Clinical Research Directory

Prosthetic Limb Movement Feedback for Upper and Lower Extremity Amputees

To assess the functional characteristics and utility of upper and lower limb prosthetic devices (advanced bionic and current clinical standard-of-care) that incorporate physiologically relevant touch and/or movement feedback.

Cryo NerVe Block Extremity AmputatioN RegIStry for Post Operative and pHantom Limb Pain

The goal of this Registry is to see how the device is used when freezing nerves during an amputation procedure.

Evaluating the Experience of Upper Limb Prosthesis Use

The goal is to understand the critical factors associated with outcome acceptance following upper limb loss. The investigators aim to develop a unified theoretical model that describes the psychosocial experience of upper limb prosthesis use and predicts outcome acceptance following upper limb loss. The investigators will also examine experiences with prosthesis education, selection, and training as well as how psychological and social issues impact prosthesis use. In addition, the investigators will use the findings to develop a prototype decision tool to assist with matching persons to prostheses. Study findings will help providers, technology developers, and researchers better understand the complex experience of upper limb prosthesis use. This conceptual framework will enable clinicians and researchers to evaluate and predict patient outcomes following limb loss, and to design interventions that improve outcomes. The proposed study is a mixed methods (qualitative and quantitative) study using an observational design. The qualitative component of the study will involve data collection through telephone interviews with 42 participants and analyses using a grounded theory approach with constant comparison methods. The quantitative component involves administration of standardized measures quantifying constructs of the theoretical model in 120 participants and analyses to produce a structural equation model of outcome acceptance. Participants will include persons with unilateral acquired upper limb loss at the trans radial or trans humeral level who use currently available prosthetic devices. Up to 16 individuals will participate in a series of focus groups that will be conducted to provide feedback on the model generated from previous data.

The Effect of Perioperative Intravenous Lidocaine Infusion on Post-amputation Pain in Amputee Patients

This study aimes to evaluate whether perioperative intravenous lidocaine infusion effectively relieves postoperative pain, enhances recovery, and reduces chronic stump and phantom limb pain after amputation, thereby informing future multicenter trials and clinical guideline development.

Ultrasonic Enhancement Delivery of Phosphodiesterase Inhibitors Nanoparticles for Diabetic Management of the Foot

The enhancement of cGMP levels at the wound site has shown beneficial effects in wound healing. Thus, topical or systemic application of phosphodiesterase 5 (PDE5) inhibitors, for example, sildenafil (Viagra), which is well-known for its use in the treatment of erectile dysfunction, enhanced contraction, re-epithelialization, and tensile strength of rat wounds and reduced pressure ulcer size in a few patients. In addition, Nanofibers Specifically designed for topical drug delivery enable the sustained release of therapeutic molecules, such as growth factors. This targeted approach ensures optimal cell-to-cell interactions, proliferation, and vascularization, fostering effective and controlled wound healing. Diabetic foot is Diabetic foot ulcers (DFUs) are the most common complications associated with diabetes mellitus. DFUs are displayed as open sores or wounds on the bottom of the foot as a secondary complication of diabetes mellitus (DM). DFUs are associated with significant morbidity and mortality and can subsequently lead to hospitalization and lower limb amputation if not recognized and treated on time. An immense challenge to conventional treatments is caused by the chronic nature of diabetic foot syndrome, and it has led to the emergence of nanotechnology-based therapeutics.

Short-term Implanted Electrodes Following Regenerative Peripheral Nerve Surgery for Improving Prosthetic Limb Control Signals

The device, a bipolar percutaneous intramuscular electromyography electrode, is intended for use in upper-limb amputation patients who have received the regenerative peripheral nerve interface surgical procedure, in order to enable the use of advanced prosthetic arms and hands.

