A Randomized Control Trial comparing functional and radiological outcomes in management of intertrochanteric fractures of femur using dual screws without cementation vs. dual screws with cementation.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- The radiological and functional outcomes in patients with proximal femur nailing.
研究概览
简要总结
Title: Functional and Radiological Outcomes of Dual Screws with and
without Cementation in Intertrochanteric Femur Fractures: A Randomized
Controlled Trial
Background: Intertrochanteric hip fractures are prevalent among the elderly
and pose substantial healthcare burdens. Commonly resulting from falls in
osteoporotic individuals, these fractures are associated with perioperative
complexities due to comorbidities. Intramedullary implants, such as dual
screws, are frequently utilized for managing unstable pertrochanteric
fractures. However, mechanical failures, including catastrophic events like
cut-out or cut-through, remain a concern despite optimal reduction and
implant placement. Bone cement augmentation around screws offers potential
to enhance primary stability and long-term implant anchorage.
Justification: Given the clinical significance of reducing catastrophic failures
and associated complications, investigating the efficacy of bone cement
augmentation in mobile elderly patients with closed unstable trochanteric
fractures is crucial. This study aims to evaluate the impact of bone cement
use on radiological and functional outcomes, including postoperative
radiographs, complications, and hip function scores.
Study Design: This randomized controlled trial will compare outcomes
between two cohorts: one receiving dual screws with bone cement
augmentation and the other without augmentation. Radiological assessments,
complications, and functional outcomes, measured through modified Harris
Hip Score and Numerical Pain Rating Score, will be evaluated
postoperatively.
The concise title encapsulates the study’s focus on assessing the effects of
dual screw fixation with and without cementation on functional and
radiological outcomes in intertrochanteric femur fractures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 50.00 Year(s) 至 99.00 Year(s)(—)
- 性别
- All
入选标准
- •1.Radiological findings confirming intertrochanteric fractures 2.Patients more than 50 years of age.
排除标准
- •1.Patients with pathological fracture 2.Patients with other lower limb fractures 3.Presence of infection in affected limb 4.Those with open fractures
- •Patient unwilling for surgery.
结局指标
主要结局
The radiological and functional outcomes in patients with proximal femur nailing.
时间窗: Baseline, one month, three months and six months from baseline
次要结局
- The secondary objectives of this study are(Complications of proximal femoral nailing such as)
研究者
Rishabh Verma
aiims raipur
