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