Above Knee Amputation

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23 Above Knee Amputation Trials Near You

Power is an online platform that helps thousands of Above Knee Amputation patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ethical standards, giving patients an easy way to discover promising new treatments in the research stage.

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Prosthetic Foot Adaptability for Amputation

Mount Sterling, Ohio
People with lower extremity amputation (LEA) have persistent problems with balance, falls, residual limb pain, functional mobility, cognitive attention during gait, and satisfaction with participation in daily activities, despite using prostheses. The purpose of this randomized clinical trial is to advance understanding of how dynamic foot design features may help people with LEA This study will include people with above-knee amputations, or with bilateral amputations, or with below-knee amputations and lower levels of mobility. The main study questions/goals are: 1a) To determine if frontal plane adaptation in a foot prosthesis impacts performance, comfort, activities of daily living, and community mobility in the study populations. To answer this question, we will compare a locked and unlocked version of the novel prosthesis. 1b) To determine how the unlocked investigational foot condition compares to the person's usual foot using the outcomes listed above. 2) To examine the participants' lived experience during community activities. The study will use performance tests, questionnaires, logbooks, and interviews to monitor person-centered outcomes and perceptions of personal functioning during the use of the investigational foot (locked and unlocked) compared to the person's usual foot.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:16+

96 Participants Needed

MPK vs NMPK Prosthetics for Above-Knee Amputation

Zanesville, Ohio
This trial tests advanced artificial knees with built-in computers in above-knee or knee-level amputees who have limited walking ability. The goal is to see if these knees can reduce fear of falling, improve quality of life, and increase participation in activities. These advanced knees are well-established devices that significantly increase patient safety, walking ability, and performance in daily activities.
No Placebo Group

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:65+

107 Participants Needed

Stem Cell Injections for Amputation Complications

Indianapolis, Indiana
Patients undergoing semi-elective lower extremity major amputation from complications associated with atherosclerotic limb ischemia will received intra-muscular injections of allogeneic Mesenchymal Stromal Cells in the leg above and below the point of amputation to prevent ischemic wound complications after surgery and decrease the incidence of revision and further amputation. Cohort Groups 1-4 will serve as controls.
No Placebo Group

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Phase 1
Age:40 - 90

81 Participants Needed

Powered vs Conventional Prosthetic Knees for Amputation

Chicago, Illinois
Microprocessor-controlled knees (MPKs) do not typically utilize motors to power joint rotation, but they automatically adjust resistance or damping in the joint to improve swing- and/or stance-phase control as appropriate for the prosthesis user during gait. The Ossur Power Knee is the only commercially-available MPK that uses a motor to provide active power generation during walking and other activities. The purpose of this proposed investigation is to perform and compare biomechanical evaluations of the Power Knee and Ossur Rheo XC, a passive MPK, during walking and other activities by prosthesis users. Furthermore, mobility between male and female subjects will be compared to determine if there are differences in prosthetic knee usage on the basis of sex.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:45 - 75

20 Participants Needed

Powered Prosthetics for Knee Amputations

Chicago, Illinois
The goal of this study is to understand how providing power at the knee or ankle individually, or providing power at both the knee and ankle, impacts ambulation for K2 level transfemoral amputees. Aim 1: measure functional performance of K2 level ambulators when using a commercially available passive microprocessor knee prosthesis (Ottobock Cleg/Ottobock foot) or a powered knee and ankle prosthesis (SRALab Hybrid Knee and SRAlab Polycentric Powered Ankle. Aim 2: Participants will be evaluated on the contribution of adding power at the knee only or the ankle only. Aim 3: The investigators will evaluate the functional performance after intensive clinical gait training on the powered knee and ankle prosthesis (SRALab Hybrid Knee and SRALab Polycentric Powered Ankle). Our hypothesis is that providing powered componentry will improve function and that intensive training will magnify those improvements.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased

