Clinical trials: Amputees
Traumatic Amputee
Early Feasibility Study of the Percutaneous Osseointegrated Prosthesis (POP)
The purpose of the clinical study is to characterize the efficacy and safety of a Percutaneous Osseointegrated Prosthesis (POP) device that can provide a satisfactory platform for direct skeletal attachment of prosthetic limbs…
- Trial name
- POP (NCT02720159)
- Testing
- Percutaneous Osseintegrated Prosthesis
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Encore Medical, L.P.
Amputation Stumps, Amputees
Moisture Management Liner Effectiveness 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 Stumps, Amputees, Amputation, Lower Limb Deformities, Congenital
- Trial name
- NCT04427007
- Testing
- Moisture Management Liner, Control Liner
- Where
- United States
- Volunteers
- 2 people, healthy volunteers welcome
- Sponsor
- Liberating Technologies, Inc.
Prosthesis User, Amputation
Biomechanical Assessment of Load Applied on Residuum of Individuals With Limb Loss Fitted With a Prosthetic Limb
This study will aim at performing biomechanical analyses of the actual load applied on the end of the stump (residuum) of individuals with transfemoral limb loss fitted with bionics bone-anchored prostheses during activities of…
- Trial name
- NCT05870267
- Testing
- Power Knee with bone anchored suspension, C-Leg, Rheo Knee XC
- Where
- Australia
- Volunteers
- 20 people
- Sponsor
- YourResearchProject Pty Ltd
Amputation of Hip and Thigh, Level Unspecified
Assessment of Disability Compensation With the C-LEG COMPACT 2 Knee (Ref. 3C60 et 3C60=ST)
Moderately active amputees may have lost their limb due to diabetes, vascular conditions, trauma, tumour or congenital causes. These amputees currently cannot benefit from having a computerised knee because of the performance…
- Trial name
- NCT02382991
- Testing
- 3C60-NMPK, NMPK-3C60
- Where
- 15 sites in Austria, France and 1 more
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Otto Bock France SNC
Lower Limb Amputation Above Knee (Injury)
C-Leg 3 and C-Leg 4 Study in Transfemoral Amputees
The aim of this post-market study is to confirm that the microprocessor controlled prosthetic knee components (C-Leg 3 and C-Leg 4) in comparison to mechanical knee joints can bring additional benefit to the users primarily on…
- Trial name
- NCT02765035
- Testing
- C-Leg 4, C-Leg 3
- Where
- 2 sites in Austria, Belgium
- Volunteers
- 18 people
- Sponsor
- Otto Bock Healthcare Products GmbH
Amputation, Upper Limb
Study of Efficacy of the MyoTrain System in a Population of Individuals With Trans-radial Limb Loss
The investigators propose to evaluate the efficacy of MyoTrain in a prospective clinical study involving 16 individuals with trans-radial upper-limb loss over a period of 206 days.
- Trial name
- NCT05888428
- Testing
- MyoTrain, Motor Imagery
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Infinite Biomedical Technologies
Transtibial Amputees
Using Direct Molding Socket Technology for Trans-tibial Prosthesis in Developing Regions
The study aims to understand how well CPOs and amputees can adapt to using the Amparo socket technology. CPOs at the APDK and The Cure will be trained to use the Amparo socket technology then use it with their consenting patients…
- Trial name
- NCT04679701
- Testing
- Amparo Confidence Socket
- Where
- 2 sites in Kenya
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Amparo GmbH
Testing of Methodology of Attachment of External Foot Prothesis Based on Anthropomorphism Criteria
Numerical Standard of Anthropomorphicity of Prosthetic Feet for Improvement of Amputee Performance
The study concerns the testing of methodology of attachment of external foot prothesis based on anthropomorphism criteria
- Trial name
- NCT05411601
- Testing
- Methodology of attachment of external foot prothesis
- Volunteers
- 56 people
- Sponsor
- PolyOrth International
Amputation
e-OPRA Implant System for Lower Limb Amputees
The e-OPRA Implant System, is a further development of the OPRA (Osseointegrated Prostheses for the Rehabilitation of Amputees) Implant System, approved under HDE (Humanitarian Device Exemption) H080004.
