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.... Show moreOBjECTIVE 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. Show less
Objective To assess the costs and cost-effectiveness of percutaneous transforaminal endoscopic discectomy (PTED) compared with open microdiscectomy among patients with sciatica.Methods This... Show moreObjective To assess the costs and cost-effectiveness of percutaneous transforaminal endoscopic discectomy (PTED) compared with open microdiscectomy among patients with sciatica.Methods This economic evaluation was conducted alongside a 12-month multicentre randomised controlled trial with a non-inferiority design, in which patients were randomised to PTED or open microdiscectomy. Patients were aged from 18 to 70 years and had at least 6 weeks of radiating leg pain caused by lumbar disc herniation. Effect measures included leg pain and quality-adjusted life years (QALYs), as derived using the EQ-5D-5L. Costs were measured from a societal perspective. Missing data were multiply imputed, bootstrapping was used to estimate statistical uncertainty, and various sensitivity analyses were conducted to determine the robustness.Results Of the 613 patients enrolled, 304 were randomised to PTED and 309 to open microdiscectomy. Statistically significant differences in leg pain and QALYs were found in favour of PTED at 12 months follow-up (leg pain: 6.9; 95% CI 1.3 to 12.6; QALYs: 0.040; 95% CI 0.007 to 0.074). Surgery costs were higher for PTED than for open microdiscectomy (ie, euro4500/patient vs euro4095/patient). All other disaggregate costs as well as total societal costs were lower for PTED than for open microdiscectomy. Cost-effectiveness acceptability curves indicated that the probability of PTED being less costly and more effective (ie, dominant) compared with open microdiscectomy was 99.4% for leg pain and 99.2% for QALYs.Conclusions Our results suggest that PTED is more cost-effective from the societal perspective compared with open microdiscectomy for patients with sciatica. Show less
Gadjradj, P.S.; Harhangi, B.S.; Amelink, J.; Susante, J. van; Kamper, S.; Tulder, M. van; ... ; Rubinstein, S.M. 2021
Study Design. Systematic review and meta-analysis. Objective. To give a systematic overview of effectiveness of percutaneous transforaminal endoscopic discectomy (PTED) compared with open... Show moreStudy Design. Systematic review and meta-analysis. Objective. To give a systematic overview of effectiveness of percutaneous transforaminal endoscopic discectomy (PTED) compared with open microdiscectomy (OM) in the treatment of lumbar disk herniation (LDH). Summary of Background Data. The current standard procedure for the treatment of sciatica caused by LDH, is OM. PTED is an alternative surgical technique which is thought to be less invasive. It is unclear if PTED has comparable outcomes compared with OM. Methods. Multiple online databases were systematically searched up to April 2020 for randomized controlled trials and prospective studies comparing PTED with OM for LDH. Primary outcomes were leg pain and functional status. Pooled effect estimates were calculated for the primary outcomes only and presented as standard mean differences (SMD) with their 95% confidence intervals (CI) at short (1-day postoperative), intermediate (3-6 months), and long-term (12 months). Results. We identified 2276 citations, of which eventually 14 studies were included. There was substantial heterogeneity in effects on leg pain at short term. There is moderate quality evidence suggesting no difference in leg pain at intermediate (SMD 0.05, 95% CI -0.10-0.21) and long-term follow-up (SMD 0.11, 95% CI -0.30-0.53). Only one study measured functional status at short-term and reported no differences. There is moderate quality evidence suggesting no difference in functional status at intermediate (SMD -0.09, 95% CI -0.24-0.07) and long-term (SMD -0.11, 95% CI -0.45-0.24). Conclusion. There is moderate quality evidence suggesting no difference in leg pain or functional status at intermediate and long-term follow-up between PTED and OM in the treatment of LDH. High quality, robust studies reporting on clinical outcomes and cost-effectiveness on the long term are lacking. Show less
Gerven, P. van; Dongen, J.M. van; Rubinstein, S.M.; Termaat, M.F.; Moumni, M. el; Zuidema, W.P.; ... ; WARRIOR Study Grp 2020
Background: To evaluate the cost-effectiveness of a reduction in the number of routine radiographs in the follow-up of patients with ankle fractures.Methods: We performed an economic evaluation... Show moreBackground: To evaluate the cost-effectiveness of a reduction in the number of routine radiographs in the follow-up of patients with ankle fractures.Methods: We performed an economic evaluation alongside the multicentre, randomised WARRIOR trial. Participants were randomised to a reduced imaging follow-up protocol (i.e. radiographs at week 6 and 12 follow-up obtained on clinical indication) or usual care (i.e. routine radiography at weeks 6 and 12). The Olerud & Molander Ankle Score (OMAS) was used to assess ankle function and the EQ-5D-3L was used to estimate Quality-Adjusted Life Years (QALYs). Costs and resource use were assessed using self-reported questionnaires