EFFECT ON INTERVERTEBRAL MOTION OF A NOVEL MINIMALLY INVASIVE INTERSPINOUS IMPLANT

Abstract

Introduction: Interspinous implants have recently been proposed as an alternative in the treatment of lumbar spinal stenosis and foraminal stenosis. Interspinous implants are thought to unload the facet joints, restore foraminal height and provide improved spinal stability especially in extension with a minimally invasive approach. It has been proposed that, combined with a tension band, stabilisation could also be obtained in flexion, thus avoiding the need for pedicle screw fixation. Little biomechanical data exists to support these notions. The aim of this in vivo study was to investigate the effect of a novel, minimally invasive, unilaterally inserted interspinous implant on flexion-extension range of motion of the lumbar spine.

Methods: Following the induction of general anesthesia, ten adolescent Merino lambs (24–30 kg) underwent a destabilisation procedure at the level of L1–L2, thus simulating a stenotic degenerative spondylolisthesis, as described previously. All animals were placed in a sidelying posture and lateral radiographs were taken in the neutral posture and in end stage flexion and extension trunk positions with the central ray at the level of L1–L2. The flexion manouvre was reproduced in each subject by securing a rope above the carpus (forelimb) and the tarsus (hindlimb). This same radiographic protocol was repeated following the insertion of an 8 mm InSwing interspinous device at L1–L2, and again with the implant secured by means of a tension band tightened to 1 N/m around the L1 and L2 spinous processes. Care was given to respect the integrity of the supra-spinous ligament. The insertion technique requires a minimally invasive unilateral approach, therefore leaving the attachment of the erector spinae muscle on the contralateral side intact. Using Cobb’s method, intersegmental range of motion (ROM) was assessed in each of the conditions and compared. A paired t-test compared ROM for each of the experimental conditions (P< .05).

Results: The addition of the InSwing interspinous implant reduced mean total flexion-extension ROM from 6.3 degrees to 5.3 degrees which was further reduced to 3.6 degrees with the device secured by means of a tension band. These differences were not statistically significant, but the addition of the tension band to the interspinous device resulted in a significant reduction of lumbar flexion (p< .05).

Discussion: The interspinous device tended to reduce the total flexion-extension ROM at the level of the implant, however the results were not significant. The addition of a tension band was found to significantly stabilize the spine in flexion. To our knowledge, this is the first in vivo study radiographically showing the advantage of using an interspinous device, specifically InSwing, to stabilize the spine in flexion. These results are important findings particularly for patients with clinical symptoms of instable degenerative spondylolisthesis.