Pilot Investigation of Ewing Amputation in Veterans With Peripheral Arterial Disease Undergoing Below Knee Amputation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 6
- 主要终点
- PROMIS Numeric Rating Scale
研究概览
简要总结
This study follows the Pilot Investigation of Ewing Amputation for Veterans with PAD Undergoing a Below Knee Amputation. The 2 year pilot feasibility phase has concluded recruitment and enrollment.
The current phase is a 5 year randomized study of Ewing Below Knee Amputation vs. Standard Below Knee Amputation. If Veterans participate, they will be randomized to either Ewing Amputation or Standard Below Knee Amputation.
The scientific premise motivating this proposal is that Ewing Amputation is a promising surgical technique that may improve walking metrics in dysvascular Veterans by providing a better residual limb and improving pain and balance.
In preparation of this proposal, we have formed multi-disciplinary surgical teams at each site, and we have been supported by a clinical trial planning meeting to garner the considerable expertise in rehabilitation and amputee assessment from VA and DOD experts to assist in the design of this proposal, testing the overall hypothesis that: Ewing Amputation can help Veterans walk.
详细描述
Major amputations lead to significant challenges for Veterans and their loved ones. Thus, amputations and the care of amputees are a major focus of the VHA. Hence, the tripartite goals of the VHA Amputation System of Care (ASoC) are to: provide state of the art care, maximize health and independence, and to be the provider of choice for amputated Veterans. Veterans undergo ~1000 transtibial amputations (TTA) annually, making TTA a commonly performed operation in the VA. Almost all Veterans requiring TTA are dysvascular with peripheral artery disease (PAD) and/or diabetes. TTA is a safe operation with a low 30-day mortality rate, and ambulation with prosthesis rates are much better for TTA versus transfemoral amputations (TFA). Since ~50% of Veterans are satisfied with their ambulation after major amputation, improving ambulation is an important benchmark forward in the care of Veterans. Importantly, the lower ambulation rates in Veterans are attributed to modifiable sequelae of major amputation, including: slower wound healing9,10; chronic pain, imbalance, and falls. Excitingly, new techniques can improve pain and balance and may improve wound healing/prevent falls. Ewing amputation (EA) recreates the agonist-antagonist myoneural interface (AMI) maintaining muscle tension, proprioception and limiting fibrofatty muscle degeneration of muscle flaps. EA also creates regenerative peripheral neural interfaces (RPNI) to improve pain control. Thus, EA may have a significant benefit to Veterans undergoing TTA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Veterans who have reasonable blood flow to heal a TTA (defined as palpable popliteal pulse or palpable femoral pulse with popliteal artery signal)
- •Veterans with an expectation of participating in rehabilitation and resuming ambulation after amputation (defined by the Veteran interest, recent ambulation by the Veteran, ability to participate in physical therapy as deemed by the investigators' physical therapy team)
- •Veterans who will be undergoing below knee amputation for reasons other than infection (uninfected patients) or Veterans who have had foot infection localized below the ankle (retinaculum uninfected) that has been adequately debrided and treated with appropriate antibiotic course.
排除标准
- •Veterans with end-stage renal disease (ESRD)
- •Veterans requiring major amputation due to infection that includes the ankle retinaculum
- •Veterans deemed to have inadequate blood flow to heal a TTA
- •Veterans who cannot participate in rehabilitation or are not expected to be able to ambulate with a prosthesis for any reason
- •Veterans who were randomized for their other limb (to prevent Veteran from the possibility of having 2 different amputations)
研究组 & 干预措施
Ewing Amputation
Ewing Below Knee Amputation - incorporates RPNI and AMI
干预措施: Ewing Below Knee Amputation (Procedure)
Standard Below Knee Amputation
Standard Below Knee Amputation
干预措施: Standard Below Knee Amputation (Procedure)
结局指标
主要结局
PROMIS Numeric Rating Scale
时间窗: 12 months
Patient reported rating scale to assess pain intensity and pain interference.
Lower Extremity Amputee Data Collection Form
时间窗: 12 months
Patient reported questionnaire to assess amputation system of care.
Lower Limb Mobility Rating Scale
时间窗: 12 months
Patient reported scale to assess movement with prosthetic leg.
Amputee Single Item Mobility Measure
时间窗: 12 months
Patient reported measure to assess current level of mobility.
Activities-specific Balance Scale
时间窗: 12 months
Patient reported scale to assess balance while performing every day activities.
RAND Health Survey
时间窗: 12 months
Patient reported survey to assess general health while performing usual activities.
CRIS Fixed Form Instrument
时间窗: 12 months
Patient reported rating scale to assess usual activities in previous two weeks.
Patient Two Minute Walk Test
时间窗: 12 months
To measure distance patient can walk without assistance in 2 minutes.
Patient Timed Up and Go Test
时间窗: 12 months
To measure amount of time patient walks 3 meters.
Amputee Mobility Predictor Questionnaire
时间窗: 12 months
To measure the patient's sitting, standing, turning and walking/stepping with and without prosthesis.
Phantom and Residual Limb Questionnaire
时间窗: 12 months
Patient reported questionnaire to assess sensation in phantom limb.
Self-Reported Falls Measure
时间窗: 12 months
Patient reported one question survey to calculate falls in the previous month.
Berg Balance Scale
时间窗: 12 months
To assess the patient's sitting and standing balance levels.
Socket Comfort Score
时间窗: 12 months
Patient reported rating scale to assess socket fit of prosthesis.
次要结局
未报告次要终点