Myoelectric Prosthesis for Elbow Amputation
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores new methods to help individuals with arm amputations above the elbow use prosthetic arms more effectively in daily life. It focuses on bone-anchored prostheses (BAPs), which connect directly to the bone, and targeted muscle reinnervation (TMR), a surgery that enhances muscle signals for prosthesis control. The study aims to determine if these advanced prostheses, combined with specialized muscle training, can improve daily use of artificial limbs. Individuals who have undergone an elbow amputation and are scheduled for bone-anchored prostheses may be suitable candidates for this trial. As an unphased trial, it offers participants the chance to contribute to pioneering research that could enhance prosthetic use for future patients.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications.
What prior data suggests that this protocol is safe for individuals with above-elbow amputation?
Research has shown that bone-anchored prostheses (BAPs) are generally safe for individuals with lower limb amputations. In a long-term study, 64% of patients reported improvement when the implant connected with the bone, a process called osseointegration. However, risks such as infections at the implant site require monitoring.
For targeted muscle reinnervation (TMR), studies indicate that patients experience less pain and fewer painful nerve growths, known as neuromas, when TMR is performed during the initial amputation surgery. This suggests that TMR is usually well-tolerated.
Both procedures have been in use for some time and are generally considered safe. They aim to enhance the fit and function of prostheses, making everyday activities easier.12345Why are researchers excited about this trial?
Researchers are excited about the combination of Bone-anchored Prostheses (BAPs) and Targeted Muscle Reinnervation (TMR) for elbow amputation because this approach offers a unique integration of skeletal and neural technologies. Unlike traditional socket prostheses that rely on fit and external support, BAPs are directly attached to the bone, providing a more stable and natural movement. TMR, on the other hand, reroutes nerves to new muscle targets, allowing the myoelectric device to be controlled by natural muscle signals for more intuitive and precise control. This combination has the potential to significantly improve both the functionality and comfort of prosthetic limbs, enhancing the quality of life for amputees.
What evidence suggests that this study's treatments could be effective for improving prosthesis use and function in daily life?
Research has shown that bone-anchored prostheses (BAPs) can greatly enhance life for individuals with upper limb loss. These devices eliminate the need for sockets, which often cause discomfort and instability. Studies have found that BAPs increase the duration of prosthesis use and facilitate daily activities.
In this trial, participants will receive a combination of treatments. Targeted muscle reinnervation (TMR) has been shown to help users control prostheses operated by muscle signals. TMR improves the accuracy of these signals and reduces post-amputation pain, making prosthetics more comfortable and easier to use.
Additionally, an improved muscle training program, included in this trial, enhances users' ability to operate myoelectric arms. This training teaches them to understand and use muscle signals effectively, leading to better control of the prosthesis in everyday tasks. Overall, combining BAPs, TMR, and enhanced training in this study can make prosthetic use more functional and comfortable.23467Are You a Good Fit for This Trial?
This trial is for individuals with an above-elbow amputation who are scheduled to receive bone-anchored prostheses through the Alberta Limb Osseointegration Program. Participants should have good shoulder movement without pain and potential muscle signals that can be trained for myoelectric prosthesis control.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Surgery
Participants undergo osseointegration and targeted muscle reinnervation surgeries
Treatment
Enhanced muscle training protocol and fitting with a myoelectric device
Follow-up
Participants are monitored for prosthesis use and function in daily life
What Are the Treatments Tested in This Trial?
Interventions
- Bone-anchored Prostheses (BAPs)
- Enhanced Muscle Training Protocol
- Targeted Muscle Reinnervation (TMR)
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Alberta
Lead Sponsor