Stopped: Study was not sufficiently funded. No enrollment took place.
This early feasibility study proposes to evaluate use of the electronic-Osseoanchored Prostheses for the Rehabilitation of Amputees (e-OPRA) device, a transhumeral implant system for direct skeletal anchorage of amputation prostheses, with a test prosthesis. The e-OPRA System is being investigated to better understand the ability to improve the functionality of the prosthesis and enhance the sense of embodiment of the prosthesis itself. This will be a 10 subject Early Feasibility Study in which the primary objective is to capture preliminary safety and effectiveness information on the implanted e-OPRA system. With the addition of electrodes to the muscle segments, this biological interface allows for both the extraction of fine motor control signals from the nerve fascicles and the generation of sensory percepts via electrical stimulation of the muscles. In addition, electrodes placed on muscles within the residuum with native vascularization and innervation also allow the extraction of critical motor control signals and the generation of sensory feedback through muscle stimulation. The electrical activity recorded from these muscle segments (called electromyography or EMG) is specific to certain movements and can be used to determine precisely how a person wants to move their arm and hand. Use of the e-OPRA device with the well-documented neuro-electronic capabilities of EMG control systems provides an alternative to traditional socket prostheses by establishing a direct, loadbearing link between the patient's skeleton and prosthesis.
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Change in Electrical signal quality between implanted electrodes and test prosthesis
Timeframe: Baseline, 24 months
Adverse Events
Timeframe: Baseline
Adverse Events
Timeframe: 3 Months Post-Op
Adverse Events
Timeframe: 6 Months Post-Op
Adverse Events
Timeframe: 9 Months Post-Op
Adverse Events
Timeframe: 12 Months Post-Op
Adverse Events
Timeframe: 15 Months Post-Op
Adverse Events
Timeframe: 18 Months Post-Op
Adverse Events
Timeframe: 21 Months Post-Op
Adverse Events
Timeframe: 24 Months Post-Op