Early Feasibility Study of the Percutaneous Osseointegrated Prosthesis (POP)
Not Applicable
- Conditions
- Traumatic Amputee
- Interventions
- Device: Percutaneous Osseintegrated Prosthesis
- Registration Number
- NCT02720159
- Lead Sponsor
- Encore Medical, L.P.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 10
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description TREATMENT Percutaneous Osseintegrated Prosthesis -
- Primary Outcome Measures
Name Time Method Changes in Bone Mineral Density as collected using DEXA scan 1 year 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 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 Changes in ability to carry out activities that require physical actions using PROMIS: Physical Function 1 yr 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 overall quality of life using QOL Visual Analog Scale, no numerical weighting 1 yr Assess changes in Donning and Doffing prosthetic time 1 year Changes in consequences of pain on relevant aspects of persons' lives using PROMIS: Pain Interference questions 1 yr Changes in at-home prosthetic usage using StepWatch activity monitor 1 yr
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
George E. Wahlen Department of Veterans Affairs Medical Center
🇺🇸Salt Lake City, Utah, United States