Gait Training and Balance Using Artificial Intelligence

Effect of Using Artificial Intelligence on Gait Training and Balance in Above Knee Amputation Patients

Influence Of A Slope Adaptive Foot On Participation Of Veterans With Lower-Limb Amputations

Veterans with below-knee amputations are limited by prosthetic feet that cannot adapt to sloped and uneven terrain. This limitation results in reduced mobility, reduced balance confidence, and a higher risk of falls among some individuals who use below-knee prostheses, which have been shown to negatively impact participation in daily and recreational activities. The investigative group has designed a novel Slope Adaptive Foot (SAF) that is mechanically passive, capable of slope adaption on every step of walking, and maintains high levels of energy storage and return. Pilot testing of the SAF with Veterans has generated excellent results to date, with comments suggesting potential improvements in participation. This study will evaluate the extent to which participation and fall-related health outcomes are influenced by using the SAF versus a typical hydraulic foot in a cross-over randomized controlled trial. Using mixed-methods, the investigators will also collect long-term data of Veterans using their preferred foot to inform the development of evidence-based education materials for use in clinical decision making.

Advancing Antimicrobial Photodynamic Therapy to Prevent Infection in Osseointegrated Prosthesis Patients

This will be a prospective observational trial enrolling 20 patients with osseointegrated prostheses. Participants will be recruited from the orthopaedic outpatient clinic at Walter Reed National Military Medical Center in Bethesda, MD. All eligible consenting patients will undergo daily stoma management per standard of care. Patients will integrate antimicrobial photodynamic therapy into their stoma management program. The first treatment will take place in the orthopaedic clinic. All others will take place at home. Topical 5-ALA will be applied to the metal at the penetration site. After 2 hours, the light delivery device will be utilized and light will be administered for 15 minutes. Data collection: After obtaining informed consent, study personnel will record injury-specific variables, surgery-specific variables, other variables related to their hospital course, demographic variables as well as comorbidities on the study case report forms (CRFs). They will obtain this information directly from the participant, from the participant's medical record, and the participant's treating orthopaedic surgeon or other health care providers. Baseline data collection points include participant characteristics and amputation details such as age, sex, comorbidities, highest education level achieved, social support, initial reason for amputation, type of amputation and all surgical dates. Study participants will be followed at 1 and 2 weeks after initiation of PDT treatment. To ensure research participant safety, serious adverse events (SAEs) will be documented and promptly submitted to the local IRB as per the required reporting processes. Follow-up: Study participants will be followed at 1 week and 2 weeks.

Assessing Ambulatory and Non-ambulatory Community Mobility in People With Lower Limb Amputation

Mobility is a fundamental aspect of daily life, enabling individuals to participate in social, occupational, and recreational activities. Community mobility, defined as movement in environments outside the home, is particularly important for quality-of-life. Following lower limb amputation (LLA), mobility limitations are common and persistent. With rehabilitation and prosthetic training, many regain the ability to ambulate but results vary as only 25 - 58% of patients regain ambulatory ability and less than half of those who become ambulatory achieve sufficient ability to walk in community settings. As a result, \~40% of people with LLA are ambulatory but also use wheeled mobility (e.g., wheelchair, scooter) for some or all of their community mobility tasks. To date, the complementary role of wheeled and ambulatory mobility in maximizing community mobility has been overlooked, with clinical research overwhelmingly focused on assessing and improving ambulatory ability despite its impracticality for many community settings.

Targeted Muscle Reinnervation Study (TMR)

The purpose of this study is to examine the effect of targeted muscle reinnervation on the outcomes of amputees at a level 1 trauma center. The investigators propose to randomize all patients requiring amputation with and without targeted muscle reinnervation. This study will help delineate the efficacy of targeted muscle reinnervation in the general population.