20 Participants Needed

Ischemic Conditioning for Peripheral Arterial Disease

Chicago, Illinois
Lower limb amputation is common in the United States, with approximately 150,000 amputations annually. Most individuals walking with a prosthesis demonstrate asymmetrical loading-i.e., they favor the amputated side by placing more weight and increased ground reaction forces through the intact limb-which likely contributes to increased metabolic cost of walking. Lack of adequate muscular strength in the lower limb to attenuate these forces places increased stress on the joints, which may be displaced proximally, and may play a role in reported knee and hip pain in the intact limb. Lower limb muscle weakness following amputation has been well documented. Increasing quadriceps strength is important after an amputation because it is positively correlated with gait speed. Gait speed may also be associated with successful community mobility, which leads to improved quality of life following amputation. Individuals with amputation who resume an active lifestyle are able to maintain strength. However, these individuals represent a minority of persons with lower limb amputation; most individuals report more barriers than motivators to adopt an active lifestyle. Ischemic conditioning (IC) may strengthen leg muscles and reduce the metabolic cost of activity after amputation. In IC, the limb is exposed to brief, repeated bouts of ischemia (reduced blood flow) immediately followed by reperfusion. IC has been shown to improve muscle performance in healthy and diseased populations. IC has also been used more recently in patients with peripheral artery disease (PAD) as an intervention to improve function, such as walking ability. Acute exposure to IC increases muscle strength and activation, both in healthy, active individuals and in those with severe neuromuscular dysfunction, such as stroke survivors. IC also attenuates muscular fatigue. Increased fatigue resistance at submaximal contraction levels following IC may be due to increased neural activation of skeletal muscle. Changes in neural activation of muscle may be particularly beneficial during cortical reorganization after amputation. Reduced quadriceps fatigue during submaximal activities may also drive changes in gait kinematics, such as increased knee flexion during loading and mid-stance. Exposure to IC may also increase the oxidative properties of skeletal muscle, offering a direct pathway to reduce metabolic cost. Therefore, IC may lead to cellular changes that lower the metabolic cost of activity. The primary aim of this study is to quantify the benefits of acute and chronic IC on quadriceps strength and walking economy in individuals with PAD and history of lower limb amputation.

Trial Details

Trial Status:Active Not Recruiting

80 Participants Needed

Wearable Airbag Technology for High Fall Risk

Chicago, Illinois
The purpose of this study is to evaluate the feasibility and efficacy of a smart airbag system that detects and mitigates fall-related impact in individuals with high fall risk.
No Placebo Group

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Unphased

200 Participants Needed

VR Therapy for Phantom Limb Pain

Chicago, Illinois
The objective of this study is to develop a virtual rehabilitation system that can be used to effectively treat Phantom Limb Pain (PLP) within the research setting and for at-home use by individuals with upper and lower extremity amputation. We hypothesize that the system will improve PLP for individuals with upper or lower extremity amputation, as measured through with various outcome measures and questionnaires.
No Placebo Group

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Unphased

48 Participants Needed

IMPACT-L3 for Amputation

Toronto, Ontario
Loss of a lower limb due to diabetes can have a devastating impact on physical and mental health and quality of life. Individuals are at risk of other diseases such as cardiovascular disease, loss of the other limb and death. Physical activity can reduce risk of chronic disease and improve health outcomes; however, physical activity levels in people with limb loss are low, often due to reduced balance and walking ability. Rehabilitation services are not readily available and the cost of delivering such programs remains high. Working with individuals with lower limb amputation, we created a virtual, peer-led physical activity behaviour change intervention called IMproving Physical Activity through Coaching and Technology following Lower Limb Loss (IMPACT-L3). We will conduct a pilot study to assess feasibility and optimize design of a future trial of effectiveness.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased

