Clinical trials: Transfemoral Amputation
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, Transfemoral Amputation
Investigation on a New Power Knee Firmware Update on Gait and Daily Life Activities for Transfemoral Amputees
The goal of this interventional study is to investigate a new firmware in development for Power Knee on gait and daily life activities in unilateral transfemoral amputees.
- Trial name
- NCT06620861
- Testing
- Power Knee Firmware Update, Power Knee Current Marketed Firmware
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Össur Iceland ehf
Amputation, Artificial Limbs
Functional Performance Evaluation of NU-FlexSIV Socket
The overall objective of this study is to provide a more comfortable and functional prosthetic socket for persons with transfemoral amputation that will ultimately improve their quality of life.
- Trial name
- NCT02678247
- Testing
- Northwestern University Flexible Sub-Ischial Vacuum Socket, Ischial Containment Socket
- Where
- 3 sites in United States
- Volunteers
- 30 people
- Sponsor
- Northwestern University
Prosthesis User, Amputation
Basic Mobility and Balance Performance of Low Active Transfemoral Prosthesis Users With a Powered Prosthetic Knee
This was a prospective case series design investigation with 6 prosthesis user subjects. Subjects performed the Timed up and go (TUG) test and the two minute walk test (2MWT) along with some activities of daily living (ADL), on…
- Trial name
- NCT04799145
- Testing
- Investigational device, Prescribed device
- Volunteers
- 6 people
- Sponsor
- Össur Iceland ehf
Mastectomy, Upper Limb Amputation Below Elbow
Cryoanalgesia to Prevent Acute and Chronic Pain Following Surgery: A Randomized, Double-Masked, Sham-Controlled Study
The ultimate objective of the proposed line of research is to determine if cryoanalgesia is an effective adjunctive treatment for pain in the period immediately following various painful surgical procedures; and, if this…
- Conditions
- Mastectomy, Upper Limb Amputation Below Elbow, Upper Limb Amputation Above Elbow, Lower Limb Amputation Below Knee
- Trial name
- NCT03578237
- Testing
- Cryoneurolysis (active)
- Where
- United States
- Volunteers
- 99 people
- Sponsor
- University of California, San Diego
Transfemoral Amputation, Unilateral Traumatic Amputation of Leg at or Above Knee
Functional Outcomes in Dysvascular Transfemoral Amputees
In older adults, poor circulation in the lower extremities leads to serious health complications including limb loss. In addition, individuals with dysvascular disease also suffer from other co-morbidities like diabetes, coronary…
- Trial name
- CLEG (NCT01537211)
- Testing
- C leg compared to subject's mechanical leg (Otto Bock)
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Shirley Ryan AbilityLab
Lower Limb Amputation
Development of Adaptive Vacuum Suspension to Improve Prosthetic Fit and Residual Limb Health
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
- DoD (NCT03927404)
- Testing
- Active vacuum test prosthesis
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Indiana University
Transfemoral Amputation
Personalizing MPK Prescription
In current clinical prosthetic practice, there is no evidence based method for selecting a microprocessor knee (MPK) joint for a patient with an above the knee amputation.
- Trial name
- NCT06399471
- Testing
- Microprocessor prosthetic knee
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Georgia Institute of Technology
Lower Limb Amputation Below Knee (Injury), Lower Limb Amputation Above Knee (Injury)
Feasibility Study to Evaluate a New Energy Storage and Return Prosthetic Foot
A prospective, interventional, multicenter pilot study to characterize differences in performance and patient reported outcomes between the Taleo, Proflex XC, and the new Revo prosthetic foot.
- Conditions
- Lower Limb Amputation Below Knee (Injury), Lower Limb Amputation Above Knee (Injury), Lower Limb Amputation Knee
- Trial name
- NCT04239222
- Testing
- Revo-M, Taleo, Proflex XC
- Where
- 4 sites in United States
- Volunteers
- 27 people
- Sponsor
- Otto Bock Healthcare Products GmbH
Amputation, Amputation; Traumatic, Leg, Lower
A Comparative Assessment of Transfemoral Prosthetic Sockets
The objective of the proposed work is to enhance understanding of the potential benefits of adjustable sockets and inform clinical decision making.
