Immediate Weight-bearing Verses Non-Weight-bearing After Foot & Ankle Surgery
2021年9月20日 更新者：Ryan McMillen、Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Immediate Weight-bearing Verses Non-Weight-bearing After Foot & Ankle Surgery: A Prospective Analysis
The primary objective of this study is to determine whether immediate weight-bearing following foot and ankle surgery provides similar or superior results to the traditional non-weight-bearing post-operative course, while reducing the disuse atrophy and length of rehabilitation necessary to recover during the transition to weight-bearing following an extended course of non-weight-bearing.
This will be done by way of clinical follow-up, serial radiographs and/or other appropriate imaging modalities, and patient reported outcomes by way of AOFAS and SF-36 surveys.
研究概览
详细说明
The study is a randomized 1:1, controlled trial, prospective in nature, where participants undergoing foot and ankle surgery will be randomly placed into one of two groups; an immediate weight-bearing group or a non-weight-bearing group. The patients will be randomly placed into the study group and control group if they meet all eligibility criteria.
This study will be conducted at 5 investigative clinic sites; West Penn Hospital, Forbes Regional Hospital, Jefferson Regional Hospital, Bethel Park Surgery Center, and Monroeville Surgery. Recruitment will stop when a minimum of 230 subjects are consented.
The study duration will require 7 visits to the clinic plus a surgery day therefore will require a pre-surgical visit/screening, surgery procedural day and six outpatient post-operative visits to the clinics. The entire follow up period will occur over 2 years.
研究类型
介入性
注册 (实际的)
5
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Pennsylvania
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Clairton、Pennsylvania、美国、15025
- Steel Valley Orthopaedic and Sports Medicine
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Pittsburgh、Pennsylvania、美国、15224
- The Foot & Ankle Institute/Western Pennsylvania Hospital
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 89年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Males or females age 18 to 89 years
- Undergoing foot and ankle surgery
- Must be able to read and understand English and consent for themselves
Exclusion Criteria:
- Diagnosed peripheral neuropathy
- Diagnosed peripheral vascular disease
- Documented infection to the surgical extremity
- Previous surgery to the surgical limb
- Laboratory abnormalities that indicate clinically significant hematologic, hepatobiliary, or renal disease which would predispose patients to poor healing and/or non-union
- Subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他：Immediate protected weight-bearing
|
Immediate protected weight bearing in a CAM walking boot following foot & ankle surgery
其他名称：
|
|
其他：Traditional non weight bearing
Strict non-weight-bearing
|
Strict non weight bearing for 6 weeks following foot & ankle surgery
其他名称：
|
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 |
|---|---|---|
|
Safety/Tolerability/Quality of Life/Satisfaction:Both Patient & Physician Assessment - American Orthopaedic Foot and Ankle Score (AOFAS) Ankle-Hindfoot Scale
大体时间：Both Arms: Screening
|
American Orthopaedic Foot and Ankle Score (AOFAS) Ankle-Hindfoot Scale as it pertains to the patient's ankle/foot.
Pain, Function, Alignment Score 0-100, 100 being most healthy
|
Both Arms: Screening
|
|
Safety/Tolerability/Quality of Life/Satisfaction:Both Patient & Physician Assessment - American Orthopaedic Foot and Ankle Score (AOFAS) Ankle-Hindfoot Scale
大体时间：Both Arms: Post-operative 6-8 weeks
|
American Orthopaedic Foot and Ankle Score (AOFAS) Ankle-Hindfoot Scale as it pertains to the patient's ankle/foot.
Pain, Function, Alignment Score 0-100, 100 being most healthy
|
Both Arms: Post-operative 6-8 weeks
|
|
Safety/Tolerability/Quality of Life/Satisfaction:Both Patient & Physician Assessment - American Orthopaedic Foot and Ankle Score (AOFAS) Ankle-Hindfoot Scale
大体时间：Both Arms: Post-operative 3 month
|
American Orthopaedic Foot and Ankle Score (AOFAS) Ankle-Hindfoot Scale as it pertains to the patient's ankle/foot.
Pain, Function, Alignment Score 0-100, 100 being most healthy
|
Both Arms: Post-operative 3 month
|
|
Safety/Tolerability/Quality of Life/Satisfaction:Both Patient & Physician Assessment - American Orthopaedic Foot and Ankle Score (AOFAS) Ankle-Hindfoot Scale
大体时间：Both Arms: Post-operative 12 month
|
American Orthopaedic Foot and Ankle Score (AOFAS) Ankle-Hindfoot Scale as it pertains to the patient's ankle/foot.
Pain, Function, Alignment Score 0-100, 100 being most healthy
|
Both Arms: Post-operative 12 month
|
|
Safety/Tolerability/Quality of Life/Satisfaction:Both Patient & Physician Assessment - American Orthopaedic Foot and Ankle Score (AOFAS) Ankle-Hindfoot Scale
大体时间：Both Arms: Post-operative 24 month
|
American Orthopaedic Foot and Ankle Score (AOFAS) Ankle-Hindfoot Scale as it pertains to the patient's ankle/foot.
