| Summary: | Lumbar Spinal Stenosis (LSS) is becoming increasingly prevalent in the ageing population and surgery is regarded as the gold standard treatment after conservative measures have failed. Many patients do not improve however, and the complication rates are high. Interspinous distraction devices (IDDs) have been proposed as a safe alternative however their cost and their failure rate has made their use controversial. No UK data exists to date with regards to the cost-effectiveness of the surgical management of IDDs in LSS and there is a lack of long term follow up. Objective – To determine the cost-effectiveness and quality of life after the treatment of LSS with the X-Stop device and laminectomy. Method – A randomised control trial of 47 patients with LSS (26 laminectomy and 21 X-Stop). The primary outcome was cost and quality of life measured using EQ5D. Other clinical outcomes were measured using SF36, ZCQ, ODI and QBPDS. Secondary measures included, operating time, length of stay and complication rates. Patients were followed up at 6 months, 12 months and 24 months. Results – The mean cost of the Laminectomy group was £2,711.8 and the mean cost of the X-Stop group was £5,148 (£1,799 plus the cost of the device £2,605 per device). Using intention to treat analysis, the mean QALY gain for the laminectomy group was 0.92 and for the X-Stop group was 0.81. The incremental cost effectiveness ratio was £-22,247.27. The complication rate for the laminectomy group was 19.2% vs 9.5% for the X-Stop group. Conclusion – Laminectomy is more cost-effective than X-Stop insertion for the treatment of LSS, mainly due to the high cost of the device. The X-Stop device does not replace a laminectomy as gold standard treatment however it should be considered when a less invasive procedure is required.
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