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AbstractObjectiveTo assess whether percutaneous transforaminal endoscopic discectomy (PTED) is non-inferior to conventional open microdiscectomy in reduction of leg pain caused by lumbar disc herniation.DesignMulticentre randomised controlled trial with non-inferiority design.SettingFour hospitals in the Netherlands.Participants613 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.InterventionsPTED (n=179) compared with open microdiscectomy (n=309).Main outcome measuresThe 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.ResultsAt 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.ConclusionsPTED 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 registrationNCT02602093ClinicalTrials.gov NCT02602093.

A Prospective randomised controlled study was done to determine statistical difference between the standard microsurgical discotomy (MC) and a minimally invasive microscopic procedure for disc prolapse surgery by comparing operation duration and clinical outcome. Additionally, the transferability of the results was determined by a bicentric design. The microscopic assisted percutaneous nucleotomy (MAPN) has been advocated as a minimally invasive tubular technique. Proponents have claimed that minimally invasive procedures reduce postoperative pain and accelerate the recovery. In addition, there exist only a limited number of well-designed comparison studies comparing standard microdiscotomy to a tubular minimally invasive technique that support this claim. Furthermore, there are no well-designed studies looking at the transferability of those results and possible learning curve phenomena. We studied 100 patients, who were planned for disc prolapse surgery at two centres [50 patients at the developing centre (index) and 50 patients at the less experienced (transfer) centre]. The randomisation was done separately for each centre, employing a block-randomisation procedure with respect to age and preoperative Oswestry score. Operation duration was chosen as a primary outcome parameter as there was a distinguished shortening observed in a preliminary study at the index centre enabling a sound case number estimation. The following data were compared between the two groups and the centres with a 12-month follow-up: surgical times (operation duration and approach duration), the clinical results, leg and back pain by visual analogue scale, the Oswestry disability index, length of hospital stay, return to work time, and complications. The operation duration was statistically identical for MC (57.8 ± 20.2 min) at the index centre and for MAPN (50.3 ± 18.3 min) and MC (54.7 ± 18.1 min) at the transfer centre. The operation duration was only significantly shorter for the MAPN technique at the index centre with 33.3 min (SD 12.1 min). There was a huge clinical improvement for all patients regardless of centre or method revealed by a repeated measures ANOVA for all follow-up visits Separate post hoc ANOVAs for each centre revealed that there was a significant time–method (MAPN vs. MC) interaction at the index centre ( F  = 3.75, P  = 0.006), whereas this crucial interaction was not present at the transfer centre ( F  = 0.5, P  = 0.7). These results suggest a slightly faster clinical recovery for the MAPN patients only at the index centre. This was due to a greater reduction in VAS score for back pain at discharge, 8-week and 6-month follow up ( P  < 0.002). The Oswestry-disability scores reached a significant improvement compared to the initial values extending over the complete follow-up at both centres for both methods without revealing any differences for the two methods in either centre. There was no difference regarding complications. The results demonstrate that a shorter operation duration and concomitant quicker recovery is comprehensible at an experienced minimally invasively operating centre. These advantages could not be found at the transfer centre within 25 minimally invasive procedures. In conclusion both procedures show equal mid term clinical results and the same complication rate even if the suggested advantages for the minimally invasive procedure could not be confirmed for the transfer centre within the framework of this study.

Purpose Transforaminal endoscopic discectomy (TED) minimises paraspinal muscle damage. The aim of this trial was to compare clinical outcomes of TED to Microdiscectomy (Micro). Methods 143 patients, age 25–70 years and <115 kg, with single level lumbar prolapse and radiculopathy, were recruited and randomised. 70 received TED under conscious sedation and 70 Micro under general anaesthesia. Oswestry Disability Index (ODI), visual analogue scores (VAS) of back and leg pain, and Short Form Health Survey indices (SF-36) were measured preoperatively and at 3, 12 and 24 months. Results All outcome measures improved significantly in both groups ( p  < 0.001). Affected side leg pain was lower in the TED group at 2 years (1.9 ± 2.6 vs 3.5 ± 3.1, p  = 0.002). Hospital stay was shorter following TED (0.7 ± 0.7 vs 1.4 ± 1.3 days, p  < 0.001). Two Micro patients and five TED patients required revision giving a relative risk of revision for TED of 2.62 (95% CI 0.49–14.0). Conclusions Functional improvements were maintained at 2 years in both groups with less ongoing sciatica after TED. A greater revision rate after TED was offset by a more rapid recovery.

