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BACKGROUND: In patients with aneurysmal subarachnoid haemorrhage, short-term antifibrinolytic therapy with tranexamic acid has been shown to reduce the risk of rebleeding. However, whether this treatment improves clinical outcome is unclear. We investigated whether ultra-early, short-term treatment with tranexamic acid improves clinical outcome at 6 months.METHODS: In this multicentre prospective, randomised, controlled, open-label trial with masked outcome assessment, adult patients with spontaneous CT-proven subarachnoid haemorrhage in eight treatment centres and 16 referring hospitals in the Netherlands were randomly assigned to treatment with tranexamic acid in addition to care as usual (tranexamic acid group) or care as usual only (control group). Tranexamic acid was started immediately after diagnosis in the presenting hospital (1 g bolus, followed by continuous infusion of 1 g every 8 h, terminated immediately before aneurysm treatment, or 24 h after start of the medication, whichever came first). The primary endpoint was clinical outcome at 6 months, assessed by the modified Rankin Scale, dichotomised into a good (0-3) or poor (4-6) clinical outcome. Both primary and safety analyses were according to intention to treat. This trial is registered at ClinicalTrials.gov, NCT02684812.FINDINGS: Between July 24, 2013, and July 29, 2019, we enrolled 955 patients; 480 patients were randomly assigned to tranexamic acid and 475 patients to the control group. In the intention-to-treat analysis, good clinical outcome was observed in 287 (60%) of 475 patients in the tranexamic acid group, and 300 (64%) of 470 patients in the control group (treatment centre adjusted odds ratio 0·86, 95% CI 0·66-1·12). Rebleeding after randomisation and before aneurysm treatment occurred in 49 (10%) patients in the tranexamic acid and in 66 (14%) patients in the control group (odds ratio 0·71, 95% CI 0·48-1·04). Other serious adverse events were comparable between groups.INTERPRETATION: In patients with CT-proven subarachnoid haemorrhage, presumably caused by a ruptured aneurysm, ultra-early, short-term tranexamic acid treatment did not improve clinical outcome at 6 months, as measured by the modified Rankin Scale.FUNDING: Fonds NutsOhra.

Background and ObjectivesThe ULTRA trial showed that ultra-early and short-term tranexamic acid treatment after subarachnoid hemorrhage did not improve clinical outcome at 6 months. An expected proportion of the included patients experienced nonaneurysmal subarachnoid hemorrhage. In this post hoc study, we will investigate whether ultra-early and short-term tranexamic acid treatment in patients with aneurysmal subarachnoid hemorrhage improves clinical outcome at 6 months.MethodsThe ULTRA trial is a multicenter, prospective, randomized, controlled, open-label trial with blinded outcome assessment, conducted between July 24, 2013, and January 20, 2020. After confirmation of subarachnoid hemorrhage on noncontrast CT, patients were allocated to either ultra-early and short-term tranexamic acid treatment with usual care or usual care only. In this post hoc analysis, we included all ULTRA participants with a confirmed aneurysm on CT angiography and/or digital subtraction angiography. The primary endpoint was clinical outcome at 6 months, assessed by the modified Rankin scale (mRS), dichotomized into good (0–3) and poor (4–6) outcomes.ResultsOf the 813 ULTRA trial patients who experienced an aneurysmal subarachnoid hemorrhage, 409 (50%) were assigned to the tranexamic acid group and 404 (50%) to the control group. In the intention-to-treat analysis, 233 of 405 (58%) patients in the tranexamic acid group and 238 of 399 (60%) patients in the control group had a good clinical outcome (adjusted odds ratio [aOR] 0.92; 95% CI 0.69–1.24). None of the secondary outcomes showed significant differences between the treatment groups: excellent clinical outcome (mRS 0–2) (aOR 0.76; 95% CI 0.57–1.03), all-cause mortality at 30 days (aOR 0.91; 95% CI 0.65–1.28), and all-cause mortality at 6 months (aOR 1.10; 95% CI 0.80–1.52).DiscussionUltra-early and short-term tranexamic acid treatment did not improve clinical outcomes at 6 months in patients with aneurysmal subarachnoid hemorrhage and therefore cannot be recommended.Trial Registration InformationClinicalTrials.gov(NCT02684812; submission date February 18, 2016, first patient enrollment on July 24, 2013).Classification of EvidenceThis study provides Class II evidence that tranexamic acid does not improve outcomes in patients presenting with aneurysmal subarachnoid hemorrhage.

