Broomfield, Colo.-based Zimmer Biomet released two-year trial results of its Aspen MIS Fusion System as an adjunct to anterior and lateral interbody fusion.
The prospective, randomized, controlled, multi-center, non-inferiority trial involved 103 patients undergoing single-level anterior and lateral interbody fusion. Sixty-six patients received supplemental interspinous process fixation with the Aspen MIS system and 37 patients received supplemental pedicle screw fixation. The patients were receiving treatment for degenerative disc disease and/or spondylolisthesis.
The researchers studied fusion outcomes through 24 months.
Here are three insights:
1. The study found no statistically significant variants between patient groups in terms of patient-reported outcomes for pain and satisfaction at 24-month follow up.
2. Interbody fusion success rate for the Aspen system came in at 94.9 percent, compared to 85 percent for pedicle screw fixation.
3. The trial revealed the Aspen MIS system is a clinically effective alternative to pedicle screw fixation for posterior stabilization.
Adam Johnson, group president of Zimmer Biomet Spine, Dental, CMF and Thoracic, noted the findings validate that "ISPF (the Aspen System) can provide the biomechanical rigidity necessary to support the quality and longevity of outcomes observed with the current standard of care."