Internal Fixation Versus Hip Replacement in Older Adults with an Garden I/II Femoral Neck Fracture: Physical Function and Pain in Elderly Patients - a Substudy of the Hipsther Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 340
- 试验地点
- 1
- 主要终点
- New Mobility Score
研究概览
简要总结
Aim To investigate the effect of internal fixation versus hip arthroplasty on physical function and pain in elderly patients.
Methods This is a substudy of an on-going nationwide multicenter registry-based RCT named HipSTHeR- (Hip Screws or Total Hip replacement or undisplaced femoral neck fracture in elderly patients) [21]. The aim is to recruit 340 patients with undisplaced or minimally displaced femoral neck fracture, Garden 1 or 2, are randomized to surgery either with internal screw fixation or hip arthroplasty.
This substudy aims to investigate the potential differences between internal fixation versus hip arthroplasty regarding physical function and pain 4- and 12- months after surgery. Those included in the main study will be contacted by letter a few weeks after the surgery to be invited to participate in a further study. The assessor will then contact the person by telephone to answer further questions and to obtain informed consent. The follow-ups will be conducted over telephone and mail at 4 and 12 months. During the follow-up the participants will answer questions about their functional level.
Information on randomisation and fracture data will be acquired from the Swedish Fracture Register and treatment data from the Swedish Hip Arthroplasty Register.
Primary outcome The New Mobility Score will be used as the primary outcome with follow-up at 4- and 12 months.
Secondary outcome WOMAC will be used as an additional hip specific patient reported outcome.
Activities of daily living will be assessed with Katz ADL index to evaluate the patients' performance and the need of assistance in ADL.
Patients' cognitive status will be assessed ALFI-MMSE, adapted from Adult Lifestyles and Function Interview (ALFI-MMSE).
The Geriatric Depression Scale (GDS-15), which are developed to identify depressive symptoms.
The Philadelphia Geriatric Center Morale Scale (PGCMS) and have been used in several studies including frail people living in residential care facilities and can be used among patients with cognitive impairment.
详细描述
Aim To investigate the effect of internal fixation versus hip arthroplasty on physical function and pain in elderly patients.
Methods This is a substudy of an on-going nationwide multicenter registry-based RCT named HipSTHeR- (Hip Screws or Total Hip replacement or undisplaced femoral neck fracture in elderly patients) [21]. Patients with undisplaced or minimally displaced femoral neck fracture, Garden 1 or 2, are randomized to surgery either with internal screw fixation or hip arthroplasty.
This substudy aims to investigate the potential differences between internal fixation versus hip arthroplasty regarding physical function and pain 4- and 12- months after surgery. Those included in the main study will be contacted by letter a few weeks after the surgery to be invited to participate in a further study. The assessor will then contact the person by telephone to answer further questions and to obtain informed consent. The follow-ups will be conducted over telephone and mail at 4 and 12 months. During the follow-up the participants will answer questions about their functional level.
The inclusion criteria for the Hipsther trial are: >75 years and an undisplaced or minimally displaced femoral neck fracture, classified as Garden I or II on conventional radiograph, eligible for internal fixation and hip arthroplasty and treatment at participating unit. The exclusion criteria are pathological or stress fractures, peri-implant femoral neck fracture and previous inclusion of a contralateral Garden 1 or 2 femoral neck fracture. Patients with cognitive impairment are also included. The inclusion criteria for this substudy is inclusion in the Hipsther trial and the participants require a functional language in Swedish.
Information on randomisation and fracture data will be acquired from the Swedish Fracture Register and treatment data from the Swedish Hip Arthroplasty Register.
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
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undisplaced (Garden I-II) femoral neck fracture (within 72h)
- •Treated at participating unit
- •Informed consent
- •Amenable for both treatment options
- •Included in the Hipsther trial
排除标准
- •No informed consent
- •Pathological or stress fracture
- •Peri-implant fracture
- •Previous inclusion of a contralateral Garden 1 or 2 femoral neck fracture
结局指标
主要结局
New Mobility Score
时间窗: 4- and 12 months
The New Mobility Score is an evaluation of patient's ability to perform: walking indoor, outdoor and shopping. Each item is scored between 0 and 3 (0: not at all, 1: with help from another person, 2: with an aid, 3: no difficulty) resulting in a total of 9 points.
次要结局
- WOMAC(4- and 12 months)
- Katz ADL index(4- and 12 months)
- ALFI-MMSE(4- and 12 months)
- Philadelphia Geriatric Center Morale Scale (PGCMS)(4- and 12 months)