Direct Anterior Approach for Femoral Neck Fractures

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合作者:

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追踪信息

首次提交日期 ^ICMJE

October 2, 2018

首次发布日期e ^ICMJE

October 4, 2018

最后更新发布日期

October 5, 2018

预计研究开始日期 ^ICMJE

October 1, 2018

预计主要完成日期

October 2022 (主要结果测量的最终数据收集日期)

目前主要观察指标 ^ICMJE

Change in Time Up and Go Test (TUG)[ Time Frame: 2,6,12 weeks, and 1 year ]

Change in Forgotten Joint Score for hip (FJS-12)[ Time Frame: 2,6,12 weeks, and 1 year ]

12 questions. Every question is scored 1 (never) to 5 (mostly) according to the selected response categories. Thus, the raw score ranges from 12 to 60. The raw score is linearly transformed to a 0-100 scale and then reversed to obtain the final score. Final score = 100 - ((sum(item01 to item12) - 12)/48*100) For the final 'Forgotten Joint Score -12' a high score indicates good outcome.

Change in Oxford Hip Score (OHS)[ Time Frame: 2,6,12 weeks, and 1 year ]

12 questions. Every question is scored 4 to 0 according to the selected response. Thus it is a continuous score ranging from 48-0. Each of the 12 questions on the Oxford hip score is scored in the same way with the score decreasing as the reported symptoms increase (ie. become worse). All questions are laid out similarly with response categories denoting least (or no) symptoms being to the left of the page (scoring 4) and those representing greatest severity lying on the right hand side (scoring 0).

原始主要观察测量 ^ICMJE

与当前相同

目前的二级观察 ^ICMJE

Change in EQ-5D-5L score[ Time Frame: 2,6,12 weeks, and 1 year ]
5 questions. Every question is scored 1 to 5 where 5 is worse outcome. For example one profile could be` 12233` We then convert this specific health state to an index value specific for that country. The index value calculator can be downloaded from the EuroQol Office

描述性信息

简略标题 ^ICMJE

Direct Anterior Approach for Femoral Neck Fractures

正式标题 ^ICMJE

A Randomized Controlled Trial Comparing Direct Anterior Approach to Direct Lateral Approach in Patients Receiving a Total Hip Arthroplasty for Femoral Neck Fracture - a 1 Year Follow-up Study

简要概况

The primary objective is to examine if in patients with a dislocated femoral neck fracture who receive a total hip arthroplasty, direct anterior approach will give a better result in terms of mobilization, function and pain in the first weeks and months postoperatively, than direct lateral approach.

详细说明

研究类型 ^ICMJE

Interventional

研究阶段

N/A

研究设计 ^ICMJE

分配: Randomized
干预模型: Parallel Assignment
干预模型描述:
盲法: Interventional
盲法描述:
主要目的: Treatment

适用条件 ^ICMJE

干预项目 ^ICMJE

Procedure: Direct anterior approach
total hip arthroplasty with DDA
Procedure: Direct Lateral Approach
total hip arthroplasty with DLA

研究工具

Experimental: Direct anterior approach
total hip arthroplasty with direct anterior approach
Experimental: Direct Lateral Approach
total hip arthroplasty with direct lateral approach

招募信息

招募状态 ^ICMJE

Not yet recruiting

预计入组 ^ICMJE

130

原始预计入组 ^ICMJE

与当前相同

预计研究完成日期

October 2022

预计主要完成日期

October 2022 (主要结果测量的最终数据收集日期)

合格标准 ^ICMJE

Inclusion Criteria: - Dislocated femoral neck fracture Exclusion Criteria: - Infection around the hip (soft tissue or bone) - Pathologic fracture - Excessive alcohol or substance abuse that most likely will give reduced compliance - Patients with any fractures of the long bones in the lower extremity, fracture of the spine, and/or intra-thoracic or intra-abdominal injury (i.e., multiple trauma). Because the outcomes and clinical course of patients with multiple trauma may be quite different from a non-trauma patient. - Bedridden patients/non-walkers

性别

参与研究的性别:

All

年龄

最小年龄：50 Years ，最大年龄：N/A

接受健康的志愿者

没有

可入组国家 ^ICMJE

Norway

管理信息

数据检测委员会

Yes

研究涉及美国FDA监管的产品

研究美国FDA监管的药品: No
研究涉及美国FDA监管的设备产品: No

IPD 共享声明

计划分享 IPD:

责任方

，

研究赞助商 ^ICMJE

Helse Møre og Romsdal HF

合作者 ^ICMJE

研究员 ^ICMJE

Study Chair: Øystein B Lian, md phd Helse Møre og Romsdal Hospital Trust (HF), Kristiansund Hospital

PRS 账户

验证日期

October 2018

^ICMJE 国际医学期刊编辑委员会和世界卫生组织 ICTRP 要求的元素

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