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Amputation clinical trials

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NCT ID: NCT05840601 Withdrawn - Amputation Clinical Trials

Evaluation of Dexterous Terminal Device

Start date: December 22, 2022
Phase: N/A
Study type: Interventional

Liberating Technologies, Inc. (LTI) has developed Pointdexter, a dexterous prosthetic fingertip that is integrated into a commercial prosthetic hand and allows for an additional fine grasp. The Pointdexter device interfaces with upper limb prostheses by swapping the usual prosthetic pointer finger with the Pointdexter device. The dexterous prosthetic fingertip utilizes the same control strategy used to operate the prosthetic hand. This solution aims to combine the advantages of the common terminal devices into one product by combining the practicality and dexterity of a split-hook or gripper with the aesthetics of multi-articulating hands.

NCT ID: NCT05344261 Withdrawn - Amputation Clinical Trials

Effect of Prophylactic TMR and RPNI on Neuroma and Phantom Limb Pain

Start date: March 1, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to analyze the efficacy of novel interventions in post-amputation surgical care (specifically Targeted Muscle Reinnervation and Regenerative Peripheral Nerve Interface) on post-amputation pain and functional outcomes at the time of amputation. These novel interventions have been shown to be successful in treating the downstream effects of amputations (pain, phantom limb pain, neuroma pain, etc.), but has not been studied in a randomized manner at the time of amputation.

NCT ID: NCT04248907 Withdrawn - Amputation Clinical Trials

Transtibial Pin Lock Suspension at Varying Distraction Values Using a Modified Air Bladder Casting System

Start date: January 28, 2020
Phase: N/A
Study type: Interventional

To assess the effects various distraction values have on the 'slippage' effect of a transtibial pin-lock system

NCT ID: NCT04018469 Withdrawn - Amputation Clinical Trials

Patterned Electric Dressing Effects on Open Wounds

PED
Start date: April 2022
Phase:
Study type: Observational [Patient Registry]

1. This study is a pilot feasibility study to determine treatment effects to estimate sample size for future studies that evaluate wound bacteria colonization. 2. The secondary objective of this study aims to observe the effect of PED on an open wound and its effects in wound bacteria colonization.

NCT ID: NCT03957226 Withdrawn - Amputation Clinical Trials

An Osseoanchored Percutaneous Prosthesis Study Evaluating Stable Neural Signal Transmission in Subjects With Transhumeral Amputations

Start date: January 30, 2020
Phase: N/A
Study type: Interventional

This early feasibility study proposes to evaluate use of the electronic-Osseoanchored Prostheses for the Rehabilitation of Amputees (e-OPRA) device, a transhumeral implant system for direct skeletal anchorage of amputation prostheses, with a test prosthesis. The e-OPRA System is being investigated to better understand the ability to improve the functionality of the prosthesis and enhance the sense of embodiment of the prosthesis itself. This will be a 10 subject Early Feasibility Study in which the primary objective is to capture preliminary safety and effectiveness information on the implanted e-OPRA system. With the addition of electrodes to the muscle segments, this biological interface allows for both the extraction of fine motor control signals from the nerve fascicles and the generation of sensory percepts via electrical stimulation of the muscles. In addition, electrodes placed on muscles within the residuum with native vascularization and innervation also allow the extraction of critical motor control signals and the generation of sensory feedback through muscle stimulation. The electrical activity recorded from these muscle segments (called electromyography or EMG) is specific to certain movements and can be used to determine precisely how a person wants to move their arm and hand. Use of the e-OPRA device with the well-documented neuro-electronic capabilities of EMG control systems provides an alternative to traditional socket prostheses by establishing a direct, loadbearing link between the patient's skeleton and prosthesis.

