Amputation
Amputation is the surgical removal of a limb or part of a limb, often due to trauma, disease, or infection.
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Found 148 Actively Recruiting clinical trials
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Healthy Volunteer
Digital technologies have evolved exponentially in the dental medicine field endorsing a change between the conventional methods to virtually based methodologies in daily clinical and laboratorial practice. Combining facial aspects and proportions with dento-gingival parameters are the basis when planning a new smile design and a final rehabilitationFacial surface images can be used for more predictable measurement and quantification of vertical dimension of occlusion and lip support before, during and after a full mouth rehabilitation. Besides that, the information obtained by facial scanners have a major impact in treatment planning process especially in multidisciplinary complex cases with the simulation of the treatment, identification of patient's expectations and the implementation of an effective communication tool. The 4D-virtual patient is the future regarding the management of a patient in dental medicine, since the beginning of the process with data acquisition for the diagnosis to the definitive oral rehabilitation procedures. Similar to any methodology, it is important to understand what are the basis of the facial scanning and what protocols can obtain better results in terms of accuracy and reliability.
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The anatomical knee is a complex, polycentric joint characterized by a large range of motion in the sagittal plane and limited mobility in the coronal and transverse planes. The sagittal plane motion is used for progression in stance phase, and limb clearance and advancement in swing. Limb prostheses are intended to restore function and cosmesis in persons with limb loss. The complexity and function of prosthetic components have advanced significantly as technology has improved, but a state-of-the-art artificial limb is still a relatively poor substitute for an anatomical one. Microprocessor-controlled knees (MPKs) do not typically utilize motors to power joint rotation, but they automatically adjust resistance or damping in the joint to improve swing- and/or stance-phase control as appropriate for the user during gait. The Ossur Power Knee, which was first introduced in 2006, is the only MPK that uses a motor to provide active power generation during walking and other activities involving knee flexion and extension. Last year, Ossur released the 3rd generation of its Power Knee and appears to have addressed many of the previous shortcomings in terms of reduced weight, less noise, lower cost and longer battery life. Therefore, the newest version of the Power Knee warrants a fresh evaluation since it is, in essence, substantially different in design and function from previous models. The purpose of this proposed investigation is to perform biomechanical evaluations of the new Ossur Power Knee during walking and other activities by transfemoral prosthesis users. Using a cross-over experimental design, approximately 20 unilateral, transfemoral amputee subjects (10 men and 10 women) will be evaluated in the Jesse Brown VAMC Motion Analysis Research Laboratory (MARL) while wearing the Ossur Power Knee and Ossur Rheo XC, which is a passive MPK device. Furthermore, the Ossur Power Knee may offer distinct advantages to female prosthesis users, so mobility will be compared between men and women to determine if differences exist on the basis of sex. The specific aims and hypotheses of this project are: Aim 1: To compare the effects of the Ossur Power Knee and Ossur Rheo XC on the gait of unilateral, transfemoral prosthesis users during level walking. Kinematic and kinetic data will be collected as subjects walk in the MARL. Hypothesis--the active knee flexion and extension provided by the Ossur Power Knee will (1) improve walking performance, and (2) reduce metabolic energy cost during ambulation. Aim 2: To compare the effects of the Ossur Power Knee and Ossur Rheo XC on stairs, slopes and during sit-to-stand/stand-to-sit activities of unilateral, transfemoral prosthesis users. Kinematic data will be collected as subjects perform these activities. Hypothesis--subjects will have improved performance when using the Ossur Power Knee. Aim 3: To analyze and compare gender specific data between subjects using the Ossur Power Knee and the Ossur Rheo XC. Hypothesis--male and female subjects will demonstrate substantially different abilities to use the two knee components, indicating that gender specific components should be further investigated and developed. Research focusing on the unique prosthetic needs of women Veterans is currently a special emphasis area of the VA RR\&D Service. Subjects will also be administered questionnaires and provided at-home diaries to document their perceptions of comfort, exertion and stability while using the different prosthetic knee units. The repeated-measures, cross-over protocol design enables each subject to serve as their own control, and it will be determined whether statistically significant changes occur in their performance measures. A two-way mixed-methods ANOVA will be used to assess the main and interaction effects of sex (male, female) and knee type (Ossur Power Knee, Rheo XC). As a conservative approach, a Bonferroni correction will be used to account for the family-wise Type I error rate because multiple outcomes will be used to address each hypothesis. Increased understanding about how the Ossur Power Knee affects the abilities of transfemoral prosthesis users will facilitate appropriate component selection by prosthetists and ultimately improve quality of life for prosthesis users.
