跳至主要内容
临床试验/CTRI/2024/08/073143
CTRI/2024/08/073143尚未招募2/3 期

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.

Dr Rishabh Verma1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2024年9月8日最近更新:

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

发起方
Dr Rishabh Verma
申办方类型
Other []
责任方
Principal Investigator
主要研究者

Rishabh Verma

aiims raipur

研究点 (1)

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