Full endoscopic versus open discectomy for sciatica: randomised controlled non-inferiority trial

Abstract

Objective To assess whether percutaneous transforaminal endoscopic discectomy (PTED) is non-inferior to conventional open microdiscectomy in reduction of leg pain caused by lumbar disc herniation. Design Multicentre randomised controlled trial with non-inferiority design. Setting Four hospitals in the Netherlands. Participants 613 patients aged 18-70 years with at least six weeks of radiating leg pain caused by lumbar disc herniation. The trial 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. Interventions PTED (n=179) compared with open microdiscectomy (n=309). Main outcome measures 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 5.0. 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. Patients belonging to the PTED learning curve were omitted from the primary analyses. Results At 12 months, patients who were randomised to PTED had a statistically significantly lower visual analogue scale score for leg pain (median 7.0, interquartile range 1.0-30.0) compared with patients randomised to open microdiscectomy (16.0, 2.0-53.5) (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. 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. Conclusions PTED was non-inferior to open microdiscectomy in reduction of leg pain. PTED resulted in more favourable results for self-reported leg pain, back pain, functional status, quality of life, and recovery. These differences, however, were small and may not reach clinical relevance. PTED can be considered as an effective alternative to open microdiscectomy in treating sciatica. Trial registration NCT02602093ClinicalTrials.gov NCT02602093 .

Cost-effectiveness of full endoscopic versus open discectomy for sciatica

“…The findings of the PTED study are expected to have implications, both for patients at an individual level as for society. At an individual level, it has been shown that PTED is non-inferior to open microdiscectomy in the treatment of leg pain and that PTED has more favourable patient-reported outcomes such as less low back pain, less functional disability due to low back pain and a higher health-related quality of life at 12 months after surgery 21. These differences in outcomes between PTED and open microdiscectomy, however, were relatively small.…”

“…The PTED-study aimed to assess the effectiveness and cost-effectiveness (CE) of PTED compared with open microdiscectomy in patients with lumbar disc herniation 20. Results of the effectiveness analyses suggest that PTED is non–inferior to open microdiscectomy in leg pain reduction at 12 months after surgery 21. Furthermore, PTED had more favourable results for patient-reported leg pain and health-related quality of life as compared with open microdiscectomy.…”

Long-Term Clinical Results of Percutaneous Cervical Nucleoplasty for Cervical Radicular Pain: A Retrospective Cohort Study

“…The step-by-step operative procedure of PCN has been published elsewhere. 12 In brief, PCN was performed under antibiotic prophylaxis and local anesthesia. After identifying the correct level of the cervical spine using fluoroscopy, an entry point for the needle was marked next to the medial part of the sternocleidomastoid muscle.…”

A retrospective comparative study of local anesthesia only and local anesthesia with sedation for percutaneous endoscopic lumbar discectomy

“…Conventional open lumbar surgery has been perceived as an effective intervention but carries several disadvantages, including postoperative back pain and a long recovery period. Subsequently, percutaneous endoscopic lumbar discectomy has been developed to facilitate lumbar discectomy 4 – 6 , with the following advantages such as paravertebral soft tissue protection, shorter hospital stays, less blood loss, and faster patient recovery 6 – 8 . Consequently, the percutaneous endoscopic technique received increasing attention from spinal surgeons around the worldwide 9 .…”