跳至主要内容
临床试验/CTRI/2021/01/030336
CTRI/2021/01/030336尚未招募不适用

Comparision between Dual Mobility Cup and Conventional Total Hip Replacement for Fracture Neck Of Femur

SUNSHINE HOSPITAL1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年11月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
50
试验地点
1
主要终点
Functional outcome

研究概览

简要总结

Total hip arthroplasty is regularly performed in patients with a

femoral neck fracture. However, dislocation is common after THA in hip fracture patients,

and this complication is deleterious to quality of life. The dual mobility cup offers a technical solution that potentially

reduces the risk of dislocation.There is however no high-level evidence to support the general use

of dual mobility cups in patients with displaced femoral neck

fractures and the purpose of the proposed study is to provide

evidence to support or refute the use of this concept in Neck of

Femur fracture patients.

AIMS AND OBJECTIVES

1.EVALUATING THE FUNCTIONAL OUTCOME OF

PATIENTS UNDERGOING TOTAL HIP REPLACEMENT

WITH CONVENTIONAL TOTAL HIP REPLACEMENT

AND DUAL MOBILITY CUP IN FRACTURE NECK OF

FEMUR

2.COMPARING THE COMPLICATIONS AND

DISLOCATION RATES IN THE TWO GROUPS.

PATIENTS AND METHODS

Source of data

The proposed study is a hospital-based prospective study

centred in Sunshine Hospitals, Secunderabad and Gachibowli.

Study design

The study will be a prospective, Non-Time-bound hospital-based ,

randomized study. Cases satisfying the inclusion criteria admitted in

Sunshine Hospitals during the study period from August 2019 till

sample size criteria is met. Patients will be followed for a period of

6 months to 1 year and evaluated clinically with Harris hip score.

Scores and outcome will be used for evaluation.

Sample Size: 50 ( 25 in each group)

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Investigator Blinded

入排标准

年龄范围
50.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • ALL NECK OF FEMUR FRACTURES REQUIRING TOTAL HIP REPLACEMENT IRRESPECTIVE OF AGE.

排除标准

  • Other Revisions and IT fractures.

结局指标

主要结局

Functional outcome

时间窗: Functional outcome

次要结局

  • Rate of dislocations(NA)

研究者

申办方类型
Private hospital/clinic

研究点 (1)

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