Human Penile Allotransplantation

Injuries to the genitalia are of concern to the military with emphasis placed on the surgical reconstruction and psychological health of these Wounded Warriors. However, despite significant surgical advances in microvascular surgery and autologous free tissue transfer, conventional reconstructions cannot truly replace the complicated structures and functions of the penis including the urethra, erogenous sensation, and erectile corporal bodies. Conventional reconstruction poses several challenges: patients may not have sufficient donor tissue due to other injuries or previous surgery; multiple operations are often needed to restore the neophallus; the final reconstruction only approximates the penis' native form; recreating the urethra is challenging and the new urethra is prone to stricture and fistula formation; the erectile function necessary for sexual intercourse is often lacking; and insufficient protective sensation can lead to penile implant extrusion, infection, subsequent explantation or loss of the reconstruction. The investigators propose this clinical trial to determine functional outcomes and quality of life for Wounded Warriors and civilians who choose to undergo penile allotransplantation. The investigators will combine extensive experience performing total penile reconstruction in a large population affected by congenital, traumatic, and therapeutically extirpated Genitourinary deformities and expertise in reconstructive transplantation using an immunomodulatory protocol to for this study. The investigators anticipate penile transplantation can potentially replace "like with like," restoring the appearance, anatomy, and function of the recipient in a manner far superior to autologous reconstruction. This project will establish the ability to perform penile allotransplantation using an immunomodulatory protocol and will compare outcomes with conventional phalloplasty patient results. Study Design: This is a non-randomized subject self-controlled clinical trial to implement a cell-based immunomodulatory protocol for penile allotransplantation. An intermediate deliverable is achieving allograft survival and functional return with reduced dosing/frequency of maintenance immunosuppression on steroid-free monotherapy (tacrolimus) immunosuppression. The long-term deliverable and goal is to demonstrate superior outcomes when compared to satisfaction and QOL in conventional phalloplasty patients 12-60 months post-transplant.

A Novel Approach to Upper Extremity Amputation to Augment Volitional Control and Restore Proprioception

The hypothesis of this research protocol is that the investigators will be able to redesign the manner in which upper limb amputations are performed so as to enable volitional control of next generation prosthetic devices and restore sensation and proprioception to the amputated limb. The investigators will test this hypothesis by performing modified above elbow or below elbow amputations in ten intervention patients, and compare their outcomes to ten control patients who have undergone tradition amputations at similar levels. The specific aims of the project are: 1. To define a standardized approach to the performance of a novel operative procedure for both below elbow (BEA) and above elbow amputations (AEA) 2. To measure the degree of volitional motor activation and excursion achievable in the residual limb constructs, and to determine the optimal configuration and design of such constructs 3. To describe the extent of proprioceptive feedback achievable through the employment of these modified surgical techniques 4. To validate the functional and somatosensory superiority of the proposed amputation technique over standard approaches to BEA and AEA 5. To develop a modified acute postoperative rehabilitation strategy suited to this new surgical approach This will be a phase I/pilot clinical trial to be performed over a three-year period as a collaborative initiative involving Brigham \& Women's Hospital/Brigham \& Women's Faulkner Hospital (BWH/BWFH), Walter Reed National Military Medical Center (WRNMMC), and the Massachusetts Institute of Technology (MIT). The investigators will plan to perform 6 of the 10 amputations at BWH/BWFH, and 4 of the amputations at WRNMMC.

AMI Construction in Lower Extremity Residual Limbs

This study will involve the development of a novel approach to lower extremity residual limb surgical revision that offers the promise of augmenting volitional motor control, restore proprioception and reverse atrophy

Magnetic Bead Tracking System and eOPRA Implant System With Bionic Prosthesis for Transtibial Amputees

The e-OPRA Implant System, is a further development of the OPRA (Osseointegrated Prostheses for the Rehabilitation of Amputees) Implant System. The e-OPRA Implant system is an implant system for direct skeletal anchorage of amputation prostheses. The added feature in the e-OPRA Implant system, is a bidirectional interface into the human body that allows permanent and reliable communication using implanted electrodes. These electrodes will provide long-term stable bioelectric signals for an improved control of the prosthetic limb. The Magnetic Bead Tracking System, which will be implanted and used in combination with the e-OPRA Implant system, is an investigational device that consists of pairs of magnetic beads, and a set of magnetic field sensors that measure and track the length of muscles and the speed at which they move in real-time. When the beads are implanted in muscle in the residual limb of an amputee, the muscle length signal is communicated to an investigational, robotic ankle-foot prosthesis. The purpose of the study is to evaluate the feasibility of a transtibial amputee with the e-OPRA Implant System and Magnetic Bead Tracking System exhibiting full neural control over a neuro-mechanical prosthetic system. A maximum of seven subjects will be enrolled. Each subject will undergo one or more surgeries where the e-OPRA Implant System and Magnetic Bead Tracking System will be implanted. The subjects will participate in follow-up sessions the last of which occurs approximately 24 months after the surgery. This is a prospective, non-randomized, uncontrolled study.

