Wouter A. Moojen

Interspinous process device versus standard conventional surgical decompression for lumbar spinal stenosis: randomized controlled trial.

Objective To assess whether interspinous process device implantation is more effective in the short term than conventional surgical decompression for patients with intermittent neurogenic claudication due to lumbar spinal stenosis. Design Randomized controlled trial. Setting Five neurosurgical centers (including one academic and four secondary level care centers) in the Netherlands. Participants 203 participants were referred to the Leiden-The Hague Spine Prognostic Study Group between October 2008 and September 2011; 159 participants with intermittent neurogenic claudication due to lumbar spinal stenosis at one or two levels with an indication for surgery were randomized. Interventions 80 participants received an interspinous process device and 79 participants underwent spinal bony decompression. Main outcome measures The primary outcome at short term (eight weeks) and long term (one year) follow-up was the Zurich Claudication Questionnaire score. Repeated measurements were made to compare outcomes over time. Results At eight weeks, the success rate according to the Zurich Claudication Questionnaire for the interspinous process device group (63%, 95% confidence interval 51% to 73%) was not superior to that for standard bony decompression (72%, 60% to 81%). No differences in disability (Zurich Claudication Questionnaire; P=0.44) or other outcomes were observed between groups during the first year. The repeat surgery rate in the interspinous implant group was substantially higher (n=21; 29%) than that in the conventional group (n=6; 8%) in the early post-surgical period (P<0.001). Conclusions This double blinded study could not confirm the hypothesized short term advantage of interspinous process device over conventional “simple” decompression and even showed a fairly high reoperation rate after interspinous process device implantation. Trial registration Dutch Trial Register NTR1307.

Long-term results: adjuvant radiotherapy in en bloc resection of sacrococcygeal chordoma is advisable.

Study Design. A cross-sectional study. Objective. The purpose of this report is to define the role of postoperative radiotherapy in the prevention of local recurrence (LR). Summary of Background Data. Sacrococcygeal chordoma is a slow growing, malignant tumor with a clinical poor outcome due to a high LR rate. Several studies emphasize that margin-free tumor resection is the most important predictor of LR. However, even after extralesional resection a high LR up to 80% remains. Methods. A retrospective series of 15 patients who underwent surgical treatment for sacrococcygeal chordoma in one center between 1981 and 2003 was reviewed. Overall survival and continuous disease-free survival rates were compared between patients with intralesional resection with standard radiotherapy and patients with extralesional resection and no standard radiotherapy. Results. The median age at surgery was 53 years. The mean follow-up was 7 years or until death. Mean duration of preoperative complaints was 3 years. In 10 patients, an en bloc resection was (histologic resection margins were free) performed and in 5 patients, an intralesional resection was achieved. All but one patients with intralesional resection received radiotherapy (>50 Gy) and patients with extralesional resection only received radiotherapy in case of LR (6 of 10 patients). After extralesional resection (no initial radiotherapy), all 10 patients had LR of the tumor with a mean time to recurrence of 2 years. Six of these ten patients received radiotherapy after LR and had mean survival duration of 7 years. Only one (of five patients) in the group with intralesional resection and postoperative radiotherapy had LR after 11 years. The time to recurrence was significantly longer and we found a trend toward a longer overall survival in the group that received immediate radiotherapy after surgery. Conclusion. The results support the strategy to add radiotherapy as standard adjuvant therapy to sacrococcygeal chordoma tumor resection.

The Felix-trial. Double-blind randomization of interspinous implant or bony decompression for treatment of spinal stenosis related intermittent neurogenic claudication

