Comparison of Intramedullary and Extramedullary Fixation of Basicervical Fractures of the Femur in the Elderly: a Prospective, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 主要终点
- mobility score
研究概览
简要总结
This prospective, randomized study included patients aged over 65 years with basicervical fracture of femur from January 2016 to January 2018. The permuted block randomization method was used to randomize participants into groups. The patients were allocated to one of two groups treated via cephalomedullary nail (CMN) or sliding hip screw (SHS). Functional and radiological evaluations was included the mobility score, Harris hip score, modified Barthel index, the Singh index, the tip-apex distance, and fracture settling.
详细描述
Approval for this prospective randomized study was granted by the Local Ethics Review Board and all procedures were performed in accordance with the ethical standards of the Declaration of Helsinki (1964). Patients with a basicervical femur fracture were identified on admission to the Emergency Department of our tertiary hospital from January 2016 to January 2018. Patients with scheduled surgery who met the inclusion criteria and provided written informed consent were included in the study.
Patients were randomly allocated to a study group by permuted blocks of randomly mixed sizes and stratification according to the type of surgery (CMN or SHS). Randomization was applied using pre-prepared randomization cards, which were placed in opaque sealed envelopes and given to the surgeons to open just prior to surgery, and the designated procedure was then performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •basicervical fracture,
- •age of ≥65 year,
- •an isolated fracture,
- •the ability to walk independently (with or without an aid) prior to fracture,
- •a fracture that had occurred less than one week prior to admission.
排除标准
- •history of ipsilateral femoral fracture,
- •a fracture due to malignancy,
- •limited life expectancy due to medical comorbidities,
- •any contraindication to surgery,
- •diagnosed dementia,
- •any other traumatic fracture on admission.
结局指标
主要结局
mobility score
时间窗: 12 months
Functional outcome was assessed by the mobility score of Parker and Palmer (Parker MJ, Palmer CR (1993) A new mobility score for predicting mortality after hip fracture. J Bone Joint Surg Br 75: 797-798), which uses a nine-point scale.
Harris hip score
时间窗: 12 months
Hip function was rated with Harris Hip Score. The score has a maximum of 100 points (best possible function), covering pain (1 item, 0-44 points), function and activities (7 items, 0-47 points), and range of motion and absence of deformity (3 items, 0-9 points).
modified Barthel index
时间窗: 12 months
Barthel Index (Mahoney FI, Barthel DW (1965) Functional evaluation: the Barthel Index. A simple index of independence useful in scoring improvement in the rehabilitation of the chronically ill. Md State Med J 13:61-65), which measures the level of functional independence for 10 activities of daily living and ranges from 0 to 100.
the tip-apex distance
时间窗: 12 months
It uses a numerical value (the distance between tip of screw and subchondral area) to show placement of the screw in the head: higher values indicating higher likelihood of fixation failure by extrusion of the screw.
fracture settling
时间窗: 12 months
It uses a numerical value to show placement of shortening of the fractured femoral neck in time
次要结局
未报告次要终点
研究者
Huseyin Bilgehan Cevik
Orthopaedic surgeon
Dr. Lutfi Kirdar Kartal Training and Research Hospital