and medical records, and analysed from a societal perspective. Multiple imputation was used for missing data, and data were analysed using seemingly unrelated regression analysis and bootstrapping.Results: In total, 246 patients had data available for analysis (reduced imaging = 118; usual care = 128). Fewer radiographs were obtained in the reduced imaging group (median = 4) compared with the usual-care group (median = 5). Functional outcome was comparable in both groups. The difference in QALYs was - 0.008 (95% CI:-0.06 to 0.04) and the difference in OMAS was 0.73 (95% CI:-5.29 to 6.76). Imaging costs were lower in the reduced imaging group (-(sic)48; 95% CI:- (sic)72 to -(sic)25). All other cost categories did not statistically differ between the groups. The probability of the reduced imaging protocol being cost-effectiveness was 0.45 at a wiliness-to-pay of (sic)20,000 per QALY.Conclusions: Reducing the number of routine follow-up radiographs has a low probability of being cost-effective compared with usual care. Functional outcome, health-related quality of life and societal costs were comparable in both groups, whereas imaging costs were marginally lower in the reduced imaging group. Given this, adherence to a reduced imaging follow-up protocol for those with routine ankle fractures can be followed without sacrificing quality of care, and may result in reduced costs. Show less
Gerven, P. van; Krijnen, P.; Zuidema, W.P.; Moumni, M. el; Rubinstein, S.M.; Tulder, M.W. van; ... ; WARRIOR Trial Study Grp 2020
Background: The clinical consequences of routine follow-up radiographs for patients with ankle fracture are unclear, and their usefulness is disputed. The purpose of the present study was to... Show moreBackground: The clinical consequences of routine follow-up radiographs for patients with ankle fracture are unclear, and their usefulness is disputed. The purpose of the present study was to determine if routine radiographs made at weeks 6 and 12 can be omitted without compromising clinical outcomes. Methods: This multicenter randomized controlled trial with a noninferiority design included 246 patients with an ankle fracture, 153 (62%) of whom received operative treatment. At 6 and 12 weeks of follow-up, patients in the routine-care group (n = 128) received routine radiographs whereas patients in the reduced-imaging group (n = 118) did not. The primary outcome was the Olerud-Molander Ankle Score (OMAS). Secondary outcomes were the American Academy of Orthopaedic Surgeons (AAOS) foot and ankle questionnaire, health-related quality of life (HRQoL) as measured with the EuroQol-5 Dimensions-3 Levels (EQ-5D-3L) and Short Form-36 (SF-36), complications, pain, health perception, self-perceived recovery, the number of radiographs, and the indications for radiographs to be made. The outcomes were assessed at baseline and at 6, 12, 26, and 52 weeks of follow-up. Data were analyzed with use of mixed models. Results: Reduced imaging was noninferior compared with routine care in terms of OMAS scores (difference [beta], -0.9; 95% confidence interval [CI], -6.2 to 4.4). AAOS scores, HRQoL, pain, health perception, and self-perceived recovery did not differ between groups. Patients in the reduced-imaging group received a median of 4 radiographs, whereas those in the routine-care group received a median of 5 radiographs (p < 0.05). The rates of complications were similar (27.1% [32 of 118] in the reduced-imaging group, compared with 22.7% [29 of 128] in the routine-care group, p = 0.42). The types of complications were also similar. Conclusions: Implementation of a reduced-imaging protocol following an ankle fracture has no measurable negative effects on functional outcome, pain, and complication rates during the first year of follow-up. The number of follow-up radiographs can be reduced by implementing this protocol. Show less
Gerven, P. van; Dongen, J.M. van; Rubinstein, S.M.; Termaat, M.F.; Moumni, M. el; Zuidema, W.P.; ... ; WARRIOR Trial Study Grp 2020
Objective To assess the cost effectiveness of a reduced imaging follow-up protocol of distal radius fractures compared with usual care. Design An economical evaluation conducted alongside a... Show moreObjective To assess the cost effectiveness of a reduced imaging follow-up protocol of distal radius fractures compared with usual care. Design An economical evaluation conducted alongside a multicentre randomised controlled trial (RCT). Setting Four level-one trauma centres in the Netherlands. Participants 341 patients participated (usual care (n=172), reduced imaging (n=169)). Interventions Patients were randomised to usual care (routine radiography at 1, 2, 6 and 12 weeks) or a reduced imaging strategy (radiographs at 6 and 12 weeks only for a clinical indication). Outcome measures Functional outcome was assessed using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire and quality-adjusted life years (QALYs) using the EuroQol-5Dimensions-3 Levels (EQ-5D-3L). Costs were measured using self-reported questionnaires and medical records, and analysed from a societal perspective. Multiple imputation, seemingly unrelated regression analysis and bootstrapping were used to analyse the data. Results Clinical overall outcomes of both