40 Participants Needed

Gait Rehabilitation for Amputation

Richmond, Virginia
The population of older Veterans with non-traumatic lower limb amputation is growing. Following lower limb amputation, asymmetrical movements persist during walking and likely contribute to disabling sequelae including secondary pain conditions, poor gait efficiency, impaired physical function, and compromised skin integrity of the residual limb. This study seeks to address chronic gait asymmetry by evaluating the efficacy of two error-manipulation gait training programs to improve gait symmetry for Veterans with non-traumatic lower limb amputation. Additional this study will evaluate the potential of error-manipulation training programs to improve secondary measures of disability and residual limb skin health. Ultimately, this study aims to improve conventional prosthetic rehabilitation for Veterans with non-traumatic amputation through gait training programs based in motor learning principles, resulting in improved gait symmetry and lower incidence of long-term disability after non-traumatic lower limb amputation.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:40 - 89

54 Participants Needed

ENABLE Sensing Pad for Prosthetic Leg Fitting in Below Knee Amputees

Raleigh, North Carolina
Lower limb amputees (LLA) rely on their prosthetic legs to remain active and lead an independent life. For most LLAs, a well-fitted prosthetic socket is the only option to interface with their prosthetic leg, however, it is a real challenge to make a prosthetic socket to interface with residual limbs accurately. One of the reasons is that there lack of accurate approaches to evaluate the pressure distribution on the residual limb accurately and effectively. To overcome this issue, the research team will develop an innovative sensing system, which permits the prosthetists to track the pressure distribution on the residual limb visually. The capability of the new sensing system will be demonstrated on lower limb amputees.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased

3 Participants Needed

EMG-Controlled Prosthetic Ankle for Below Knee Amputation

Raleigh, North Carolina
The objective of this proposal is to investigate the effects of training to use direct electromyographic (dEMG) control of a powered prosthetic ankle on transtibial amputees'. The aimed questions to answer: 1. whether dEMG control will improve balance and postural stability of amputees, 2. whether dEMG control will lead to more natural neuromuscular control and coordination, 3) whether dEMG control will reduce cognitive processes. Participants will go through PT guided training on using dEMG controlled prosthetic ankles and are evaluated for their capability on functional tasks. The results will be compared with a comparison group, which goes through the same training but with their everyday passive prostheses on balance capability, neuromuscular coordination, and cognitive load during locomotion.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased

50 Participants Needed

Multifunctional Angioplasty for Peripheral Artery Disease

Wilmington, Delaware
Below-the-Knee Interventions for Limb Salvage: Use of Multifunctional Angioplasty Balloon Catheters ("BTK Multicath Registry") A non-randomized clinical registry This study is designed to obtain preliminary data on clinically relevant procedural variables during percutaneous below-knee artery revascularization procedures among consecutive patients treated with either the Finesse BTK Multicath® ("Finesse") or the standard of care using conventional angioplasty balloon catheters. This registry will enroll participants with a history of chronic limb threatening ischemia and below-knee arterial insufficiency who will be assigned to revascularization with or without use of the Finesse BTK Multicath. The registry is an acute study examining procedural data only. The primary endpoints of interest are the volume of contrast used for the intervention, overall procedure time, radiation dose, number of catheter exchanges during revascularization, and medical device supply costs. For the first phase 12 consecutive patients will be treated with the standard of care. For the second phase 12 consecutive patients will be treated with Finesse. 24 participants total Up to 5 study sites in the United States Initial anticipated enrollment: Q4 2024 Last anticipated enrollment: Q2 2025 Patients \>=18 years old with documented history of unilateral chronic limb threatening ischemia due to below-knee arterial insufficiency with angiographic runoff in the foot and limited arterial insufficiency above the knee 1. Contrast volume administered during the revascularization portion of a procedure. 2. Number of catheter exchanges during revascularization 3. Fluoroscopy time 4. Radiation dose during revascularization 5. Procedure time post-enrollment 6. Equipment costs 7. Reduced use of supplies 8. Technical success 9. Safety/Major Adverse Peripheral Events On-treatment sample Intention-to-treat
No Placebo Group

