Treatment of Lumbar Spinal Stenosis with an Interspinous Fixation and Fusion Device: A Preliminary Multicenter Registry Analysis.
10 affiliations
- 1Crimson Pain Management, Overland Park, KS, USA.
- 2Comprehensive Pain & Spine Specialists, Indianapolis, IN, USA.
- 3Florida Spine Care, Fort Lauderdale, FL, USA.
- 4Anesthesiology, Pain and Perioperative Medicine, University of Kansas Medical Center, Kansas City, KS, USA.
- 5Comprehensive Specialty Care, Edmond, OK, USA.
- 6Colorado Pain Care, Denver, CO, USA.
- 7PainCARE, Overland Park, KS, USA.
- 8AK Pain & Spine Center, Houston, TX, USA.
- 9Trinity Pain Medicine Associates, Fort Worth, TX, USA.
- 10Spinal Simplicity, LLC, Overland Park, KS, USA.
Abstract
To evaluate real-world safety and efficacy of a minimally invasive lateral interspinous fixation/fusion device for the treatment of lumbar spinal stenosis. 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). 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. 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.
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BibTeX
@article{kloster2026treatment,
title = {{Treatment of Lumbar Spinal Stenosis with an Interspinous Fixation and Fusion Device: A Preliminary Multicenter Registry Analysis.}},
author = {Daniel Kloster and Andrew Trobridge and Kevin Cairns and Usman Latif and Douglas Beall and Robert Moghim and Morteza Rabii and Ankur Khosla and Ashley Bailey-Classen and Thomas Hedman and Ayushmita De and Adam Rogers and Connor Huxman},
journal = {Medical devices (Auckland, N.Z.)},
year = {2026},
month = nov,
doi = {10.2147/mder.s639620},
url = {https://europepmc.org/article/MED/42999595},
note = {CC BY-NC},
}
RIS
TY - JOUR
TI - Treatment of Lumbar Spinal Stenosis with an Interspinous Fixation and Fusion Device: A Preliminary Multicenter Registry Analysis.
AU - Daniel Kloster
AU - Andrew Trobridge
AU - Kevin Cairns
AU - Usman Latif
AU - Douglas Beall
AU - Robert Moghim
AU - Morteza Rabii
AU - Ankur Khosla
AU - Ashley Bailey-Classen
AU - Thomas Hedman
AU - Ayushmita De
AU - Adam Rogers
AU - Connor Huxman
PY - 2026
DA - 2026/11/03
JO - Medical devices (Auckland, N.Z.)
DO - 10.2147/mder.s639620
UR - https://europepmc.org/article/MED/42999595
AB - To evaluate real-world safety and efficacy of a minimally invasive lateral interspinous fixation/fusion device for the treatment of lumbar spinal stenosis. 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). 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. 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.
SN - 1179-1470
ER -