---
title: Early Feasibility Study of the Percutaneous Osseointegrated Prosthesis (POP)
nct_id: NCT02720159
overall_status: UNKNOWN
phase: NA
sponsor: Encore Medical, L.P.
study_type: INTERVENTIONAL
primary_condition: Traumatic Amputee
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02720159.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02720159"
ct_last_update_post_date: 2016-03-25
last_seen_at: "2026-05-12T06:58:27.285Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Early Feasibility Study of the Percutaneous Osseointegrated Prosthesis (POP)

**Official Title:** A Prospective, Early Feasibility Study to Characterize the Efficacy and Safety of a Percutaneous Osseointegrated Prosthesis

**NCT ID:** [NCT02720159](https://clinicaltrials.gov/study/NCT02720159)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 10
- **Lead Sponsor:** Encore Medical, L.P.
- **Collaborators:** VA Salt Lake City Health Care System
- **Conditions:** Traumatic Amputee
- **Start Date:** 2015-12
- **CT.gov Last Update:** 2016-03-25

## Brief Summary

The purpose of the clinical study is to characterize the efficacy and safety of a Percutaneous Osseointegrated Prosthesis (POP) device that can provide a satisfactory platform for direct skeletal attachment of prosthetic limbs, which includes a subdermal seal, thus allowing a proper biobarrier around the implant.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* US Military veteran with transfemoral amputation that is not a result of dysvascular disease
* Has used or is using a "socket suspension technology" prosthesis
* Use of non-propulsive, passive microprocessor-regulated devices
* Agrees not to participate in high levels of physical activity while in the study
* Subject meets anatomical and eligibility criteria for the investigational device

Exclusion Criteria:

* Currently on active military duty
* More than 1 limb amputated
* Has insulin dependent or adult onset diabetes
* Recent tobacco use
```

## Arms

- **TREATMENT** (EXPERIMENTAL)

## Interventions

- **Percutaneous Osseintegrated Prosthesis** (DEVICE)

## Primary Outcomes

- **Assess AP & Lateral x-rays for osteolysis, radioulucencies indicative of component moevent and orientation and stress shielding or bone remodeling around the implant** _(time frame: 1 year)_
- **Changes in Bone Mineral Density as collected using DEXA scan** _(time frame: 1 year)_
- **Changes in implant exit site using Modified Holgers Skin Metric** _(time frame: 1 yr)_
- **Analyze measurable changes in the stoma punch** _(time frame: 1 year)_
- **Analyze changes of walking and standing** _(time frame: 1 year)_ — Three dimensional motion capture of walking and standing through a calibration volume that contains force plates
- **Analyze changes in metabolic efficiency** _(time frame: 1 year)_ — Measure CO2 and O2 exhaled, total energy cost for walking at slow, normal, fast; self-selected and/or fixed speeds while wearing a two-way valve.
- **Analyze changes in 6 minute walk test** _(time frame: 1 year)_
- **Assess changes in Donning and Doffing prosthetic time** _(time frame: 1 year)_
- **Assess changes in Comprehensive High-Level Activity Mobility Predictor (CHAMP) test** _(time frame: 1 year)_
- **Changes in psychosocial adjustment with the Trinity Amputation and Prosthesis Experience Scales - Revised (TAPES-R) Part I, 37 questions** _(time frame: 1 yr)_
- **Changes in depressive symptomatology using the Center for Epidemiologic Studies Depression Scale Revisited (CES-D)** _(time frame: 1 yr)_
- **Changes in consequences of pain on relevant aspects of persons' lives using PROMIS: Pain Interference questions** _(time frame: 1 yr)_
- **Changes in ability to carry out activities that require physical actions using PROMIS: Physical Function** _(time frame: 1 yr)_
- **Changes in overall quality of life using QOL Visual Analog Scale, no numerical weighting** _(time frame: 1 yr)_
- **Changes in at-home prosthetic usage using StepWatch activity monitor** _(time frame: 1 yr)_

## Locations (1)

- George E. Wahlen Department of Veterans Affairs Medical Center, Salt Lake City, Utah, United States — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.george e. wahlen department of veterans affairs medical center|salt lake city|utah|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT02720159.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT02720159*  
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