Temporary axial rotation stabilization for lumbar disc herniation surgery with the ARO® spinal system: a prospective analysis of safety and clinical efficacy.

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® Spinal System as part of lumbar discectomy surgery in 20 patients. All subjects had a single level posterolateral lumbar herniation with symptoms lasting more than 6 weeks. They underwent an open discectomy at the symptomatic level, and received the implant.

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.