xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05990062</url>
    </required_header>
    <id_info>
      <org_study_id>A4257-R</org_study_id>
      <nct_id>NCT05990062</nct_id>
    </id_info>
    <brief_title>Improving Prosthetic Arms for Amputee: A Better Fit and More Functionality</brief_title>
    <acronym>KSH</acronym>
    <official_title>The Advancement of a New Variable-Compliance Socket and Frame System for Transradial Amputees to Optimize Socket Fit and Upper Limb Function</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>VA Office of Research and Development</agency>
        <agency_class>U.S. Fed</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Stumpworx LLC</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>VA Office of Research and Development</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This research and development will improve upon and investigate the potential validity of an&#xD;
        innovative new transradial socket and harness design (the KSH system) that offers an&#xD;
        alternative to standard hard sockets and rubber liners with a hybrid polymer and&#xD;
        textile-based design derived from advanced athletic shoe technology. The project consists of&#xD;
        designing, custom fitting and evaluating the function and comfort of the this new novel&#xD;
        system. The study will take place in 3 phases; Phase 1, five experienced Veterans with&#xD;
        transradial arm amputations will be recruited to provide guidance and to assist with the&#xD;
        design and development. Experienced end-user Veterans and Clinical staff will work together&#xD;
        to assist with design, develop the fitting process and working with engineers on the design&#xD;
        of a completely digital fitting device for measuring the residual limb and locating bony&#xD;
        prominences of the limb to inform the socket design. Phase 2, testing and assessment, the&#xD;
        design and process validation will take place with the five Veteran upper transradial arm&#xD;
        amputees Phase 3, an additional 20 Veterans with transradial arm amputations will be&#xD;
        recruited and fit with the KSH system and undergo a series of evaluative tests. Veterans will&#xD;
        perform a series of static and dynamic tasks to evaluate function, comfort and load bearing&#xD;
        failure. The primary goal of this study is to improve upon the current preliminary prototype&#xD;
        and to test it with a broader population of potential users to help advance the engineering&#xD;
        and design, and to learn the potential to fit a range of Veterans with transradial&#xD;
        amputations.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Acceptance of prosthetic arms has long been a problem for clinical prosthetics, and recent&#xD;
        studies indicate that recent advancements have done little to improve usage. Objections&#xD;
        related to the fit and comfort of prosthetic arms remain the main reasons cited for the&#xD;
        disuse of the devices, numbering nine of the top ten reasons cited for abandonment in a&#xD;
        survey study. By addressing the literal point of pain for these users, the investigators hope&#xD;
        to increase use and acceptance, allowing existing devices to have more positive impact on&#xD;
        Veterans' lives. The breathability of composite sockets has been an acknowledged problem&#xD;
        nearly since their development by the VA in the 1940s. Indeed, while the VA successfully&#xD;
        developed a breathable composite socket very early on, it was quickly abandoned after it was&#xD;
        discovered that the breathable composite recreated the problems with odor and cleanliness&#xD;
        with leather sockets that the composites had been developed to solve. Industry leader Otto&#xD;
        Bock discovered the same thing when it developed a porous silicone liner decades later. While&#xD;
        VA and civilian providers were successful in replacing leather sockets with composites&#xD;
        through the innovations in composites and other materials following World War II. Prosthetic&#xD;
        clinics used to employ leatherworkers skilled in the art of making custom sockets and braces&#xD;
        out of these traditional materials, but these services have disappeared along with the&#xD;
        Veterans demanding them, and the workers capable of delivering them. By taking advantage of&#xD;
        the benefits of the advanced materials and construction techniques that have replaced leather&#xD;
        in the athletic shoe industry over the last seventy-five years, the investigators hope to&#xD;
        restore much of the comfort and fit of these extinct socket designs, while at the same time&#xD;
        delivering the improvements that have been delivered by the athletic shoe industry and&#xD;
        advances in design and manufacturing over the same period. Lim design is working on a textile&#xD;
        based prosthetic socket; however, the approach differs from the investigators': 1) The Lim&#xD;
        design is not intended or currently suitable for upper limbs; 2) While a textile design, the&#xD;
        Lim design cannot dynamically change in volume through the range of motion and constrains&#xD;
        motion similar to any other socket once it has been adjusted; 3) The textile design of the&#xD;
        Lim socket is nether breathable nor wicking and is designed to be used with silicone and/or&#xD;
        gel liners, hence suffers from the same deficiencies with respect to heat and moisture&#xD;
        management as traditional sockets. Lim Innovations and Ossur have publicly stated that they&#xD;
        do not intend to pursue further innovations in the upper limb market. These frank admissions&#xD;
        make it clear that the development of orphan devices for Veterans, must become the&#xD;
        responsibility of the VA, whose goals for serving Veterans are sometimes in contrast with and&#xD;
        not limited to the constraints of large and profitable markets. VA in collaboration with&#xD;
        small companies can help fill this much needed void for innovation. VA has shown leadership&#xD;
        in related domains with the research and design for ultralight wheelchairs, alternative&#xD;
        controls for powered wheelchairs, and adaptive sports and recreation equipment, all of which&#xD;
        eventually assisted the broader populations of Americans with disabilities. Harness&#xD;
        discomfort is just as detrimental to acceptance as poor socket-body interface and can lead to&#xD;
        contralateral damage to the axilla. Indeed, one recent study concluded that there was no&#xD;
        acceptable level of force at which a body powered prosthesis could be operated pain and&#xD;
        fatigue free with a traditional harness. While the conclusions of this study obviously&#xD;
        contradict the staying power of the body powered prosthesis and harness system accepted by&#xD;
        more than 90 per cent of the roughly half of users who accept a prosthesis at all, it does&#xD;
        indicate that there is substantial improvement to be made in harnessing that could&#xD;