Purpose For cervical nerve root compression, anterior cervical discectomy with fusion (anterior surgery) or posterior foraminotomy (posterior surgery) are safe and effective options. Posterior surgery might have a more beneficial economic profile compared to anterior surgery. The purpose of this study was to analyse if posterior surgery is cost-effective compared to anterior surgery. Methods An economic evaluation was performed as part of a multicentre, noninferiority randomised clinical trial (Foraminotomy ACDF Cost-effectiveness Trial) with a follow-up of 2 years. Primary outcomes were cost-effectiveness based on arm pain (Visual Analogue Scale (VAS; 0–100)) and cost-utility (quality adjusted life years (QALYs)). Missing values were estimated with multiple imputations and bootstrap simulations were used to obtain confidence intervals (CIs). Results In total, 265 patients were randomised and 243 included in the analyses. The pooled mean decrease in VAS arm at 2-year follow-up was 44.2 in the posterior and 40.0 in the anterior group (mean difference, 4.2; 95% CI, − 4.7 to 12.9). Pooled mean QALYs were 1.58 (posterior) and 1.56 (anterior) (mean difference, 0.02; 95% CI, − 0.05 to 0.08). Societal costs were €28,046 for posterior and €30,086 for the anterior group, with lower health care costs for posterior (€12,248) versus anterior (€16,055). Bootstrapped results demonstrated similar effectiveness between groups with in general lower costs associated with posterior surgery. Conclusion In patients with cervical radiculopathy, arm pain and QALYs were similar between posterior and anterior surgery. Posterior surgery was associated with lower costs and is therefore likely to be cost-effective compared with anterior surgery.

We set out to determine whether a minimally invasive approach for one-level instrumented posterior lumbar interbody fusion reduced undesirable changes in the multifidus muscle, compared to a conventional open approach. We also investigated associations between muscle injury during surgery (creatinine kinase levels), clinical outcome and changes in the multifidus at follow-up. We studied 59 patients treated by one team of surgeons at a single institution (minimally invasive approach in 28 and conventional open approach in 31, voluntarily chosen by patients). More than 1 year postoperatively, all the patients were followed up with the visual analogue scale (VAS) and Oswestry disability index (ODI), and 16 patients from each group were evaluated using MRI. This enabled the cross-sectional area (CSA) of lean multifidus muscle, and the T2 signal intensity ratio of multifidus to psoas muscle, to be compared at the operative and adjacent levels. The minimally invasive group had less postoperative back pain ( P  < 0.001) and lower postoperative ODI scores ( P  = 0.001). Multifidus atrophy was less in the minimally invasive group ( P  < 0.001), with mean reductions in CSA of 12.2% at the operative and 8.5% at the adjacent levels, compared to 36.8% and 29.3% in the conventional open group. The increase in the multifidus:psoas T2 signal intensity ratio was similarly less marked in the minimally invasive group where values increased by 10.6% at the operative and 8.3% at the adjacent levels, compared to 34.4 and 22.7% in the conventional open group ( P  < 0.001). These changes in multifidus CSA and T2 signal intensity ratio were significantly correlated with postoperative creatinine kinase levels, VAS scores and ODI scores ( P  < 0.01). The minimally invasive approach caused less change in multifidus, less postoperative back pain and functional disability than conventional open approach. Muscle damage during surgery was significantly correlated with long-term multifidus muscle atrophy and fatty infiltration. Furthermore these degenerative changes of multifidus were also significantly correlated with long-term clinical outcome.

