Ewing Amputation in Veterans With PAD Undergoing BKA

Study Overview
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Brief Summary
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The objective is to quantify in 2 years the feasibility of recruiting and retaining Veterans at the AVAMC in an EA protocol. The investigators will implement a training protocol for AMI and RPNI. The investigators will document competence and timing to competence for the AVAHCS surgical team. The investigators will perform EA in AVAHCS Veterans who meet inclusion/exclusion parameters and elect EA surgical intervention. Veterans will then participate in the investigators' postoperative protocol out to 6 months. The criteria to moving to phase 2 includes clinically consenting and and performing EA in 30 Veterans and collecting 6 months follow up data over 18 months at AVAHCS and 70% or better complete follow-up at 6 month time point after operation.

Detailed Description
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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.

Official Title
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Pilot Investigation of Ewing Amputation in Veterans With Peripheral Arterial Disease Undergoing Below Knee Amputation

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Other: Ewing Amputation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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;
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Collect feasibility criteria for recruitment, retention, and data collection.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Ewing Amputation<br>Single Arm Pilot Study : To implement lead-in surgeon training and test the feasibility of recruiting and retention of veterans undergoing Ewing Amputation in a single arm study at Atlanta VAMC. | Other: Ewing Amputation<br>* All patients will receive Ewing Amputation to test feasibility.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PROMIS Numeric Rating Scale | Patient reported rating scale to assess pain intensity and pain interference. | 12 months | 
| Socket Comfort Score | Patient reported rating scale to assess socket fit of prosthesis. | 12 months | 
| Phantom and Residual Limb Questionnaire | Patient reported questionnaire to assess sensation in phantom limb. | 12 months | 
| Lower Extremity Amputee Data Collection Form | Patient reported questionnaire to assess amputation system of care. | 12 months | 
| Lower Limb Mobility Rating Scale | Patient reported scale to assess movement with prosthetic leg. | 12 months | 
| Amputee Single Item Mobility Measure | Patient reported measure to assess current level of mobility. | 12 months | 
| Activities-specific Balance Scale | Patient reported scale to assess balance while performing every day activities. | 12 months | 
| Self-Reported Falls Measure | Patient reported one question survey to calculate falls in the previous month. | 12 months | 
| RAND Health Survey | Patient reported survey to assess general health while performing usual activities. | 12 months | 
| CRIS Fixed Form Instrument | Patient reported rating scale to assess usual activities in previous two weeks. | 12 months | 
| Patient Two Minute Walk Test | To measure distance patient can walk without assistance in 2 minutes. | 12 months | 
| Patient Timed Up and Go Test | To measure amount of time patient walks 3 meters. | 12 months | 
| Berg Balance Scale | To assess the patient's sitting and standing balance levels. | 12 months | 
| Amputee Mobility Predictor Questionnaire | To measure the patient's sitting, standing, turning and walking/stepping with and without prosthesis. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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amputation