scholarly journals 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

BMJ Open ◽  
2017 ◽  
Vol 7 (12) ◽  
pp. e018230 ◽  
Author(s):  
Ankie Seiger ◽  
Pravesh S Gadjradj ◽  
Biswadjiet S Harhangi ◽  
Job LC van Susante ◽  
Wilco C. Peul ◽  
...  
Keyword(s):  
Economic Evaluation ◽  
Cost Effectiveness ◽  
Lumbar Disc Herniation ◽  
Disc Herniation ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Lumbar Disc ◽  
Endoscopic Discectomy ◽  
Percutaneous Transforaminal Endoscopic Discectomy ◽  
Randomised Controlled

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.

scholarly journals Clinical evaluation of percutaneous transforaminal endoscopic discectomy (PTED) and paraspinal minitubular microdiscectomy (PMTM) for lumbar disc herniation: study protocol for a randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (12) ◽  
pp. e033888
Author(s):  
Ze Yan Liang ◽  
Yuan Dong Zhuang ◽  
Chun Mei Chen ◽  
Rui Wang
Keyword(s):  
Randomised Controlled Trial ◽  
Minimally Invasive ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Lumbar Disc ◽  
Minimally Invasive Techniques ◽  
Endoscopic Discectomy ◽  
Percutaneous Transforaminal Endoscopic Discectomy ◽  
Randomised Controlled ◽  
Invasive Techniques

IntroductionFor sciatica caused by lumbar disc herniation (LDH), the standard surgical technique is conventional microdiscectomy. In recent years, minimally invasive techniques (eg, percutaneous transforaminal endoscopic discectomy (PTED), paraspinal minitubular microdiscectomy (PMTM)) have gained increasing interest. PTED and PMTM are considered alternative minimally invasive techniques for the treatment of LDH. Due to insufficient evidence, the differences in efficacy between PTED and PMTM have been debated. A pragmatic, multicentre, non-inferiority, randomised controlled trial has been designed to determine the efficacy and cost-effectiveness of PTED versus PMTM for the treatment of LDH.Methods and analysisA total of 280 patients (18–70 years) presenting with significant symptoms of sciatica and failure after 3 months of conservative treatment will be recruited. Patients must have an indication for surgery based on MRI demonstrating LDH with nerve root compression. Patients will be randomised to PTED or PMTM treatment. The primary outcome is Oswestry Disability Index scores. Secondary outcomes include Visual Analogue Scale scores, Short Form 36 health survey scores, physical examination, length of hospital stay, costs and complications. Outcomes will be measured the day following surgery, at 1 week, and at 1, 3, 6, 12 and 24 months after surgical treatment. Physical examination will be conducted at 1 week, 1 month and 12 months after surgery. The non-inferiority margin for the primary outcome is 5.Ethics and disseminationEthical approval has been granted by the Ethics Committee of Fujian Medical University Union Hospital, Fuzhou, China (2018YF010-02). Results of the research will be published in an international peer-reviewed scientific journal and disseminated through presentation at scientific conferences.Trial registration numberChiCTR1800015727; Pre-results.

scholarly journals Percutaneous transforaminal endoscopic discectomy compared with microendoscopic discectomy for lumbar disc herniation: 1-year results of an ongoing randomized controlled trial

2018 ◽  
Vol 28 (3) ◽  
pp. 300-310 ◽  
Author(s):  
Zihao Chen ◽  
Liangming Zhang ◽  
Jianwen Dong ◽  
Peigen Xie ◽  
Bin Liu ◽  
...  
Keyword(s):  
Lumbar Disc Herniation ◽  
Disc Herniation ◽  
Controlled Trial ◽  
Lumbar Disc ◽  
Treatment Groups ◽  
Randomized Controlled ◽  
Endoscopic Discectomy ◽  
Percutaneous Transforaminal Endoscopic Discectomy ◽  
Microendoscopic Discectomy

OBJECTIVEA prospective randomized controlled study was conducted to clarify whether percutaneous transforaminal endoscopic discectomy (PTED) results in better clinical outcomes and less surgical trauma than microendoscopic discectomy (MED).METHODSIn this single-center, open-label, randomized controlled trial, patients were included if they had persistent signs and symptoms of radiculopathy with corresponding imaging-confirmed lumbar disc herniation. Patients were randomly allocated to the PTED or the MED group by computer-generated randomization codes. The primary outcome was the Oswestry Disability Index (ODI) score 1 year after surgery. Secondary outcomes included scores of the Medical Outcomes Study 36-Item Short-Form Health Survey bodily pain and physical function scales, EuroQol Group’s EQ-5D , and the visual analog scales for back pain and leg pain. Data including duration of operation, in-bed time, length of hospital stay, surgical cost and total hospital cost, complications, and reoperations were recorded.RESULTSA total of 153 participants were randomly assigned to 2 treatment groups (PTED vs MED), and 89.5% (137 patients) completed 1 year of follow-up. Primary and secondary outcomes did not differ significantly between the treatment groups at each prespecified follow-up point (p > 0.05). For PTED, there was less postoperative improvement in ODI score in the median herniation subgroup at 1 week (p = 0.027), 3 months (p = 0.013), 6 months (p = 0.027), and 1 year (p = 0.028) compared with the paramedian subgroup. For MED, there was significantly less improvement in ODI score at 3 months (p = 0.008), 6 months (p = 0.028), and 1 year (p = 0.028) in the far-lateral herniation subgroup compared with the paramedian subgroup. The total complication rate over the course of 1 year was 13.75% in the PTED group and 16.44% in the MED group (p = 0.642). Five patients (6.25%) in the PTED group and 3 patients (4.11%) in the MED group suffered from residue/recurrence of herniation, for which reoperation was required.CONCLUSIONSOver the 1-year follow-up period, PTED did not show superior clinical outcomes and did not seem to be a safer procedure for patients with lumbar disc herniation compared with MED. PTED had inferior results for median disc herniation, whereas MED did not seem to be the best treatment option for far-lateral disc herniation.Clinical trial registration no.: NCT01997086 (clinicaltrials.gov).