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This observational study aims to compare myoelectric and bionic hands in terms of upper extremity function, body image and satisfaction. The main questions it aims to answer are: \- Does upper extremity function differ between bionic and myoelectric hands? The main questions it aims to answer are: Does upper extremity function differ between bionic and myoelectric hands?
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All subjects that will be enrolled in this investigation should have been treated with the OPRA Implant System for a transhumeral unilateral or bilateral amputation and completed the second stage surgery (S2) and had at least 6 months of usage experience with the OPRA Implant System before enrolment. This retrospective, non-interventional, clinical investigation is designed as a multicenter, multinational, cohort investigation for long-term follow-up of safety and efficacy endpoints. The investigation will also include prospective visit(s) for enrollment of subjects and collection of present data on device functionality and the use of the device. No control group or comparator will be used in this investigation. All patient reported outcome questionnaires used in the investigation will be available at the investigation site for completion by the subjects during one of the subjects' visits to the site. Depending on the subjects' preferences it will also be possible to provide those questionnaires to the subjects, through use of regular mail, email or through an electronic Patient Reported Outcome system (ePRO). It will be possible for the subjects to complete the questionnaires either on paper, electronically or over phone, depending on their preferences. Preferably, the subjects prosthesis functional tests should be performed as part of the follow-up visit at the site. The tests may also be performed remotely, depending on subjects' preferences. If done remotely, this will require the functionality test being performed during a videoconference with the test administrator. No photos or video-recordings (if conducted according to the sites normal practice) of the performed tests will be part of the investigation documentation, only the related medical record notes will be used as source data for those parameters.
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Healthy Volunteer
Upper extremity amputation is among the oldest known surgical procedures in medical history, with many of its technical principles having first been elucidated by Hippocrates. Despite the passage of more than two millennia, relatively little has changed in the operative approach to upper limb sacrifice. An estimated 58,000 patients in the United States currently suffer from upper extremity limb loss at either the above elbow (AEA) or below elbow (BEA) level, and the prevalence of upper limb amputation is expected to rise to approximately 95,000 patients by 2050. Normal function of the upper limb is enabled through the dynamic interplay of multiple muscle groups acting in concert. Manual dexterity is a remarkably orchestrated biomechanical process that is dependent upon a complex feedback loop involving the central and peripheral nervous systems and the musculoskeletal system. In their native state, the muscles of the upper extremity exist in a balanced agonist/antagonist situation in which volitional activation of one muscle leads not only to its contracture, but also to passive stretch of its opposite. Changes in muscle tension manifest through this interaction of agonist and antagonist units lead to stimulation of specialized receptors within the muscle fibers (e.g., muscle spindle fibers and Golgi tendon organs) that transmit joint position information to the cerebral cortex. Such feedback, in conjunction with cutaneous sensory information from skin mechanoreceptors, provides us with a sense of limb proprioception that ultimately enables high fidelity limb control, even in the absence of visual feedback. Unfortunately, the standard operative approach to upper limb amputation at either the AEA or BEA level obliterates many of the dynamic relationships characteristic of the uninjured upper extremity. Initial surgical exposure is typically accomplished through a fishmouth-pattern incision, followed by progressive transection of muscles, vessels, nerves and bone at the level of the incision. Tissues distal to the site of structural transection are discarded, regardless of whether or not there may be viable segments, and the proximal residual muscles are layered over the distal transected bone in order to provide insulation to this exposed osseous surface. The surrounding skin is then advanced over the bone/muscle construct in order to achieve definitive closure. The rudimentary approximation of discordant tissues in the distal limb in this approach results in a disorganized scar mass in which normal dynamic muscle relationships are destroyed. The uncoupling of native agonist/antagonist muscle