Bio-Leg for Above Knee Amputation
(BAM Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to help individuals with a transfemoral amputation (above-knee amputation) improve their walking ability. It compares the current C-leg prosthetic to the new Bio-Leg, a powered microprocessor knee. Participants will first undergo assessment with their current C-leg, then switch to the Bio-Leg for a few weeks before being assessed again. This study suits those who have had an above-knee amputation for over a year, use a C-leg, and can walk with a cane. As an unphased trial, it offers participants the chance to explore innovative prosthetic technology that could enhance mobility and quality of life.
Do I need to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that the Bio-Leg is safe for use in individuals with transfemoral amputations?
Research shows that the Bio-Leg, a powered prosthetic knee with advanced technology, helps people with above-the-knee amputations walk better. It aims to make walking smoother and more efficient, enabling users to walk faster and climb stairs more easily.
Specific safety data for the Bio-Leg is not available, but it is part of the latest prosthetic technology, which generally proves safe when tested in controlled environments. Studies suggest that these types of prosthetic legs reduce the risk of falling compared to traditional ones, indicating that the Bio-Leg could be comfortable and safe for users.
Since this trial does not specify a phase, it likely focuses on the device's effectiveness rather than initial safety. In clinical trials, this usually indicates that any major safety concerns have already been addressed.12345Why are researchers excited about this trial?
The Bio-Leg is unique because it offers an innovative approach to prosthetic limbs for those with above-knee amputations. Unlike standard options like the C-leg, which relies on existing microprocessor technology, the Bio-Leg focuses on a custom fitting process that aims to improve comfort and ease of use. Researchers are excited about the Bio-Leg because it allows for a tailored acclimation period, potentially enhancing the user's mobility and adaptability through dedicated physical therapy sessions. This personalized approach could lead to better outcomes and improved quality of life for users.
What evidence suggests that the Bio-Leg is effective for improving mobility in individuals with above knee amputation?
Research shows that the Bio-Leg prosthetic knee, which participants in this trial will use, could help people with above-knee amputations move better. Studies have found that powered prosthetics like the Bio-Leg make walking easier and less tiring by providing extra knee support during movement. Clinical experience indicates that the Bio-Leg is easy to use, helping users quickly adapt and regain mobility. Users of similar powered prosthetics have reported walking longer distances and handling obstacles more easily. These findings suggest that the Bio-Leg could greatly improve the daily lives of those with above-knee amputations.12678
Who Is on the Research Team?
Emily J Fox, PT, DPT, MHS, PhD
Principal Investigator
University of Florida & Brooks Rehabilitation
Are You a Good Fit for This Trial?
This trial is for adults who have had an above-the-knee amputation and currently use a C-leg prosthetic knee. Participants should be able to walk with their current device and want to try a new type of powered prosthetic knee.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
C-Leg Assessment
Participants are assessed using their current C-Leg microprocessor prosthesis
Bio Leg Acclimation and Assessment
Participants undergo a Bio Leg fitting and acclimation period, followed by assessment
Follow-up
Participants are monitored for safety and effectiveness after the trial
What Are the Treatments Tested in This Trial?
Interventions
- Bio-Leg
Trial Overview
The study compares walking ability in people using the standard C-leg prosthesis versus the new Bio Leg, which is a powered, microprocessor-controlled artificial knee. Each participant will try both devices.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
After the Bio Leg fitting, the participant will exclusively wear the Bio Leg knee component for an acclimation period that will be a minimum of 4 weeks and up to 6 depending on participant's schedule and comfort/ease of using the device. Each participant will complete a minimum of 2 and up to 4 physical therapy sessions during the acclimation period. These physical therapy sessions will involve standard physical therapy training for use of a prosthetic limb after amputation. Following the acclimation period, the participant will complete the second assessment, which will mirror the first assessment.
The first assessment will involve testing the participant with their current C-leg microprocessor prosthesis.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Florida
Lead Sponsor
Brooks Rehabilitation
Collaborator
Citations
Through‐knee versus above‐knee amputation for vascular ...
Above‐knee amputation offers a good chance of primary healing and an even appearance with a prosthesis. However, the transected femur is associated with worse ...
2.
brooksrehab.org
brooksrehab.org/resources/bionicm-and-brooks-rehabilitation-launch-clinical-study-for-bio-leg/BionicM and Brooks Rehabilitation Launch Clinical Study ...
“In my clinical experience, the Bio Leg has demonstrated promising outcomes and a level of intuitive use that is unique among prosthetic knee ...
Surgical and rehabilitation outcomes of patients ...
However, overall, people with through knee amputation were just as likely to walk with an artificial leg as those with above knee amputation, ...
Study Details | NCT07613502 | Bio Leg: Advancing Mobility
The purpose of this study is to compare walking function in individuals with transfemoral amputations who are current users of the C-leg ( ...
Real-World Outcomes of Above-Knee Amputation
All-cause mortality: All-cause mortality after above-knee amputation was 0.6% on day 1 and increased to 2.9% within 7 days. At 30 days, ...
Predictors of receiving a prosthesis for adults with above-knee ...
The odds of receiving a prosthesis were almost 30 times higher in those able to walk independently prior to an amputation relative to those who could not walk ...
Product | BionicM
Bio Leg® is designed to assist various types of patient's ambulation and ADL with safe and controlled power, rather than counter intuitive functioning. Bio Leg ...
8.
news.mit.edu
news.mit.edu/2025/bionic-knee-integrated-into-tissue-can-restore-natural-movement-0710A bionic knee integrated into tissue can restore natural ...
The new bionic knee can help people with above-the-knee amputations walk faster, climb stairs, and avoid obstacles more easily than they could with a ...
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