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| Name | Class |
|---|---|
| VA Salt Lake City Health Care System | FED |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TREATMENT | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous Osseintegrated Prosthesis | Device |
|
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| George E. Wahlen Department of Veterans Affairs Medical Center | Recruiting | Salt Lake City | Utah | 84148 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35908658 | Derived | Sinclair S, Beck JP, Webster J, Agarwal J, Gillespie B, Stevens P, Gililland J, Kubiak E. The First FDA Approved Early Feasibility Study of a Novel Percutaneous Bone Anchored Prosthesis for Transfemoral Amputees: A Prospective 1-year Follow-up Cohort Study. Arch Phys Med Rehabil. 2022 Nov;103(11):2092-2104. doi: 10.1016/j.apmr.2022.06.008. Epub 2022 Jul 29. |
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| 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 |