Clinical trial NCT02720159: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Traumatic Amputee
Lead sponsor: Encore Medical, L.P.
Sponsor class: INDUSTRY
Collaborators: name: VA Salt Lake City Health Care System
First posted: 2016-03-25
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 criteria: 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

Primary outcomes:
measure: Assess AP & Lateral x-rays for osteolysis, radioulucencies indicative of component moevent and orientation and stress shielding or bone remodeling around the implant
timeFrame: 1 year
measure: Changes in Bone Mineral Density as collected using DEXA scan
timeFrame: 1 year
measure: Changes in implant exit site using Modified Holgers Skin Metric
timeFrame: 1 yr
measure: Analyze measurable changes in the stoma punch
timeFrame: 1 year
measure: Analyze changes of walking and standing
timeFrame: 1 year
measure: Analyze changes in metabolic efficiency
timeFrame: 1 year
measure: Analyze changes in 6 minute walk test
timeFrame: 1 year
measure: Assess changes in Donning and Doffing prosthetic time
timeFrame: 1 year
measure: Assess changes in Comprehensive High-Level Activity Mobility Predictor (CHAMP) test
timeFrame: 1 year
measure: Changes in psychosocial adjustment with the Trinity Amputation and Prosthesis Experience Scales - Revised (TAPES-R) Part I, 37 questions
timeFrame: 1 yr
measure: Changes in depressive symptomatology using the Center for Epidemiologic Studies Depression Scale Revisited (CES-D)
timeFrame: 1 yr
measure: Changes in consequences of pain on relevant aspects of persons' lives using PROMIS: Pain Interference questions
timeFrame: 1 yr
measure: Changes in ability to carry out activities that require physical actions using PROMIS: Physical Function
timeFrame: 1 yr
measure: Changes in overall quality of life using QOL Visual Analog Scale, no numerical weighting
timeFrame: 1 yr
measure: Changes in at-home prosthetic usage using StepWatch activity monitor
timeFrame: 1 yr
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: George E. Wahlen Department of Veterans Affairs Medical Center
state: Utah
Study officials:
References: