International journal of spine surgery · 2026
A Prospective, Observational, Open-Label, Nonrandomized, Multicenter Study Measuring Functional Outcomes in a Novel Interspinous Stabilization Device in Patients With Low Back Pain: 12-Month Results for the REFINE Study.
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Falowski Steven M, Raso Louis J, Mangal Vipul, Nairizi Ali, Patterson Denis G, Danko Michael D, Justiz Rafael, Vogel Rainer S, Koga Sebastian, Josephson Youssef, Handal Brian, Martineck Sarah, Pope Jason E
Аннотация
BACKGROUND: Lumbar spinal stenosis associated with degenerative disc disease is a common source of pain and reduced quality of life in older adults. Current focus has centered on minimally invasive options. Previous reports of the performance of a novel standalone interlaminar fixation device have been previously reported. This cohort represents the 12-month outcomes, looking at safety and efficacy.
METHODS: Ninety-four patients underwent implantation, and 79 completed follow-ups. The primary endpoint was a composite clinical success, incorporating the absence of index-level revision or reoperation, clinically meaningful improvement in pain using the visual analog scale, disability improvement as measured by the Oswestry Disability Index, and better disease-specific status as measured by the Zurich Claudication Questionnaire. Secondary outcomes included changes in PROMIS-29 and Patient Global Impression of Change. Safety assessment included adverse events, readmissions, and reoperations. Analyses used the implanted cohort with paired comparisons for follow-up data and interpretation using prespecified minimal clinically important difference thresholds.
RESULTS: Patients demonstrated statistically significant improvement in disability, pain, and disease-specific function. Mean Oswestry Disability Index improved by 22.0 points; back and leg pain visual analog scale score improved by 35.7 and 36.5 points, respectively. Zurich Claudication Questionnaire symptom severity and physical function also improved, and PROMIS-29 domains were favorable across pain interference, sleep disturbance, fatigue, anxiety, depression, social roles, and physicality. Patient Global Impression of Change responses indicated 83% of patients reported at least minimal improvement. Six adverse events were reported, 3 of which were deemed related to the device or procedure. No index-level reoperations, device explants, or symptomatic spinous process fractures were reported.
CONCLUSIONS: In this prospective multicenter cohort, standalone interlaminar fixation produced clinically meaningful improvement in pain, disability, and patient-reported quality of life.
CLINICAL RELEVANCE: This study represents the first prospectively acquired data for a posterior interspinous fixation device used without other instrumentation to treat systematic spinal stenosis in the presence of degenerative disc disease.
LEVEL OF EVIDENCE: Level 2: prospective, nonrandomized, multicenter trial.
METHODS: Ninety-four patients underwent implantation, and 79 completed follow-ups. The primary endpoint was a composite clinical success, incorporating the absence of index-level revision or reoperation, clinically meaningful improvement in pain using the visual analog scale, disability improvement as measured by the Oswestry Disability Index, and better disease-specific status as measured by the Zurich Claudication Questionnaire. Secondary outcomes included changes in PROMIS-29 and Patient Global Impression of Change. Safety assessment included adverse events, readmissions, and reoperations. Analyses used the implanted cohort with paired comparisons for follow-up data and interpretation using prespecified minimal clinically important difference thresholds.
RESULTS: Patients demonstrated statistically significant improvement in disability, pain, and disease-specific function. Mean Oswestry Disability Index improved by 22.0 points; back and leg pain visual analog scale score improved by 35.7 and 36.5 points, respectively. Zurich Claudication Questionnaire symptom severity and physical function also improved, and PROMIS-29 domains were favorable across pain interference, sleep disturbance, fatigue, anxiety, depression, social roles, and physicality. Patient Global Impression of Change responses indicated 83% of patients reported at least minimal improvement. Six adverse events were reported, 3 of which were deemed related to the device or procedure. No index-level reoperations, device explants, or symptomatic spinous process fractures were reported.
CONCLUSIONS: In this prospective multicenter cohort, standalone interlaminar fixation produced clinically meaningful improvement in pain, disability, and patient-reported quality of life.
CLINICAL RELEVANCE: This study represents the first prospectively acquired data for a posterior interspinous fixation device used without other instrumentation to treat systematic spinal stenosis in the presence of degenerative disc disease.
LEVEL OF EVIDENCE: Level 2: prospective, nonrandomized, multicenter trial.