The surgery aimed at implanting the electrodes took place on Thursday November 20th, 2008, in Operating Room 5 of the University “Campus Bio-Medico” Hospital.

The surgery was conducted by a team consisting of 14 people belonging to four different Operational Units of the University “Campus Bio-Medico” of Rome (Neurology, Anesthesiology and Intensive Care, Orthopedics, Biomedical Engineering), in addition to a neurosurgeon.

A single longitudinal incision, approximately 7-8 cm long, was made in the medial surface of the patient’s left arm.

During the surgery, two electrodes were inserted in the median nerve and two in the ulnar nerve of the arm, above the amputation area (indicatively at the elbow level).

The hardest challenge of the surgical act consisted in positioning the electrodes tf-LIFE  inside the nerves in the best way possible, despite the fact that they consist of extremely thin polyimide filaments with tungsten needle, thus easily breakable., For this purpose, the Neurosurgeon had a training period on animals in Denmark and in Spain.

The operation was structured in six different phases: 

1. induction of general anesthesia;
2. isolation and exposure of the median and ulnar nerves above the amputation by the Surgeon, Professor Vincenzo Denaro; the electrodes were then inserted into the nerves by means of a tungsten introducer needle (diameter: 80 µm); 
3. implantation of the tf-LIFE electrodes in the exposed nerves by the Neurosurgeon, Dr. Luca Denaro, and by Dr. Andrea Marinozzi (2nd operator);
4. anchoring of electrodes to adjacent structures, “tunnelization” of the cables via four holes through the skin and suturing of surgical wounds;
5. neurophysiological monitoring: during the surgery, with the patient alert, the sensitive responses evoked as a result of electrical stimulation by means of tf-LIFE electrodes were recorded at the cortical, cervical and armpit levels; at the same time, an attempt was made to record neural sensorial responses coming from the patient’s nervous system, generated by the proximal stimulation of the ulnar and median nerves at the armpit level;
6. end of the surgery, with the last dressings and the patient being returned to the hospital room.

No problems were encountered during the actual surgery. To prevent complications associated with surgery involving soft tissues, specifically complications due to local infections, a thorough post-operative monitoring was arranged for and maintained.

The post-operatory stay lasted two days, after which the patient was discharged so that he could proceed with the training and experimentation as per the project. Data obtained from experiments carried out on animals had shown that implant of the tf-LIFE electrodes could cause a minimum inflammatory, and consequently fibrotic, response at the implantation site, nevertheless without causing an alteration of the morphological and functional characteristics of the peripheral nerve. Similar symptoms were observed in the patient, however they did not stop the progress of the experimentation. 

The surgery to remove the electrodes was carried out with the same methods as the implantation procedure, in general anesthesia. Removal was necessary since the IBMT Fraunhofer Institut, which developed the electrodes, guaranteed their proper operation and biocompatibility only for a month after the surgery. As a result, this time limit was also set by the protocol of the LifeHand project approved by the pertinent bodies.

At the end of the procedures provided by the project, one scar approximately six centimeters long, along with four other smaller scars, remained on the stump of the amputated left arm, a consequence of the exit holes of the cable for the tf-LIFE electrodes.