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Procedure

Regenerative Peripheral Nerve Interface (RPNI) for Amputation

N/A

Recruiting

Research Sponsored by University of Michigan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Awards & highlights

Study Summary

This trial aims to improve the function of above-knee prosthetic limbs by developing a biologic interface called the Regenerative Peripheral Nerve Interface (RPNI). This interface involves implanting a peripheral nerve

Who is the study for?

This trial is for individuals with an above-knee amputation on one leg, who have had it for at least 6 months. They should be able to walk using a motorized prosthetic leg without extra support and have healthy enough tissue in the remaining limb for surgery. People with severe scarring or those considered high-risk for surgery can't participate.Check my eligibility

What is being tested?

The study tests a new way to control advanced robotic legs using Regenerative Peripheral Nerve Interfaces (RPNIs). It involves nerve-implanted muscle grafts that could potentially provide better movement control and sensory feedback of prosthetic limbs over time.See study design

What are the potential side effects?

Potential side effects may include discomfort or complications from surgical implantation of electrodes, issues related to the health and healing of the muscle grafts, and possible malfunction or rejection of the implanted device.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Amplitude and signal-to-noise ratio for each RPNI

Classification accuracy for movements of the phantom limb

Health-Related Quality of Life

+3 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Regenerative Peripheral Nerve Interface (RPNI)Experimental Treatment1 Intervention

Participants will have regenerative peripheral nerve interfaces (RPNIs) created on nerves in their residual thighs. During either the same surgery or a separate surgery, electrodes will be implanted into these RPNIs.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

United States Department of DefenseFED

865 Previous Clinical Trials

327,696 Total Patients Enrolled

University of MichiganLead Sponsor

1,799 Previous Clinical Trials

6,378,635 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still available openings for new participants in this research study?

"As per the details available on clinicaltrials.gov, this study is currently in active recruitment phase. The trial was initially posted on March 1st, 2024 and last updated on March 22nd, 2024."

Answered by AI

Are individuals who are above the age of 45 being sought for participation in this research endeavor?

"Individuals aged 22 years and older but under the age of 75 are eligible for enrollment in this research."

Answered by AI

What is the total number of participants being selected for enrollment in this clinical trial?

"Affirmative. As per the details on clinicaltrials.gov, this research project is actively in search of suitable candidates. The trial was first listed on 3/1/2024 and last modified on 3/22/2024. It aims to enroll 3 participants at a single designated site."

Answered by AI

Which specific criteria must be met for individuals to be eligible for participation in this medical investigation?

"The clinical trial seeks to enroll 3 individuals aged between 22 and 75 who have undergone amputation. Eligible participants must meet specific requirements: those lacking prior RPNI grafts should display adequate soft tissue quality in the residual limb for RPNI procedures; individuals with significant scarring from severe crushing or avulsion injuries may not be suitable candidates. Other key criteria include clearance for a motorized prosthetic leg without requiring contralateral shoe lifts, unilateral leg amputation above the knee at least six months before enrollment, low surgical risk (American Society of Anesthesiologists Class I and II), and an Amputee Mobility Predictor with"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Regenerative Peripheral Nerve Interfaces for the Control of Above-knee Prostheses

Deanna H Gates 2024. "Regenerative Peripheral Nerve Interfaces for the Control of Above-knee Prostheses". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06275282.