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Prosthesis

POP Device for Traumatic Amputees (POP Trial)

N/A

Waitlist Available

Research Sponsored by Encore Medical, L.P.

Eligibility Criteria Checklist

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

Must have

US Military veteran with transfemoral amputation that is not a result of dysvascular disease

Agrees not to participate in high levels of physical activity while in the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

POP Trial Summary

This trial will study whether a new kind of prosthetic device is effective and safe.

Who is the study for?

This trial is for US military veterans who have lost a leg above the knee not due to poor blood flow. They should be current or past users of socket-type prosthetic limbs and agree to avoid high-impact activities during the study. Smokers, active duty personnel, diabetics, and those with more than one amputation cannot participate.Check my eligibility

What is being tested?

The study tests a new type of limb prosthesis called Percutaneous Osseointegrated Prosthesis (POP), which directly attaches to bone and has a special seal against infection. The goal is to see if it's effective and safe as an alternative to traditional socket prostheses.See study design

What are the potential side effects?

Potential side effects may include infection at the implant site, skin irritation around the area where the device comes out of the body, pain at the bone attachment point, possible injury to surrounding tissues or bones.

POP Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I am a US Military veteran with an above-knee amputation not due to blood vessel issues.

Select...

I agree to limit my physical activity during the study.

POP Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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

Analyze changes in 6 minute walk test

Analyze changes in metabolic efficiency

Analyze changes of walking and standing

+12 more

POP Trial Design

1Treatment groups

Experimental Treatment

Group I: TREATMENTExperimental Treatment1 Intervention

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Encore Medical, L.P.Lead Sponsor

21 Previous Clinical Trials

3,592 Total Patients Enrolled

VA Salt Lake City Health Care SystemFED

24 Previous Clinical Trials

264,921 Total Patients Enrolled

Media Library

Percutaneous Osseintegrated Prosthesis (Prosthesis) Clinical Trial Eligibility Overview. Trial Name: NCT02720159 — N/A

Traumatic Amputee Research Study Groups: TREATMENT

Traumatic Amputee Clinical Trial 2023: Percutaneous Osseintegrated Prosthesis Highlights & Side Effects. Trial Name: NCT02720159 — N/A

Percutaneous Osseintegrated Prosthesis (Prosthesis) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02720159 — N/A

Frequently Asked Questions

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

Are there any vacancies still available for participants in this investigation?

"According to the information posted on clinicaltrials.gov, this trial is not currently seeking participants. The study was initially made public in December 2015 and has since had its entry edited as recently as March 2021; nevertheless, there are 1 other studies actively recruiting patients now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Early Feasibility Study of the Percutaneous Osseointegrated Prosthesis (POP)

2015. "Early Feasibility Study of the Percutaneous Osseointegrated Prosthesis (POP)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02720159.

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