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Procedure

AMI Prosthesis for Below-Knee Amputation

N/A

Recruiting

Led By Hugh M Herr, PhD

Research Sponsored by Massachusetts Institute of Technology

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 0 - 5 years

Awards & highlights

Study Summary

This trial is testing a new kind of prosthesis for people with below-knee amputations. The hypothesis is that this new prosthesis will offer better motor control and proprioceptive sensation than existing prostheses.

Who is the study for?

This trial is for active individuals with a below-knee amputation who are proficient in using standard lower limb prostheses and have a high activity level (K3 to K4). Participants must have fully healed amputations. The experimental group will have had AMI surgery at Brigham and Women's Hospital, Boston. Exclusions include pregnancy, smoking, age restrictions, or certain health conditions like heart disease.Check my eligibility

What is being tested?

The study compares two groups: one received an innovative surgical technique called AMI during their amputation which may improve control of new prosthetic limbs; the other had standard amputations. It tests muscle activation via EMG data collection and the ability to use advanced prosthesis that allows independent joint movement.See study design

What are the potential side effects?

While specific side effects are not detailed here, potential risks could include issues related to surgery such as infection or poor wound healing, discomfort from EMG testing or functional electrical stimulation if used in the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0 - 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0 - 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0 - 5 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Economy of Motion during Joint Position and Impedance Control in Free Space

Late Swing Ankle Dorsiflexion during Stair Ascent

Late Swing Ankle Plantar Flexion during Stair Descent

+2 more

Secondary outcome measures

Controllability over Prosthetic Joint Plantar Flexion Torque

Ankle

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention groupExperimental Treatment1 Intervention

Intervention: AMI transtibial amputation

Group II: Control groupActive Control1 Intervention

Intervention: Standard transtibial amputation

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Massachusetts Institute of TechnologyLead Sponsor

97 Previous Clinical Trials

12,729,955 Total Patients Enrolled

National Institutes of Health (NIH)NIH

2,696 Previous Clinical Trials

6,952,507 Total Patients Enrolled

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH

1,964 Previous Clinical Trials

2,674,698 Total Patients Enrolled

Media Library

AMI transtibial amputation (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT03913273 — N/A

Amputation Research Study Groups: Intervention group, Control group

Amputation Clinical Trial 2023: AMI transtibial amputation Highlights & Side Effects. Trial Name: NCT03913273 — N/A

AMI transtibial amputation (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03913273 — N/A

Frequently Asked Questions

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

Does this investigation accept persons who are 45 or older as participants?

"As in accordance with the predetermined parameters, participants must be aged 18 or older and no more than 65 years old to qualify for enrollment."

Answered by AI

May I be admitted as a participant in this experiment?

"This medical trial is open to 32 individuals between 18 and 65 years old who have undergone amputation surgery at the Brigham & Women's Hospital in Boston, MA. Applicants must also exhibit a healed site of amputation, with an activity level or K-Level rating of 3 or 4 (which implies they are able to walk using variable strides)."

Answered by AI

How much participation can this trial expect to receive?

"Affirmative. According to information accessible on clinicaltrials.gov, this scientific research is presently enrolling participants. It was initially posted in June of 2019 and the latest update happened during August 2022. For successful completion, 32 individuals need to be enrolled from 1 healthcare facility."

Answered by AI

Is it currently possible for people to sign up for this research study?

"Affirmative. Clinicaltrials.gov data indicates that this trial is actively searching for participants, with 32 candidates to be recruited from 1 site since its posting on June 12th 2019 and recent update on August 4th 2022."

Answered by AI