Patient-Reported and Functional Outcomes After Nonoperative Management of Minimally Displaced Femoral Neck Fractures
Patient-Reported and Functional Outcomes After Nonoperative Management of Minimally Displaced Femoral Neck Fractures: A Prospective Cohort Study
The goal of this observational study is to understand how hip function changes over 24 months in adults with minimally displaced femoral neck fractures who are treated without surgery. The study will also describe outcomes for patients who receive surgery as part of their usual clinical care.
Participants will:
- Receive treatment chosen through shared decision-making with their orthopaedic surgeon; the study will not change their clinical care.
- Complete questionnaires about hip function, pain, quality of life, mobility, and daily activities.
研究概览
研究类型
注册 (估计的)
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
Patients presenting to Stanford Health Care Emergency Department or Orthopaedic Trauma Clinic
描述
Inclusion Criteria:
- Acute minimally displaced femoral neck fracture, valgus-impacted or nondisplaced
- AO/OTA 31-B1 fracture pattern
- Presentation within 7 days of injury
Exclusion Criteria:
- Displaced femoral neck fracture
- Pathologic fracture
- Periprosthetic fracture
- Open fracture
- Previous ipsilateral femoral neck fracture
- Previous isilateral hip arthroplasty
- Polytrauma
- Delayed presentation to ED
学习计划
研究是如何设计的?
设计细节
- 观测模型:COHORT
- 时间观点:PROSPECTIVE
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Non-operative management group
Participants treated non-operatively for femoral neck fractures |
Patient reported outcome measures and functional outcomes at 6 weeks, 4 months, 12 months and 24 months post injury |
|
Operative management group
Participants treated operatively for femoral neck fractures |
Patient reported outcomes and functional outcomes at 6 weeks, 4 months, 12 months, and 24 months post injury |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Changes in Modified Harris Hip Score
大体时间:6 weeks, 4 months, 12 months post injury
|
Changes from baseline to 12 months. The modified Harris Hip Score (mHHS) is a measure of physical function scored from 0 to 100, where higher scores indicate better physical function and lower scores indicate worse physical function. |
6 weeks, 4 months, 12 months post injury
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Failure of non-operative management
大体时间:6 weeks, 4 months, 12 months, 24 months post injury
|
Failure rate of non-operative management defined as conversion to hemiarthroplasty, or total hip arthroplasty. |
6 weeks, 4 months, 12 months, 24 months post injury
|
|
Changes in Oxford Hip Score
大体时间:6 weeks, 4 months, 12 months, 24 months post injury
|
Changes from baseline to 24 months. The Oxford Hip Score is a measure of physical function scored on the 0 to 48 scale. Each of the 12 items scored 0 to 4, higher scores indicating better physical function and lower scores indicate worse physical function. |
6 weeks, 4 months, 12 months, 24 months post injury
|
|
Changes in health related quality of life
大体时间:6 weeks, 4 months, 12 months, 24 months post injury
|
Changes from baseline to 24 months in EQ-5D-5L. EQ-5D-5L is a patient reported outcome measure to measure health related quality of life scored on a 5 to 25 scale where higher scores indicate worse health status and lower scores indicates better health status. |
6 weeks, 4 months, 12 months, 24 months post injury
|
|
Changes to Barthel Index
大体时间:6 weeks, 4 months, 12 months, 24 months post injury
|
Changes from baseline to 24 months. The Barthel index is a measure of a participant's level of functional independence in basic activities of daily living. It is scored on a 0-100 scale, where higher score indicating higher level of independence and lower score indicating higher level of dependence. |
6 weeks, 4 months, 12 months, 24 months post injury
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.