        significantly improve both acceptance and comfort of the users who have been willing to&#xD;
        tolerate the uncomfortable standard of care that has seen slow progress for decades.&#xD;
  &#xD;
        Study Objectives and Hypothesis:&#xD;
  &#xD;
        Specific Aim 1: Improve and develop the design and systems for fitting an innovative new&#xD;
        transradial suspension design based on currently available technology used in athletic shoe&#xD;
        construction.&#xD;
  &#xD;
          -  Design Criteria 1a: Optimize CAD documentation by revising and translating the current&#xD;
             Autodesk Fusion 360 design to SolidWorks, aiding customization and improving design for&#xD;
             manufacture.&#xD;
  &#xD;
          -  Design Criteria 1b: Verify that the currently Direct Metal Laser Sintered (DMLS) printed&#xD;
             wrist and quick release can be efficiently and effectively CNC machined.&#xD;
  &#xD;
          -  Design Criteria 1c: Create fixturing and finalize CNC programming for manufacture,&#xD;
             including the specification of manufacturing tolerances to ensure proper fit of&#xD;
             components.&#xD;
  &#xD;
          -  Design Criteria 1e: Verify forearm and elbow counter parts-currently printed in Multijet&#xD;
             Fusion (MJF)-in Selective Laser Sintering (SLS) or Fused Deposition or Fused Filament&#xD;
             (FDM/FFF) Nylon material.&#xD;
  &#xD;
          -  Design Criteria 1f: Automate adaptation of the design through plugin and API&#xD;
             development.&#xD;
  &#xD;
          -  Design Criteria 1g: Optimize production of 2D textile patterns with, for example,&#xD;
             ExactFlat.&#xD;
  &#xD;
          -  Design Criteria 1h: Design a digital or Brannock-like fitting device for measuring the&#xD;
             residual limb and locating bony prominences of the limb to inform the socket design.&#xD;
  &#xD;
          -  Design Criteria 1i: Design the device to weigh less than 2-pounds total weight. Jon is a&#xD;
             50-year-old Veteran with a transradial arm amputation. He has had multiple carpal tunnel&#xD;
             release surgeries on his remaining hand. An inconsistent but long-term user of&#xD;
             prostheses, Jon settled on body-powered arms after extensive trials of myoelectric&#xD;
             prostheses at Walter Reed immediately following his injury in Iraq in 2005, primarily&#xD;
             because of the discomfort and lack of range of motion in the socket. He uses them mostly&#xD;
             for true bimanual tasks, including bicycle riding, hunting, shotgun sports, and home&#xD;
             improvement. Jon was not selected for a trial of the DEKA arm in 2018, and instead&#xD;
             received a Bebionic hand and hard self-suspended socket from the VA. This arm was&#xD;
             quickly rejected: it was heavy, incapable, uncomfortable, and restrictive. Blistering&#xD;
             and irritation to Jon's arm from sweating and friction in a silicone lined carbon fiber&#xD;
             vacuum socket.&#xD;
  &#xD;
        Specific Aim 2: Verify performance gains for the innovative KSH system that can be delivered&#xD;
        to Veterans. The new design is expected to significantly exceed the performance of the&#xD;
        standard-of-care prosthesis in quantitative measures.&#xD;
  &#xD;
          -  Hypothesis 2a (H2a): That the improved KSH will provide a higher tensile static load&#xD;
             bearing capacity before failure than the current standard-of-care prosthesis.&#xD;
  &#xD;
          -  Hypothesis 2b (H2b): That the improved KSH will provide greater tensile loads in a&#xD;
             dynamic environment. The KSH system will allow users to perform better on a rowing&#xD;
             ergometer 10-minute test before failure than the current standard-of-care prosthesis, as&#xD;
             measured using strokes per minute, power in Watts, distance in meters, maximal force,&#xD;
             and time before failure.&#xD;
  &#xD;
          -  Hypothesis 2c (H2c): The improved KSH will provide a greater range of motion in&#xD;
             flexion/extension than the current standard-of-care prosthesis.&#xD;
  &#xD;
          -  Hypothesis 2d (H3d): Participants will require less time for donning/doffing the KSH&#xD;
             than their current standard-of-care prosthesis.&#xD;
  &#xD;
        Specific Aim 3: Verify functionality of the KSH system through testing with end-users.&#xD;
  &#xD;
          -  Hypothesis 3a (H3a): Participants will report high usability with setup and operation of&#xD;
             the device (&gt;80 on the System Usability Scale (SUS)).&#xD;
  &#xD;
          -  Hypothesis 3b (H3b): Participants will report significantly higher Socket Comfort Scores&#xD;
             (SCS) with the KSH than their current standard-of-care prosthesis.&#xD;
  &#xD;
          -  Hypothesis 3c (H3c): Lower weight will correlate with greater user satisfaction, and the&#xD;
             KSH will be statistically and clinically significantly lighter than participants'&#xD;
             current devices.&#xD;
  &#xD;
          -  Hypothesis 3d (H3d): Participants will report that they would switch to the new design&#xD;
             or have an additional prosthesis with the new design.&#xD;
  &#xD;
          -  Hypothesis 3e (H3e): Participants will report significantly higher Orthotics and&#xD;
             Prosthetics User Survey (OPUS) scores with the KSH than their current standard-of-care&#xD;
             prosthesis.&#xD;
  &#xD;
        Relevance to Veterans: According to the DoD/VA Extremity Amputation Center of Excellence&#xD;
        there were about 3,000 Veterans with transradial amputations enrolled for VA Healthcare in&#xD;
        FY21, out of about 62,000 Veterans with limb amputations enrolled for VA healthcare. Veterans&#xD;
        with arm amputations from Post-911 conflicts number just over 200, and because the total&#xD;
        number of Veterans missing arms is demographically small, this very fact has severely limited&#xD;
        innovation in the field of prosthetic arms. Those missing at least all five fingers of a hand&#xD;
        are among the VA's most significantly disabled Veterans, rated at 80 per cent disabled alone&#xD;
        for the loss of a dominant hand. Many arm amputees are eligible for Special Monthly&#xD;
        Compensation as well as vehicle and housing modifications, reflecting the degree to which&#xD;
        these Veterans' lives are impacted by the impairment. Indeed, even among the civilian&#xD;
        population, arm amputation is rare enough to easily meet the FDA's medical orphan criteria of&#xD;
        fewer than 200,000 patients, though the FDA's orphan drug law specifically excludes medical&#xD;
        devices, and the FDA has a lower device threshold of 8,000 patients, further limiting&#xD;
        innovation. The NIH's Genetic and Rare Diseases Information Center (GARD) lists limb absence&#xD;
        as a rare birth condition but doesn't mention the same disability acquired by trauma or&#xD;
        through other diseases, such as cancer, which is the second most common cause despite the&#xD;
        small total number from all causes. While the subject design can be extended to other levels&#xD;
