Introduction

Open microdiscectomy (OM) is the current standard procedure to treat sciatica caused by lumbar disk herniation. Percutaneous transforaminal endoscopic discectomy (PTED) is an alternative procedure which is performed under local anesthesia. It is uncertain whether if PTED is non-inferior in treating sciatica compared to OM.

Methods

A pragmatic, multicenter, non-inferiority, randomized controlled trial was conducted in which patients were randomized between PTED or OM in a 1:1 ratio. Patients between 18-70 years of age with at least 6 weeks of excessive radiating pain were recruited from 4 participating centers. The primary outcome is self-reported leg pain measured by the 0-100 Visual Analogue Scale (VAS) with a non-inferiority margin of 5. Secondary outcomes include self-reported ODI, back pain, costs, QALYs, health-related quality of life and self-perceived recovery. Outcomes were measured the day following surgery, at 2, 4, and 6 weeks, and at 3, 6, 9, and 12, 24 months. Data were longitudinally analyzed according to the intention-to-treat principle.

Results

A total of 613 were randomized to either PTED (n=304) or OM (n=309). At 24 months, 92% of the patients had follow-up data available. At 24 months, the adjusted between group difference of the VAS leg pain was 7.3 in favor of PTED (17.0 ± 22.4 vs. 24.3 ± 26.5). Back pain was less in the PTED-group during the first 12 months but showed no differences at 24 months compared to the OM group. All other secondary patient-reported outcomes such as the ODI, VAS quality of life, SF-36 physical and mental component summary, QALYs, self-perceived recovery of symptoms and satisfaction with treatment, showed small but statistically more favorable results for the PTED-group. Complications rates appear similar between both groups, while estimated perioperative blood loss and length of hospital stay was smaller in the PTED-group. Rate of repeated surgery at 24 months was similar between both groups.

Except for costs of the surgery itself, all other costs were lower for PTED than OM. Cost-effectiveness acceptability curves indicated that the probability of PTED being cost-effective compared with OM was almost 100% for leg pain and QALYs, regardless of the willingness-to-pay.

Discussion

PTED is non-inferior to OM in the treatment of sciatica at 24 months of follow-up and clinical outcomes appear to be more favorable for PTED albeit not exceeding established MCIDs.Furthermore, PTED is cost-effective compared to OM in treating sciatica. Therefore, based on these study results, implementation of PTED as an invasive treatment option for sciatica is warranted.