Abstract
Purpose: To determine if the short term benefits we reported from X STOP implants for lumbar radiculopathy were maintained at 2 yr follow up
Methods and Results: We followed all patients, of one neurosurgeon (TG), having XSTOP implants to treatment lumbar radiculopathy secondary to foraminal stenosis. We measured patient-reported pain and disability outcomes (Oswestry disability index, ODI; Short Form 36 bodily pain scale, SF-36 BP) immediately pre-op and approximately 2 years post op. Changes were examined in terms of statistical significance (Wilcoxon signed ranks test) and clinical significance (effect sizes – mean change divided by SD change).
2 yr follow up data were available for 13 of the 15 people who had the surgery. One had died of an unrelated condition before follow up, the other had further lumbar surgery thus affecting the interpretation of the data. Mean duration of follow up was 30.5 months.
Both ODI and SF-36 BP detected sustained improvements 2 yrs after surgery. Results for both scales were statistically significant (z = −3.059 & −3.062; p = 0.002). Mean change scores for both scales were substantial (ODI = 31.7; SF36 BP = 47.4), and effect sizes were very large (ODI = 1.35; SF-36 BP = 1.37) indicating clinically significant improvement. There have been no complications.
Conclusions: These provisional data, albeit from a small sample, provide increasing evidence to imply that the X STOP procedure may suit people with radiculopathy secondary to foraminal stenosis. Moreover, it has been safe and does not jeopardise future surgery in the event of failure.
Ethics approval: None, Audit
Interest Statement: None
Correspondence should be addressed to BASS/BCSS c/o BOA, at the Royal College of Surgeons, 35–43 Lincoln’s Inn Fields, London, WC2A 3PE, England.