Amputation

The trial investigates the biomechanical effects of the Ossur Power Knee, a microprocessor-controlled prosthetic knee with active motor-driven flexion and extension, compared to the Ossur Rheo XC, a passive microprocessor-controlled knee. The study focuses on unilateral transfemoral amputees aged 45 to 75 years, aiming to evaluate differences in walking and mobility, including a comparison by gender to identify any sex-specific prosthesis needs. The research is designed to improve understanding of prosthetic knee function and enhance prosthesis selection for users. Participants will be fitted with both the Ossur Power Knee and the Ossur Rheo XC in a crossover design, receiving one month of accommodation with each device before evaluation. The Power Knee provides powered knee flexion and extension, while the Rheo XC modulates damping passively during movement. Subjects will perform walking, stair climbing, slope navigation, and sit-to-stand activities while wearing each knee. Questionnaires and at-home diaries will capture user perceptions of comfort, exertion, and stability. During the study, detailed biomechanical data such as walking speed, metabolic energy cost, symmetry during sit-to-stand movements, step length, toe clearance, leg loading, and pelvic motion will be collected. Assessments occur after each one-month accommodation period. The study uses motion analysis labs for gait data and includes participant self-reporting. The total participation timeline includes fitting, training, accommodation, and evaluation phases for both knee types, allowing each participant to serve as their own control.

This research aims to compare myoelectric and bionic prosthetic hands to understand differences in upper limb function, body image, and user satisfaction among individuals with upper limb amputations. It focuses on answering whether the functional abilities differ between these two types of prosthetic devices used by people with amputations. The study is observational and involves adults aged 18 to 65 who regularly use prosthetic hands. Participants will either use advanced bionic prosthetic hands featuring multi-articulating structures and enhanced control systems designed to improve function and dexterity or myoelectric prosthetic hands controlled by muscle signals from the residual limb that provide basic powered hand movements. These groups allow comparison of the newer bionic technology against conventional myoelectric devices. During the study, participants will complete assessments including the Upper Limb Functional Index-15, Amputee Body Image Scale, and Orthotics and Prosthetics Users Survey at baseline. These measures will help evaluate hand function, body image perception, and satisfaction with prosthetic use. The study is led by Gulhane School of Medicine and participation spans from November 2025 to March 2026, involving adults with unilateral upper limb amputation who have been using prostheses for at least six months.

Researchers are conducting a long-term, non-interventional clinical investigation to collect and evaluate data on the safety and performance of the OPRA Implant System used for transhumeral amputees. This study includes patients who have already received the implant and completed the second stage of surgery, focusing on outcomes over a period that may span from 6 months to over 20 years. Participants in this study have undergone treatment with the OPRA Implant System for unilateral or bilateral transhumeral amputation and have had at least six months of experience with the device before enrollment. The investigation is multicenter and multinational and involves no control group. Data collection includes retrospective review and prospective visits for device functionality and usage assessment. Patient-reported outcomes are gathered through questionnaires, which can be completed in person, by mail, email, electronically, or by phone. Functional tests of the prosthesis may be performed during follow-up visits or remotely via videoconference. Participants will attend visits where clinical data, device safety, and performance are evaluated. Medical records will document prosthesis function tests and patient responses to questionnaires. The primary outcome focuses on implant safety and effectiveness two years after surgery, with secondary outcomes assessing safety and effectiveness over periods up to more than ten years. The study emphasizes long-term follow-up and continuous monitoring of implant performance and patient experience.

Researchers are exploring a new surgical method for upper limb amputations to improve voluntary control and restore sensation and proprioception in amputated limbs. This phase I pilot trial will compare outcomes of modified above elbow or below elbow amputations with traditional amputations in adult patients. The study aims to develop a standardized procedure, measure motor control and proprioceptive feedback, and validate the benefits of the new technique over standard methods. Participants will receive either a modified amputation procedure that preserves or reconstructs dynamic muscle pairings and redirects sensory nerves, or a standard amputation without these modifications. The modified surgery targets specific muscles and nerves to create a biological interface that can better connect with next-generation prosthetic devices. Ten patients will receive the modified procedure and ten will undergo the standard approach, with some procedures performed at Brigham & Womens Hospital and others at Walter Reed National Military Medical Center. During the study, participants will be monitored for motor unit innervation, motor unit movement, and proprioceptive recovery over up to 36 months. Secondary outcomes include rates of infection, wound healing, surgical revisions, seroma formation, and mortality, as well as assessments of general health, muscle atrophy, and sensory recovery. Participants will provide feedback on their sensorimotor recovery and will be followed closely with various assessments to evaluate the functional and sensory outcomes of the new amputation technique.

Researchers are evaluating the safety and effectiveness of the Symani Surgical System in microsurgical anastomosis during free tissue transfer and lymphovenous anastomosis surgeries. The study focuses on how well the device maintains vessel connection at the first attempt and monitors any device-related adverse events. Participants include adults with clinical indications for these specific microsurgical procedures. The Symani Surgical System, designed for open microsurgery with articulated and interchangeable instruments, is used during surgeries involving vessels between 0.1 and 2.5 mm in diameter. Participants undergo treatment as part of standard care and may be in either free tissue transfer surgery or lymphovenous anastomosis surgery groups. Those in the lymphovenous anastomosis group complete questionnaires and follow prescribed self-care and compression garment use over the study. Participants provide consent for researchers to access their medical information and agree to attend follow-up visits, completing all study procedures and questionnaires. Researchers measure outcomes including device-related adverse events up to 30 days post-procedure and intraoperative vessel patency at first attempt and prior to closure. Additional assessments include procedure times, suturing details, and technical success. The study runs from 2025 to 2027, with ongoing monitoring during the procedure and follow-up visits.