Trial Details

Trial Status:Not Yet Recruiting
Trial Phase:Unphased

24 Participants Needed

Nerve Stimulation + Local Anesthetic for Pain After Amputation

Iowa City, Iowa
This multi-site clinical trial aims to assess the efficacy and safety of combining peripheral nerve stimulation with local anesthetic nerve blockade compared to the standard of care, i.e., local anesthetic blockade only using safe stimulation parameters in a condition associated with high postoperative pain state, i.e. a patient undergoing lower limb amputation.
No Placebo Group

Trial Details

Trial Status:Not Yet Recruiting
Trial Phase:Unphased

62 Participants Needed

NU-FlexSIS Prosthetic Socket for Leg Amputation

Minneapolis, Minnesota
The objective of this trial is to assess use and benefits of the subischial socket for persons with transfemoral amputation and lower mobility levels. Specifically, the investigators will evaluate whether the subischial socket improves comfort, socket wear time, mobility, participation, quality of life and satisfaction with device than the standard-of-care ischial containment socket.
No Placebo Group

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Unphased

115 Participants Needed

Powered Knee Prosthesis for Above-Knee Amputation

Cambridge, Massachusetts
The purpose of the study is to investigate the clinical and functional outcomes of a powered knee prosthesis for people with a transfemoral amputation in the domain of gait, free space control, and embodiment
No Placebo Group

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:22 - 65

7 Participants Needed

Prosthetic Knees for Above-Knee Amputation

Austin, Texas
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 maximize the benefit for each patient). The investigators intend to use this trial data along with a concurrent study being conducted within the K3-K4 level population to guide the implementation of effective prescriptions towards those that can benefit most from a given device and limit prescription to those who would not see benefit in order to ensure the most judicious use of Department of Defense (DoD) and Veteran's Affairs healthcare dollars. The findings will also be shared with the research community to help drive the design of future devices by identifying what features and functions are most beneficial to which patient populations when the devices are used outside of the laboratory. In summary, more community-based data on how powered prosthetic knees compare with the current standard in TFA populations is needed to allow for improved clinical decision making and clinical outcomes.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased

26 Participants Needed

Microprocessor-controlled Prosthetic Knees for Above Knee Amputation

Austin, Texas
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. The main questions are: * Do individuals with MPKs have fewer fall-related health issues compared to those with non-microprocessor-controlled prosthetic knees (nMPKs)? * Do individuals with MPKs have increased mobility, faster walking speed, and improved quality of life compared to those with nMPKs? Participants who have recently received an nMPK as part of their regular care can join the study. Those randomized to the control group will keep using their nMPK, while those randomized to the intervention group will receive a stance-and-swing MPK or a stance-only MPK.
No Placebo Group

Trial Details

Trial Status:Not Yet Recruiting
Trial Phase:Unphased

100 Participants Needed

Limb Load Biofeedback Training for Osseointegration

Aurora, Colorado
This randomized controlled trial (n=25 enrolled, n=15 expected to complete) will 1) determine the feasibility of a 40-week limb-load biofeedback training intervention, 2) determine if there is an intervention signal of efficacy, and 3) identify functional movement priorities for people with transfemoral osseointegrated (OI) prostheses. A limb-load biofeedback training group (EXP (n=10)) will be compared to a standard of care attention-control group without limb-load biofeedback training (CTL (n=5)). Outcomes will be assessed at standard of care pre-habilitation end (Week 5), standard of care rehabilitation end (Week 24), and one year after OI Stage 2 surgery (Week 64).

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased

25 Participants Needed

Telehealth Walking Exercise for Lower Limb Amputation

Aurora, Colorado
This trial aims to help Veterans with lower-limb amputation stay active through a walking exercise self-management program. The program provides remote support, personalized exercise plans, and peer encouragement. By promoting regular walking, the program seeks to improve health outcomes and reduce disability in this group.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:40 - 89

78 Participants Needed

Why Other Patients Applied

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ADHD PatientAge: 31

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Pancreatic Cancer PatientAge: 40

"I changed my diet in 2020 and I’ve lost 95 pounds from my highest weight (283). I am 5’3”, female, and now 188. I still have a 33 BMI. I've been doing research on alternative approaches to continue my progress, which brought me here to consider clinical trials."