        of amputation, this study will focus on transradial, or below elbow amputees. This population&#xD;
        represents approximately seventy-five per cent of the VA population of Veterans with arm&#xD;
        amputations, a subset that is also much more likely to successfully wear a prosthetic arm.&#xD;
        Over 90% of these users choose body powered. The design could be extended to other Veteran&#xD;
        populations, including people with lower-limb amputations and other levels of amputation,&#xD;
        potentially increasing the benefit by offering the same benefits to those Veterans. By&#xD;
        targeting the portion of an orphan population that is already more likely to use the device&#xD;
        for which improvement is sought, and by targeting the concerns that are most likely to lead&#xD;
        to abandonment, this research stands to increase acceptance and therefore access to&#xD;
        activities of daily living, employment and recreation that can improve quality of life for&#xD;
        some of the VA's most impaired patients. Success could then also be translated to larger&#xD;
        populations with similar needs. The proposed design is intended to address more than half the&#xD;
        total population of Veterans with upper limb amputations and could with additional research&#xD;
        and development be designed in the future for other levels of amputation, including lower&#xD;
        limb and myoelectric upper limb use.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2024</start_date>
    <completion_date type="Anticipated">September 30, 2028</completion_date>
    <primary_completion_date type="Anticipated">May 31, 2028</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Crossover Assignment</intervention_model>
      <intervention_model_description>The protocol consists of three phases with iterative design and development process involving input from Veterans with disabilities at various stages. In addition, 5 certified Prosthetists with at least five years of experience working with Veterans with transradial arm amputations will also be recruited to provide guidance and to assist with the design and development of the K-Socket Harness (KSH).</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Static tensile load bearing capacity to reach a 50-pound load on an industrial scale</measure>
      <time_frame>20 minutes</time_frame>
      <description>We will test tensile static load bearing capacity up to a 50 -pound load or to failure. The Veteran will stand safely on an industrial scale with the arm extended at their side and weight will be added to the distal end of the prosthesis until the goal is met or the prosthesis fails. We will perform the task on both the KSH socket and the standard socket.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Elbow range of motion in flexion/extension</measure>
      <time_frame>30 minutes</time_frame>
      <description>We will measure range of motion (in degrees) in flexion/extension with a standard goniometer. We will perform the task on both the KSH socket and the standard socket.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Donning/doffing prosthesis</measure>
      <time_frame>30 minutes</time_frame>
      <description>We will record the time it takes to donn/doff each prosthesis for both the KSH socket and the standard socket.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Power in Watts generated on rowing machine</measure>
      <time_frame>10 minutes</time_frame>
      <description>We will test tensile loads in a dynamic environment before failure. We will test the performance on a rowing ergometer 10-minute test before failure, as measured using power in Watts. We will perform the task on both the KSH socket and the standard socket.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Strokes per 10-minute period</measure>
      <time_frame>10 minutes</time_frame>
      <description>We will test tensile loads in a dynamic environment before failure. We will test the performance on a rowing ergometer 10-minute test before failure, as measured using strokes per minute. We will perform the task on both the KSH socket and the standard socket.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Distance rowed in meters</measure>
      <time_frame>10 minutes</time_frame>
      <description>We will test tensile loads in a dynamic environment before failure. We will test the performance on a rowing ergometer 10-minute test measuring distance in meters before failure or to time expiration. We will perform the task on both the KSH socket and the standard socket.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Maximal force before failure</measure>
      <time_frame>10 minutes</time_frame>
      <description>We will test tensile loads in a dynamic environment before failure. We will test the performance on a rowing ergometer 10-minute test measuring maximal force (Newton) before failure. We will perform the task on both the KSH socket and the standard socket.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Total time before failure</measure>
      <time_frame>10 minutes</time_frame>
      <description>We will test tensile loads in a dynamic environment before failure. We will test the performance on a rowing ergometer 10-minute test recording the time (in minutes and seconds) before failure. We will perform the task on both the KSH socket and the standard socket.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Usability of prosthesis using the System Usability Score (SUS) on scale from 0-100</measure>
      <time_frame>15 minutes</time_frame>
      <description>Participants will report usability with setup and operation of the device from ten questions using a five point Likert scale. The higher the score, the more usable (user friendly) the device is rated by the Veteran. We would like the KSH system to score &gt;80 on the System Usability Scale (SUS)).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Socket Comfort Scores (SCS) on a scale from 0-10</measure>
      <time_frame>30 minutes</time_frame>
      <description>Participants will report Socket Comfort Scores (SCS) after wearing and testing of the devices for both with the KSH and current standard-of-care prosthesis by using an 11 point scale, (0-10) Zero being the most uncomfortable socket fit you can image, and 10 being the most comfortable socket fit.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Weight of device in pounds</measure>
      <time_frame>30 minutes</time_frame>
      <description>We will correlate the weight of the prosthesis in pounds with user satisfaction of both the KSH device and the participants' current device.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Participant preference</measure>
      <time_frame>10 minutes</time_frame>
      <description>We will ask the participant which device design they prefer to use.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Orthotics and Prosthetics User Survey (OPUS)</measure>
      <time_frame>1 hour</time_frame>
