Traumatic Amputee
Conditions
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.
Interventions
DEVICEPercutaneous Osseintegrated Prosthesis
Sponsors
VA Salt Lake City Health Care System
Encore Medical, L.P.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 1 year | Three dimensional motion capture of walking and standing through a calibration volume that contains force plates |
| Analyze changes in metabolic efficiency | 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 | 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 | — |
Countries
United States
Outcome results
None listed