Spinal Fusion Device Trial With Fusion Review

Challenge

Establishing the effectiveness of a spinal fusion medical device requires objective, repeatable evidence that fusion has occurred and that the implant has remained stable. Fusion status and subsidence had to be assessed consistently across 24 months of post-surgical follow-up, with measurements sufficiently reproducible to support the trial's fusion endpoint. Given the well-documented subjectivity of radiographic fusion assessment, the sponsor needed a central methodology that could withstand scrutiny in an IDE final report.

Our Solution

Intrinsic Imaging's musculoskeletal radiologists employed calibrated measurement tools to quantify angular and translational motion on flexion-extension radiographs, providing an objective biomechanical complement to morphological assessment. CT examinations were reviewed for bridging bone formation under standardized criteria, and the two lines of evidence were integrated into a single documented fusion determination for each timepoint. Uniform methods applied across the full follow-up period ensured that longitudinal comparisons rested on a stable measurement foundation.

Results

• Reader agreement above 0.90 on fusion status
• Complete 24-month imaging dataset
• Core lab findings included in the IDE final report