Background: Awareness of treatment group assignment in a clinical trial may influence patient behavior and bias outcome reporting. The objective of this study was to compare 2-year clinical outcomes in blinded vs unblinded patients who were treated with lumbar discectomy and a bone-anchored annular closure device (ACD) for prevention of lumbar disc reherniation. Methods: This was a secondary analysis of a randomized trial comparing lumbar discectomy with (n=272) vs without (n=278) implantation of a bone-anchored ACD. Among patients who received ACD implantation, 35 (13%) were blinded and 237 (87%) were unblinded to treatment allocation. In patients treated with ACD, propensity score-matching (1:1) was performed to account for imbalances in patient characteristics between blinded and unblinded groups. Key clinical outcomes were back pain severity (0–100 scale), leg pain severity (0–100 scale), Oswestry Disability Index (ODI, 0–100 scale), symptomatic reherniation, reoperation at the treated lumbar level, and device-or procedure-related serious adverse events (AEs). Outcomes were reported through 2 years of follow-up, which coincided with the time at which blinded patients were unblinded. Results: There were no statistically significant differences in 2-year outcomes between propensity score-matched blinded (n=35) and unblinded (n=35) patients treated with the ACD. In blinded vs unblinded ACD patients compared to baseline, back pain severity decreased by 40 vs 37 points (P=0.61), leg pain severity decreased by 75 points in each group (P>0.99), and ODI decreased by 47 vs 43 points (P=0.19). The risks of symptomatic reherniation (5.7% vs 9.1%; P=0.59), reoperation (8.6% vs 12.2%, P=0.62), and device-or procedure-related serious AEs (5.7% vs 8.9%, P=0.63) were comparably low in blinded and unblinded patients. Conclusion: In patients treated with lumbar discectomy and a bone-anchored ACD, there were no clinically important or statistically significant differences in back pain, leg pain, ODI, symptomatic reherniation, reoperation, or serious AEs over 2 years of follow-up when comparing patients who were blinded vs unblinded to their treatment assignment. The main limitations of this study were the post hoc nature of the analysis and the potential for bias due to surgeon awareness of treatment assignment.

BACKGROUND CONTEXT: Anterior cervical discectomy with an interbody cage (ACDF) to obtain fusion is a common procedure in cervical spine surgery. Presently, polyetheretherketone (PEEK) with (auto) graft is frequently used for interbody fusion although alternative implant tech- nology like 3-D printing titanium has been introduced recently. PURPOSE: Reporting the clinical and quantitative radiological outcome of a prospective cohort of 3-D printed porous titanium implants. STUDY DESIGN/SETTING: Prospective study of patients with single level ACDF using 3-D printed porous titanium cervical implants. These data were compared with 48 patients from the PEEK with autograft group of the previously performed CAncellous Structured Ceramic Arthrode- sis DEvice trial. PATIENT SAMPLE: Fourty-nine patients were included. OUTCOME MEASURES: Neck disability index (NDI), visual analog scale (VAS), self -reported perceived recovery, and fusion status. METHODS: The clinical outcomes and fusion rates were documented at 3, 6, and 12 months. Dynamic X-rays were analyzed to determine range of motion (ROM) of the operated level. Fusion was defined as rotation

