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Procedure

Evaluation of Powered Prosthesis for use with Transfemoral Osseointegration Recipients for Amputation

N/A

Recruiting

Led By Levi Hargrove, PhD

Research Sponsored by Shirley Ryan AbilityLab

Eligibility Criteria Checklist

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

Must have

Candidate for OI surgery as verified by surgical team or has previously received OI

Candidate for TMR surgery as verified by surgical team or has previously received TMR

Timeline

Screening 3 weeks

Treatment Varies

Follow Up completion of study, an average of 1 year from enrollment

Awards & highlights

Study Summary

This trial evaluates how well people with above-knee amputations walk with a powered prosthesis after OI & TMR surgery.

Who is the study for?

This trial is for individuals aged 18-70 with an above-knee amputation who currently use a prosthesis and can safely operate it. They must be able to walk at various levels (K2/K3/K4), produce detectable muscle signals, and either are candidates for or have had osseointegration (OI) and targeted muscle reinnervation (TMR) surgeries.Check my eligibility

What is being tested?

The study tests how well people with above-knee amputations can move, control, and feel satisfied using a powered knee and ankle prosthesis after receiving OI and TMR surgeries. It involves training on the new prosthesis as well as collecting muscle activity data.See study design

What are the potential side effects?

Potential side effects may include discomfort from adapting to the powered prosthesis, skin irritation around electrode sites, surgical risks associated with OI/TMR procedures such as infection or poor bone integration, but specific device-related side effects aren't detailed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a candidate for or have had orthopedic implant surgery.

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I am a candidate for or have had TMR surgery as confirmed by my surgical team.

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I am between 18 and 70 years old.

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I can walk with little to no assistance.

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I have had one leg amputated above the knee.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ completion of study, an average of 1 year from enrollment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~completion of study, an average of 1 year from enrollment

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

Treatment Details

Study Objectives

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

Primary outcome measures

Amputee Mobility Predictor with Prosthesis (AMPPRO)

Berg Balance Scale (BBS)

Four Square Step Test (FSST)

+6 more

Secondary outcome measures

Determine changes in EMG signal quality and neural information resulting from OI and TMR as compared to an instrumented socket for control of a powered leg prosthesis.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Evaluation of Powered Prosthesis for use with Transfemoral Osseointegration RecipientsExperimental Treatment2 Interventions

Perform Osseointegration (OI)Surgery and Targeted Muscle Reinnervation (TMR) and evaluate powered prosthesis training and use. The participant will complete non-weightbearing neural control tasks along with functional, biomechanical, metabolic and qualitative patient-reported outcome measures using the OI interface and the powered leg prosthesis.

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Northwestern Memorial HospitalOTHER

40 Previous Clinical Trials

16,710 Total Patients Enrolled

Shirley Ryan AbilityLabLead Sponsor

194 Previous Clinical Trials

16,906 Total Patients Enrolled

Northwestern UniversityOTHER

1,589 Previous Clinical Trials

917,120 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 participants over the age of thirty-five being admitted into this experiment?

"This clinical trial is recruiting individuals who are younger than 70 years old and have reached the age of majority."

Answered by AI

How many study participants are taking part in this clinical experiment?

"Affirmative. According to clinicaltrials.gov, this medical trial is recruiting patients at the present moment. Initially posted on January 1st 2024, it was most recently updated on December 5th 2023 and requires 6 individuals from a single location for participation."

Answered by AI

Are individuals being accepted for the current iteration of this research endeavor?

"This clinical trial is actively recruiting patients, as per the information found on clinicaltrials.gov. The original posting date was January 1st 2024 and has since been updated for accuracy on December 5th 2023."

Answered by AI

May I join the experiment and take part in the research?

"To be considered for inclusion, applicants must have had amputation and belong to the 18-70 age bracket. Only 6 people are eligible for recruitment into this trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Powered Prosthesis for Use With TF Osseointegration Recipients

Levi Hargrove 2024. "Powered Prosthesis for Use With TF Osseointegration Recipients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06160882.