A Biomechanical Study of the Instrumented and Adjacent Lumbar Levels After In-Space Interspinous Spacer Insertion

Object: Interspinous process implants are becoming more common for the treatment of lumber disc degeneration. The authors undertook this study to evaluate the effect of the In-Space interspinous spacer on the biomechanics of the lumbosacral spine.

Methods: Seven L2-S1 cadaver spines were physiologically loaded in extension, flexion, lateral bending, and axial rotation modes. The range of motion (ROM) and intervertebral disc pressure (DP) at the level implanted with an In-Space device and at adjacent levels were measured under 4 experimental conditions. Biomechanical testing was carried out on 7 sequentially prepared specimens in the following states: 1) the intact L2-S1 cadaver spine and 2) the L2-S1 cadaver specimen implanted with an In-Space interspinous spacer at L3-4 (Group 1), 3) after an additional L3-4 discectomy (with the In-Space interspinous spacer still in place) (Group 2), and finally, 4) after removal of the In-Space interspinous spacer, leaving only the discectomized (that is, destabilized) spine model (Group 3).

Results: The extension ROM at the implanted level after experimental conditions 2 and 3 above was statistically significantly reduced. An increase of ROM at the adjacent levels compensated for the reduction at the implanted level. However, there was no statistically significant change in ROM in any of the other modes of motion at any of the levels studied. Likewise, the DP reduction at L3-4 during extension was statistically significant, but in all other modes of motion, there was no statistically significant change in DP at any measured level. The In-Space interspinous spacer statistically significantly reduced the ROM of the L3-4 motion segment in Groups 1 and 2 (extension: 67%, p = 0.018 and 70%, p = 0.018; flexion: 72%, p = 0.028 and 80%, p = 0.027). After placement of the In-Space interspinous spacer, the DP was decreased at L3-4 in extension for Groups 1 and 2 in the posterior anular region (63%, p = 0.028; 59%, p = 0.043), Group 2 in the center region (73%, p = 0.028), and Groups 1 and 2 in the anterior anular region (57%, p = 0.018; 60%, p = 0.018).

Conclusions: The In-Space interspinous spacer both stabilizes the spine and reduces the intervertebral DP at the instrumented level during extension. The biomechanics for other modes of motion and at the adjacent levels are not affected statistically significantly, however. The device thus performed as intended. It significantly stabilized the motion segments at the instrumented level, but not at the segment adjacent to the instrumented level.