Researchers are evaluating how different prosthetic feet affect stability and fall-related outcomes in Veterans with below-knee leg amputations. The study aims to improve understanding of how a customizable robotic prosthetic foot emulator PFE can help predict which commercial prosthetic feet best support stability, balance confidence, and functional mobility. This research focuses on optimizing prosthetic prescription strategies to enhance quality of life and reduce falls for people with lower leg amputations. Participants will use the multiaxial Prosthetic Foot Emulator, which mimics the mechanical properties of various commercial prosthetic feet, during walking tests on different surfaces like inclines and uneven ground. The study involves a randomized, participant-blinded crossover design where Veterans will test three different foot modes with the PFE and three corresponding actual commercial prosthetic feet. After initial testing, participants will wear each commercial foot at home and in the community for about one week before switching to the next foot. During up to six study visits, participants will complete walking tests, self-report surveys, and performance-based assessments such as the Narrowing Beam Walking Test and Four Square Step Test. Researchers will measure perceived stability, balance confidence, and biomechanical stability outcomes. The study includes both laboratory assessments and real-world use of prosthetic feet, with follow-up testing to evaluate longer-term effects. Total study participation spans multiple weeks with repeated measurements to capture comprehensive stability and functional outcomes.

Researchers are evaluating whether an anesthetic called Lidocaine may be effective when injected around the sciatic nerve of the intact limb in patients experiencing pain in the opposite limb after limb loss. This study focuses on people with phantom limb pain or residual limb pain who have undergone lower extremity amputation more than a year ago. The trial is a double-blind, randomized controlled study to assess pain relief and functional improvement. Participants will be randomly assigned to receive either a 2% lidocaine injection or a saline placebo injection in the back of their residual limb. The study compares these two treatments to understand their effects on pain and function. The trial is scheduled to start in June 2024 and will monitor participants shortly after injection and for several days following treatment. During the study, participants will be assessed for changes in pain levels at baseline and 60 minutes after injection, as well as changes in functional ability and disability five days post-injection. Additional measurements include pressure-pain sensitivity and step counts five days after treatment. Researchers will closely monitor participants and collect data related to these outcomes to evaluate the impact of the injections over time.

Researchers are studying patients with subacute stroke to evaluate the additional effects of kinesio taping combined with conventional physical therapy on upper limb function, range of motion, and spasticity. This randomized control trial aims to determine whether adding kinesio taping provides significant improvements compared to physical therapy alone. The study is conducted in rehabilitation settings and includes adults aged 40 to 65 years with a history of diagnosed stroke and moderate spasticity. Participants are divided into two groups. The experimental group receives kinesio taping three times per week along with physical therapy exercises including passive and active range of motion ROM, PNF stretching, D1 flexion and extension movements, and resistance training with a medium resistance band from weeks 3 to 6. The control group receives the same physical therapy regimen but without kinesio taping. Treatments last 30 minutes on alternate days over six weeks. During the study, participants upper limb spasticity and function are assessed at baseline, week 3, and week 6 using the Modified Ashworth Scale and the Wolf Motor Function Test. Range of motion is measured with a goniometer for shoulder, elbow, and wrist joints. Data collection includes demographic information and questionnaires. The study monitors outcomes throughout the six-week treatment period to analyze differences between groups.

Researchers are evaluating the effect of adding hyperbaric oxygen therapy after lower extremity amputation. The study focuses on patients who have had amputations due to chronic wounds, osteomyelitis, ischemia, or necrosis, conditions commonly associated with poor healing. Hyperbaric oxygen therapy has been used for decades to help heal difficult wounds by increasing oxygen levels in tissues, potentially improving healing at the amputation site and reducing the need for further amputations. Participants who have undergone lower extremity amputation will be randomly assigned to one of two groups. One group will receive 30 sessions of hyperbaric oxygen therapy, each lasting 90 minutes at 2.4 atmosphere absolute ATA with 100% oxygen. The first treatment must begin within seven days after amputation, and the therapy is provided as outpatient care after hospital discharge. The other group will receive standard care and outpatient follow-up without hyperbaric oxygen therapy. During the study, participants will be monitored for skin healing at the amputation site up to 12 months, including assessments at 12 weeks, 6 months, 9 months, and 1 year. Researchers will measure outcomes like intact skin without abnormal openings, time to wound closure, reamputations, wound revisions, hospital days, pain levels, quality of life, mobility, and foot and ankle function. Follow-up visits and evaluations will occur regularly to track healing progress and overall health after treatment.

Researchers are studying a new surgical method for patients with lower extremity amputations. This approach aims to improve motor control, restore proprioception, reduce phantom limb pain, and reverse muscle loss in residual limbs. The study focuses on revising above knee and below knee amputations using innovative biological actuators. Participants will undergo a surgical procedure called residual limb revision, which constructs agonist-antagonist myoneural interfaces AMIs in their residual limbs. These biological actuators are designed to enhance muscle and nerve function, with the goal of improving movement control and sensory feedback. The study will also develop a specialized rehabilitation strategy tailored to this surgery. Throughout the study, participants will be monitored for changes in muscle volume, motor activation, sensory perception, proprioception, general health, and any complications. These measures will be collected over a period of one to three years post-surgery to evaluate the effectiveness and durability of the surgical revision and rehabilitation techniques.