pairings results in isometric contraction of residual muscle groups upon volitional activation, producing incomplete, unbalanced neural feedback to the brain that results in aberrant perception of residual limb position. Such disturbed feedback not only leads to impaired limb function with prostheses, but also manifests as pathological sensory perception of the extremity in the form of phantom limb and phantom pain symptoms. To date, the limitations of these approaches have been tolerated due to the fairly simplistic goal of upper limb amputation: to provide a stable, padded surface for mounting a prosthesis. Historically, upper limb prostheses have afforded amputees the opportunity to recover at least some measure of upper limb function. However, such devices have generally not been able to recapitulate the complex biomechanics of the human upper limb due to limited ranges of motion and lack of feedback control. These limitations have resulted in reported upper limb prosthesis rejection rates ranging from 23% to 45%, including both body-powered and myoelectric devices. However, the capabilities of modern prostheses are now expanding remarkably. Technological advances including increasingly miniaturized electronics, wireless communications and ever-refined positional sensors have enabled prosthetic developers to create next-generation bionic limbs with greatly enhanced degrees of freedom over prior models. Even more advanced prostheses are currently being developed that have the potential to offer sensory feedback - both tactile and positional - in a manner never before seen. Such prosthetic devices, while not yet available commercially, are presently being studied in experimental settings. For example, the Defense Advanced Research Projects Agency (DARPA) recently issued a request for proposals under the Hand, Proprioception and Touch Interfaces (HAPTIX) Program incorporating an upper limb prosthesis including six degrees of freedom at the wrist, thumb and all digits, 10 pressure sensors capable of providing sensory feedback, and joint angle and velocity sensors capable of providing joint position data. Despite these technological advances in prosthesis development, surgical methods regarding management of the residual limb have not kept pace with these enhanced prosthesis capabilities. Classic techniques of upper limb amputation do not provide innervated interfaces that can serve as relays for complex prosthetic control; without such biological actuators in the residual limb to provide afferent and efferent conduits for information exchange, next generation prostheses are of little use. Stated another way, next generation prosthetic devices currently incorporate drivers and sensors capable of providing far more enhanced functionality than ever before seen, but standard approaches to limb amputation do not deliver a way to effectively link these prosthetics to their intended beneficiaries. An evolution in the manner in which upper limb amputations are performed - one that will provide a biological interface that will allow upper limb amputees to take advantage of the enhanced capabilities offered by the remarkable prostheses currently under development - is now required. Recognition of the increased need for effective neural interfaces for prosthetic limbs can be seen in the expanding number of efforts in this sphere over the past decade. Initial efforts to provide high-resolution control of distal prostheses were focused primarily on indirect and direct brain interfaces, either through placement of electroencephalographic scalp sensors or implantable parenchymal electrodes, respectively. However, such endeavors have been plagued by poor resolution, inconsistencies in signal acquisition and, in the case of implantable devices, progressive foreign body reactions leading to impulse degradation over time. As the limitations of brain interfaces have become more evident, focus has shifted instead to peripheral control loci. Efforts in this vein have included direct peripheral nerve interfaces including interposed sieves and cuffs designed to transduce electrical signals directly from individual nerve fascicles to distal prostheses. Such monitors have, however, shown little clinical promise due to progressive nerve compression secondary to scarring, as well as to significant neurological crosstalk and interference in biological models. The most promising efforts regarding peripheral nerve interface development are now within the realm of biological systems. These models consist of configurations in which native tissues are innervated with distal nerve endings to create biological actuators for distal prosthesis control and feedback. The two leading models in this sphere are as follows: * Targeted Muscle Re-innervation (TMR): Pioneered by Dumanian and Kuiken et al, TMR is a technique whereby a series of nerve transfers is used to re-innervate specific target muscles to create additional prosthesis control sites after distal limb amputation. * Regenerative