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Prosthesis User clinical trials

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NCT ID: NCT06361966 Completed - Amputation Clinical Trials

Evaluating User Satisfaction and Feasibility of a Remote Model for 3d Scanned and Printed Transtibial Prosthetic Sockets

Start date: January 11, 2022
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to investigate the repeatability of application of a fully remote method of manufacturing 3D printing of prosthetic sockets for transtibial amputees, and determine user satisfaction of sockets produced through these methods. The study also aims to evaluate the time and cost effectiveness of this production model. The main question[s] it aims to answer are: 1. To determine the repeatability and user satisfaction with transtibial sockets produced using a remote-digital method as compared to conventional manufacturing methods. 2. To determine if transtibial prosthetic users have greater prosthetic satisfaction scores across the 4 Prosthesis Evaluation Questionnaire (PEQ) subscales of Utility (UT), Appearance (AP), Sounds (SO) and Residual Limb Health (RL) with the 3D printed socket fabricated through the remote-digital method compared to the laminate socket made using the conventional method. 3. To determine if transtibial prosthetic users experience greater socket comfort with the 3D printed socket compared to the laminate socket. Participants will receive a 3D printed socket (trial intervention) and a laminate socket (control intervention) and will use each socket for a period of 4 weeks.The order of socket use will be randomised. At the end of each 4 week period, participants will rate their comfort and satisfaction with the socket. At the end of the trial, participants will indicate their preferred socket, which will be fitted to their prosthesis. Participants will attend 6 visits across a total duration of 11 weeks during the course of the study.

NCT ID: NCT06109792 Completed - Prosthesis User Clinical Trials

Patient Satisfaction and Oral Health-related Quality of Life (OHRQL) For Two Pick-up Techniques

Start date: April 10, 2021
Phase: N/A
Study type: Interventional

This study aimed to evaluate patient satisfaction and OHRQL using two pick-up methods for locator retained mandibular overdenture

NCT ID: NCT06109519 Completed - Prosthesis User Clinical Trials

Comparative Clinical Study for Two Types of Locator Attachments for Mandibular Implant Supported Overdenture

Start date: February 16, 2020
Phase: N/A
Study type: Interventional

This study aims to evaluate the clinical and radiographic outcomes for mandibular implant-supported overdenture using two different types of locator attachment after 3 years of using the two types of locator attachments

NCT ID: NCT06105944 Completed - Amputation Clinical Trials

Economic Evaluation of Lower Limb Prostheses for Persons With a Knee-disarticulation or Transfemoral Amputation

Start date: December 17, 2022
Phase:
Study type: Observational

The goal of this retrospective questionnaire study is to evaluate the cost-effectiveness of non-microprocessor controlled prosthetic knees (NMPK) versus microprocessor controlled prosthetic knees (MPK) in persons with a knee-disarticulation or transfemoral amputation. The main aims are: - to provide an overview of the costs, health-related quality of life, and user experiences associated with the use of different types of prosthetic knees. - to evaluate the cost-effectiveness of the NMPK compared to the MPK for adult prosthesis users. Participants will fill out three questionnaires about (1) their medical consumption and productivity costs; (2) health-related quality of life; (3) utility, ambulation and well-being. Researchers will compare the persons with a NMPK to the persons with an MPK to investigate the cost-efficiency of both types of knees.

NCT ID: NCT05999539 Completed - Quality of Life Clinical Trials

Comparison of Characteristics Between Faller and Non-faller Transtibial Amputees

Start date: August 25, 2023
Phase:
Study type: Observational

Researchers aim to compare demographic characteristics, prosthesis type, functional capacity, and quality of life between faller and non-faller transtibial amputees.

NCT ID: NCT05790148 Completed - Prosthesis User Clinical Trials

Precision of Three Different Scanbodies Used for Direct Digitalization Technique

Start date: August 11, 2020
Phase: N/A
Study type: Interventional

The goal of this clinical trials to evaluate precision of different scanbodies in same participant group. The main guestion it aim to answer is: 1. Are the precision of the three different scanbodies used in direct digitalization the same for the produce of implant-supported prostheses? Participants are healty and have short edentulous span in posterior region that will receive implant-supported prostheses.

NCT ID: NCT05749952 Completed - Amputation Clinical Trials

Digital Weight Bearing Shape Capture Socket Technology

DWB
Start date: March 6, 2023
Phase: N/A
Study type: Interventional

The study will determine if Symphonie Aqua Digital System, a new method of socket creation, in a weight-bearing environment, may produce more successful fitting and comfortability & functional outcomes than traditional sockets (non-weight bearing scanning). Additionally, the study will determine if a well-fitting socket will positively impact the overall health of amputee residual limb.

NCT ID: NCT05601349 Completed - Diabetes Mellitus Clinical Trials

TeleEducation for Implementing a Clinical Practice Guideline For Amputees

TEFICA
Start date: January 1, 2020
Phase: N/A
Study type: Interventional

The publication of a Clinical Practice Guideline (CPG) is often not enough for its correct use in the field of health care. There are barriers to the implementation of the CPG recommendations, including those related to the lack of knowledge or skills on the part of health service providers. Strategies have been proposed to improve the implementation of the CPGs through interventions with different levels of effectiveness, such as the use of reminders, informative meetings, sending educational material, audits, among others. Some of these interventions can be carried out through Telehealth strategies, that is, with remote services. The purpose of this study is to evaluate the effectiveness of a Telehealth program to improve the implementation of the Clinical Practice Guideline for diagnosis and preoperative, intraoperative and postoperative treatment of the amputee, the prescription of the prosthesis and comprehensive rehabilitation, through strategies to publicize the recommendations included in the CPG and train doctors, reducing the barriers related to the lack of knowledge of the CPG. For this, two groups of institutions that provide health services in Antioquia will be compared, randomized according to two interventions: the socialization of the recommendations of the CPG for amputees, against a combined strategy of education through a Telehealth platform and the delivery of educational material. Compliance with prioritized recommendations of the CPG will be evaluated, related to surgical techniques, perioperative practices, the prescription of prosthetic components and referral to services that allow the comprehensive rehabilitation of the person with amputation. Additionally, the theoretical knowledge of the doctors of each participating institution before and after the interventions will be evaluated through a written test.

NCT ID: NCT05190354 Completed - Amputation Clinical Trials

Post Market Clinical Protocol - Xtremity Polymer Prosthetic Socket System

Start date: November 16, 2021
Phase: N/A
Study type: Interventional

Single-arm, prospective multi-center study assessing user preference of the Xtremity prosthetic socket in below the knee amputation prostheses.

NCT ID: NCT05124873 Completed - Amputation Clinical Trials

Moisture Management Liner At-Home Evaluation

Start date: May 12, 2021
Phase: N/A
Study type: Interventional

The comfort and fit of the residual limb within a prosthetic socket are of primary concern for many amputees. The residual limb is typically covered by nonbreathable and non-thermally conductive materials that can create a warm and ultimately moist environment. The investigators have developed a silicone liner approach to passively conduct heat from the skin using thermally conductive elastomers. A technology that can provide thermal control while retaining adequate suspension, weight, and other prosthetic characteristics would benefit many prosthesis wearers.