PTED study: design of a non-inferiority, randomised controlled trial to compare the effectiveness and cost-effectiveness of percutaneous transforaminal endoscopic discectomy (PTED) versus open microdiscectomy for patients with a symptomatic lumbar disc herniation

Abstract

IntroductionLumbosacral radicular syndrome is often caused by a disc herniation. The standard surgical technique to remove a disc herniation is open microdiscectomy. An alternative technique is percutaneous transforaminal endoscopic discectomy (PTED), which is less invasive. In the Netherlands, PTED is not currently considered as standard care, and therefore not reimbursed within public health insurance. A pragmatic, multicentre, non-inferiority, randomised controlled trial has been designed to determine the effectiveness and cost-effectiveness of PTED versus open microdiscectomy for the treatment of lumbar disc herniation.Method and analysisIn total, 682 patients between 18 and 70 years of age with >10 weeks of radiating pain or with >6 weeks of excessive radiating pain are to be recruited from participating centres. Patients must have an indication for surgery based on an MRI demonstrating compression of the nerve root from a lumbar disc herniation. Patients are to be randomised to PTED or open microdiscectomy. The primary outcome is self-reported leg pain measured by the 0–100 mm Visual Analogue Scale. Secondary outcomes include self-reported health and functional status, back pain, self-perceived recovery and a physical examination. Outcomes will be measured the day following surgery, at 2, 4 and 6 weeks, and at 3, 6, 9, 12 and 24 months. Physical examination will be performed at 6 weeks, and 3 and 12 months. An economic evaluation will be performed from a societal perspective and cost questionnaires will be used (eg, EQ-5D-5L). The data will be analysed longitudinally; the non-inferiority margin for the primary outcome is 5. Bootstrapping techniques will be used for the economic evaluation.Ethics and disseminationThis study has received approval of the Medical Ethical Committee of the VU Medical Centre Amsterdam: NL50951.029.14. The results will be published in an international peer-reviewed scientific journal.Trial registration numberNCT02602093; Pre-results, recruiting stage.

Incidence, Management, and Cost of Complications After Transforaminal Endoscopic Decompression Surgery for Lumbar Foraminal and Lateral Recess Stenosis: A Value Proposition for Outpatient Ambulatory Surgery

“…One such randomized controlled trial is currently underway in the Netherlands to compare the effectiveness and cost-effectiveness of percutaneous transforaminal endoscopic discectomy versus open microdiscectomy for patients with a symptomatic lumbar disc herniation. 59 However, results have not been published. While it may be more appropriate to measure and compare the cost-effectiveness of these 2 different procedures in additional quality-adjusted life-years gained to assess the overall societal benefit, the actual direct cost and payment data for complication-and sequelae-related aftercare obtained in this study still seems highly tangible information in negotiations with clinical care facilities and insurers for any spine surgeon who is attempting to establish an outpatient spinal decompression program in an ASC.…”

How I do it: percutaneous transforaminal endoscopic discectomy for lumbar disk herniation

“…Good three-dimensional anatomical knowledge of the facet joint, ligaments, and nerves is mandatory. Currently, the PTED technique is under investigation in a large randomized controlled trial: PTED study [ 8 ]. In this trial, spine surgeons started training with a cadaveric workshop, followed by 20 procedures under strict supervision of an experienced surgeon (BSH).…”

Comparison Between Percutaneous Transforaminal Endoscopic Discectomy and Fenestration in the Treatment of Degenerative Lumbar Spinal Stenosis

“…With percutaneous transforaminal endoscopic discectomy (PTED), which requires only local anesthesia, patients with DLSS are operated on through a working cannula to which a camera is attached. Use of PTED reportedly costs less and results in fewer iatrogenic injuries and greater patient satisfaction [ 14 , 15 ]. However, more research is needed to evaluate the efficacy of PTED for management of DLSS.…”