Peripheral Nerve Interfaces (RPNI): Championed by Cederna et al, RPNI offers an alternative version of an innervated biological interface. An RPNI is a surgical construct that consists of a non-vascularized segment of muscle that is coapted to a distal motor or sensory nerve ending. While both TMR and RPNIs have demonstrated promise in offering improved functionality to patients who have already undergone amputation, neither technique has been incorporated into a fundamental redesign of the way in which amputations are performed in the first place; in all cases of clinical implementation of TMR or RPNIs reported to date in the literature, these techniques have been employed to further optimize the functionality of patients who had already experienced limb loss. The clinical protocol proposes a reinvention of the manner in which upper limb amputations are performed, building upon several of the principles established in the work already performed in the realm of TMR and RPNIs. As elaborated below, the core innovation is the utilization of distal limb tissues that would ordinarily be sacrificed in the course of standard lower limb amputations to provide the substrate for natively innervated pairings of agonist/antagonist muscles capable not only of intuitive, volitional motor activation but also proprioceptive feedback. Conceptually, this idea consists of physical linkage of biologically opposed muscles (e.g., the biceps and triceps) such that when neurologically triggered contraction of one muscle is effected, simultaneous stretch of its partner is also achieved, resulting in observable motion of the dyad and stimulation of standard proprioceptive pathways. The investigators have named this construct the agonist-antagonist myoneural interface (AMI). The manner in which this dynamic agonist/antagonist muscle concept may be operationalized clinically depends upon whether or not intact, innervated and vascularized native muscles are present at the time of operative intervention. Over the past five years, the research group has developed experimental models for a variety of clinical scenarios through a series of preclinical investigations in both murine and caprine populations. If healthy native muscle is available as a reconstructive substrate, coaptation of the distal ends of disinserted agonist/antagonist pairs may be incorporated into the design of the residual limb; when coupled with a native synovial canal as a gliding interface, a pulley-like system can be established to provide a dynamic muscle construct. Construction of AMIs in a rat model have demonstrated preservation of construct muscle bulk, viability over time and production of graded afferent signals in response to ramp and hold stretches in a manner similar to native muscle architecture. Furthermore, performance of an amputation at the transtibial level with incorporation of AMI construction in a goat model has demonstrated clear coupled motion of the agonist-antagonist pair in the presence of both natural neural commands and artificial muscle stimulation. Based on these proof of concept animal studies, the investigators hypothesize that the AMI offers the potential to provide a biological relay for volitional control that is superior to other neural interface strategies, with the additional benefit of being able to restore limb proprioception. When coupled with an appropriately adapted next-generation prosthesis, the AMI thus may provide the first biological mechanism to achieve true closed-loop neural interactivity with a mechanical limb. The investigators here propose a three-year, prospective, controlled assessment of the functional and somatosensory advantages of the modified amputation model in an upper extremity scenario. The investigators believe this model has the potential to provide upper limb amputees with a biological interface that offers not only unprecedented, high-resolution motor control of prostheses, but also is highly intuitive and capable of restoring limb proprioception. If manifest, these augmented capabilities may result in improved functionality and overall health outcomes, including more robust return to work status and diminished psychological strain.
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The objective of this study is to evaluate the Symani System's safety and effectiveness for microsurgical anastomosis during free tissue transfer surgery and lymphovenous anastomosis surgery. The primary endpoints are: * Effectiveness- Rate of intraoperative anastomosis patency at first attempt. * Safety- Freedom from device-related adverse events. Participants will receive treatment as standard of care and be asked to: * Allow the researchers to access and use their information. * If participants are undergoing a lymphedema procedure, they will be asked to undergo a questionnaire as part of the study. * Participants will be asked to comply with the follow-up visits and complete all study procedures/questionnaires as outlined in the protocol.