      <description>We will ask the participant to complete the questionnaire focusing on five modules; lower and upper extremity functional status (LEFS and UEFS), client satisfaction with device and services (CSD and CSS), and the health related quality of life (HRQoL) Scores are based on a 100 point scale. The higher the score indicates a better outcome.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">25</enrollment>
    <condition>Amputation, Surgical</condition>
    <arm_group>
      <arm_group_label>Verify performance gains for the innovative KSH system that can be delivered to Veterans. The new de</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The investigators will perform several functional tests of the both the KSH system and the standard of care prosthesis: tensile static load bearing capacity before failure, test rowing ergometer 10-minute test before failure measured using strokes per minute, power in Watts, distance in meters, maximal force, and time before failure, range of motion in flexion/extension, and donning/doffing time.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Verify functionality of the KSH system through testing with end-users.</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The investigators will use System Usability Scale (SUS) to assess high usability with setup and operation of the device. The investigators will assess Comfort Scores (SCS), evaluate weight and correlate it with user satisfaction. The investigators will report selection outcome between new design and current design. The investigators will asses 1) functional status, (2) health- related quality of life, and (3) satisfaction with services and (4) device scores through the Orthotics and Prosthetics User Survey (OPUS).</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>K-Socket-Harness</intervention_name>
      <description>A transradial socket and harness design that offers a hybrid polymer and textile-based design derived from advanced athletic shoe technology. The KSH integrated socket, frame, and wrist, the &quot;variable compliance prosthetic socket with breathable matrix,&quot; creates a dynamic and secure attachment with a combination of two lacing systems. The lacing systems lengthen and shorten six flexible hinges at the elbow, maintaining a secure attachment throughout the range of motion and accounting for volume changes in the soft tissue of the elbow that would otherwise restrict range of motion or cause the socket to separate from the residual limb.</description>
      <arm_group_label>Verify functionality of the KSH system through testing with end-users.</arm_group_label>
      <arm_group_label>Verify performance gains for the innovative KSH system that can be delivered to Veterans. The new de</arm_group_label>
      <other_name>KSH System</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Unilateral transradial arm amputation&#xD;
  &#xD;
            -  Possession of a functioning and wearable previously fit prosthetic arm of any type&#xD;
  &#xD;
            -  Residual limb length of at least 4 inches from the lateral epicondyle to the distal&#xD;
               tip&#xD;
  &#xD;
            -  Residual limb length less than or equal to that allowing a clearance of 1.5 inches&#xD;
               from a fitted wrist&#xD;
  &#xD;
            -  Must have at least 5-years of prosthetic use experience (For Phase 1 &amp; 2)&#xD;
  &#xD;
            -  Must have at least 1-year of prosthetic use experience (For Phase 3 only)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Current open sores or incisions, Heterotopic ossification (HO), traumatic neuromas, or&#xD;
               any other condition preventing the wearing of a prosthetic socket&#xD;
  &#xD;
            -  Residual limb length less than 4 inches&#xD;
  &#xD;
            -  Residual limb length greater than that allowing 1.5 inches clearance from a fitted&#xD;
               wrist.&#xD;
  &#xD;
          The investigators will make every effort to recruit Veterans. If its found that it is not&#xD;
          possible to recruit enough Veterans, the investigators will perform a non-Veteran amendment&#xD;
          to this protocol.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Rory A Cooper, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Elizabeth B Toth, BA</last_name>
      <phone>(412) 954-5382</phone>
      <email>elizabeth.toth2@va.gov</email>
    </overall_contact>
    <location>
      <facility>
        <name>VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA</name>
        <address>
          <city>Pittsburgh</city>
          <state>Pennsylvania</state>
          <zip>15240</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Elizabeth B Toth, BA</last_name>
        <phone>412-954-5382</phone>
        <email>elizabeth.toth2@va.gov</email>
      </contact>
      <investigator>
        <last_name>Rory A Cooper, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <reference>
      <citation>Salminger S, Stino H, Pichler LH, Gstoettner C, Sturma A, Mayer JA, Szivak M, Aszmann OC. Current rates of prosthetic usage in upper-limb amputees - have innovations had an impact on device acceptance? Disabil Rehabil. 2022 Jul;44(14):3708-3713. doi: 10.1080/09638288.2020.1866684. Epub 2020 Dec 30.</citation>
      <PMID>33377803</PMID>
    </reference>
    <reference>
      <citation>Biddiss E, Chau T. Upper-limb prosthetics: critical factors in device abandonment. Am J Phys Med Rehabil. 2007 Dec;86(12):977-87. doi: 10.1097/PHM.0b013e3181587f6c.</citation>
      <PMID>18090439</PMID>
    </reference>
    <reference>
      <citation>Hichert M, Vardy AN, Plettenburg D. Fatigue-free operation of most body-powered prostheses not feasible for majority of users with trans-radial deficiency. Prosthet Orthot Int. 2018 Feb;42(1):84-92. doi: 10.1177/0309364617708651. Epub 2017 Jun 16.</citation>
      <PMID>28621577</PMID>
    </reference>
    <reference>
      <citation>Hanspal RS, Fisher K, Nieveen R. Prosthetic socket fit comfort score. Disabil Rehabil. 2003 Nov 18;25(22):1278-80. doi: 10.1080/09638280310001603983.</citation>
      <PMID>14617445</PMID>
    </reference>
    <reference>
      <citation>Heinemann AW, Bode RK, O'Reilly C. Development and measurement properties of the Orthotics and Prosthetics Users' Survey (OPUS): a comprehensive set of clinical outcome instruments. Prosthet Orthot Int. 2003 Dec;27(3):191-206. doi: 10.1080/03093640308726682.</citation>
      <PMID>14727700</PMID>
    </reference>
    <reference>
      <citation>Dillingham TR, Pezzin LE, MacKenzie EJ. Limb amputation and limb deficiency: epidemiology and recent trends in the United States. South Med J. 2002 Aug;95(8):875-83. doi: 10.1097/00007611-200208000-00018.</citation>
      <PMID>12190225</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 18, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 4, 2023</last_update_submitted>
    <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>function</keyword>
    <keyword>breathability</keyword>
    <keyword>comfort</keyword>
