Amputation

This research aims to evaluate how full-arch implant-supported prostheses affect lip support in patients undergoing complex dental rehabilitation. The study focuses on how different clinical and laboratory decisions between diagnosis and prosthesis delivery may influence the prosthetic design and the patient's facial profile. Advanced 3D facial scanning and superimposition techniques allow precise measurement of vertical occlusion and lip support. Participants will undergo removal of their full-arch implant-supported prostheses, with digital facial images captured before and after this procedure using a facial scanner. This observational study leverages modern digital technology to measure changes objectively and does not involve experimental treatments. During the study, researchers will assess changes in the volume around the mouth area, distances between the lips and esthetic lines on the facial profile, and angles related to the nose and lips. These measurements occur on the same day as the prosthesis removal. The study helps improve understanding of facial changes related to dental prostheses and involves participants collaborating with the research protocol through imaging and clinical assessments.

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 investigating a new surgical approach to upper limb amputation aimed at improving control and sensation for advanced prosthetic devices. The study compares a modified amputation technique designed to preserve muscle dynamics and restore proprioception with standard amputation methods. This phase I pilot trial involves ten patients receiving the new procedure and ten controls with traditional amputations, conducted over three years at multiple medical centers. The modified procedure involves creating dynamic agonist-antagonist muscle pairings in the residual limb to enable better motor control and sensory feedback. Surgeons will isolate and reconnect specific muscles and nerves to promote natural muscle interactions, while standard amputations follow traditional methods without these reconstructions. Sensory nerve endings are redirected to skin patches to enhance feedback, and the surgical site is carefully closed with drainage. Outcomes will be assessed up to 36 months post-operation. Participants will undergo detailed evaluations including motor unit innervation, movement range, and proprioception recovery. Researchers will monitor safety through infection rates, wound healing, and other complications. Functional and sensory outcomes will also be assessed alongside general health and muscle condition. Follow-up includes rehabilitation tailored to the new technique, with assessments conducted at involved hospitals and Massachusetts Institute of Technology. Total participation spans three years from surgery.

Researchers are evaluating the safety and effectiveness of the Symani Surgical System in microsurgical anastomosis during free tissue transfer surgery and lymphovenous anastomosis surgery. This observational study aims to assess the device's performance in real-world settings, focusing on the rate of successful vessel connection in the first surgical attempt and the absence of device-related adverse events. Participants will receive standard surgical care using the Symani Surgical System, which offers articulated, interchangeable instruments designed for open microsurgery procedures. The study includes patients undergoing free tissue transfer of the breast or extremities and those having lymphovenous anastomosis surgery for lymphedema. During the trial, participants will have their surgical procedures assessed and may complete questionnaires if undergoing lymphedema procedures. Throughout the study, researchers will monitor the safety and effectiveness of the device by evaluating intraoperative vessel patency and tracking any adverse events up to 30 days after surgery. Participants will be asked to allow access to their medical information, attend follow-up visits, and complete all study procedures and questionnaires. The total participation covers the surgery period and a 30-day post-surgery follow-up to ensure comprehensive safety and outcome monitoring.

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.