Early Feasibility Study of the Percutaneous Osseointegrated Prosthesis (POP)

N/AUnknownNCT02720159

Encore Medical, L.P.10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Traumatic Amputee

Interventions

Percutaneous Osseintegrated ProsthesisDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

George E. Wahlen Department of Veterans Affairs Medical Center

Salt Lake City, Utah, United States

RECRUITING

Outcomes

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

Three dimensional motion capture of walking and standing through a calibration volume that contains force plates

Time frame: 1 year

Analyze changes in metabolic efficiency

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.

Time frame: 1 year

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

Data from ClinicalTrials.gov

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