    <keyword>transradial</keyword>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Any information obtained from this study will be treated as confidential and will be safeguarded in accordance with the HIPAA privacy and security regulations. Research records may be released or disclosed if required by federal law. Records will be coded by assigning a case number and the information linking the case number to the subject's identity will be stored electronically on the VAPHS network. Any protected health information (PHI) stored electronically is in compliance with the HIPAA security rule. Study subjects will not be specifically identified in any publication of research results. Paper source documents of the coded research records will be kept in file cabinets within a locked file room. Any records which contain direct subject identifiers will be stored separately, with a different identification code, in a locked file cabinet within a locked file room. Records will be maintained in accordance with the Veterans Health Administration (VHA) Records Control Schedule.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_time_frame>Data sharing will begin upon the start of enrolling the first subject (10/1/2024) and end at the completion of the study (9/30/2028).</ipd_time_frame>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05990062
  org study id: A4257-R
  nct id: NCT05990062
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  This research and development will improve upon and investigate the potential validity of an
        innovative new transradial socket and harness design (the KSH system) that offers an
        alternative to standard hard sockets and rubber liners with a hybrid polymer and
        textile-based design derived from advanced athletic shoe technology. The project consists of
        designing, custom fitting and evaluating the function and comfort of the this new novel
        system. The study will take place in 3 phases; Phase 1, five experienced Veterans with
        transradial arm amputations will be recruited to provide guidance and to assist with the
        design and development. Experienced end-user Veterans and Clinical staff will work together
        to assist with design, develop the fitting process and working with engineers on the design
        of a completely digital fitting device for measuring the residual limb and locating bony
        prominences of the limb to inform the socket design. Phase 2, testing and assessment, the
        design and process validation will take place with the five Veteran upper transradial arm
        amputees Phase 3, an additional 20 Veterans with transradial arm amputations will be
        recruited and fit with the KSH system and undergo a series of evaluative tests. Veterans will
        perform a series of static and dynamic tasks to evaluate function, comfort and load bearing
        failure. The primary goal of this study is to improve upon the current preliminary prototype
        and to test it with a broader population of potential users to help advance the engineering
        and design, and to learn the potential to fit a range of Veterans with transradial
        amputations.
  Acceptance of prosthetic arms has long been a problem for clinical prosthetics, and recent
        studies indicate that recent advancements have done little to improve usage. Objections
        related to the fit and comfort of prosthetic arms remain the main reasons cited for the
        disuse of the devices, numbering nine of the top ten reasons cited for abandonment in a
        survey study. By addressing the literal point of pain for these users, the investigators hope
        to increase use and acceptance, allowing existing devices to have more positive impact on
        Veterans' lives. The breathability of composite sockets has been an acknowledged problem
        nearly since their development by the VA in the 1940s. Indeed, while the VA successfully
        developed a breathable composite socket very early on, it was quickly abandoned after it was
        discovered that the breathable composite recreated the problems with odor and cleanliness
        with leather sockets that the composites had been developed to solve. Industry leader Otto
        Bock discovered the same thing when it developed a porous silicone liner decades later. While
        VA and civilian providers were successful in replacing leather sockets with composites
        through the innovations in composites and other materials following World War II. Prosthetic
        clinics used to employ leatherworkers skilled in the art of making custom sockets and braces
        out of these traditional materials, but these services have disappeared along with the
        Veterans demanding them, and the workers capable of delivering them. By taking advantage of
        the benefits of the advanced materials and construction techniques that have replaced leather
        in the athletic shoe industry over the last seventy-five years, the investigators hope to
        restore much of the comfort and fit of these extinct socket designs, while at the same time
        delivering the improvements that have been delivered by the athletic shoe industry and
        advances in design and manufacturing over the same period. Lim design is working on a textile
        based prosthetic socket; however, the approach differs from the investigators': 1) The Lim
        design is not intended or currently suitable for upper limbs; 2) While a textile design, the
        Lim design cannot dynamically change in volume through the range of motion and constrains
        motion similar to any other socket once it has been adjusted; 3) The textile design of the
        Lim socket is nether breathable nor wicking and is designed to be used with silicone and/or
        gel liners, hence suffers from the same deficiencies with respect to heat and moisture
        management as traditional sockets. Lim Innovations and Ossur have publicly stated that they
        do not intend to pursue further innovations in the upper limb market. These frank admissions
        make it clear that the development of orphan devices for Veterans, must become the
        responsibility of the VA, whose goals for serving Veterans are sometimes in contrast with and
        not limited to the constraints of large and profitable markets. VA in collaboration with
        small companies can help fill this much needed void for innovation. VA has shown leadership
        in related domains with the research and design for ultralight wheelchairs, alternative
        controls for powered wheelchairs, and adaptive sports and recreation equipment, all of which
        eventually assisted the broader populations of Americans with disabilities. Harness
        discomfort is just as detrimental to acceptance as poor socket-body interface and can lead to
        contralateral damage to the axilla. Indeed, one recent study concluded that there was no
        acceptable level of force at which a body powered prosthesis could be operated pain and
        fatigue free with a traditional harness. While the conclusions of this study obviously
        contradict the staying power of the body powered prosthesis and harness system accepted by
        more than 90 per cent of the roughly half of users who accept a prosthesis at all, it does
        indicate that there is substantial improvement to be made in harnessing that could
        significantly improve both acceptance and comfort of the users who have been willing to
        tolerate the uncomfortable standard of care that has seen slow progress for decades.
  
