Randomized Clinical Trial: Treatment of Unstable Trochanteric Hip Fractures With Intramedullary Nail Versus Hip Arthroplasty: Survival, Complications and Postoperative Patient Reported Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Patient Reported Outcome Measure (PROM)
研究概览
简要总结
A hip fracture is a large burden to the patient with increased mortality, pain and increased need for daily assistance. Trochanteric fractures of the femur (FTF) represents about 35% of the hip fractures. Today FTFs are mainly treated with internal fixation using sliding hips screws (SHS) or intramedullary nail (IMN), whilst hip arthroplasty (THA/HA) is rarely used. Despite advances in the design of the internal fixation implants there is a high failure rate, in particular in cases of FTFs classified as unstable fractures. Since the introduction of hip arthroplasty in femoral neck fractures there has been a reduction in complication rates, early mobilization and shorter hospital stays.
The primary objective of this project is to investigate if treatment with hip arthroplasty in unstable FTFs will increase the postoperative mobility, give a better general health outcome for the patient, better quality of life and reduce re-operation rate for the patients compared to those operated with the traditional IMN.
详细描述
Proximal femoral fractures also termed "hip" fractures are one of the most common fractures among adults over 50 years of age. With increase in life expectancy, the incidence of these fractures is also increasing. By 2040, the number of these fractures are expected to double in Norway. Trochanteric fractures of the femur (Fractura Trochanterica Femoris, FTF) represents about 35% of the hip fractures in Norway . There are many classification systems for FTFs, but The Orthopaedic Trauma Association (OTA) have adopted the system developed by the Arbeitsgemeinschaft Osteosynthese (AO ) group, and is the most commonly used in addition to the Evans Jensens classification.
The mean age of hip fracture patients is 82 years for women and 78 for men. The comorbidity in this patient group is high with large amount of dementia, sarcopenia and osteoporosis. The one-year mortality rate after a hip fractures is 20-35%. According to the Norwegian Hip Fracture Register 15 % of the hip fractures are unstable trochanteric fractures (AO 31A2.2-A3). The prognosis is poor, in particular for unstable (multi fragmented) fractures, with reported complications up to 35-51 %.
Substantial research has established better understanding and best practice guidelines to treat the femoral neck fractures, mostly with hip arthroplasty, however no superior method is established for the unstable trochanteric fractures. 'Getting It Right First Time' is important for these fragile patients, thus post-operative complications are associated with a large increase in the mortality.
Today, most of the FTFs are reduced and fixated with a sliding hip screw (SHS), although the use of intramedullary nails (IMN) is increasing. RCTs have shown better survival of IMN compared to SHS for the more distal FTFs and subtrochanteric fracture. Unstable FTFs (AO 31A2 - A3, EVJ III-V) have high reoperation rates (21-35%) when operated either with SHS or IMN. Unacceptable shortening, external rotation deformity of the limb and long time to recover/mobilization have been the problems with osteosynthesis.
The question is if hip arthroplasty can give a superior treatment outcome for patients suffering from unstable subtypes of trochanteric hip fractures compared to the traditional treatment with IMN. A randomized clinical trial is to be conducted comparing these two treatment methodologies.
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
- 65 Years 至 120 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 65 years
- •American Society of Anesthesiology Score (ASA) < 4
- •Ambulant with or without aid (preinjury)
- •Radiological verified unstable trochanteric hip fracture (AO 31A2.2 - 3.3)
- •Written consent obtained by patient or his/her next of kin
排除标准
- •Previous hip surgery on ipsilateral or contralateral side
- •Non-ambulant preinjury
- •Patient not living in the area of hospital care
研究组 & 干预措施
Intramedullary nail
Intramedullary nail with proximal lagscrew and distal locking screw(s)
干预措施: Intramedullary nail (Procedure)
Hip arthroplasty
Hemiarthroplasty (HA) or Total hip arthroplasty (THA). A cemented dual-mobility cup will be utilized in THA. Addition of cerclage/trochanter claw plate to fixate trochanter major will be used when suitable.
干预措施: Hip arthroplasty (Procedure)
结局指标
主要结局
Patient Reported Outcome Measure (PROM)
时间窗: Collected from 2 to 12 months from primary surgery
EuroQol EQ-5D. "The descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the 5 dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement." Change in EQ-5D score will be observed from 2-, 6- and 12 months.
次要结局
- Radiological assessment of horizontal center of rotation (prosthesis)(Collected at 2, 6 and 12 months from primary surgery)
- Complications related to prosthesis(Collected from 2 to 12 months from primary surgery)
- Radiological assessment of vertical center of rotation (prosthesis)(Collected at 2, 6 and 12 months from primary surgery)
- Radiological assessment of hip offset (intramedullary nail)(Collected at 2, 6 and 12 months from primary surgery)
- Complications related to osteosynthesis(Collected from 2 to 12 months from primary surgery)
- Reoperation rate(Collected at 2, 6 and 12 months from primary surgery)
- Radiological assessment of acetabular inclination (prosthesis)(Collected at 2, 6 and 12 months from primary surgery)
- Radiological assessment of medial cortical support (intramedullary nail)(Collected at 2, 6 and 12 months from primary surgery)
- Mortality(2, 6 and 12 months from primary surgery)
- Radiological assessment of femoral stem positioning (prosthesis)(Collected at 2, 6 and 12 months from primary surgery)
- Radiological assessment of leg length discrepancy (intramedullary nail)(Collected at 2, 6 and 12 months from primary surgery)
- Radiological assessment of tip-to-apex (intramedullary nail)(Collected at 2, 6 and 12 months from primary surgery)
- Somatic postoperative complications(Collected from 2 to 12 months from primary surgery)
- Radiological assessment of acetabular anteversion (prosthesis)(Collected at 2, 6 and 12 months from primary surgery)
- Radiological assessment of femoral neck length (intramedullary nail)(Collected at 2, 6 and 12 months from primary surgery)
- Radiological assessment of anterior cortical support (intramedullary nail)(Collected at 2, 6 and 12 months from primary surgery)
- Radiological assessment of trochanter major dislocation (intramedullary nail)(Collected at 2, 6 and 12 months from primary surgery)
- Clinical leg length discrepancy(Collected at 2, 6 and 12 months from primary surgery)
- Timed Up and Go test (TUG test)(Collected at 2, 6 and 12 months from primary surgery)
- Trendelenburg test(Collected at 2, 6 and 12 months from primary surgery)