Early Feasibility Study of the Percutaneous Osseointegrated Prosthesis (POP)

Study Overview
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Brief Summary
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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.

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

Conditions
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Traumatic Amputee

Intervention / Treatment
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* Device: Percutaneous Osseintegrated Prosthesis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TREATMENT<br> | Device: Percutaneous Osseintegrated Prosthesis<br> <br> |

What is the study measuring?
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Primary Outcome Measures

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