The Hip Fracture Surgical Approach Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 476
- 试验地点
- 2
- 主要终点
- Harris Hip Score ( HHS)
研究概览
简要总结
The HIFSAT study will compare the standard direct lateral approach to hemiarthroplasty to a new muscle sparing approach (SPAIRE) in femoral neck fracture patients.
详细描述
Femoral neck fractures are mostly treated with a hemiarthroplasty, where the fractured femoral head is replaced with a metal implant. The most common surgical approach to hemiarthroplasty has been the lateral approach, in which the gluteus medius tendon is partially released from the greater trochanter. Hip pain and limping is not uncommon after this approach has been used. A new surgical approach (SPAIRE) has been developed to alleviate this problem, and in this method the surgeon approaches the injured hip joint from posterior, preserving most of the muscles and tendons around the hip. This trial is designed to assess if this new SPAIRE approach leads to better results than the lateral approach in patients with femoral neck fractures.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Femoral neck fracture
- •Clinical indication for hemiarthroplasty
- •Age over 50 years
排除标准
- •Previous hip implants in the same hip
- •Patients assessed to be in a terminal state with an expected survival of less than 1 week
- •Other factors that makes follow-up impossible
结局指标
主要结局
Harris Hip Score ( HHS)
时间窗: 4 months
Harris Hip Score (HHS) is an outcome measure for hip-related symptoms. The score is based on both patient-reported information and clinical examination, and is administered by a qualified health care professional. It covers four domains: Pain, function, absence of deformity and range of motion. The score ranges from 0 (worst) to 100 (best).
次要结局
- Oxford Hip score(4,12 and 24 months)
- EuroQol-5d-5l(4,12 and 24 months)
- Trendelenburg test(4,12 and 24 months)
- Numerical Pain Rate Scale( NPRS)(4, 12 and 24 months)
- New Mobility Score (NMS)(4,12 and 24 months)
- Adverse events(0-24 months)
- Duration of surgery(1.st day after surgery)
- Preferred Walking Speed(4,12 and 24 months)
- Harris Hip Score (HHS)(12 and 24 months)
- Short Physical Performance Battery (SPPB)(4, 12, an 24 months)
- Repeated Chair Stand Test(4,12 and 24 months)
- Cumulated Ambulation Score(1-5 days after surgery)
- Timed up and go test(4,12 and 24 months)
- Use of analgesia during admission(1. day after surgery)
- Days Alive At Home (DAH)(4,12 and 24 months)