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New treatment option for Amputation
Official title Regenerative Peripheral Nerve Interface for Control of Lower Limb Prostheses
ClinicalTrials.gov ID: NCT06275282
What this study is testing
- What it's testing
- Individuals with an above-knee lower limb amputation are known to walk more slowly, expend more energy, have a greater risk of falling, and have reduced quality of life compared to individuals without amputation and those with below knee amputation. One of the driving factors behind these deficits is the lack of active function provided by above-knee prostheses with prosthetic knees and ankles.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Unilateral amputation of the leg proximal to the knee at least 6 months prior to enrollment.
- Low surgical risk (American Society of Anesthesiologists Class I and II).
- For participants without existing RPNI grafts (at the time of enrollment), the residual limb must have sufficient soft tissue quality to support...
- Amputee Mobility Predictor with prosthesis (AMPPRO) score of at least 37 (Gailey et al. 2002).
- Sufficient clearance to a motorized prosthetic leg without the necessity for shoe lifts or extenders on the contralateral limb.
You likely can't join if
- Severe pain syndrome including complex regional pain syndrome or severe phantom pain. All of these conditions would suggest pathological activity of...
- Untreated mental health disorders and if they have any DSM-5 diagnoses, they must receive approval to participate from their mental health...
- Any medical conditions that, in the opinion of the Principal Investigator, would place them at high risk for a surgical procedure including recent...
- Participants must not have used tobacco for at least one month prior to enrollment in the study.
- Participants must agree to not use tobacco for the duration of the study.
- Pregnancy.
See the full eligibility criteria
- Unilateral amputation of the leg proximal to the knee at least 6 months prior to enrollment.
- Low surgical risk (American Society of Anesthesiologists Class I and II).
- For participants without existing RPNI grafts (at the time of enrollment), the residual limb must have sufficient soft tissue quality to support performance of the RPNI operative procedures. Participants sustaining...
- Amputee Mobility Predictor with prosthesis (AMPPRO) score of at least 37 (Gailey et al. 2002).
- Sufficient clearance to a motorized prosthetic leg without the necessity for shoe lifts or extenders on the contralateral limb.
- Severe pain syndrome including complex regional pain syndrome or severe phantom pain. All of these conditions would suggest pathological activity of the nerve and would exclude the participant from participation.
- Untreated mental health disorders and if they have any DSM-5 diagnoses, they must receive approval to participate from their mental health professional.
- Any medical conditions that, in the opinion of the Principal Investigator, would place them at high risk for a surgical procedure including recent myocardial infarction, cerebrovascular accidents, deep venous...
- Participants must not have used tobacco for at least one month prior to enrollment in the study.
- Participants must agree to not use tobacco for the duration of the study.
- Pregnancy.
- No other indwelling electronic implants like pacemakers, implantable cardioverter defibrillators, implantable neurostimulators, body worn insulin pumps, or body worn patient monitoring devices.
- Severe peripheral vascular occlusive disease, venous hypertension of the extremity, or severe lymphedema of the extremity.
- An autoimmune condition which is not well controlled by medication.
- A significant injury of the contralateral limb.
- Significant, uncorrected vision problems.
- Impaired mental capacity that negatively impacts verbal communication with the clinicians and research team or requires a Legally Authorized Representative to facilitate communication.
The study team makes the final eligibility decision.
Where it's taking place
- Ann Arbor, Michigan, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ann Arbor, Michigan, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.