        Study Objectives and Hypothesis:
  
        Specific Aim 1: Improve and develop the design and systems for fitting an innovative new
        transradial suspension design based on currently available technology used in athletic shoe
        construction.
  
          -  Design Criteria 1a: Optimize CAD documentation by revising and translating the current
             Autodesk Fusion 360 design to SolidWorks, aiding customization and improving design for
             manufacture.
  
          -  Design Criteria 1b: Verify that the currently Direct Metal Laser Sintered (DMLS) printed
             wrist and quick release can be efficiently and effectively CNC machined.
  
          -  Design Criteria 1c: Create fixturing and finalize CNC programming for manufacture,
             including the specification of manufacturing tolerances to ensure proper fit of
             components.
  
          -  Design Criteria 1e: Verify forearm and elbow counter parts-currently printed in Multijet
             Fusion (MJF)-in Selective Laser Sintering (SLS) or Fused Deposition or Fused Filament
             (FDM/FFF) Nylon material.
  
          -  Design Criteria 1f: Automate adaptation of the design through plugin and API
             development.
  
          -  Design Criteria 1g: Optimize production of 2D textile patterns with, for example,
             ExactFlat.
  
          -  Design Criteria 1h: Design a digital or Brannock-like fitting device for measuring the
             residual limb and locating bony prominences of the limb to inform the socket design.
  
          -  Design Criteria 1i: Design the device to weigh less than 2-pounds total weight. Jon is a
             50-year-old Veteran with a transradial arm amputation. He has had multiple carpal tunnel
             release surgeries on his remaining hand. An inconsistent but long-term user of
             prostheses, Jon settled on body-powered arms after extensive trials of myoelectric
             prostheses at Walter Reed immediately following his injury in Iraq in 2005, primarily
             because of the discomfort and lack of range of motion in the socket. He uses them mostly
             for true bimanual tasks, including bicycle riding, hunting, shotgun sports, and home
             improvement. Jon was not selected for a trial of the DEKA arm in 2018, and instead
             received a Bebionic hand and hard self-suspended socket from the VA. This arm was
             quickly rejected: it was heavy, incapable, uncomfortable, and restrictive. Blistering
             and irritation to Jon's arm from sweating and friction in a silicone lined carbon fiber
             vacuum socket.
  
        Specific Aim 2: Verify performance gains for the innovative KSH system that can be delivered
        to Veterans. The new design is expected to significantly exceed the performance of the
        standard-of-care prosthesis in quantitative measures.
  
          -  Hypothesis 2a (H2a): That the improved KSH will provide a higher tensile static load
             bearing capacity before failure than the current standard-of-care prosthesis.
  
          -  Hypothesis 2b (H2b): That the improved KSH will provide greater tensile loads in a
             dynamic environment. The KSH system will allow users to perform better on a rowing
             ergometer 10-minute test before failure than the current standard-of-care prosthesis, as
             measured using strokes per minute, power in Watts, distance in meters, maximal force,
             and time before failure.
  
          -  Hypothesis 2c (H2c): The improved KSH will provide a greater range of motion in
             flexion/extension than the current standard-of-care prosthesis.
  
          -  Hypothesis 2d (H3d): Participants will require less time for donning/doffing the KSH
             than their current standard-of-care prosthesis.
  
        Specific Aim 3: Verify functionality of the KSH system through testing with end-users.
  
          -  Hypothesis 3a (H3a): Participants will report high usability with setup and operation of
             the device (>80 on the System Usability Scale (SUS)).
  
          -  Hypothesis 3b (H3b): Participants will report significantly higher Socket Comfort Scores
             (SCS) with the KSH than their current standard-of-care prosthesis.
  
          -  Hypothesis 3c (H3c): Lower weight will correlate with greater user satisfaction, and the
             KSH will be statistically and clinically significantly lighter than participants'
             current devices.
  
          -  Hypothesis 3d (H3d): Participants will report that they would switch to the new design
             or have an additional prosthesis with the new design.
  