Bio Leg: Advancing Mobility (BAM)

Following transfemoral amputation, regaining functional mobility, particularly the ability to navigate curbs, ramps, long distances, and the ability to stand is challenging and often unattainable. Use of advanced prosthetic limb technology can dramatically influence mobility outcomes. The purpose of this study is to compare walking function in individuals with transfemoral amputations who are current users of the C-leg (micro-processor controlled prosthetic knee; current clinical standard) to function achieved when using the Bio Leg powered micro-processor prosthetic knee.

Prosthetic Performance Enhancement Trial

The purpose of this research is to determine the feasibility of an uneven terrain walking program for lower limb prosthesis users. The training is designed to induce step-to-step variability during walking within a safe environment, with the aim of improving walking skill and confidence.

Junior LP Foot - Clinical Investigation Protocol

The purpose of the following study is of exploratory nature to provide design input for a prosthetic foot under development for children with lower limb loss, amputation or deficiency.

Usability of the Smart Hallway System in Clinical Setting

The aim of the study is to examine suitability of data and processed reports acquired from the Smart Hallway system for clinical settings in terms of user acceptability and accuracy for use in clinical practice.

PO vs IV Antibiotics for the Treatment of Infected Nonunion of Fractures After Fixation

This is a Phase III clinical randomized control trial to investigate differences between patient with an infected nonunion treated by PO vs. IV antibiotics. The study population will be 250 patients, 18 years or older, being treated for infected nonunion after internal fixation of a fracture with a segmental defect less than one centimeter. Patients will be randomly assigned to either the treatment (group 1) PO antibiotics for 6 weeks or the control group (group 2) IV antibiotics for 6 weeks. The primary hypothesis is that the effectiveness of oral antibiotic therapy is equivalent to traditional intravenous antibiotic therapy for the treatment of infected nonunion after fracture internal fixation, when such therapy is combined with appropriate surgical management. Clinical effectiveness will be measured as the primary outcome as the number of secondary re-admissions related to injury and secondary outcomes of treatment failure (re-infection, nonunion, antibiotic complications) within the first one year of follow-up, as defined by specified criteria and determined by a blinded data assessment panel. In addition, treatment compliance, the cost of treatment, the number of surgeries required, the type and incidence of complications, and the duration of hospitalization will be measured.

The Effect of Negative Pressure Wound Therapy on Wound Healing in Major Amputations of the Lower Limb

The socioeconomic costs of problematic and delayed wound healing following lower limb amputations are enormous to the society. Lower limb amputations is one of the longest known surgical treatments, but also one of the least investigated in the field of medical science. Negative Pressure Wound Therapy (NPWT) has emerged as a great instrument to aid healing. Studies have shown that it has a positive and measurable effect on wound healing following eg. total Knee and hip replacements. The aim of this study is to evaluate the effect of a closed NPWT on incidence of postoperative wound complications, in patients undergoing lower extremity amputation.

Autologous Volar Fibroblast Injection Into the Stump Site of Amputees

This study is a clinical trial testing the safety and efficacy of volar fibroblast (skin cells from the palm or sole) injections for thickening the epidermal (skin) layer at the stump site in people with below the knee amputations. The study will enroll adults seen at Johns Hopkins.

Comparing the Attentional Demands and Functional Outcomes in People With Transradial Amputation

Different ways of controlling an upper-limb prosthesis can affect how easy it is to use and how helpful it is in everyday activities. One common method, called direct control, uses signals from two muscles and can make switching between movements difficult. Another clinically available option, called pattern recognition control, uses signals from several muscles to better understand the user's intended movement and may feel more natural to use. This study compares these two control methods to see how they affect function for adults with below-the-elbow limb loss.

Tolerability and Feasibility Pilot Clinical Study of a Large-Diameter Nerve Cap for Protecting and Preserving Terminated Nerve Ends

This pilot study evaluates the tolerability and feasibility of the Axoguard Large-Diameter Nerve Cap (sizes 5-7 mm) for protecting and preserving terminated nerve endings after limb trauma or amputation when immediate attention to the nerve injuries is not possible.