Temporary axial rotation stabilization for lumbar disc herniation surgery with the ARO

BACKGROUND

Decompressive surgery has a failure rate of between 25% and 32% based on patient reported improvement in clinical symptoms. Significant back pain is associated with 53% of failures of decompressive surgery, while also being associated with abnormal axial rotation motion. We report on the clinical performance of subjects receiving a novel axial rotation stabilization implant (ARO Spinal System, ARO Medical), while undergoing a surgical decompression for a herniated lumbar disc, a condition associated with low back pain and abnormal movement.

METHODS

This Danish Medicines Agency and Ethics Committee approved clinical trial prospectively investigated the use of the ARO

RESULTS

No complications with the implant were observed. Four serious adverse events not related to the devices were reported, one subject had reoperation at 3 months. Leg pain median VAS score decreased from 70 to 2 at 1 year (P=0.01) back pain median VAS score from 48 to 6 (P=0.04). Satisfaction with surgery was 88%. Oswestry Disability Index scored likewise improvement going from 38 pre-operative to 5 at 1 year. Follow-up rate was excellent 100%.

CONCLUSIONS

Discectomy with the ARO Spinal System proves equally safe as a standard discectomy at 1 year follow-up. The subjects had significant improvements in both leg and back pain. In addition, they did better than historical controls, though not statistically so in this patient sample.

Déclaration de conflit d'intérêts

Conflicts of Interest: Dr. Cody Bünger reports grants, personal fees, non-financial support and other from University of Aarhus, grants from “Spydspidspulje” (Public funded by the hospital) for growth rod project, grants from Danish Strategic Research Foundation, grants from Mærsk Foundation, grants from Danish Rheumatism Association, grants from Danish Regional Fund, personal fees from Stryker, personal fees from Globus Medical, personal fees from Medtronic, personal fees from DePuy Synthes, outside the submitted work; and hold global patents for early-onset scoliosis instrumentation, not applied in the study. Bruce Robie reports ownership interest in ARO Medical. Other authors have no conflicts of interest to declare.