BackgroundDecompressive laminotomy is the standard surgical procedure in the treatment of patients with canal stenosis related intermittent neurogenic claudication. New techniques, such as interspinous process implants, claim a shorter hospital stay, less post-operative pain and equal long-term functional outcome. A comparative (cost-) effectiveness study has not been performed yet. This protocol describes the design of a randomized controlled trial (RCT) on (cost-) effectiveness of the use of interspinous process implants versus conventional decompression surgery in patients with lumbar spinal stenosis.Methods/DesignPatients (age 40-85) presenting with intermittent neurogenic claudication due to lumbar spinal stenosis lasting more than 3 months refractory to conservative treatment, are included. Randomization into interspinous implant surgery versus bony decompression surgery will take place in the operating room after induction of anesthesia. The primary outcome measure is the functional assessment of the patient measured by the Zurich Claudication Questionnaire (ZCQ), at 8 weeks and 1 year after surgery. Other outcome parameters include perceived recovery, leg and back pain, incidence of re-operations, complications, quality of life, medical consumption, absenteeism and costs. The study is a randomized multi-institutional trial, in which two surgical techniques are compared in a parallel group design. Patients and research nurses are kept blinded of the allocated treatment during the follow-up period of 1 year.DiscussionCurrently decompressive laminotomy is the golden standard in the surgical treatment of lumbar spinal stenosis. Whether surgery with interspinous implants is a reasonable alternative can be determined by this trial.Trial registerDutch Trial register number: NTR1307

Interspinous process device versus standard conventional surgical decompression for lumbar spinal stenosis: randomised controlled trial

STUDY QUESTION Is interspinous process device implantation more effective in the short term (eight weeks) than conventional surgical decompression for patients with intermittent neurogenic claudication due to lumbar spinal stenosis? SUMMARY ANSWER The use of interspinous implants did not result in a better outcome than conventional decompression, but the reoperation rate was significantly higher. WHAT IS KNOWN AND WHAT THIS PAPER ADDS Bony decompression and treatment with interspinous process devices are superior to conservative and non-surgical treatment for intermittent neurogenic claudication due to lumbar spinal stenosis. Interspinous implants surgery is not superior to bony decompression, and the reoperation rate is significantly higher.

Interspinous process devices versus standard conventional surgical decompression for lumbar spinal stenosis: cost-utility analysis

BACKGROUND CONTEXT In the 1980s, a new implant was developed to treat patients with intermittent neurogenic claudication caused by lumbar spinal stenosis (LSS). This implant is now widely used. PURPOSE The objective of this study is to determine whether a favorable cost-effectiveness for interspinous process devices (IPDs) compared with conventional bony decompression is attained. STUDY DESIGN/SETTING Cost-utility analysis was performed alongside a double-blind randomized controlled trial. Five neurosurgical centers (including one academic and four secondary level care centers) included participants for this study. PATIENT SAMPLE One hundred fifty-nine patients with LSS were treated with the implantation of IPD and with bony decompression. Eighty participants received an IPD, and seventy-nine participants underwent spinal bony decompression. OUTCOME MEASURES Outcome measures were quality-adjusted life-years (QALYs) and societal costs in the first year (estimated per quarter), estimated from patient-reported utilities (US and The Netherlands EuroQol 5D [EQ-5D] and EuroQol visual analog scale) and diaries on costs (health-care costs, patient costs, and productivity costs). METHODS All analyses followed the intention-to-treat principle. Given the statistical uncertainty of differences between costs and QALYs, cost-effectiveness acceptability curves graph the probability that a strategy is cost effective, as a function of willingness to pay. Paradigm Spine funded this trial but did not have any part in data analysis or the design and preparation of this article. RESULTS According to the EQ-5D, the valuation of quality of life after IPD and decompression was not different. Mean utilities during all four quarters were, not significantly, less favorable after IPD according to the EQ-5D with a decrease in QALYs according to the US EQ-5D of 0.024 (95% confidence interval, -0.031 to 0.079). From a health-care perspective, the costs of IPD treatment were higher (difference €3,030 per patient, 95% confidence interval, €561-€5,498). This significant difference is mainly because of additional cost of implants of €2,350 apiece. From a societal perspective, a nonsignificant difference of €2,762 (95% confidence interval, -€1,572 to €7,095) in favor of conventional bony decompression was found. CONCLUSIONS Implantation of IPD as indirect decompressing device is highly unlikely to be cost effective compared with bony decompression for patients with intermittent neurogenic claudication caused by LSS. TRIAL REGISTRATION Dutch Trial Register Number: NTR1307.

