Lower Dislocation But Higher Fracture Risk: Posterior vs. Lateral Approaches in Hemiarthroplasty for Femoral Neck Fractures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 225
- 试验地点
- 1
- 主要终点
- Prosthetic dislocation rate
研究概览
简要总结
This prospective, single-center, randomized clinical trial compared the clinical and functional outcomes of hemiarthroplasty performed via lateral versus posterior surgical approaches in elderly patients with displaced intracapsular femoral neck fractures. The primary objective was to compare prosthetic dislocation and intraoperative femoral fracture rates between the two approaches. Secondary outcomes included functional scores, radiological parameters, complications, and mortality.
详细描述
This study is a prospective, single-center, randomized clinical trial designed to compare the clinical, functional, and radiological outcomes of hemiarthroplasty performed via lateral and posterior surgical approaches in elderly patients with displaced intracapsular femoral neck fractures.
Between March 2016 and June 2019, eligible patients were randomized in a 1:1 ratio to undergo hemiarthroplasty using either the lateral or posterior approach. Randomization was performed using a computer-generated sequence. All procedures were performed or supervised by experienced orthopedic surgeons following standardized surgical and postoperative protocols.
Clinical parameters, perioperative data, and radiological indices including cortical index, Singh index, and Dorr classification were recorded. Functional outcomes were assessed using the Parker and Palmer Mobility Score (PPMS) and the Harris Hip Score (HHS). Patients were followed for a minimum of 12 months.
The primary outcome measure was the prosthetic dislocation rate within 12 months postoperatively. Secondary outcomes included intraoperative periprosthetic femoral fracture rate, functional scores, complications, and mortality. The study was conducted in accordance with the principles of the Declaration of Helsinki, with approval obtained from the local ethics committee, and written informed consent was obtained from all participants or their legal representatives.
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
盲法说明
This study was conducted as an open-label trial. Due to the nature of the surgical interventions, blinding of surgeons and participants was not feasible.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 60 years or older
- •Displaced intracapsular femoral neck fracture
- •Treated with hemiarthroplasty
- •Ability to provide informed consent by the patient or a legal representative
排除标准
- •Pathological femoral neck fractures
- •Previous surgery on the affected hip
- •Polytrauma patients
- •Periprosthetic fractures
研究组 & 干预措施
Lateral Approach Group
Patients underwent hemiarthroplasty using the direct lateral surgical approach.
干预措施: Lateral approach hemiarthroplasty (Procedure)
Posterior Approach Group
Patients underwent hemiarthroplasty using the posterior surgical approach.
干预措施: Posterior approach hemiarthroplasty (Procedure)
结局指标
主要结局
Prosthetic dislocation rate
时间窗: Within 12 months postoperatively
Incidence of postoperative prosthetic hip dislocation following hemiarthroplasty.
次要结局
- Intraoperative periprosthetic femoral fracture rate(During surgery)
- Harris Hip Score (HHS)(Preoperative baseline and final follow-up at minimum 12 months postoperatively)
- Parker and Palmer Mobility Score (PPMS) change(Preoperative baseline and final follow-up at minimum 12 months postoperatively)
- One-year mortality(Within 12 months postoperatively)
研究者
Yusuf Bayram
Orthopaedic Surgeon
Umraniye Education and Research Hospital