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Obesity PatientAge: 58

"I have dealt with voice and vocal fold issues related to paralysis for over 12 years. This problem has negatively impacted virtually every facet of my life. I am an otherwise healthy 48 year old married father of 3 living. My youngest daughter is 12 and has never heard my real voice. I am now having breathing issues related to the paralysis as well as trouble swallowing some liquids. In my research I have seen some recent trials focused on helping people like me."

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"I've tried several different SSRIs over the past 23 years with no luck. Some of these new treatments seem interesting... haven't tried anything like them before. I really hope that one could work."

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Depression PatientAge: 51

Terrain Locomotor Training for Amputation

Las Vegas, Nevada
The purpose of this research is to determine the feasibility of an uneven terrain walking program for lower limb prosthesis users. The training is designed to induce step-to-step variability during walking within a safe environment, with the aim of improving walking skill and confidence.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased

35 Participants Needed

Powered Prosthetic Knee for Below Knee Amputation

Loma Linda, California
The purpose of this industry-initiated research study is to test that a powered microprocessor controlled knee improves metabolic function during walking in level and sloped conditions as compared to the subject's physician prescribed prosthesis.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased

12 Participants Needed

Auto-Adjusting Prosthetic Socket for Below Knee Amputation

Seattle, Washington
People with leg amputations often experience daily changes in the size (volume) of their residual limb. These daily changes can cause a prosthesis to fit poorly. They can also cause limb problems like pain or skin breakdown. Prosthetic socket systems that accommodate limb volume changes can help address these issues, but they require users to make adjustments throughout the day. The aim of this research is to create a 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 their prosthesis.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased

100 Participants Needed

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How Do Clinical Trials Work?Are Clinical Trials Safe?What Can I Expect During a Clinical Trial?

Frequently Asked Questions

How much do Above Knee Amputation clinical trials pay?

Each trial will compensate patients a different amount, but $50-100 for each visit is a fairly common range for Phase 2–4 trials (Phase 1 trials often pay substantially more). Further, most trials will cover the costs of a travel to-and-from the clinic.

How do Above Knee Amputation clinical trials work?

After a researcher reviews your profile, they may choose to invite you in to a screening appointment, where they'll determine if you meet 100% of the eligibility requirements. If you do, you'll be sorted into one of the treatment groups, and receive your study drug. For some trials, there is a chance you'll receive a placebo. Across Above Knee Amputation trials 30% of clinical trials have a placebo. Typically, you'll be required to check-in with the clinic every month or so. The average trial length for Above Knee Amputation is 12 months.

How do I participate in a study as a "healthy volunteer"?

Not all studies recruit healthy volunteers: usually, Phase 1 studies do. Participating as a healthy volunteer means you will go to a research facility several times over a few days or weeks to receive a dose of either the test treatment or a "placebo," which is a harmless substance that helps researchers compare results. You will have routine tests during these visits, and you'll be compensated for your time and travel, with the number of appointments and details varying by study.

What does the "phase" of a clinical trial mean?

The phase of a trial reveals what stage the drug is in to get approval for a specific condition. Phase 1 trials are the trials to collect safety data in humans. Phase 2 trials are those where the drug has some data showing safety in humans, but where further human data is needed on drug effectiveness. Phase 3 trials are in the final step before approval. The drug already has data showing both safety and effectiveness. As a general rule, Phase 3 trials are more promising than Phase 2, and Phase 2 trials are more promising than phase 1.

Do I need to be insured to participate in a Above Knee Amputation medical study?

Clinical trials are almost always free to participants, and so do not require insurance. The only exception here are trials focused on cancer, because only a small part of the typical treatment plan is actually experimental. For these cancer trials, participants typically need insurance to cover all the non-experimental components.

What are the newest Above Knee Amputation clinical trials?

Most recently, we added Nerve Stimulation + Local Anesthetic for Pain After Amputation, Terrain Locomotor Training for Amputation and Multifunctional Angioplasty for Peripheral Artery Disease to the Power online platform.

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