Scientific evaluation of spinal implants: an ethical necessity

The clinical introduction of novel medical devices often occurs without evidence of good methodological quality and with relatively little oversight and regulation. As a consequence, the safety, efficacy, and long-term effects of devices are frequently insufficiently known upon device approval. Recent controversies surrounding the Poly Implant Prothèse (PIP) breast implants, metal-on-metal hip implants, and interspinous implants underscore the need to reconsider how innovation in medical devices can adhere to sound ethical standards without inhibiting surgical research and development. In this article, the introduction of spinal implants is taken as an example to firstly discuss the scientific and ethical challenges of developing, testing, and introducing novel medical devices and to secondly identify avenues for improving the existing regulatory frameworks for such innovation. Two measures for improvement are most feasible in the short term: demanding prospective studies before device introduction and developing registries to monitor and evaluate new medical devices. Level of Evidence: 5

Preoperative MR Imaging in Patients with Intermittent Neurogenic Claudication: Relevance for Diagnosis and Prognosis.

Study Design. We studied baseline magnetic resonance images of 155 patients with intermittent neurogenic claudication and lumbar spinal stenosis (LSS). Magnetic resonance imaging (MRI) and patient data were gathered from participants of a randomized trial. Objective. It is believed that the narrowness of the lumbar spinal canal correlates to the severity of complaints and that it may be a good predictor of clinical outcome if treated. However, this hypothesis has never been (prospectively) tested. Summary of Background Data. MRI is an important tool to confirm the diagnosis of LSS as a cause for intermittent neurogenic claudication. Methods. Three raters were asked to evaluate the magnetic resonance images (Schizas scale). Symptom severities at baseline and 1-year follow-up were quantified. The radiological scores were correlated with clinical baseline and outcome scores to assess diagnostic and prognostic value of MRI findings at baseline. Results. There was good agreement on the clinically relevant level of LSS (kappa range 0.57–0.64). MRI assessment of grading of compression (kappa 0.33–0.46) did not correlate with baseline MRDQ nor with outcome based on postoperative change in MRDQ (P = 0.61). However, both absence of epidural fat and presence of tortuous caudal nerves on magnetic resonance images (kappa 0.53–0.72 and 0.67–0.70) in patients with LSS were relatively good predictors for satisfactory recovery after surgery (P = 0.03 and P < 0.01). Conclusion. The grading of compression on the preoperative MRI is neither ambiguous nor correlating to severity of clinical condition. It does, furthermore, not have the ability to predict the outcome after 1 year if surgically treated. Level of Evidence: 2

The Changing Health Care Landscape and Implications of Organizational Ethics on Modern Medical Practice

INTRODUCTION Medicine is rapidly changing, both in the level of collective medical knowledge and in how it is being delivered. The increased presence of administrators in hospitals helps to facilitate these changes and ease administrative workloads on physicians; however, tensions sometimes form between physicians and administrators. ANALYSIS This situation is based on perceptions from both sides that physicians obstruct cost-saving measures and administrators put profits before patients. In reality, increasing patient populations and changes in health care are necessitating action by hospitals to prevent excessive spending as health care systems become larger and more difficult to manage. Recognizing the cause of changes in health care, which do not always originate with physicians and administrators, along with implementing changes in hospitals such as increased physician leadership, could help to ease tensions and promote a more collaborative atmosphere. Ethically, there is a need to preserve physician autonomy, which is a tenet of medical professionalism, and a need to rein in spending costs and ensure that patients receive the best possible care. CONCLUSION Physicians and administrators both need to have a well-developed personal ethic to achieve these goals. Physicians need be allowed to retain relative autonomy over their practices as they support and participate in administrator-led efforts toward distributive justice.