- Trial name
- NCT03720171
- Testing
- e-OPRA Implant System
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Integrum
Lower Limb Amputation
Evaluation of a Novel Transfemoral Prosthetic Socket System
The purpose of the study is to evaluate residual limb circulation and skin health associated with the use of a novel prosthetic transfemoral socket system.
- Trial name
- NCT01846845
- Testing
- Conventional Prosthetic Transfemoral Socket System, Novel Prosthetic transfemoral socket system
- Where
- 2 sites in United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Ohio Willow Wood
Amputation, Amputation, Traumatic
Evaluation of Dexterous Terminal Device
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.
- Conditions
- Amputation, Amputation, Traumatic, Amputation; Traumatic, Hand, Limb; Absence, Congenital, Upper
- Trial name
- NCT05840601
- Testing
- Pointdexter, Comparator
- Sponsor
- Liberating Technologies, Inc.
Amputation, Amputation; Traumatic, Hand
Dexterous Partial Hand Prosthesis Outcomes
Liberating Technologies, Inc. (LTI) has developed a dexterous prosthetic fingertip that will be fit onto an i-Digits™ partial hand prosthesis and allow for an additional fine grasp.
- Conditions
- Amputation, Amputation; Traumatic, Hand, Limb; Absence, Congenital, Upper, Prosthesis User
- Trial name
- NCT05038566
- Testing
- Pointdexter
- Where
- 2 sites in United States
- Volunteers
- 4 people, healthy volunteers welcome
- Sponsor
- Liberating Technologies, Inc.
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; Traumatic, Hand
Validation of User Needs of the Point Digit With Partial Hand Amputees
The objective of the device feasibility study will be to validate the user needs of the Point Digit system. This study will be a single group intervention model where one group of 5 partial hand amputees will be asked to perform…
- Trial name
- NCT04763278
- Testing
- Point Digit
- Where
- 2 sites in United States
- Volunteers
- 7 people
- Sponsor
- Point Designs
Prosthesis User, Amputation
An Investigation of Functional Improvements in the RHEO KNEE Compared to Hydraulic Microprocessor Controlled Knees (MPKs)
The aim of this study was to evaluate the mobility, perceived safety and functioning of unilateral transfemoral (TF) amputees using the Rheo Knee XC compared to their existing prosthetic knee (RHEO KNEE II, III or Genium, X2 or…
- Trial name
- NCT04023578
- Testing
- RHEO KNEE XC
- Where
- 4 sites in United States
- Volunteers
- 15 people
- Sponsor
- Össur Iceland ehf
Lower Limb Amputation
Evaluation of Limb Health Associated With a Prosthetic Vacuum Socket System
The purpose of the study is to evaluate residual limb circulation and skin health associated with the use of a prosthetic vacuum socket. A conventional non-vacuum prosthetic socket will be compared to a vacuum prosthetic socket.
- Trial name
- NCT01839123
- Testing
- Prosthetic Suction or Pin Socket, Prosthetic LimbLogic Vacuum Socket
- Where
- 2 sites in United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Ohio Willow Wood
Amputation, Amputation of Lower Limb
Cryo NerVe Block Extremity AmputatioN RegIStry for Post Operative and pHantom Limb Pain
The goal of this Registry is to see how the device is used when freezing nerves during an amputation procedure.
- Conditions
- Amputation, Amputation of Lower Limb, Amputation of Upper Limb, Amputation, Limb Loss
- Trial name
- VANISH (NCT06908538)
- Testing
- cryoablation
- Where
- 6 sites in United States
- Volunteers
- 2,000 people
- Sponsor
- AtriCure, Inc.
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 Stump, Amputation
Moisture Management Liner At-Home Evaluation
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 unbreathable and non-thermally conductive materials that can create a warm…
- Conditions
- Amputation Stump, Amputation, Amputees, Lower Limb Deformity
- Trial name
- NCT05124873
- Testing
- Moisture Management Liner
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Liberating Technologies, Inc.
Amputation; Traumatic, Hand
To Assess the Utility of the Point Partial in a Clinical Take-home Study of Partial Hand Amputees
This study will allow us to assess whether the Point Partial confers functional and psychological benefit to persons with partial finger amputations in an unconstrained environment.
- Trial name
- NCT05012683
- Testing
- Point Partial
- Where
- 7 sites in United States
- Volunteers
- 11 people
- Sponsor
- Point Designs