Percutaneous transforaminal endoscopic discectomy (PTED) can be considered as an effective alternative to open microdiscectomy in treating sciatica. This is the key finding from new research published in the British Medical Journal by Pravesh Gadjradj (Weill Cornell, Brain and Spine Centre, New York, USA) et al.
The multicentre randomised controlled non-inferiority trial showed that PTED is non-inferior to conventional open microdiscectomy in reduction of leg pain caused by lumbar disc herniation. PTED was also found to result in more favourable results for self-reported leg pain, back pain, functional status, quality of life, and recovery. However, these differences “were small and may not reach clinical relevance”, note the researchers.
The study included 613 patients from four hospitals in the Netherlands, aged between 18-70 years, and with at least six weeks of radiating leg pain caused by lumbar disc herniation. This number included a predetermined set of 125 patients receiving PTED who were the learning curve cases performed by surgeons who did not do PTED before the trial and who were ultimately omitted from the primary analyses.
Of the 488 remaining patients, 170 had PTED compared with 309 who received open microdiscectomy.
The primary outcome was self-reported leg pain measured by a 0-100 visual analogue scale at 12 months, assuming a non-inferiority margin of five. Secondary outcomes included complications, reoperations, self-reported functional status as measured with the Oswestry Disability Index, visual analogue scale for back pain, health related quality of life, and self-perceived recovery. Outcomes were measured until one year after surgery and were longitudinally analysed according to the intention-to-treat principle.
The study found that at 12 months, patients who were randomised to PTED had a statistically significantly lower visual analogue scale score for leg pain (median 7, interquartile range 1–30) compared with patients randomised to open microdiscectomy (median 16, interquartile range 2–53.5), (between group difference of 7.1, 95% confidence interval 2.8 to 11.3).
Blood loss was less, length of hospital admission was shorter, and timing of postoperative mobilisation was earlier in the PTED group than in the open microdiscectomy group.
Secondary patient reported outcomes such as the Oswestry Disability Index, visual analogue scale for back pain, health related quality of life, and self-perceived recovery, were similarly in favour of PTED. In addition, within one year, nine (5%) in the PTED group compared with 14 (6%) in the open microdiscectomy group had repeated surgery. Per protocol analysis and sensitivity analyses including the patients of the learning curve resulted in similar outcomes to the primary analysis.
Speaking to Spinal News International, Gadjradj said: “Aside from scientific reasons, one of the most important reasons for conducting this study was to get full-endoscopic surgery for sciatica reimbursed. Several guidelines do not recommend full-endoscopic surgery for sciatica due to the lack of scientific back-up and the learning curve associated with this procedure. Full-endoscopic procedures, however, are becoming increasingly popular by both surgeons and patients. A robust randomised controlled trial was, therefore, long due.
“The results of our study surprised us as researchers as we wanted to show non-inferiority of PTED compared to microdiscectomy, and we ended up showing even some more favourable results. Our cost-effectiveness analysis showed dominance over microdiscectomy as PTED was on average less costly and more effective. One of the hidden gems of this study is the inclusion of a learning curve in the sample size, as we showed that even during the learning curve, PTED is more cost-effective than microdiscectomy.
“I hope these studies will facilitate the reimbursement of these procedures, will encourage surgeons to adopt endoscopic procedures, and will provide patients a better alternative to surgically treat their sciatica.”