This investigation was undertaken to simulate in an animal model the particles released from a porous nitinol interbody fusion
device and to evaluate its consequences on the dura mater, spinal cord and nerve roots, lymph nodes (abdominal para-aortic),
and organs (kidneys, spleen, pancreas, liver, and lungs). Our objective was to evaluate the compatibility of the nitinol particles
with the dura mater in comparison with titanium alloy. In spite of the great use of metallic devices in spine surgery, the
proximity of the spinal cord to the devices raised concerns about the effect of the metal debris that might be released onto
the neural tissue. Forty-five New Zealand white female rabbits were divided into three groups: nitinol (treated:
N = 4 per implantation period), titanium (treated:
N = 4 per implantation period), and sham rabbits (control:
N = 1 per observation period). The nitinol and titanium alloy particles were implanted in the spinal canal on the dura mater
at the lumbar level L2–L3. The rabbits were sacrificed at 1, 4, 12, 26, and 52 weeks. Histologic sections from the regional
lymph nodes, organs, from remote and implantation sites, were analyzed for any abnormalities and inflammation. Regardless
of the implantation time, both nitinol and titanium particles remained at the implantation site and clung to the spinal cord
lining soft tissue of the dura mater. The inflammation was limited to the epidural space around the particles and then reduced
from acute to mild chronic during the follow-up. The dura mater, sub-dural space, nerve roots, and the spinal cord were free
of reaction. No particles or abnormalities were found either in the lymph nodes or in the organs. In contact with the dura,
the nitinol elicits an inflammatory response similar to that of titanium. The tolerance of nitinol by a sensitive tissue such
as the dura mater during the span of 1 year of implantation demonstrated the safety of nitinol and its potential use as an
intervertebral fusion device.
Keywords Spinal cord - Nitinol - Titanium - Biocompatibility - Intervertebral fusion device