          -  Hypothesis 3e (H3e): Participants will report significantly higher Orthotics and
             Prosthetics User Survey (OPUS) scores with the KSH than their current standard-of-care
             prosthesis.
  
        Relevance to Veterans: According to the DoD/VA Extremity Amputation Center of Excellence
        there were about 3,000 Veterans with transradial amputations enrolled for VA Healthcare in
        FY21, out of about 62,000 Veterans with limb amputations enrolled for VA healthcare. Veterans
        with arm amputations from Post-911 conflicts number just over 200, and because the total
        number of Veterans missing arms is demographically small, this very fact has severely limited
        innovation in the field of prosthetic arms. Those missing at least all five fingers of a hand
        are among the VA's most significantly disabled Veterans, rated at 80 per cent disabled alone
        for the loss of a dominant hand. Many arm amputees are eligible for Special Monthly
        Compensation as well as vehicle and housing modifications, reflecting the degree to which
        these Veterans' lives are impacted by the impairment. Indeed, even among the civilian
        population, arm amputation is rare enough to easily meet the FDA's medical orphan criteria of
        fewer than 200,000 patients, though the FDA's orphan drug law specifically excludes medical
        devices, and the FDA has a lower device threshold of 8,000 patients, further limiting
        innovation. The NIH's Genetic and Rare Diseases Information Center (GARD) lists limb absence
        as a rare birth condition but doesn't mention the same disability acquired by trauma or
        through other diseases, such as cancer, which is the second most common cause despite the
        small total number from all causes. While the subject design can be extended to other levels
        of amputation, this study will focus on transradial, or below elbow amputees. This population
        represents approximately seventy-five per cent of the VA population of Veterans with arm
        amputations, a subset that is also much more likely to successfully wear a prosthetic arm.
        Over 90% of these users choose body powered. The design could be extended to other Veteran
        populations, including people with lower-limb amputations and other levels of amputation,
        potentially increasing the benefit by offering the same benefits to those Veterans. By
        targeting the portion of an orphan population that is already more likely to use the device
        for which improvement is sought, and by targeting the concerns that are most likely to lead
        to abandonment, this research stands to increase acceptance and therefore access to
        activities of daily living, employment and recreation that can improve quality of life for
        some of the VA's most impaired patients. Success could then also be translated to larger
        populations with similar needs. The proposed design is intended to address more than half the
        total population of Veterans with upper limb amputations and could with additional research
        and development be designed in the future for other levels of amputation, including lower
        limb and myoelectric upper limb use.
  allocation: Non-Randomized
  intervention model: Crossover Assignment
  intervention model description: The protocol consists of three phases with iterative design and development process involving input from Veterans with disabilities at various stages. In addition, 5 certified Prosthetists with at least five years of experience working with Veterans with transradial arm amputations will also be recruited to provide guidance and to assist with the design and development of the K-Socket Harness (KSH).
  primary purpose: Other
  masking: None (Open Label)
  measure: Static tensile load bearing capacity to reach a 50-pound load on an industrial scale
  time frame: 20 minutes
  description: We will test tensile static load bearing capacity up to a 50 -pound load or to failure. The Veteran will stand safely on an industrial scale with the arm extended at their side and weight will be added to the distal end of the prosthesis until the goal is met or the prosthesis fails. We will perform the task on both the KSH socket and the standard socket.
  measure: Elbow range of motion in flexion/extension
  time frame: 30 minutes
  description: We will measure range of motion (in degrees) in flexion/extension with a standard goniometer. We will perform the task on both the KSH socket and the standard socket.
  measure: Donning/doffing prosthesis
  time frame: 30 minutes
  description: We will record the time it takes to donn/doff each prosthesis for both the KSH socket and the standard socket.
  measure: Power in Watts generated on rowing machine
  time frame: 10 minutes
  description: We will test tensile loads in a dynamic environment before failure. We will test the performance on a rowing ergometer 10-minute test before failure, as measured using power in Watts. We will perform the task on both the KSH socket and the standard socket.
  measure: Strokes per 10-minute period
  time frame: 10 minutes
  description: We will test tensile loads in a dynamic environment before failure. We will test the performance on a rowing ergometer 10-minute test before failure, as measured using strokes per minute. We will perform the task on both the KSH socket and the standard socket.
  measure: Distance rowed in meters
  time frame: 10 minutes
  description: We will test tensile loads in a dynamic environment before failure. We will test the performance on a rowing ergometer 10-minute test measuring distance in meters before failure or to time expiration. We will perform the task on both the KSH socket and the standard socket.
  measure: Maximal force before failure
  time frame: 10 minutes
  description: We will test tensile loads in a dynamic environment before failure. We will test the performance on a rowing ergometer 10-minute test measuring maximal force (Newton) before failure. We will perform the task on both the KSH socket and the standard socket.
  measure: Total time before failure
  time frame: 10 minutes
  description: We will test tensile loads in a dynamic environment before failure. We will test the performance on a rowing ergometer 10-minute test recording the time (in minutes and seconds) before failure. We will perform the task on both the KSH socket and the standard socket.
  measure: Usability of prosthesis using the System Usability Score (SUS) on scale from 0-100
  time frame: 15 minutes