Existing studies on micro-endoscopic lumbar discectomy report similar outcomes to those of open and microdiscectomy and conflicting results on complications. We designed a randomised controlled trial to investigate the hypothesis of different outcomes and complications obtainable with the three techniques. 240 patients aged 18–65 years affected by posterior lumbar disc herniation and symptoms lasting over 6 weeks of conservative management were randomised to micro-endoscopic (group 1), micro (group 2) or open (group 3) discectomy. Exclusion criteria were less than 6 weeks of pain duration, cauda equina compromise, foraminal or extra-foraminal herniations, spinal stenosis, malignancy, previous spinal surgery, spinal deformity, concurrent infection and rheumatic disease. Surgery and follow-up were made at a single Institution. A biomedical researcher independently collected and reviewed the data. ODI, back and leg VAS and SF-36 were the outcome measures used preoperatively, postoperatively and at 6-, 12- and 24-month follow-up. 212/240 (91%) patients completed the 24-month follow-up period. VAS back and leg, ODI and SF36 scores showed clinically and statistically significant improvements within groups without significant difference among groups throughout follow-up. Dural tears, root injuries and recurrent herniations were significantly more common in group 1. Wound infections were similar in group 2 and 3, but did not affect patients in group 1. Overall costs were significantly higher in group 1 and lower in group 3. In conclusion, outcome measures are equivalent 2 years following lumbar discectomy with micro-endoscopy, microscopy or open technique, but severe complications are more likely and costs higher with micro-endoscopy.

Abstract BACKGROUND Ten-year follow-up data from the US Food and Drug Administration investigational device exemption trial comparing BRYAN® Cervical Disc (Medtronic, Dublin, Ireland) arthroplasty to anterior cervical discectomy and fusion (ACDF) demonstrated that disc arthroplasty maintained range of motion and improvements in overall success and neck disability. OBJECTIVE To compare the 10-yr rates of symptomatic adjacent level disease requiring surgery (SALDRS). METHODS Prospective randomized trial data were analyzed comparing BRYAN® Cervical Disc arthroplasty to ACDF for single-level cervical disc disease with concordant radiculopathy or myelopathy with clinicoradiographic analysis at 10 yr. Secondarily, 84-mo data were pooled with PRESTIGE® Cervical Disc arthroplasty (Medtronic) study data to provide overall rates of SALDRS. RESULTS Significantly greater overall success was maintained at every postoperative interval with an overall success rate of 81.3% with BRYAN® disc and 66.3% with ACDF (P = .005) without loss of motion preservation (8.69° vs 0.60°). Reoperation at adjacent levels up to the 120-mo visit was 9.7% in the arthroplasty group and 15.8% in the ACDF group (P = .146). The combined data from BRYAN® and Prestige ST demonstrate that BRYAN® and Prestige disc groups had a lower rate of second surgeries at the adjacent levels, up to the 84-mo visit, compared to the combined ACDF groups (6.9% vs 11.7%; P = .023). CONCLUSION Compared with ACDF, fewer patients with the BRYAN® disc required surgery for symptomatic adjacent level degeneration, but this did not achieve statistical significance. Analysis of combined study data using Bryan and Prestige discs shows significant differences in SADLRS as early as 7 yr.

Abstract BACKGROUND i-Factor™ Bone Graft (Cerapedics Inc, Westminster, Colorado) is a composite bone substitute material consisting of P-15 synthetic collagen fragment adsorbed onto anorganic bone mineral suspended in an inert biocompatible hydrogel carrier. A pivotal, noninferiority, US FDA Investigational Device Exemption study demonstrated the benefits of i-Factor™ compared to local autograft bone in single-level anterior cervical discectomy and fusion at 1-yr postoperative. OBJECTIVE To report 2-yr follow-up. METHODS Subjects randomly received either autograft (n = 154) or i-Factor™ (n = 165) in a cortical ring allograft and followed using radiological, clinical, and patient-reported outcomes. RESULTS At 2 yr, the fusion rate was 97.30% and 94.44% in i-Factor™ and autograft subjects, respectively (P = .2513), and neurological success rate was 94.87% (i-Factor™) and 93.79% (autograft; P = .7869). Neck Disability Index improved 28.30 (i-Factor™) and 26.95 (autograft; P = .1448); Visual Analog Scale arm pain improved 5.43 (i-Factor™) and 4.97 (autograft) (p = .2763); Visual Analog Scale neck pain improved 4.78 (i-Factor™) and 4.41 (autograft; P = .1652), Short Form-36 (SF-36v2) Physical Component Score improved 10.23 (i-Factor™) and 10.18 (autograft; P = .4507), and SF36v2 Mental Component Score improved 7.88 (i-FactorTM) and 7.53 (autograft; P = .9872). The composite endpoint of overall success (fusion, Neck Disability Index improvement >15, neurological success, and absence of re-operations) was greater in i-Factor™ subjects compared to autograft subjects (69.83% and 56.35%, respectively, P = .0302). Twelve (7.45%) i-Factor™ subjects and 16 (10.53%) autograft subjects underwent re-operation (P = .3411). There were no allergic reactions associated with i-Factor™. CONCLUSION Use of i-Factor™ in anterior cervical discectomy and fusion is effective and safe, and results in similar outcomes compared to local autograft bone at 2 yr following surgery.

