Periacetabular Osteotomy With and Without Arthroscopic Management of Central Compartment Pathology: A Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 204
- 试验地点
- 14
- 主要终点
- iHOT-33
研究概览
简要总结
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.
详细描述
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.
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
- 16 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
iHOT-33
时间窗: 24 months
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.
次要结局
- Hospital Length of Stay(up to one month)
- Operative time(intra-operative)
- Adverse Events(2-4 weeks and 3 months after surgery)
- Cost-Effectiveness(6 months, 12 months, and 24 months after surgery)
- HOOS(before surgery, 6 months, 12 months, 24 months after surgery)
- PROMIS Global 10(before surgery, 6 months, 12 months, 24 months after surgery)