Recruiting

Percutaneous Osseointegrated Prosthesis

Sponsor:

Encore Medical, L.P.

Code:

NCT02720159

Conditions

Traumatic Amputee

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Percutaneous Osseintegrated Prosthesis

Study Details

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.

Conditions

Traumatic Amputee

Study ID

NCT02720159

Start date

Dec, 2015

Status verified date

Mar, 2016

Primary completion date

Dec, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: TREATMENT

Interventions

Percutaneous Osseintegrated Prosthesis

Primary outcome measure

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

Central Contacts and Locations

Locations

George E. Wahlen Department of Veterans Affairs Medical Center

Recruiting

Salt Lake City, Utah, United States, 84148

Contacts

Sarina Sinclair, PhD

801-582-1565sarina.sinclair@va.gov

Principal Investigator:

Erik Kubiak, MD

More Information

Sponsor

Encore Medical, L.P.

Last update posted

Mar 25, 2016

Last verified

Mar, 2016

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Encore Medical, L.P. on 2016-03-25.