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Using a prosthesis allows many who experience lower leg amputation to regain functional abilities, but walking may be more difficult, and people with limb loss suffer from a wide range of mobility limitations including balance and stability impairments. Selecting an optimal prosthetic foot is an important aspect of maximizing mobility, limiting falls, and the achievement of functional goals for people with lower leg amputation (LLA), however there is limited evidence to guide this process. The current prosthetic prescription process relies on clinician experience and typically does not allow people with a leg amputation to easily try out different prosthetic feet. The investigators have developed a customizable robotic prosthetic foot that can mimic the mechanical properties of commercially available prosthetic feet in the coronal and sagittal planes without physically changing feet. This multiaxial 'prosthetic foot emulator' (PFE) can be attached to the prescribed prosthetic socket and worn like a regular prosthetic foot within the laboratory or clinic, providing people with LLA the opportunity to quickly 'test-drive' many prosthetic foot designs within a single test session. Trial and error with actual commercial prosthetic feet can be inefficient given the time and expense required for the purchasing and fitting of prosthetic feet. The PFE could provide a means to explore a range of feet over uneven, incline, and cross sloped surfaces in a very short period of time. This study aims to optimize stability and balance-related outcomes, to minimize falls, and to optimize vocational and avocational participation and functional quality for life for Veterans with LLA. This study will determine the effects of coronal and sagittal plane commercially-available prosthetic foot stiffness on stability and falls related outcomes and will evaluate the use of a test-drive strategy using a PFE to predict stability and balance-confidence outcomes with corresponding commercial prosthetic feet. Results from this study may contribute to increased understanding of how a patient-centered strategy for optimizing prosthetic prescription can improve patient satisfaction, functional outcomes, and balance confidence for Veterans and others with LLA.
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This research is being done to determine if an anesthetic like Lidocaine, may be effective when injected around the sciatic nerve of the intact limb in patients with limb loss pain on the contralateral side.
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Healthy Volunteer
We have developed a novel terminal device for a prosthetic arm that eliminates the functional tradeoffs seen in body-powered voluntary open devices. The primary goal of this study is to validate the performance of the device against the commercial state-of-the-art in upper limb terminal devices.
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OBJECTIVES: The objectives of this study are: 1. To determine the additional effects of kinesio taping in combination with physical therapy on ROM of upper limb shoulder, elbow and wrist joint in subacute stroke patients 2. To determine the additional effects of kinesio taping in combination with physical therapy on upper limb spasticity in subacute stroke patients 3. To determine the effects of kinesio taping on upper limb function in subacute stroke patients. HYPOTHESIS: Alternate Hypothesis: There is a statistically significant difference between kinesio taping combined with physical therapy on ROM, spacticity and function of upper limb Shoulder, elbow and wrist joints in patients with subacute stroke compared to conventional physical therapy. Null Hypothesis: There is no statistically significant difference between kinesio taping combined with physical therapy on ROM, spacticity and function of upper limb Shoulder, elbow and wrist joints in patients with subacute stroke compared to conventional physical therapy. Research Design: Experimental study. Randomized Control Trial Clinical setting: Rehabilitation department, Fauji Foundation Hospital , leading edge physical therapy and rehabilitation islamabad. Study duration: 6 months. Selection Criteria: Inclusion Criteria * Age group: 40-65 years onwards * Both males and females * Patients with history of diagnosed stroke and lie within subacute stage of stroke * MAS scale score of 1\_2 Exclusion Criteria * Any congenital deformities * cognitive deficits * Fractures * Upper limb surgery Sampling technique: Convenience sampling Outcome Measures: Data will be collected on Demographics and general information Goniometer will be used to assess the range of motion of shoulder, elbow and wrist joint Modified Ashworth scale will be used to determine the level of spasticity in the participants. Wolf motor function test scale for upper limb will be used to assess upper limb function. Experimental Group (A) = This group will receive kinesio taping every alternate day for six weeks combined with conservational physical therapy which includes AROMs, PROMs, PNF D1 flexion and extension, resistance raining using resistance band of medium resistane. and their outcomes will be measured at baseline and at 3rd week and at the end of 6th week treatment. Control group (B) =this group will not receieve kinesio taping , only conservationall Physical therapy will be given and their outcomes will be observed at the baseline, at third week and then after treatment of 06 weeks. Data analysis techniques: The data will be analyzed through SPSS 21 and Data would be analyzed based on the study design chosen that is random control experimental study. A printed questionnaire will be provided to the participents after obtaining written consent and providing adequate explanation regarding the study, after which the data will be presented in the form of graphs or tables. Significance of the study: This study will add data to the literature. Providing evidence-based data and aiding healthcare providers to incorporate kinesio taping as an adjunct intervention. This study will also provide a feasible and cost-effective treatment to the patient diagnosed with subacute stroke. Kinesio taping is easy to apply, potentially beneficial treatment options for patients with subacute stroke upper limb dysfunction.
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