Magnetic Bead Tracking System and eOPRA Implant System With Bionic Prosthesis for Transtibial Amputees - Trial NCT06391697
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Study Focus
eOPRA Implant System for Transtibial Amputees and Magnetic Bead Tracking System
Interventional
device
Sponsor & Location
Brigham and Women's Hospital
Timeline & Enrollment
N/A
May 01, 2024
May 01, 2028
Primary Outcome
number of participants out of total who undergo device implantation (aim: 7 participants) who can complete robotics testing activities,number of participants out of total who undergo device implantation (aim: 7 participants) who still have device successfully implanted at 24 months postop
Summary
The e-OPRA Implant System, is a further development of the OPRA (Osseointegrated Prostheses
 for the Rehabilitation of Amputees) Implant System. 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
 Magnetic Bead Tracking System, which will be implanted and used in combination with the
 e-OPRA Implant system, is an investigational device that consists of pairs of magnetic beads,
 and a set of magnetic field sensors that measure and track the length of muscles and the
 speed at which they move in real-time. When the beads are implanted in muscle in the residual
 limb of an amputee, the muscle length signal is communicated to an investigational, robotic
 ankle-foot prosthesis. The purpose of the study is to evaluate the feasibility of a
 transtibial amputee with the e-OPRA Implant System and Magnetic Bead Tracking System
 exhibiting full neural control over a neuro-mechanical prosthetic system.
 
 A maximum of seven subjects will be enrolled. Each subject will undergo one or more surgeries
 where the e-OPRA Implant System and Magnetic Bead Tracking System will be implanted. The
 subjects will participate in follow-up sessions the last of which occurs approximately 24
 months after the surgery. This is a prospective, non-randomized, uncontrolled study.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06391697
Device Trial