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Prosthesis User clinical trials

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NCT ID: NCT06100354 Active, not recruiting - Orthopedic Disorder Clinical Trials

Study of Patient Preferences in Relation to the Fitting of a Personalized and Connected Joint Prosthesis.

FKprefPat
Start date: December 12, 2022
Phase:
Study type: Observational

The goal of this observational study is to learn about patients' preference toward the use of customized and connected prosthesis. The main questions it aims to answer are: - What is the acceptability of new customization and connectivity technologies by patients? - Are they all at the same level of acceptability? Participants will have to answer to a questionnaire of choice.

NCT ID: NCT05510193 Active, not recruiting - Clinical trials for Satisfaction, Patient

Redesign, Implementation and Evaluation of the Effectiveness of the Aktio Myoelectric Prosthesis

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

In Latin America, Colombia ranks fourth in countries with the highest number of people with disabilities (6.4%), 80% of whom live in low socioeconomic strata, have little access to education and high unemployment rates. Of these nearly 3 million people with this condition, an estimated 11,476 need upper limb prostheses, 12% of whom have transradial or below-elbow amputation. Although many of the functions that have been lost by amputation can be recovered with a prosthesis, few people in Colombia use these devices. This is because, currently, only aesthetic and mechanical options are found, and the most advanced options, such as myoelectric ones, are manufactured in other countries, have very high prices and are not designed according to local needs. The only option manufactured at the national level is the one developed by Protesis Avanzadas S.A.S., but it still has aspects to improve that would lead it to better adapt to the needs of Colombian users. All of the above shows the evident need for the country to generate products that can help this population. The objective of this project is then to redesign, implement and evaluate the effectiveness of a good quality transradial myoelectric prosthesis, focused on the Colombian amputee population and improving acceptance rates. For the design phase of the study, a group made up of health professionals and patients with transradial amputation will be included to evaluate the preferences and priorities of their prosthesis. For pre-commercial validation, an effectiveness study will be carried out by means of a randomized crossover clinical trial with 12 participants in which the functioning and quality of life of the user with and without the prosthesis and satisfaction with it will be analyzed using methods of Bayesian statistics. This study is expected not only to improve the quality of life of people with transradial amputation and their families, but also to provide a functional option for the health system.

NCT ID: NCT05120063 Active, not recruiting - Surgery Clinical Trials

Benefit of 3-D Planning in Total Hip Replacement. A Prospective Randomized Study

Start date: June 1, 2012
Phase: N/A
Study type: Interventional

In this prospective randomized four-armed study the investigators aim to compare wheter 3-D planning, which necessitates preoperative CT acquisition and sophisticated planning together with engineers, results in measurable benefits in terms of objective and subjective outcome values in a collective of patients undergoing primary total hip replacement. Hypothesis: 1. When compared to 2-D planning, 3-D planning of a THR results in better hip reconstruction, better subjective and clinical outcome and better longevity of total hip implants. 2. When compared to a non-anatomical stem, an anatomical stem allows better hip reconstruction, better subjective and clinical outcome and better longevity of total hip implants.

NCT ID: NCT04536025 Active, not recruiting - Amputation Clinical Trials

Shared Decision Making Aid for Prosthetic Design

D-MAP
Start date: June 6, 2020
Phase:
Study type: Observational

This study is designed to learn more about decision making for prosthetic design, with the goal of producing a decision making aid for prosthetic design decisions.

NCT ID: NCT03505983 Active, not recruiting - Prosthesis User Clinical Trials

Criteria for Advanced Prosthetic Foot Prescription

Start date: August 1, 2017
Phase: N/A
Study type: Interventional

The purpose of this study is to develop criteria for prosthetic foot prescription for Veterans and Service Members with transtibial limb loss. The objectives are to: 1) Determine the appropriate functional outcome tests and measures to support the prescription of a type of Energy Storing and Returning (ESR) non-articulating, articulating or active plantarflexion prosthetic ankle-foot for a Veteran or Service Member with transtibial limb loss. 2) Correlate patient goals and subjective measures with objective data to determine the appropriate prosthetic ankle-foot category that will facilitate the greatest overall function to the user. 3) Develop criteria for the appropriate prescription of non-articulating ESR, articulating ESR, and active plantar flexion ESR ankle-foot units.