Clinical trials: Transfemoral Amputation
Amputation, Prosthesis User
Effects of Microprocessor-controlled Prosthetic Knees on Fall-related Health Outcomes in Limited Community Ambulators
The goal of this study is to find out if using microprocessor-controlled prosthetic knees (MPKs), prosthetic knees with a built-in computer, improves health outcomes related to falls in adults who use above-knee prostheses.
- Conditions
- Amputation, Prosthesis User, Amputation; Traumatic, Leg: Thigh, Between Hip and Knee, Limb; Absence, Congenital, Lower
- Trial name
- NCT06937242
- Testing
- Ottobock C-Leg 4 Microprocessor Knee, Ottobock Kenevo
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Hanger Institute for Clinical Research and Education, LLC
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
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.
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
Prosthesis and Implants
Transdermal Compress IDE Study
The purpose of this study is to evaluate the safety and effectiveness of the Transdermal Compress device in participants with Transfemoral Amputations.
- Trial name
- NCT06134167
- Testing
- Transdermal Compress Device
- Where
- 9 sites in United States
- Volunteers
- 100 people
- Sponsor
- Balmoral Medical company
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
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
Transfemoral Amputation, Amputation
Aerofit Post Market Investigation
The goal of this clinical investigation is to evaluate the clinical benefits of a ventilating suspension interface for individuals with transfemoral amputation.
- Conditions
- Transfemoral Amputation, Amputation, Skin Health
- Trial name
- NCT05925712
- Testing
- AeroFit Seal-In Liner / Socket, Seal-In Silicone Liner
- Where
- 7 sites in United States
- Volunteers
- 56 people
- Sponsor
- Össur Iceland ehf
Lower Limb Amputation Above Knee (Injury)
New Microprocessor-Controlled Prosthetic Knee Evaluation
The target of this clinical investigation is to compare the achievement of personal functional goals using a new MPK and current MPK.
- Trial name
- NCT06017024
- Testing
- microprocessor-controlled knee (MPK) assessment
- Where
- 5 sites in France
- Volunteers
- 18 people
- Sponsor
- Proteor Group
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
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, 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
Lower Limb Amputation Above Knee, Lower Limb Amputation Below Knee
Study on a Prosthetic Foot With Adjustable Heel Height
Most prosthetic feet have a fixed heel height, which requires users to always wear shoes with the same heel height. A fixed heel height is a significant constraint, whereas the ability to choose one's clothing freely is an…
- Trial name
- ADJUST (NCT07214493)
- Testing
- Taleo Adjust, The usual participant's foot
- Where
- 5 sites in France
- Volunteers
- 30 people
- Sponsor
- Otto Bock France SNC
Lower Limb Amputation Above Knee (Injury)
Above-knee Socket Evaluation : Sub-ischial vs Ischial Containment
Socket is key to provide comfort and function to lower limb amputees. A new socket, the sub-ischial socket, will be compared to "traditional" ischial containment sockets, based on comfort self-evaluation, and locomotor capacities.
- Trial name
- P20-EMBSUBI (NCT04791163)
- Testing
- Socket evaluation
- Where
- 9 sites in France
- Volunteers
- 25 people
- Sponsor
- Proteor Group
Transfemoral Amputation
Osseointegrated Prostheses for the Rehabilitation of Amputees
Patients with transfemoral amputations (TFA) frequently experience problems related to the use of socket-suspended prostheses 1-3. These problems increase with short or deformed stumps 4.
- Trial name
- OPRA (NCT01725711)
- Testing
- OPRA Implant System
- Where
- Sweden
- Volunteers
- 51 people
- Sponsor
- Integrum
Lower Limb Amputation Above Knee (Injury), Congenital Amputation of Lower Limb
Assessing Outcomes With Microprocessor Knee Utilization in a K2 Population
Two-phased randomized controlled trial comparing the impact of microprocessor controlled knee prostheses (MPK) with the impact of non-microprocessor controlled knee prostheses (NPMK) in patients with a transfemoral/knee…
- Conditions
- Lower Limb Amputation Above Knee (Injury), Congenital Amputation of Lower Limb, Lower Limb Amputation Knee
- Trial name
- ASCENT K2 (NCT04784429)
- Testing
- Kenevo or C-Leg 4, Non microprocessor controlled knee (NMPK)
- Where
- 90 sites in United States
- Volunteers
- 107 people
- Sponsor
- Otto Bock Healthcare Products GmbH
Amputation, Amputation; Traumatic, Leg, Lower
Clinical Outcomes With Non-Powered vs. Powered Prosthetic Knees by K2-level Amputees
The goal of this proposed project is to gather community-based data from the K2-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
- NCT06194838
- Testing
- Ossur Power Knee, Reboocon Intuy Knee
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- Liberating Technologies, Inc.
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)
Assessment of the Prosthetic System Impact on Mental Workload in Above-knee Lower Limb Amputees.
New generation of lower limb prosthesis provide improved functionalities. They are usually studied in the scope of biomechanics, sometimes PROMs like quality of life.
- Trial name
- INCREMENT (NCT06635655)
- Where
- France
- Volunteers
- 9 people
- Sponsor
- Proteor Group