Ethical difficulties in the innovative surgical treatment of patients with recurrent glioblastoma multiforme

EvEn with aggressive treatment, glioblastoma multiforme (GBM) nearly always recurs, yet there is currently no consensus on how best to manage recurrence. As a result of this uncertainty, surgical innovation in the treatment of recurrent GBM remains energetic. A thorough ethical discussion of these innovative treatment options for recurrent GBM is of paramount importance, yet little has been published on the topic in the literature. On the one hand there are those who argue that patient autonomy must permit access to innovative surgical procedures. On the other hand there are those who argue for restriction of the right to autonomy, pointing out that patients with recurrent GBM may be vulnerable to unethical experimentation, and that surgical innovation may endanger patient safety and undermine knowledge-generation structures. Patients with recurrent GBM should have some rights to innovative surgical treatments, because this aligns with the fundamental ethical principle of autonomy. This right is not absolute, however, and reasonable and appropriate measures should be taken to ensure adequate protection of these vulnerable patients. Specifically, these measures include: 1) a high standard of truly informed consent; 2) oversight and regulation of the innovative surgical treatment; 3) adequate evidence that the innovative surgical treatment will be successful, either in the form of animal model studies or in the application of closely related procedures in humans; and 4) no risk of harm to others. If these standards are not met, a patient’s right to innovative surgical treatment can be justifiably infringed. Outcomes for patients with recurrent GBM remain poor, and many patients opt for palliative care over aggressive intervention at the time of recurrence.1,26,45 Innovative treatment for GBM is desperately needed, and dozens of clinical trials around the world are investigating new treatment options for this disease.21,22,27,29 Even with the most aggressive treatment possible in a patient diagnosed early with GBM, which includes some combination of neurosurgery, radiotherapy, and systemic chemotherapy, mean survival time is short and tumor recurrence almost always occurs.21,26,29,50 Surgical innovation in the care of these patients is also robust, with current investigations examining the use of fluorescent agents, intratumoral infusion of oncolytic viruses, stem cell transplants, implantable chemotherapeutic agents, and other surgical adjuncts.22,24,54 It was in this milieu that in 2013 a neurosurgeon prac-

Risk of aspirin continuation in spinal surgery: a systematic review and meta-analysis

BACKGROUND CONTEXT Aspirin is typically discontinued in spinal surgery because of increased risk of hemorrhagic complications. The risk of perioperative continuation of aspirin in neurosurgery needed to be evaluated. PURPOSE This study aimed to evaluate all available evidence about continuation of aspirin and to compare peri- and postoperative blood loss and complication rates between patients that continued aspirin and those who discontinued aspirin perioperatively in spinal surgery. STUDY SETTING Systematic review and meta-analysis were carried out. METHOD A meta-analysis was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Studies comparing aspirin continuation with discontinuation were included. Studies using a combination of anticlotting agents or non-spinal procedures were excluded. Operative outcomes (blood loss and operative length) and different complications (surgical site infection [SSI]), stroke, myocardial infarction within 30 days postoperatively) were extracted. Overall prevalence and means were calculated for the reported outcomes in fixed-effects models with heterogeneity (I-squared [I2]) and effect modification (P-interaction) assessment. RESULTS Out of 1,339 studies, three case series were included in the meta-analysis. No significant differences in mean operating time were seen between the aspirin-continuing group (mean=201.8 minutes, 95% confidence interval [CI]=193.3; 210.3; I2=95.4%; 170 patients) and the aspirin-discontinuing group (mean=178.4 minutes, 95% CI=119.1; 237.6; I2=93.5%; 200 patients); (P-interaction=0.78). No significant differences in mean perioperative blood loss were seen between the aspirin-continuing group (mean=553.9 milliliters, 95% CI=468.0; 639.9; I2=83.4%; 170 patients) and the aspirin-discontinuing group (mean=538.7 milliliters, 95% CI=427.6; 649.8; I2=985.5%; 200 patients); (P-interaction=0.96). Similar non-significant differences between the two groups were found for cardiac events, stroke, and surgical site infections. CONCLUSIONS This meta-analysis showed an absence of significant differences in perioperative complications between aspirin continuation and discontinuation. Because of the paucity of included studies, further well-designed prospective trials are imperative to demonstrate potential benefit and safety.