Clinical trials: Lower Limb Amputation 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; Postoperative, Sequelae
Hyperbaric Oxygen and Outcome After Below Knee Amputations
This study is being conducted to assess the utility of hyperbaric oxygen as an adjunctive treatment to reduce postoperative complications.
- Trial name
- NCT04717557
- Testing
- Hyperbaric Oxygen
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Duke University
Lower Extremity Amputation
Pivot-Flex Foot: Optimal Coupling Ratio Between Transverse and Sagittal-plane Motions Using a Torsionally Adaptive Prosthesis for Individuals With Lower Limb Amputation
When prescribing a prosthetic foot, clinicians face a dizzying array of choices as more than 200 different prosthetic feet are available.
- Trial name
- NCT03532100
- Testing
- Torsionally adaptive prosthesis with 0:1 coupling ratio, Torsionally adaptive prosthesis with 1:6 coupling ratio, Torsionally adaptive prosthesis with 1:4 coupling ratio
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- VA Office of Research and Development
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
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
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
Amputation, Prosthesis User
Lower Limb Prostheses for Individuals Who Carry Infants, Toddlers, and Other Loads
The aim of this research is to identify the prosthetic foot that results in improved walking performance when individuals with lower limb amputation carry infants, toddlers, or other loads.
- Trial name
- NCT07159490
- Testing
- Standard-of-care prosthetic foot, Standard-of-care prosthetic foot with heel-stiffening wedge, Standard-of-care prosthetic foot of one category greater stiffness
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- VA Puget Sound Health Care System
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
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
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.
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