RWE Analysis for Pre-Market and Post Approval Studies of an Annular Closure Device

This Test-Case was a retrospective study leveraging claims data to compare reoperation and reimaging rates in patients treated with lumbar discectomy. Chronic back pain as a result of bulging or herniated discs is a common condition. Although discectomy is generally considered a successful treatment for patients with bulging or herniated discs who are non-responsive to conservative therapies, large population-based studies show a high failure rate over time.

This project focused on identifying a comparison cohort of patients treated with lumbar discectomy in administrative claims data to quantify the burden of additional imaging and treatment post lumbar discectomy and determine the burden of reherniation or failed discectomy in a commercially insured population. As one of the first U.S.-population-based studies to investigate post-discectomy outcomes, the goal of this Test-Case was to assess the potential impact of the utilization of a device that reduces the risk of reherniation in patients with massive spinal disc defects.

The specific aim of this project was to characterize the outcomes of post-operative imaging, post-operative readmission and reoperation following an index discectomy surgery. The project sought to establish the potential to initiate surveillance within the U.S. through the NESTcc Research Network and specifically to provide for the comparison to both the current standard of care in the U.S. as well as to the data from the pivotal study upon which the U.S. marketing approval was based.