  description: Participants will report usability with setup and operation of the device from ten questions using a five point Likert scale. The higher the score, the more usable (user friendly) the device is rated by the Veteran. We would like the KSH system to score >80 on the System Usability Scale (SUS)).
  measure: Socket Comfort Scores (SCS) on a scale from 0-10
  time frame: 30 minutes
  description: Participants will report Socket Comfort Scores (SCS) after wearing and testing of the devices for both with the KSH and current standard-of-care prosthesis by using an 11 point scale, (0-10) Zero being the most uncomfortable socket fit you can image, and 10 being the most comfortable socket fit.
  measure: Weight of device in pounds
  time frame: 30 minutes
  description: We will correlate the weight of the prosthesis in pounds with user satisfaction of both the KSH device and the participants' current device.
  measure: Participant preference
  time frame: 10 minutes
  description: We will ask the participant which device design they prefer to use.
  measure: Orthotics and Prosthetics User Survey (OPUS)
  time frame: 1 hour
  description: We will ask the participant to complete the questionnaire focusing on five modules; lower and upper extremity functional status (LEFS and UEFS), client satisfaction with device and services (CSD and CSS), and the health related quality of life (HRQoL) Scores are based on a 100 point scale. The higher the score indicates a better outcome.
  arm group label: Verify performance gains for the innovative KSH system that can be delivered to Veterans. The new de
  arm group type: Experimental
  description: The investigators will perform several functional tests of the both the KSH system and the standard of care prosthesis: tensile static load bearing capacity before failure, test rowing ergometer 10-minute test before failure measured using strokes per minute, power in Watts, distance in meters, maximal force, and time before failure, range of motion in flexion/extension, and donning/doffing time.
  arm group label: Verify functionality of the KSH system through testing with end-users.
  arm group type: Experimental
  description: The investigators will use System Usability Scale (SUS) to assess high usability with setup and operation of the device. The investigators will assess Comfort Scores (SCS), evaluate weight and correlate it with user satisfaction. The investigators will report selection outcome between new design and current design. The investigators will asses 1) functional status, (2) health- related quality of life, and (3) satisfaction with services and (4) device scores through the Orthotics and Prosthetics User Survey (OPUS).
  intervention type: Device
  intervention name: K-Socket-Harness
  description: A transradial socket and harness design that offers a hybrid polymer and textile-based design derived from advanced athletic shoe technology. The KSH integrated socket, frame, and wrist, the "variable compliance prosthetic socket with breathable matrix," creates a dynamic and secure attachment with a combination of two lacing systems. The lacing systems lengthen and shorten six flexible hinges at the elbow, maintaining a secure attachment throughout the range of motion and accounting for volume changes in the soft tissue of the elbow that would otherwise restrict range of motion or cause the socket to separate from the residual limb.
  arm group label: Verify functionality of the KSH system through testing with end-users.
  arm group label: Verify performance gains for the innovative KSH system that can be delivered to Veterans. The new de
  other name: KSH System
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Rory A Cooper, PhD
  role: Principal Investigator
  affiliation: VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
  last name: Elizabeth B Toth, BA
  phone: (412) 954-5382
  email: elizabeth.toth2@va.gov
  facility: 
  contact: 
  investigator: 
  country: United States
  citation: Salminger S, Stino H, Pichler LH, Gstoettner C, Sturma A, Mayer JA, Szivak M, Aszmann OC. Current rates of prosthetic usage in upper-limb amputees - have innovations had an impact on device acceptance? Disabil Rehabil. 2022 Jul;44(14):3708-3713. doi: 10.1080/09638288.2020.1866684. Epub 2020 Dec 30.
  PMID: 33377803
  citation: Biddiss E, Chau T. Upper-limb prosthetics: critical factors in device abandonment. Am J Phys Med Rehabil. 2007 Dec;86(12):977-87. doi: 10.1097/PHM.0b013e3181587f6c.
  PMID: 18090439
  citation: Hichert M, Vardy AN, Plettenburg D. Fatigue-free operation of most body-powered prostheses not feasible for majority of users with trans-radial deficiency. Prosthet Orthot Int. 2018 Feb;42(1):84-92. doi: 10.1177/0309364617708651. Epub 2017 Jun 16.
  PMID: 28621577
  citation: Hanspal RS, Fisher K, Nieveen R. Prosthetic socket fit comfort score. Disabil Rehabil. 2003 Nov 18;25(22):1278-80. doi: 10.1080/09638280310001603983.
  PMID: 14617445
  citation: Heinemann AW, Bode RK, O'Reilly C. Development and measurement properties of the Orthotics and Prosthetics Users' Survey (OPUS): a comprehensive set of clinical outcome instruments. Prosthet Orthot Int. 2003 Dec;27(3):191-206. doi: 10.1080/03093640308726682.
  PMID: 14727700
  citation: Dillingham TR, Pezzin LE, MacKenzie EJ. Limb amputation and limb deficiency: epidemiology and recent trends in the United States. South Med J. 2002 Aug;95(8):875-83. doi: 10.1097/00007611-200208000-00018.
  PMID: 12190225
  responsible party type: Sponsor
  sharing ipd: Yes
  ipd description: Any information obtained from this study will be treated as confidential and will be safeguarded in accordance with the HIPAA privacy and security regulations. Research records may be released or disclosed if required by federal law. Records will be coded by assigning a case number and the information linking the case number to the subject's identity will be stored electronically on the VAPHS network. Any protected health information (PHI) stored electronically is in compliance with the HIPAA security rule. Study subjects will not be specifically identified in any publication of research results. Paper source documents of the coded research records will be kept in file cabinets within a locked file room. Any records which contain direct subject identifiers will be stored separately, with a different identification code, in a locked file cabinet within a locked file room. Records will be maintained in accordance with the Veterans Health Administration (VHA) Records Control Schedule.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd time frame: Data sharing will begin upon the start of enrolling the first subject (10/1/2024) and end at the completion of the study (9/30/2028).