2).
Patients must have completed ≥3 months of non-operative management with ongoing symptoms.
Exclusion criteria:
Advanced OA, defined as <2 mm joint space (Tönnis Gr 3) or those with acetabular or femoral head cysts.
Patients who are pregnant or may become pregnant around the time of surgery.
Prior arthroplasty of the contralateral hip.
Current or prior hip dysplasia (defined by a lateral centre edge angle of <20 degrees).
Acetabular protrusio or coxa profunda, making arthroscopic access unsafe/unfeasible.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stacey Wanlin
Phone
519-661-2111
Ext
82705
Email
swanlin@uwo.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Stephanie Horst, BSc, CCRP
Phone
519-661-2111
Ext
82689
Email
stephanie.horst@lhsc.on.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ryan Degen, MD, FRCSC
Organizational Affiliation
Fowler Kennedy Sport Medicine Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fowler Kennedy Sport Medicine Clinic and University Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 3K7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ryan M Degen, MD
Phone
519-661-2171
Email
ryan.degen@lhsc.on.ca
First Name & Middle Initial & Last Name & Degree
Stacey Wanlin
Email
swanlin@uwo.ca
First Name & Middle Initial & Last Name & Degree
Ryan M Degen, MD
First Name & Middle Initial & Last Name & Degree
Kevin Willits, MD
First Name & Middle Initial & Last Name & Degree
Brent Lanting, MD
First Name & Middle Initial & Last Name & Degree
James Howard, MD
12. IPD Sharing Statement
Learn more about this trial
Hip Arthroscopy Versus Total Hip Arthroplasty RCT
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