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

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.

A comparative health care inventory for primary hip arthroplasty between Germany versus the Netherlands. Is there a downside effect to fast-track surgery with regard to patient satisfaction and functional outcome?

BACKGROUND: Treatment and rehabilitation protocol for hip arthroplasty differs between Germany and the Netherlands. The Dutch system promotes fast-track surgery whereas in Germany conventional care is provided with a longer hospital stay including rehabilitation. Clinical outcome, patient satisfaction and costs in both treatment protocols were compared in a prospective setup. MATERIAL AND METHODS: This prospective cohort study included patients allocated for primary THA in 3 German and 1 Dutch hospital in the border region. Patient-reported outcome scores (PROMS) were measured pre- and postoperatively at 6 and 12 months including the Oxford Hip Score, SF12 survey, visual analogue scale for satisfaction and pain. Length of hospitalisation and availability of postoperative rehabilitation were recorded. In addition, a total cost estimation was calculated using health insurers data. RESULTS: A total of 360 consecutive patients were included; 175 THA in Germany compared to 185 THA in the Netherlands. No cross-border healthcare was encountered in both cohorts. Mean length of hospitalisation was 11.3 (range 6-23) days in Germany, compared to 4.4 (range 3-25) days in the Netherlands. In Germany 92% of the patients was discharged with inpatient (72%) or outpatient (20%) rehabilitation, compared to 21% with only inpatient rehabilitation in the Netherlands. No significant differences were measured regarding the PROMS and patient satisfaction between both countries. Due to profound differences in health care financing only a global cost estimation could be made and no major differences were encountered. CONCLUSION: Germany and the Netherlands both offer highly protocolled care for THA with comparable functional outcome and patient satisfaction with treatment after 12 months. Despite the length of hospitalisation in Germany is significantly longer including a more intensive rehabilitation programme, no significant differences were recorded regarding functional outcome nor patient satisfaction compared to fast-track surgery performed in the Netherlands.

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.

INTRODUCTION: Lumbosacral 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 ANALYSIS: In 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 DISSEMINATION: This 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 NUMBER: NCT02602093; Pre-results, recruiting stage.