A new study published ahead-of-print by The Spine Journal indicates that the use of a novel flexion-restricting paraspinous tension band in non-fusion decompression treatment of lumbar spinal stenosis and degenerative spondylolisthesis patients is both safe and effective. The investigators used the LimiFlex paraspinous tension band (Simpirica Spine) in this study.
The prospective study, led by J N Alastair Gibson of The Royal Infirmary of Edinburgh and The University of Edinburgh, Edinburgh, UK, recruited 41 patients (seven men and 34 women) aged 45–83 years (68.2±9) with symptomatic spinal stenosis and Meyerding grade 1 or 2 degenerative spondylolisthesis at L3/4 (n=8) or L4/5 (n=33). The study’s outcome measures were made up of self-reported measures, including visual analogue (VAS) scales for leg back and hip pain and the Oswestry disability index (ODI), plus physiologic measures including quantitative and qualitative radiographic analysis performed by an independent core laboratory.
Four European spine centres took part in the investigation, collecting clinical and radiographic outcome data at three, six 12 and 24 months after surgery to be compared with preoperatively collected data.
The authors write: “Statistically significant improvements and clinically-important effect sizes were seen for all pain and disability measurements.” At 24 months follow-up, ODI scores were reduced by an average of 25.4 points (59%) and maximum leg pain on VAS by 48.1mm (65%). Back pain VAS scores improved from 54.1 by an average of 28.5 pts (53%). Of the patients available for 24 month follow-up, 82% of patients reported a reduction in ODI of >15 points, and 74% reported a reduction in maximum leg pain VAS scores of >20mm. All but one patient were satisfied with their surgery.
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