Pain, Function, Alignment Score 0-100, 100 being most healthy
|
Both Arms: Post-operative 24 month
|
|
Quality of Life/Satisfaction:Patient Report Outcome - 36 Item Short Form Survey (SF36) RAND
大体时间：Both Arms: Screening
|
36 Item Short Form Survey (SF36) RAND.
8 scaled scores, 0-100, 100 being most healthy
|
Both Arms: Screening
|
|
Quality of Life/Satisfaction:Patient Report Outcome - 36 Item Short Form Survey (SF36) RAND
大体时间：Both Arms: Post-operative 6-8 weeks
|
36 Item Short Form Survey (SF36) RAND.
8 scaled scores, 0-100, 100 being most healthy
|
Both Arms: Post-operative 6-8 weeks
|
|
Quality of Life/Satisfaction:Patient Report Outcome - 36 Item Short Form Survey (SF36) RAND
大体时间：Both Arms: Post-operative 3 month
|
36 Item Short Form Survey (SF36) RAND.
8 scaled scores, 0-100, 100 being most healthy
|
Both Arms: Post-operative 3 month
|
|
Quality of Life/Satisfaction:Patient Report Outcome - 36 Item Short Form Survey (SF36) RAND
大体时间：Both Arms: Post-operative 12 month
|
36 Item Short Form Survey (SF36) RAND.
8 scaled scores, 0-100, 100 being most healthy
|
Both Arms: Post-operative 12 month
|
|
Quality of Life/Satisfaction:Patient Report Outcome - 36 Item Short Form Survey (SF36) RAND
大体时间：Both Arms: Post-operative 24 month
|
36 Item Short Form Survey (SF36) RAND.
8 scaled scores, 0-100, 100 being most healthy
|
Both Arms: Post-operative 24 month
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Secondary Outcome: Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods
大体时间：Both arms: Screening
|
Frequency of complications during the perioperative and post-operative periods, measured by assessing osseous healing both clinical and radiographic evaluation.
|
Both arms: Screening
|
|
Secondary Outcome: Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods
大体时间：Both arms: Post-operative 2-3 weeks
|
Frequency of complications during the perioperative and post-operative periods, measured by assessing osseous healing both clinical and radiographic evaluation.
|
Both arms: Post-operative 2-3 weeks
|
|
Secondary Outcome: Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods
大体时间：Both arms: Post-operative 6-8 weeks
|
Frequency of complications during the perioperative and post-operative periods, measured by assessing osseous healing both clinical and radiographic evaluation.
|
Both arms: Post-operative 6-8 weeks
|
|
Secondary Outcome: Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods
大体时间：Both arms: Post-operative 3 month
|
Frequency of complications during the perioperative and post-operative periods, measured by assessing osseous healing both clinical and radiographic evaluation.
|
Both arms: Post-operative 3 month
|
|
Secondary Outcome: Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods
大体时间：Both arms: Post-operative 6 month
|
Frequency of complications during the perioperative and post-operative periods, measured by assessing osseous healing both clinical and radiographic evaluation.
|
Both arms: Post-operative 6 month
|
|
Secondary Outcome: Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods
大体时间：Both arms: Post-operative 12 month
|
Frequency of complications during the perioperative and post-operative periods, measured by assessing osseous healing both clinical and radiographic evaluation.
|
Both arms: Post-operative 12 month
|
|
Secondary Outcome: Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods
大体时间：Both arms: Post-operative 24 month
|
Frequency of complications during the perioperative and post-operative periods, measured by assessing osseous healing both clinical and radiographic evaluation.
|
Both arms: Post-operative 24 month
|
|
Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods
大体时间：Both arms: Screening
|
Frequency of complications during the perioperative and post-operative periods, measured by assessing healing outcomes of soft tissue procedures.
|
Both arms: Screening
|
|
Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods
大体时间：Both arms: Post-operative 2-3 weeks
|
Frequency of complications during the perioperative and post-operative periods, measured by assessing healing outcomes of soft tissue procedures.
|
Both arms: Post-operative 2-3 weeks
|
|
Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods
大体时间：Both arms: Post-operative 6-8 weeks
|
Frequency of complications during the perioperative and post-operative periods, measured by assessing healing outcomes of soft tissue procedures.
|
Both arms: Post-operative 6-8 weeks
|
|
Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods
大体时间：Both arms: Post-operative 3 month
|
Frequency of complications during the perioperative and post-operative periods, measured by assessing healing outcomes of soft tissue procedures.
|
Both arms: Post-operative 3 month
|
|
Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods
大体时间：Both arms: Post-operative 6 month
|
Frequency of complications during the perioperative and post-operative periods, measured by assessing healing outcomes of soft tissue procedures.
|
Both arms: Post-operative 6 month
|
|
Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods
大体时间：Both arms: Post-operative 12 month
|
Frequency of complications during the perioperative and post-operative periods, measured by assessing healing outcomes of soft tissue procedures.
|
Both arms: Post-operative 12 month
|
|
Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods
大体时间：Both arms: Post-operative 24 month
|
Frequency of complications during the perioperative and post-operative periods, measured by assessing healing outcomes of soft tissue procedures.
|
Both arms: Post-operative 24 month
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Ryan L. McMillen, DPM, FACFAS、Steel Valley Orthopaedic & Sports Medicine
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2019年7月29日
初级完成 (实际的)
2021年7月15日
研究完成 (实际的)
2021年7月15日
研究注册日期
首次提交
2019年5月22日
首先提交符合 QC 标准的
2019年6月21日
首次发布 (实际的)
2019年6月25日
研究记录更新
最后更新发布 (实际的)
2021年9月27日
上次提交的符合 QC 标准的更新
2021年9月20日
最后验证
2021年9月1日
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
Principal Investigator and Co-Investigators are part of the Allegheny Health Network and will have complete access to all data for the purpose of publication at study completion.
No other outside entities are involved in this research study.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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.
Weight Bearing的临床试验
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The Miriam HospitalNational Institute on Minority Health and Health Disparities (NIMHD)招聘中