Purpose Anterior cervical discectomy with fusion is a common procedure for treating radicular arm pain. Polyetheretherketone (PEEK) plastic is a frequently used material in cages for interbody fusion. Silicon nitride is a new alternative with desirable bone compatibility and imaging characteristics. The aim of the present study is to compare silicon nitride implants with PEEK cages filled with autograft harvested from osteophytes. Methods The study is a prospective, randomized, blinded study of 100 patients with 2 years follow-up. The primary outcome measure was improvement in the Neck Disability Index. Other outcome measures included SF-36, VAS arm pain, VAS neck pain, assessment of recovery, operative characteristics, complications, fusion and subsidence based on dynamic X-ray and CT scan. Results There was no significant difference in NDI scores between the groups at 24 months follow-up. At 3 and 12 months the NDI scores were in favor of PEEK although the differences were not clinically relevant. On most follow-up moments there was no difference in VAS neck and VAS arm between both groups, and there was no statistically significant difference in patients’ perceived recovery during follow-up. Fusion rate and subsidence were similar for the two study arms and about 90% of the implants were fused at 24 months. Conclusions Patients treated with silicon nitride and PEEK reported similar recovery rates during follow-up. There was no significant difference in clinical outcome at 24 months. Fusion rates improved over time and are comparable between both groups.

BackgroundThe reference surgical procedure for the treatment of lumbar disc herniation is open microdiscectomy. Minimal invasive discectomy with tubular retractors is hypothesised to cause less tissue damage and result in lower blood loss, less postoperative pain and faster recovery. We previously reported our 1 and 2-year results, and found no better outcomes of tubular discectomy compared with open microdiscectomy. Until now, no studies on tubular discectomy have reported results with more than 2 years of follow-up. Studies with long-term follow-up are required to determine if clinical outcomes are sustained and to assess specific long-term outcomes such as reoperation rate and iatrogenic low back pain due to impaired spinal integrity. The aim of this study is to evaluate the 5-year results of tubular discectomy compared with conventional microdiscectomy.MethodsThe study was designed as a double-blind randomised controlled trial. 325 patients with a symptomatic lumbar disc herniation were randomly allocated to tubular discectomy (166 patients) or conventional microdiscectomy (159 patients). Repeated standardised follow-up measurements were performed at 2, 4, 6, 8, 12, 26, 38, 52, 78, 104, 156, 208 and 260 weeks after randomisation. Main outcomes are the Roland-Morris Disability Questionnaire for Sciatica (RDQ), Visual Analogue Scale for leg pain and low back pain, self-perceived recovery and reoperation incidence.ResultsThere was no clinically significant difference between tubular discectomy and conventional microdiscectomy regarding the main clinical outcomes at any time point during the 5 years of follow-up. RDQ scores at 5 years were 4.3 (95% CI 3.3 to 5.2) in the tubular discectomy group and 3.4 (95% CI 2.4 to 4.5) in the conventional microdiscectomy group. The mean difference of 0.9 (95% CI −0.6 to 2.2) was not significant. Mean differences for leg pain and back pain were 0.2 (95% CI −5.5 to 6.0) and 0.4 (95% CI −5.9 to 6.7), respectively. 77% of patients allocated to conventional discectomy reported complete or near-complete recovery of symptoms compared with 74% of patients allocated to tubular discectomy (p=0.79). The reoperation rate was 18% in the tubular discectomy group and 13% in the conventional discectomy group (p=0.29).ConclusionsLong-term functional and clinical outcome did not differ between patients allocated to tubular discectomy and conventional microdiscectomy. Primary and secondary outcome measures did not support the hypothesised advantages of tubular discectomy over conventional microdiscectomy.Trial registration numberISRCTN51857546.