Clinical trial NCT04166227: 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
Overall status: RECRUITING
Phase: NA
Conditions: Hip Osteoarthritis
Keywords: Hip Scope
Total Hip Replacement
Lead sponsor: Western University, Canada
Sponsor class: OTHER
First posted: 2019-11-18
Enrollment: 160
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

1. Estimate the magnitude of the between-groups difference in the primary outcome (Hip Dysfunction and Osteoarthritis Outcome Score - HOOS);
2. Evaluate the clinical and cost-effectiveness of early definitive THA compared to arthroscopy for early-stage hip OA at 1-year postoperative;
3. Estimate the lifetime cost-effectiveness of arthroscopy vs THA using a Markov model; and
4. Identify imaging and biomechanical predictors of outcomes following hip arthroscopy

Eligibility criteria: Inclusion criteria:

1. Between the ages of 40-60 years at the time of surgery.
2. Radiographic evidence of mild to moderate hip OA (Tönnis Gr 0 with MRI chondral wear, Tönnis Gr 1 and 2).
3. Patients must have completed ≥3 months of non-operative management with ongoing symptoms.

Exclusion criteria:

1. Advanced OA, defined as \<2 mm joint space (Tönnis Gr 3) or those with acetabular or femoral head cysts.
2. Patients who are pregnant or may become pregnant around the time of surgery.
3. Prior arthroplasty of the contralateral hip.
4. Current or prior hip dysplasia (defined by a lateral centre edge angle of \<20 degrees).
5. Acetabular protrusio or coxa profunda, making arthroscopic access unsafe/unfeasible.

Primary outcomes:
measure: Change in Hip Dysfunction and Osteoarthritis Outcome Score (HOOS)
timeFrame: 6 weeks, 3, 6 and 12 months
Secondary outcomes:
measure: Change in International Hip Outcome Tool [iHOT]
timeFrame: 6 weeks, 3, 6 and 12 months
measure: Change in Hip Outcome Score
timeFrame: 6 weeks, 3, 6 and 12 months
measure: Change in Modified Harris Hip Score
timeFrame: 6 weeks, 3, 6 and 12 months
measure: EQ-5D
timeFrame: 6 weeks, 3, 6 and 12 months
measure: Cost Utilization
timeFrame: 6 weeks, 3, 6 and 12 months
measure: Magnetic Resonance Imaging (MRI)
timeFrame: Baseline and 12 months
measure: Change in performance on 40 meter fast-paced walk test
timeFrame: 6 weeks, 3, 6 and 12 months
measure: Change in 6-minute Walk Test
timeFrame: 6 weeks, 3, 6 and 12 months
measure: Change in Timed Up and Go Test
timeFrame: 6 weeks, 3, 6 and 12 months
measure: Change in performance on 30-second Chair Stand Test
timeFrame: 6 weeks, 3, 6 and 12 months
measure: 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)
timeFrame: 6 weeks, 3, 6 and 12 months
Other outcomes:
Locations:
city: New Westminster
country: Canada
facility: Fraser Health
state: British Columbia
city: London
country: Canada
facility: Fowler Kennedy Sport Medicine Clinic and University Hospital
state: Ontario
Study officials:
affiliation: Fowler Kennedy Sport Medicine Clinic
name: Ryan Degen, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
References: