Early Feasibility Study of the Percutaneous Osseointegrated Prosthesis (POP)

A Prospective, Early Feasibility Study to Characterize the Efficacy and Safety of a Percutaneous Osseointegrated Prosthesis

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.

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