Hip OsteoarthritisNCT04166227
Hip Arthroscopy Versus Total Hip Arthroplasty RCT
A study testing Hip Arthroscopy and Total Hip Arthroplasty in people with Hip Osteoarthritis, run by Western University, Canada at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Hip Osteoarthritis
- What is being tested?
- Hip Arthroscopy and Total Hip Arthroplasty
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Oct 2020to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Fowler Kennedy Sport Medicine Clinic and University Hospital
London, Ontario, N6A 3K7
Fraser Health
New Westminster, British Columbia, V3L 0E4
About this study
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
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.
Read the 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
- Conditions
- Hip Osteoarthritis
- Being tested
- Hip Arthroscopy, Total Hip Arthroplasty
- Keywords
- Hip Scope, Total Hip Replacement
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hip ArthroscopyProcedure or surgery
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.
Total Hip ArthroplastyProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Hip Arthroscopy | Active comparator | 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. Receives: Procedure: Hip Arthroscopy |
| Total Hip Arthroplasty | Active comparator | 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 Receives: Procedure: Total Hip Arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks, 3, 6 and 12 months
Secondary outcomes (11)
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.
Measured: 6 weeks, 3, 6 and 12 months
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
Measured: 6 weeks, 3, 6 and 12 months
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.
Measured: 6 weeks, 3, 6 and 12 months
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')
Measured: 6 weeks, 3, 6 and 12 months
Cost Utilization
Record all procedural related costs for each intervention and any additional direct and indirect resource use over the study period
Measured: 6 weeks, 3, 6 and 12 months
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)
Measured: Baseline and 12 months
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.
Measured: 6 weeks, 3, 6 and 12 months
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.
Measured: 6 weeks, 3, 6 and 12 months
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.
Measured: 6 weeks, 3, 6 and 12 months
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.
Measured: 6 weeks, 3, 6 and 12 months
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
Measured: 6 weeks, 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2019
- Study start1 Oct 2020
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Why it stopped: Feasibility study - not able to recruit intended sample size in the desired period. Randomization halted, enrolled patients will be followed to 1 year follow-up
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip OsteoarthritisStudies of the same condition, open and under way.
- 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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ryan Degen, Western University, Canada
- Investigators
- Ryan Degen, MD, FRCSC, Principal investigator, Fowler Kennedy Sport Medicine Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04166227
- Sponsor's protocol ID
- 114679
- Status last verified
- Mar 2026
- First submitted
- 12 Nov 2019
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04166227
- Acronym / sponsor ID
- 114679
- Conditions
- Hip Osteoarthritis
- Keywords
- Hip Scope, Total Hip Replacement
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Feasibility study - not able to recruit intended sample size in the desired period. Randomization halted, enrolled patients will be followed to 1 year follow-up
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 18 Nov 2019 (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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hip Arthroscopy | Active comparator | Procedure: Hip ArthroscopyPatients 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. |
| Total Hip Arthroplasty | Active comparator | Procedure: Total Hip ArthroplastyPatients 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 |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Hip ArthroscopyPatients 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. | Procedure or surgery | Hip Arthroscopy |
| Total Hip ArthroplastyPatients 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 | Procedure or surgery | Total Hip Arthroplasty |
Primary outcome
Change in Hip Dysfunction and Osteoarthritis Outcome Score (HOOS)
Time frame: 6 weeks, 3, 6 and 12 months
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.
11 secondary outcomes
Change in International Hip Outcome Tool [iHOT]
Time frame: 6 weeks, 3, 6 and 12 months
Change in Hip Outcome Score
Time frame: 6 weeks, 3, 6 and 12 months
Change in Modified Harris Hip Score
Time frame: 6 weeks, 3, 6 and 12 months
EQ-5D
Time frame: 6 weeks, 3, 6 and 12 months
Cost Utilization
Time frame: 6 weeks, 3, 6 and 12 months
Magnetic Resonance Imaging (MRI)
Time frame: Baseline and 12 months
Change in performance on 40 meter fast-paced walk test
Time frame: 6 weeks, 3, 6 and 12 months
Change in 6-minute Walk Test
Time frame: 6 weeks, 3, 6 and 12 months
Change in Timed Up and Go Test
Time frame: 6 weeks, 3, 6 and 12 months
Change in performance on 30-second Chair Stand Test
Time frame: 6 weeks, 3, 6 and 12 months
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)
Time frame: 6 weeks, 3, 6 and 12 months
Results and safety
The study was stopped early (reason given: Feasibility study - not able to recruit intended sample size in the desired period. Randomization halted, enrolled patients will be followed to 1 year follow-up). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
Related trials for Hip Osteoarthritis
Not yet recruiting
Comparison of Telerehabilitation and Usual Rehabilitation After Knee or Hip Surgery
Orthopedic Surgery, Rehabilitation
Not yet recruiting
Effects of Low-Load Blood Flow Restriction Resistance Training With and Without Hip Abductor Strengthening in Patients With Knee Osteoarthritis.(BFR)
Knee Osteoarthritis
Recruiting
FRONT Block for Quality of Recovery After Total Hip Arthroplasty
Osteoarthritis of the Hip, Postoperative Pain
RecruitingObservational study
Post-Market Clinical Follow-up of Intra-Articular Hyaluronic Acid in Hip Osteoarthritis
Hip OA
Not yet recruitingObservational study
Clinical Validation of SMARTDIAGO for Remote Functional Assessment of Musculoskeletal Conditions
Knee Osteoarthristis, Hip Osteoarthritis
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. This study is not recruiting at the moment.
Ryan Degen, MD, FRCSC principal investigator
Fowler Kennedy Sport Medicine Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hip Arthroscopy and Total Hip Arthroplasty in people with Hip Osteoarthritis, run by Western University, Canada at 2 sites in Canada.
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 3 inclusion and 5 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: stopped early, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in 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?
The study was stopped early (reason given: Feasibility study - not able to recruit intended sample size in the desired period. Randomization halted, enrolled patients will be followed to 1 year follow-up). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hip Dysfunction and Osteoarthritis Outcome Score (HOOS) (time frame: 6 weeks, 3, 6 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Mar 2026.