Andrew Dooris, Iowa City, IA, USA; Garryl Hudgins, Minnetonka, MD, USA; Vijay Goel, Toledo, OH, USA; Qi-Bin Bao, Minnetonka, MN, USA; Shinichiro Kubo, Miyazaki, JapanPurpose: Recent developments in intervertebral disc replacements offer surgeons new tools for treating degenerative disc disease. Reports of adverse effects of fusion on adjacent motion segments have been a primary motive for developing these devices as means for facilitating motion while retaining stability and restoring disc height. Some reports have described the mechanical performance of these devices, but little attention has been paid to how they affect adjacent motion segments despite this being a major factor for their use. Many such devices require considerable surgical resection, potentially disrupting normal spine load sharing. This experiment characterized in vitro multisegment biomechanics in a lumbar spine implanted with an in situ curable prosthetic intervertebral disc nucleus. We quantified changes in bending, torsional and compression stiffness of both the implanted and adjacent motion segments, as well as disc height distraction during implantation.Methods: Five fresh-frozen osteoligamentous three-segment human lumbar spines, screened for abnormal radiograph and low bone density, were prepared by potting the bottom vertebral body in a stiff polymer mixture and the top in a steel loading frame. Vertebral body rotations were tracked with an optoelectronic tracking system while specimens were loaded to 6 Nm in left/right torsion, left/right bending and flexion and extension. Displacement gauges monitored the motion of the top and bottom disc heights (one gauge each) and the implanted middle disc height (three gauges, front and left/right) when loading from 50 to 750 N in axial compression. The spines were tested under four conditions: intact, denucleated, implanted and fatigued. Fatiguing was produced by cyclic loading from 250 to 750 N at 2 Hz for at least 100,000 cycles. Nuclectomy was performed through a 5.5-mm trephine hole in the right lateral side of the middle annulus. The device consists of a compliant balloon connected to a catheter. This was inserted and liquid polymer injected into the balloon under controlled pressure (150 to 180 psi), inflating the balloon and filling the cavity. A compressive axial load of 200 N was maintained while implanting the device. Within 5 minutes the polymer cured; loads were applied after 2 hours set at room temperature.Results: Rotations generally increased with discectomy but decreased with implantation on the middle segment. After fatiguing, rotations increased again but not more than, and often less, than the adjacent segments. During polymer injection, the segment distracted approximately +1.8 mm at the disc center. Test repeatability was set at 0.25, significance at p<.05, trend at p<.10 using paired t test (d=0.25) (Tables 1 and 2)Table 1Rotation change from intact (6 Nm)Left torsionRight torsionLeft bendingMiddle segment, nuclectomized+0.47°*+0.80°+1.35°†Middle segment, implanted−0.33°‡−0.09°‡−0.32°‡Superior segment, implanted+0.23°+0.30°+0.37°Inferior segment, implanted+0.13°+0.16°+0.30°Right bendingFlexionExtensionMiddle segment, nuclectomized+1.68°†+1.22°+1.45°†Middle segment, implanted+0.43°‡+0.42°−1.12°§Superior segment, implanted+0.92°+0.03°−0.53°Inferior segment, implanted+0.36∥°+0.29°+0.77°*Significance between intact and nuclectomized.†Significance between nuclectomized and implanted.‡Trend between intact and nuclectomized.§Trend between nuclectomized and implanted.∥Trend between intact and implanted.Table 2Mean disc height change under compression from 50 N to 750 N (compression < 0, distraction > 0)Left center (mm)Front center (mm)Right center (mm)Superior (mm)Inferior (mm)Middle segment, intact−0.190.240.100.38−1.55Middle segment nuclectomized−0.56−0.840.280.35−0.80Middle segment, implanted−0.400.530.070.21−1.79.Discussion: The immediate goal of a disc replacement system is restoration of disc height and providing segment mobility without causing instability. This experiment showed that this device could reverse the destabilizing effects of a nuclectomy and restore normal segment stiffness. Significant increases in disc height can also be achieved. Long-term success of a disc replacement system, however, depends not only on mechanical endurance of the device but also on how the device affects the rest of the spine. In this test adjacent motion segments had minimal kinematic changes after implantation of the nucleus prosthesis, suggesting a normal load-sharing relationship. After fatiguing, the implanted segment behaved similar to adjacent segments, further evidence of a normal load-sharing condition. No implant extrusion or end-plate fracture was observed on any of implanted disc levels in the fatigue test. Lastly, whereas the majority of disc replacement systems require a significant annular resection for implantation, this system has the advantage of minimal surgical compromise and has the potential to be performed arthoscopically.