NCT03720171

e-OPRA Implant System for Lower Limb Amputees

An Osseointegrated Transfemoral Prosthesis Study Evaluating Stable Neural Signal Transmission in Patients With Transfemoral Amputations

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Integrum · Industry
• Sex: All
• Age: 22 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The e-OPRA Implant System, is a further development of the OPRA (Osseointegrated Prostheses for the Rehabilitation of Amputees) Implant System, approved under HDE (Humanitarian Device Exemption) H080004. The e-OPRA Implant system is an implant system for direct skeletal anchorage of amputation prostheses. The added feature in the e-OPRA Implant system, is a bidirectional interface into the human body that allows permanent and reliable communication using implanted electrodes. These electrodes will provide long-term stable bioelectric signals for an improved control of the prosthetic limb. The purpose of the study is to evaluate the feasibility of a lower limb amputee with the e-OPRA Implant System exhibiting full neural control over a neuro-mechanical prosthetic system. A maximum of six subjects will be enrolled. Each subject will undergo a surgery where the e-OPRA Implant System will be implanted. The subjects will participate in follow-up sessions of which the last one occurs approximately 24 months after the surgery. This is a prospective, non-randomized, uncontrolled study.

Conditions

• Amputation

Interventions

Type	Name	Description
DEVICE	e-OPRA Implant System	Implantation of e-OPRA Implant System in lower limb to be used with amputation limb prosthesis

Timeline

• Start date: 2018-01-17
• Primary completion: 2025-03-08
• Completion: 2025-03-08
• First posted: 2018-10-25
• Last updated: 2025-05-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study