Safety and Efficacy of Interspinous Fixation Device via Lateral Transverse Approach in Patients with Lumbar Spinal Stenosis: A Single Center, Retrospective, Observational Study.

BACKGROUND

Lumbar spinal stenosis (LSS) is a common degenerative spinal condition that limits function due to reduced space for neurovascular structures. Traditional direct open lumbar decompression (DOLD) is the standard treatment after conservative measures fail. Recently, minimally invasive options such as percutaneous image-guided lumbar decompression (PILD), interspinous spacers (ISS), and interspinous fixation devices (ISFD) have gained popularity for moderate LSS without spinal instability.

OBJECTIVE

This retrospective study evaluated the safety and efficacy of ISFD in patients with LSS treated at our center.

PATIENTS AND METHODS

Data from 45 patients (26 males, 19 females) treated with ISFD between January 2023 and October 2024 were analyzed. Adverse events and pain outcomes were recorded using numerical rating scale (NRS) scores at baseline, 2 weeks, 1 month, and 3 months post-procedure.

RESULTS

Only one minor complication was reported on the procedure day. procedure day. Mean NRS pain scores improved from 7.5 (baseline) to 3.5 (2 weeks), 3.0 (1 month), and 3.5 (3 months) (P < 0.001). At 2 weeks, 50% of patients had pain reductions ≥51%; at 1 month, 57.4% experienced ≥51% reduction; and by 3 months, 73% had more than 50% pain reduction (P < 0.001), indicating significant pain improvement over time.

LIMITATIONS

This was a single-center retrospective study with a small sample size and relatively short follow-up time.

CONCLUSION

ISFD appears to be a safe and effective minimally invasive treatment for LSS. Larger randomized controlled trials are needed to compare devices and refine procedural techniques.