Clinical trials: Amputation of Knee
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
Traumatic Amputation of Lower Extremity
Effects of Wearing a Powered Ankle-Foot Prosthesis on Amputee Walking
Amputees wearing a conventional prosthesis require 20-30% more metabolic energy to walk at the same speeds as non-amputees and this discrepancy is more apparent at faster walking speeds.
- Trial name
- NCT00869947
- Testing
- Powered ankle-foot prosthesis, No device
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- US Department of Veterans Affairs
Lower Limb Amputation Below Knee (Injury)
Auto Control of Volume Management for Limb Loss
The aim of this research is to create a prosthetic system that will automatically adjust the fit of the socket and create a well-fitting prosthesis for people with leg amputations who experience volume fluctuations when using…
- Trial name
- NCT03550118
- Testing
- Adjustable socket
- Where
- United States
- Volunteers
- 104 people
- Sponsor
- University of Washington
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 Extremity Amputation
Adherence and Perspiration While Wearing Lower Limb Prostheses
Individuals with lower limb amputation often complain about uncomfortable residual limb skin temperatures and the accumulation of sweat inside their prostheses.
- Trial name
- NCT03900845
- Testing
- Dynamic Air Exchange - Rising Edge Design (DAE-RED), Perforated elastomeric liner, As-prescribed prosthesis
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Seattle Institute for Biomedical and Clinical Research
Unilateral Traumatic Amputation, Amputation, Traumatic
Determining the Potential Benefit of Powered Prostheses
The goal of this research is to determine the effectiveness of a powered prosthesis compared to an unpowered prosthesis during short bouts of walking, extended periods of walking (to fatigue), and performance in the community.
- Trial name
- NCT02828982
- Testing
- Powered ankle prosthesis, Dynamic Response Foot
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Deanna H Gates
Prosthesis User, Amputation
Clinical Investigation (Beta) of Power Knee Mainstream - Dynamic
Prospective two group cross over investigation, comparing the investigational device (Power Knee, a powered microprocessor controlled prosthetic knee) and subjects prescribed microprocessor prosthetic knee (MPK).
- Trial name
- NCT04787627
- Testing
- Power Knee
- Where
- 2 sites in United States
- Volunteers
- 17 people
- Sponsor
- Össur Iceland ehf
Peripheral Artery Disease, Vascular Disease
Use of Autologous Concentrated Bone Marrow Aspirate in Preventing Wound Complications in Below Knee Amputation (BKA)
Patients scheduled for major extremity lower amputation to receive bone marrow cells (cBMA) injected IM in the leg proximal to the amputation in the index limb to prevent ischemic wound complications after surgery.
- Conditions
- Peripheral Artery Disease, Vascular Disease, Critical Limb Ischemia
- Trial name
- MarrowCHAMP (NCT02863926)
- Testing
- Injection of cBMA aspirate into the index leg
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Michael Murphy
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
Diabetes Mellitus, Critical Limb Ischemia
N-Acetyl-Cysteine (NAC) for Healing of Amputation Stumps in the Setting of Diabetes
In this pilot clinical study the investigators propose to conduct a prospective, randomized, double-blinded, placebo-controlled clinical trial for 30 days for participants with critical limb ischemia (CLI) who undergo a major…
- Conditions
- Diabetes Mellitus, Critical Limb Ischemia, Lower Limb Amputation Knee, Peripheral Arterial Disease
- Trial name
- NCT03253328
- Testing
- Active Arm N-acetyl cysteine (NAC)
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- Washington University School of Medicine
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
Pain, Postoperative, Amputation
Liposomal Bupivacaine vs Continuous Nerve Catheters for Below the Knee Amputations
Through this pilot prospective trial, we aim to obtain preliminary data investigating the effectiveness of perineural catheters and liposomal bupivacaine, both currently accepted as standard care at Maine Medical Center, for the…
- Trial name
- NCT05140499
- Testing
- Liposomal bupivacaine, Bupivacaine Hydrochloride 0.5 % Injectable Solution
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Aurora Quaye
Lower Limb Amputation Below Knee (Injury)
Wear and Tear Evaluation of New Nike Sport Sole for Runnnig Prosthesis
Running Specific Feet are based on the original Flex-Foot design using the energy storage and release function as the main design feature. Running specific prosthetic feet are intended for running and jogging.
- Trial name
- NCT04787640
- Testing
- Nike Sport Sole
- Volunteers
- 3 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.
Other and Unspecified Complications of Amputation Stump
Comparative Outcomes Assessment of the C-Leg With a New Knee Prosthesis
The purpose of this study is to determine if transfemoral amputees of varied etiology will demonstrate increased function, safety and quality of life following accommodation with a new knee prosthesis as compared to their former…
- Trial name
- NCT01473992
- Testing
- Otto Bock C-Leg, Otto Bock Genium
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Jason Highsmith
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 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
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
Clinical Investigation (Beta) of a New Developed Prosthetic Knee
The aim of this investigation is to evaluate the efficacy of the investigational device regarding performance improvements and satisfaction in descending activities for moderate to high active prosthesis users within the intended…
- Trial name
- NCT06748729
- Testing
- Navii Knee
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Össur Iceland ehf
Prosthesis User, Amputation
An Investigation on Function and Performance of a New Microprocessor Controlled Prosthetic Knee
This investigation aims to compare the functional performance of a new passive microprocessor-controlled Prosthetic Knee to subjects usual microprocessor-controlled prosthetic knee.
- Trial name
- NCT05523349
- Testing
- NAVii
- Where
- 4 sites in United States, Iceland
- Volunteers
- 14 people
- Sponsor
- Össur Iceland ehf