Clinical and Cost-effectiveness of Hip Arthroscopy Versus Definitive Total Hip Arthroplasty in 40-60 Year Olds With Early Hip Osteoarthritis: A Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Change in Hip Dysfunction and Osteoarthritis Outcome Score (HOOS)
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Hip Arthroscopy
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.
干预措施: Hip Arthroscopy (Procedure)
Total Hip Arthroplasty
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
干预措施: Total Hip Arthroplasty (Procedure)
结局指标
主要结局
Change in Hip Dysfunction and Osteoarthritis Outcome Score (HOOS)
时间窗: 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.
次要结局
- Change in Hip Outcome Score(6 weeks, 3, 6 and 12 months)
- Magnetic Resonance Imaging (MRI)(Baseline and 12 months)
- Change in Timed Up and Go Test(6 weeks, 3, 6 and 12 months)
- Change in performance on 30-second Chair Stand Test(6 weeks, 3, 6 and 12 months)
- Change in Modified Harris Hip Score(6 weeks, 3, 6 and 12 months)
- EQ-5D(6 weeks, 3, 6 and 12 months)
- Cost Utilization(6 weeks, 3, 6 and 12 months)
- Change in performance on 40 meter fast-paced walk test(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)(6 weeks, 3, 6 and 12 months)
- Change in International Hip Outcome Tool [iHOT](6 weeks, 3, 6 and 12 months)
- Change in 6-minute Walk Test(6 weeks, 3, 6 and 12 months)
研究者
Ryan Degen
Orthopaedic Surgeon
Western University, Canada