IntroductionRobotic guidance (RG) and computer-assisted navigation (NV) have seen increased adoption in instrumented spine surgery over the last decade. Although there exists some evidence that these techniques increase radiological pedicle screw accuracy compared with conventional freehand (FH) surgery, this may not directly translate to any tangible clinical benefits, especially considering the relatively high inherent costs. As a non-randomised, expertise-based study, the European Robotic Spinal Instrumentation Study aims to create prospective multicentre evidence on the potential comparative clinical benefits of RG, NV and FH in a real-world setting.Methods and analysisPatients are allocated in a non-randomised, non-blinded fashion to the RG, NV or FH arms. Adult patients that are to undergo thoracolumbar pedicle screw instrumentation for degenerative pathologies, infections, vertebral tumours or fractures are considered for inclusion. Deformity correction and surgery at more than five levels represent exclusion criteria. Follow-up takes place at 6 weeks, as well as 12 and 24 months. The primary endpoint is defined as the time to revision surgery for a malpositioned or loosened pedicle screw within the first postoperative year. Secondary endpoints include patient-reported back and leg pain, as well as Oswestry Disability Index and EuroQOL 5-dimension questionnaires. Use of analgesic medication and work status are recorded. The primary analysis, conducted on the 12-month data, is carried out according to the intention-to-treat principle. The primary endpoint is analysed using crude and adjusted Cox proportional hazards models. Patient-reported outcomes are analysed using baseline-adjusted linear mixed models. The study is monitored according to a prespecified monitoring plan.Ethics and disseminationThe study protocol is approved by the appropriate national and local authorities. Written informed consent is obtained from all participants. The final results will be published in an international peer-reviewed journal.Trial registration numberClinical Trials.gov registryNCT03398915; Pre-results, recruiting stage.

Objective To determine whether presence of a bone-anchored annular closure device (ACD) impacts reoperation strategies and subsequent outcomes. Methods Patients with large annular defects after single-level limited lumbar discectomy were randomly allocated to receive an ACD or discectomy alone (controls) and were followed for at least 3 years. Results Among 550 patients, reoperation risk was lower with ACD (11.0% vs. 19.3%). The types of reoperations and operative time were similar in each group, and the ACD did not interfere with surgical planning or operative technique. Fusion success was 87% with ACD versus 85% for controls. Perioperative complications occurred in 22% and 19% of reoperations, respectively. Leg pain and back function were improved with ACD versus controls after fusion procedures, and no group differences were observed after non-fusion reoperations. Conclusions In patients undergoing post-discectomy reoperation, patients with an ACD were treated with similar operative techniques, were not exposed to additional surgical risks, and reported comparable clinical outcomes versus those without an ACD.

Supplemental Digital Content is available in the text, Study design: Systematic review with network meta-analysis. Objective: To compare patient outcomes of lumbar discectomy with bone-anchored annular closure (LD + AC), lumbar discectomy (LD), and continuing conservative care (CC) for treatment of lumbar disc herniation refractory to initial conservative management. Summary of background data: Several treatment options are available to patients with refractory symptoms of lumbar disc herniation, but their comparative efficacy is unclear. Methods: A systematic review was performed to compare efficacy of LD + AC, LD, and CC for treatment of lumbar disc herniation. Outcomes included leg pain, back pain, disability (each reported on a 0–100 scale), reherniation, and reoperation. Data were analyzed using random effects network meta-analysis. Results: This review included 14 comparative studies (8 randomized) involving 3947 patients—11 studies of LD versus CC (3232 patients), 3 studies of LD + AC versus LD (715 patients), and no studies of LD + AC versus CC. LD was more effective than CC in reducing leg pain (mean difference [MD] −10, P

Anterior cervical spine surgery is associated with postoperative dysphagia, sore throat and dysphonia. It is unclear, whether this is caused by increased endotracheal tube (ETT) cuff pressure after retractor placement. This study aims to assess the effect of ETT cuff pressure adjustment on postoperative dysphagia, sore throat and dysphonia. In this, single-centre, observer and patient-blinded randomized controlled trial patients treated with anterior cervical spine surgery were randomized to adjustment of the ETT cuff pressure to 20 mmHg after placement of the retractor versus no adjustment. Primary outcome was the incidence and severity of postoperative dysphagia. Secondary outcomes were sore throat and dysphonia. Outcomes were evaluated on day one and 2 months after the operation. Of 177 enrolled patients, 162 patients (92.5%) could be evaluated. The incidence of dysphagia was 75.9% on day one and 34.6% 2 months after surgery. Dysphagia in the intervention and control group was present in 77.8% versus 74.1% of patients on day one (odds ratio (OR) 1.2, 95% confidence interval (CI) (0.6–2.5)) and 28.4% versus 40.7% of patients after 2 months (OR 0.6, 95% CI 0.3–1.1), respectively. Severity of dysphagia, sore throat and dysphonia was similar in both groups. Anterior cervical spine surgery is accompanied by a high incidence of postoperative dysphagia, lasting until at least 2 months after surgery in over a third of our patients. Adjusting ETT cuff pressure to 20 mmHg after retractor placement, as compared to controls, did not lower the risk for both short- and long-term dysphagia. Netherlands National Trial Registry Number: NTR 3542. These slides can be retrieved under electronic supplementary material.

