Evaluation of DIAM™ Spinal Stabilization System for lower lumbar disc degenerative disease: A randomized, prospective, single-site study.

OBJECTIVE: To determine the efficacy of DIAM Spinal Stabilization System compared with nonoperative treatment for patients with low back pain and lower lumbar disc degenerative disease. METHODS: A single center collected prospective outcomes data on 38 patients randomized to an interspinous device or non-operative treatment for symptomatic lumbar degenerative disc disease with treatment crossover allowed at 6 months. RESULTS: At all postoperative timepoints out to 2-years, statistically significant improvements in ODI and back pain scores were observed with the interspinous device. Clinically significant improvements (ODI >15-point improvement) were seen in 87.5% of DIAM patients at 2-years postoperatively. A high cross-over rate was noted from the non-operative cohort to the operative group (12 of 15) due to continued pain with nonoperative care. Additionally, 80% of patients receiving the DIAM implant reported a >15-point ODI reduction from pre-surgical scores at 2-year follow-up. CONCLUSION: The DIAM device demonstrates improvement in ODI and Back Pain scores maintained out to a 2-year follow-up timepoint and performed superior to conventional nonoperative treatment regimens commonly used in low back pain.