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Treatment of Lumbar Spinal Stenosis with an Interspinous Fixation and Fusion Device: A Preliminary Multicenter Registry Analysis

Year: 2026

Type: article

Abstract: Purpose: To evaluate real-world safety and efficacy of a minimally invasive lateral interspinous fixation/fusion device for the treatment of lumbar spinal stenosis. Methods: 105 patients (mean age 70.6 ± 10 years) from ten private pain/spine care centers were entered into the registry for treatment with the device. Analysis was conducted on up to 63 with diagnostic and surgical data, 41 with baseline characteristics, 41 with patient satisfaction data, and 20-23 with change-based clinical outcome data meeting completeness thresholds. Outcome measures included Oswestry Disability Index (ODI), Visual Analogue Scale (VAS) back and leg pain, and Zurich Claudication Questionnaire (ZCQ) physical function (PF), symptom severity (SS), and satisfaction scores at 6 weeks, 3, 6, 12, and 24 months. A linear mixed effects model was used to evaluate cohort changes from baseline (α=0.05). Results: Most patients had baseline opioid usage (60%), previous injections (77%), moderate to severe stenosis (83%), and markers of segmental instability including fluid in the facet joints and/or spondylolisthesis (73%). Mean blood loss was 9.3 ± 4.7 mL. All outcome measures saw mean improvements at each follow-up, with significant improvement observed as early as 6 weeks for ODI (-20%, p<0.05), VAS-back (-48%, p<0.001), VAS-leg (-35%, p<0.05) and ZCQ-SS (-26%, p<0.001). Positive trends continued through 12 months, after which the high loss to follow-up limited interpretation. Patient satisfaction was favorable (80-100% satisfied at all time points; 91% weighted overall subdomain satisfaction). No complications, adverse events, device failures or migrations, or related follow-on procedures within available early follow-up were reported. Conclusion: Patients commercially treated with a lateral interspinous fixation/fusion device had a high prevalence of prior injections, baseline opioid use, and indicators of segmental instability prior to treatment. Longitudinal analyses were limited by the small sample size but suggest favorable short-term patient-reported outcome trends, with no early adverse safety findings identified.

Source: Medical Devices Evidence and Research

DOI: 10.2147/mder.s639620