NCT ID: NCT03787862 Withdrawn - Amputation Clinical Trials

Investigation of the Use of Hyperspectral Imaging in Foot Surgery Patients

HSI
Start date: June 13, 2014
Phase:
Study type: Observational

To investigate novel advanced imaging techniques (hyperspectral imaging) that could enable clinicians to determine the degree and effectiveness of blood flow to tissues during surgery. There are a number of disorders where blood flow is inadequate to provide nutrients and oxygen to tissues. Under some circumstances, surgery is required to either improve the blood flow or remove tissues that are poorly perfused. In other cases, occlusion of the blood supply to an organ is temporarily or permanently performed to minimize blood loss during a surgical procedure. Additionally, there are disorders where the location of certain blood containing structures is important but not immediately obvious to surgeons during an operation. Knowledge of where those structures are is very important and could greatly improve the safety of various surgical procedures. Patients of the investigator who are scheduled for foot surgery will be provided the opportunity to participate in this research. After giving informed consent, hyperspectral images will be obtained at various points during the surgical procedure. As this technology is non-invasive, it is not expected to interfere with or change the procedure they are undergoing. Once the surgical procedure is complete, imaging will be saved to a disk for later evaluation. 100 subjects will participate in this study.

NCT ID: NCT03632252 Withdrawn - Amputation Clinical Trials

Evaluating and Improving Assistive Robotic Devices Continuously and in Real-time

Start date: May 1, 2019
Phase: N/A
Study type: Interventional

The goal of this research is to determine a quick, accurate and unobtrusive way to optimize the performance of powered assistive devices like ankle exoskeleton or prostheses.

NCT ID: NCT03240822 Withdrawn - Amputation Clinical Trials

Human Penile Tissue Allotransplantation for Devastating Penile and Concomitant Genital Trauma

Start date: January 2017
Phase: Phase 1
Study type: Interventional

This is a 4-year, non-randomized, single center, patient self-controlled, clinical trial (though enrolled subjects will be followed for life as are all transplant patients) for patients seeking allotransplantation of the male external genitalia (MEG), or penile tissue, as a feasible reconstructive strategy for the treatment of devastating and irreversible injuries to the genitalia. In addition to receiving penile allotransplantation and post-operative monitoring and support, enrolled patients will receive an innovative and clinically proven immunomodulatory protocol that combines lymphocyte depletion of the recipient with donor bone marrow cell infusion. Patients will be treated with lymphocyte depleting induction therapy, donor bone marrow cell infusion and tacrolimus. After the first year, maintenance immunosuppression will be modified gradually and cautiously (tapered dose reduction or spaced frequency dosing of tacrolimus) in selected patients based on a critical evaluation of clinical and immunologic outcomes. Outcomes will include but not be limited to functional metrics (sensation, erection, voiding), psychosocial (body integrity, adaptation to transplant) and health related quality of life (HRQOL) measures.

NCT ID: NCT01517061 Withdrawn - Pain Clinical Trials

Genetics and Phantom Limb Pain

Start date: January 3, 2012
Phase:
Study type: Observational

Background: - Many people who lose a limb feel pain in the missing limb. This feeling is called phantom limb pain. Researchers do not fully understand what causes this pain. Differences in people's genes may play a role. Comparing the genes of people with and without phantom limb pain may help researchers better understand this feeling, who is likely to develop it, and how to treat it. Objectives: - To study whether genetic differences affect phantom limb pain. Eligibility: - Individuals at least 18 years of age who have lost an arm or leg at least 3 months ago. Design: - Participants will be screened with a medical history and physical exam. - Participants will answer questions about how they lost the limb, and whether they feel phantom limb pain. They will also have a test to measure their sensitivity to heat and cold. - Participants will provide a blood sample for genetic testing.

NCT ID: NCT00392028 Withdrawn - Amputation Clinical Trials

Penetration of Ertapenem Into Bone

Start date: November 2006
Phase: N/A
Study type: Interventional

The aim of the study is to determine the penetration levels of ertapenem into bone tissues in patients with Diabetes Mellitus (D.M) or Peripheral Vascular Diseases (P.V.D) undergoing amputation, and to correlate theme to the concentration of the drug in blood and other soft tissues