Early Feasibility Study of the Percutaneous Osseointegrated Prosthesis (POP)

Encore Medical

Status: Unknown

Conditions: Traumatic Amputee

Treatments: Device: Percutaneous Osseintegrated Prosthesis

Study type: Interventional

Funder types: Industry; Other U.S. Federal agency

Identifiers

NCT02720159

POP

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

TREATMENT

Experimental group

Treatment:

Device: Percutaneous Osseintegrated Prosthesis