Comparison of Outcomes Postoperation between Straight Leg Raising Test Negative and Positive Patients Who Underwent Percutaneous Transforaminal Endoscopic Discectomy for Lumbar Disc Herniation

2019 ◽  
Author(s):  
Feilong Wei ◽  
Haoran Gao ◽  
Yifang Yuan ◽  
Shu Qian ◽  
Quanyou Guo ◽  
...  
Keyword(s):  
Lumbar Disc Herniation ◽  
Disc Herniation ◽  
Lumbar Disc ◽  
Related Factors ◽  
Significant Difference ◽  
Endoscopic Discectomy ◽  
Straight Leg Raising ◽  
Percutaneous Transforaminal Endoscopic Discectomy ◽  
Relevant Factors

Abstract Background: Percutaneous Transforaminal Endoscopic Discectomy is used increasingly in patients with Lumbar Disc Herniation. There is little knowledge on the related factors including SLR test influencing the operation. Therefore, we designed this prospective study to explore the relevant factors influencing postoperative effect of PTED surgery.Methods: Consecutive patients with LDH who came to our hospital from August 2015 to September 2016 and received PTED surgery. 4 kinds of scales including VAS (lumbar/leg), ODI and JOA were measured and reassessed at 1 day, 3 months, 6 months, 12months and 36 months after the PTED to assess their surgical outcomes. Results: All the patients had successful surgery. ODI and VAS (lumbar/leg) decreased in all patients and groups. And there was a statistically significant difference in each postoperative follow-up compared with that before surgery in every visit. In addition, the increase of JOA in postoperation was statistically significant compared with that before surgery. And, there is statistically significant difference between the three subpopulations (patients with SLR Positive (0°-30°), SLR Positive (31°-60°) and SLR Negative (61°-) in the changes of the scores of VAS(leg), ODI and JOA. However, there is no statistically significant difference between the three subpopulations (patients with SLR Positive (0°-30°), SLR Positive (31°-60°) and SLR Negative (61°--RRB- in the changes of the score of VAS(lumbar). Conclusions: PTED showed great effect on treating patients with lumbar disc herniation. And the main scale score such as VAS(leg). ODI and JOA showed that there is a statistically significant difference between the three subpopulations treated by PTED. Patients with SLR negative may get greater benefit from PTED.

scholarly journals Short-term clinical outcomes of percutaneous transforaminal endoscopic discectomy in treating adolescents under 25 years old with massive lumbar disc herniation

2020 ◽  
Author(s):  
Hai-Chao He ◽  
Yong-jin Zhang
Keyword(s):  
Clinical Outcomes ◽  
Lumbar Disc Herniation ◽  
Disc Herniation ◽  
Lumbar Disc ◽  
Leg Pain ◽  
Spinal Instability ◽  
Lower Limb Pain ◽  
Endoscopic Discectomy ◽  
Adolescent Patients ◽  
Percutaneous Transforaminal Endoscopic Discectomy

Abstract Background: In the last decades, endoscopic techniques to treat lumbar disc herniation (LDH) have gained popularity in clinical practice. However, few studies have described the safety and efficacy of percutaneous transforaminal endoscopic discectomy (PTED) in treating adolescent massive LDH. This study aims to evaluate the surgical outcomes of PTED in treating adolescent patients with massive LDH. Methods: Between October 2012 and December 2018, retrospective analysis of 13 adolescent patients with single segment massive LDH at the Department of Spinal Surgery of Affiliated Dongyang Hospital of Wenzhou Medical University. All patients were followed up for at least 12 months (range 12–20 months). The patients’ lower limb pain was evaluated using visual analogue scale (VAS) scores and the Oswestry Disability Index (ODI). Patient satisfaction was evaluated using the MacNab outcome scale. Clinical outcomes were measured preoperatively, at 3 days, 1 months, 3 months, 6 month and 12 months postoperatively. Results: The VAS score for leg pain was 7.08 ±1.12 preoperatively and 3.23±1.01, 3.0 ± 1.01, and 2.62 ± 0.51, and 2.32± 0.48, and 1.46± 0.52, at 3 days, 1 months, 3 months, 6 months and 12 months postoperatively respectively. The ODI scores was 51.51 ±3.08 preoperatively and 21.74±1.15, 14.81 ± 1.50, and 2.78 ± 0.64, at 3 months, 6 months and 12 months postoperatively respectively. These postoperative scores were all significantly different when compared with preoperative scores (P < 0.001). According to the modified MacNab outcome scale, excellent was obtained in 7 patients, good was obtained in 5 patients, and fair was obtained in 1 patient, and 92.31% of these patients had excellent and good outcomes at the final follow-up. There were no complications related to surgery, and no spinal instability was detected. Conclusion: The PTED is an effective and safe surgical method for the treatment of adolescent patients with massive LDH, but high-quality randomized controlled trials are still required to further verify these findings.

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