- Trial name
- NCT04038580
- Testing
- Laminated Socket, Quatro, Infinite Socket
- Where
- 2 sites in United States
- Volunteers
- 29 people
- Sponsor
- University of Michigan
Amputation, Amputation; Traumatic, Leg, Lower
Clinical Outcomes With Passive MPKs vs. Powered Prosthetic Knees
The goal of this proposed project is to gather community-based data from the K4-level Transfemoral Amputee (TFA) population to aid in evidence-based prescription of powered prosthetic knees (i.e., choosing the right device to…
- Conditions
- Amputation, Amputation; Traumatic, Leg, Lower, Limb; Absence, Congenital, Lower, Prosthesis User
- Trial name
- NCT05267639
- Testing
- Power Knee
- Where
- 2 sites in United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Liberating Technologies, Inc.
Transfemoral Amputation, Artificial Limbs
Assist-Knee: Energy-Harvesting Knee Prosthesis
The purpose of this research is to validate the Assist-Knee design and function by collecting pilot data during the stand-to-sit-to-stand transition in transfemoral prosthesis users when using the Assist-Knee to harvest energy…
- Trial name
- NCT04023045
- Testing
- Assist-Knee, Habitual Prosthesis
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Orthocare Innovations, LLC
Amputation
Intent Recognition for Prosthesis Control
This work will focus on new algorithms for powered prostheses and testing these in human subject tests. Individuals with above knee amputation will walk with a robotic prosthesis and ambulate over terrain that simulates community…
- Trial name
- NCT05537792
- Testing
- Robotic Knee/Ankle Prosthesis
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Georgia Institute of Technology
Amputation, Surgical, Amputation, Traumatic
Cryoanalgesia to Treat Phantom Limb Pain Following Above-Knee Amputation
When a limb is severed, pain perceived in the part of the body that no longer exists often develops and is called "phantom limb" pain.
- Conditions
- Amputation, Surgical, Amputation, Traumatic, Phantom Limb Pain, Phantom Pain Following Amputation of Lower Limb
- Trial name
- NCT06071715
- Testing
- ACTIVE cryoneurolysis
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- University of California, San Diego
Lower Limb Amputation Above Knee (Injury)
Comparative Effectiveness Between Microprocessor Knees and Non-Microprocessor Knees
This study will assess if the functional performance and musculoskeletal outcome of transfemoral amputees are improved after receiving a Microprocessor Knee (MPK) compared to a Non-Microprocessor Knees (NMPK).
- Trial name
- MPK-AOPA (NCT02240186)
- Testing
- Microprocessor Knee (MPK), Non-Microprocessor Knee (NMPK)
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Mayo Clinic
Amputation
Transfemoral Socket Design and Muscle Function
The objective of this pilot research project is to evaluate the effect of prosthetic socket design on amputated limb hip muscle strength and endurance in Service members, Veterans, and civilians who use above-the-knee prostheses.
- Trial name
- NCT04212299
- Testing
- Northwestern University Flexible Sub-Ischial Suction Socket (NU-FlexSIS)
- Where
- United States
- Volunteers
- 5 people, healthy volunteers welcome
- Sponsor
- University of Illinois at Chicago
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
Amputation
Immediate Fit Using Innovative Technology Transtibial & Transfemoral Prosthesis
iFIT Prosthetics, LLC® created and commercialized a modular, immediate fit, fully adjustable, prosthetic system suitable for mass production using high strength injection molded polymer materials.
- Trial name
- NCT02886936
- Testing
- iFIT Transtibial Prosthesis, iFIT Transfemoral Prosthesis
- Where
- United States
- Volunteers
- 71 people
- Sponsor
- University of Pennsylvania
Transfemoral Amputation
Microbiome and Metagenome in Percutaneous Osseointegrated Prostheses (MMPOP)
The purpose of this study is to investigate the clinical implementation of a new percutaneous prosthetic attachment system by determining the resident microbial ecology of the implant exit site and to simultaneously study the…
- Trial name
- MMPOP (NCT02564432)
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- VA Office of Research and Development
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