Clinical trials: Transtibial Amputation
Transtibial Amputee, Transtibial Amputation
Feasibility Study Evaluating the Safety and Effectiveness of Magnetic Bead Tracking System When Used With a Bionic External Prosthesis
The investigation is an early feasibility study in up to 5 subjects, in which the primary objective is to capture preliminary safety and effectiveness information on the Magnetic Bead Tracking system.
- Trial name
- NCT07195461
- Testing
- Magnetic Bead Tracking System
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- MuscleMetrix, LLC
Amputation, Prosthesis User
Post Market Clinical Protocol - Xtremity Polymer Prosthetic Socket System
Single-arm, prospective multi-center study assessing user preference of the Xtremity prosthetic socket in below the knee amputation prostheses.
- Trial name
- NCT05190354
- Testing
- Xtremity Polymer Prosthetic Socket
- Where
- 2 sites in United States, Canada
- Volunteers
- 40 people
- Sponsor
- Medical Creations, Inc.
Amputation
1C70 Feasibility Study
The objective of this study is to characterize the extent of 1C70 meeting the amputees needs in comparison with their everyday and a comparator foot, in regards of daily activities, mobility and balance, as well as quality of…
- Trial name
- NCT05628064
- Testing
- 1C70, Pro-Flex XC
- Where
- 6 sites in Germany
- Volunteers
- 22 people
- Sponsor
- Otto Bock Healthcare Products GmbH
Amputation, Limb Deficiencies
Assessing the DSR Ankle
This research is being done to conduct a preliminary investigation into a new prosthetic microprocessor controlled (MPC) ankle, called the Damping, Stiffness, and Repositioning (DSR) ankle.
- Trial name
- NCT05955378
- Testing
- DSR Ankle, Predicate Ankle
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Synchro Motion LLC
Amputation
Comparative Study Evaluating the Mobility of Transtibial Amputee Patients Using the PRO-FLEX PIVOT® Foot Versus a Class III Energy Storing and Returning (ESAR) Prosthetic Foot.
The PRO-FLEX PIVOT® is ESAR prosthetic foot with an innovative technology built around three pillars: 1. The PIVOT technology: three axes of rotation (upper support, main pivot and lower support) at the ankle, which allow both a…
- Trial name
- DEFI (NCT06627361)
- Testing
- PRO-FLEX PIVOT Foot evaluation, Class III ESAR Foot evaluation
- Where
- France
- Volunteers
- 30 people
- Sponsor
- Össur Iceland ehf
Amputation of Lower Limb, Prosthesis
LIMBER UniLeg: Rapid, On-demand, and Scaled-up Manufacturing of Customized Transtibial Prosthetic Legs for Amputees
The LIMBER UniLeg, a 3D printed single-piece transtibial prosthetic limb, is sufficiently equivalent to traditional passive prosthetic limbs (no motors or sensors), while reducing the cost and time of manufacturing and enabling…
- Conditions
- Amputation of Lower Limb, Prosthesis, Non-inferiority Trial of Prothesis
- Trial name
- NCT06648798
- Testing
- Limber Limb
- Where
- 2 sites in United States
- Volunteers
- 30 people
- Sponsor
- LIMBER Prosthetics & Orthotics Inc
Amputation
Comparative Effectiveness of Microprocessor Controlled and Carbon Fiber Prosthetic Feet in Transtibial Amputees
The purpose of this research is to evaluate benefits of a microprocessor controlled prosthetic ankle-foot device compared to a non-microprocessor controlled or passive carbon fiber prosthetic ankle-foot device.
- Trial name
- NCT02864693
- Testing
- Kinnex, Pacifica LP
- Where
- 3 sites in United States
- Volunteers
- 30 people
- Sponsor
- Ability Prosthetics and Orthotics, Inc.
Amputation
Detecting Change in Muscle Parameters, Pain, and Function With NMES for TTA
The proposal aims to investigate a non-invasive, cost-effective method for rebuilding muscle mass in individuals with transtibial limb loss.
- Trial name
- NCT06830876
- Testing
- Chattanooga Continuum Device
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Sara Peterson-Snyder
Amputation
Daily Socket Comfort in Transtibial Amputee With an Active Vacuum Suspension System
The aim of this study is to evaluate the contribution of the vacuum suspension system in an ecological environment on the fitting's comfort compared to the vacuum suspension system inactive system in a multicenter prospective…
- Trial name
- NCT04804150
- Testing
- Vacuum suspension system active or inactive
- Where
- 3 sites in France
- Volunteers
- 20 people
- Sponsor
- Össur Iceland ehf
Amputation Stumps
Investigation Into the Functional Performance of a New Thermoplastic Elastomer (TPE) Transtibial Liner
The clinical investigation is designed as an uncontrolled open prospective, multicenter, 2 group, pre-test post-test study. Testing will be conducted in the USA and Canada at 3-6 clinics, depending on enrolment requirements.
- Trial name
- NCT02622919
- Testing
- TPE Liner
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Össur Iceland ehf
Amputation, Amputation; Traumatic, Leg, Lower
Socket Cooling Effectiveness Take Home Study
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 non-breathable and non- thermally conductive materials that can create a warm…
- Conditions
- Amputation, Amputation; Traumatic, Leg, Lower, Amputation Stump, Limb; Absence, Congenital, Lower
- Trial name
- NCT04484805
- Testing
- ICE Condition
- Where
- 2 sites in United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Liberating Technologies, Inc.
Transtibial Amputation, Artificial Limbs
Energy-Harvesting Mesofluidic Impulse Prosthesis: e-MIP
The purpose of this research is to validate the e-MIP design and function by testing the ability of e-MIP to harvest energy and return a sufficient amount of energy to assist the user during gait.
- Trial name
- NCT04157608
- Testing
- Habitual Prosthesis, Energy-Harvesting Mesofluidic Impulse Prosthesis
- Where
- United States
- Sponsor
- Orthocare Innovations, LLC