groups were comparable. The difference in DASH was -2.03 (95% CI -4.83 to 0.77) and the difference in QALYs was 0.025 (95% CI -0.01 to 0.06). Patients in the reduced imaging group received on average 3.3 radiographs (SD: 1.9) compared with 4.2 (SD: 1.9) in the usual care group. Costs for radiographic imaging were significantly lower in the reduced imaging group than in the usual care group (euro-48 per patient, 95% CI -68 to -27). There was no difference in total costs between groups (euro-401 per patient, 95% CI -2453 to 1251). The incremental cost-effectiveness ratio (ICER) for QALYs was -15 872; the ICER for the DASH was 198. The probability of reduced imaging being cost effective compared with usual care ranged from 0.8 to 0.9 at a willingness to pay of euro20 000/QALY to euro80 000/QALY. Conclusions Implementing a reduced imaging strategy in the follow-up of distal radius fractures has a high probability of being cost effective for QALYs, without decreasing functional outcome. We, therefore, recommend imaging only when clinically indicated. Show less
Gerven, P. van; Moumni, M. el; Zuidema, W.P.; Rubinstein, S.M.; Krijnen, P.; Tulder, M.W. van; ... ; Warrior-Trial Study Grp 2019
Background: Routine radiography in the follow-up of distal radial fractures is common practice, although its usefulness is disputed. The aim of this study was to determine whether the number of... Show moreBackground: Routine radiography in the follow-up of distal radial fractures is common practice, although its usefulness is disputed. The aim of this study was to determine whether the number of radiographs in the follow-up period can be reduced without resulting in worse patient outcomes.Methods: In this multicenter, prospective, randomized controlled trial with a non-inferiority design, patients >= 18 years old with a distal radial fracture could participate. They were randomized between a regimen with routine radiographs at 6 and 12 weeks of follow-up (usual care) and a regimen without routine radiographs at those time points (reduced imaging). Randomization was performed using an online registration and randomization program. The primary outcome was the Disabilities of the Arm, Shoulder and Hand (DASH) score. Secondary outcomes included the Patient-Rated Wrist/Hand Evaluation (PRWHE) score, health-related quality of life, pain, and complications. Outcomes were assessed at baseline and after 6 weeks, 3 months, 6 months, and 1 year of follow-up. Data were analyzed using mixed models. Neither the patients nor the health-care providers were blinded.Results: Three hundred and eighty-six patients were randomized, and 326 of them were ultimately included in the analysis. The DASH scores were comparable between the usual-care group (n = 166) and the reduced-imaging group (n = 160) at all time points as well as overall. The adjusted regression coefficient for the DASH scores was 1.5 (95% confidence interval [CI] = -1.8 to 4.8). There was also no difference between the groups with respect to the overall PRWHE score (adjusted regression coefficient, 1.4 [95% CI = -2.4 to 5.2]), quality of life as measured with the EuroQol-5 Dimensions (EQ-5D) (-0.02 [95% CI = -0.05 to 0.01]), pain at rest as measured with a visual analog scale (VAS) (0.1 [95% CI = -0.2 to 0.5]), or pain when moving (0.3 [95% CI = -0.1 to 0.8]). The complication rate was similar in the reduced imaging group (11.3%) and the usual-care group (11.4%). Fewer radiographs were made for the participants in the reduced-imaging group (median, 3 versus 4; p < 0.05).Conclusions: This study shows that omitting routine radiography after the initial 2 weeks of follow-up for patients with a distal radial fracture does not affect patient-reported outcomes or the risk of complications compared with usual care. Show less
Gerven, P. van; Bodegom-Vos, L. van; Weil, N.L.; Berg, J. van den; Rubinstein, S.M.; Termaat, M.F.; ... ; Schipper, I.B. 2019
We aimed to evaluate the available evidence on the effectiveness of surgical interventions for a number of conditions resulting in low back pain (LBP) or spine-related irradiating leg pain. We... Show moreWe aimed to evaluate the available evidence on the effectiveness of surgical interventions for a number of conditions resulting in low back pain (LBP) or spine-related irradiating leg pain. We searched the Cochrane databases and PubMed up to June 2013. We included systematic reviews and randomised controlled trials (RCTs) on degenerative disc disease (DDD), herniated disc, spondylolisthesis and spinal stenosis due to degenerative osteoarthritis. We included comparisons between surgery and conservative care and between different techniques. The quality of the systematic reviews was evaluated using assessment of multiple systematic reviews (AMSTAR). Twenty systematic reviews were included which covered the following diagnoses: disc herniation (n = 9), spondylolisthesis (n = 2), spinal stenosis (n = 3), DDD (n = 4) and combinations (n = 2). For most of the comparisons, no significant and/or clinically relevant differences between interventions were identified. In general, surgery is only indicated for relief of leg pain in clear indications such as disc herniation, spondylolisthesis or spinal stenosis. Show less