Background Context: Patients with large annular defects after lumbar discectomy for disc herniation are at high risk of symptomatic recurrence and reoperation. Purpose: The present study aimed to determine whether a bone-anchored annular closure device, in addition to lumbar microdiscectomy, resulted in lower reherniation and reoperation rates plus increased overall success compared with lumbar microdiscectomy alone. Design: This is a multicenter, randomized superiority study. Patient Sample: Patients with symptoms of lumbar disc herniation for at least 6 weeks with a large annular defect (6–10 mm width) after lumbar microdiscectomy were included in the study. Outcome Measures: The co-primary end points determined a priori were recurrent herniation and a composite end point consisting of patient-reported, radiographic, and clinical outcomes. Study success required superiority of annular closure on both end points at 2-year follow-up. Methods: Patients received lumbar microdiscectomy with additional bone-anchored annular closure device (n=276 participants) or lumbar microdiscectomy only (control; n=278 participants). This research was supported by Intrinsic Therapeutics. Two authors received study-specific support morethan $10,000 per year, 8 authors received study-specific support less than $10,000 per year, and 11 authors received no study-specific support. Results: Among 554 randomized participants, 550 (annular closure device: n=272; control: n=278) were included in the modified intent-to-treat efficacy analysis and 550 (annular closure device: n=267; control: n=283) were included in the as-treated safety analysis. Both co-primary end points of the study were met, with recurrent herniation (50% vs. 70%, P

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. 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. 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. 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.

Object: Neuroforaminal stenosis has been documented frequently in patients with degenerative lumbar scoliosis. Pedicle screw fixation with posterior lumbar interbody fusion is usually performed although a debate has been started on the need for unilateral or bilateral screws, or interbody fusion only. Trabecular Metal is a porous tantalum biomaterial with good osteoconductive properties, which may be suitable for unilateral interbody fusion aiming at enlargement of neuroforamen. Methods: From July 2011 until January 2013, 20 consecutive patients with degenerative scoliosis-related foraminal stenosis were treated with unilateral stand-alone Trabecular Metal cages (Zimmer TM 500) without additional pedicle screw fixation. All patients presented with leg pain, with or without low back pain. Patients underwent CT and MRI to confirm neuroforaminal stenosis on the concave side of the degenerative scoliosis. All patients were followed-up and examined at 2 months after surgery (follow-up moment 1). Long-term follow-up (moment 2; mean 36 months) was available of 17 patients; 2 patients died of unrelated disease and 1 patient was lost to follow-up. On both follow-up moments, neutral and dynamic flexion-extension images were documented. Based on these images, the position of the cage was determined and the Cobb’s angle of the segmental scoliosis (angle between the cranial endplate of the upper vertebral body and the caudal endplate of the lower vertebral body) was measured. The clinical outcome was measured by the patients’ global perceived recovery according to the 7-point Likert scale; “complete recovery” and “almost complete recovery” were determined as good results. Results: Most of the patients were operated on L3L4 and L4L5 (70%). The mean duration of surgery was 56 ± 15 minutes. Surgical complications occurred in 5 patients, namely cerebrospinal fluid leakage (4 patients) and nerve root injury (1 patient) with sensory deficit. Good outcome (Likert 1 or 2) was reported by 14 patients (70%) on the shortterm follow-up (moment 1), and by 9 patients (53%) on the long-term follow-up (moment 2). Whenever Likert 1-3 was dichotomized, 95% of the patients on the short-term and 83% of the patients on the long-term reported at least some benefit from the operation. The mean Cobb’s angle improved significantly from 13.4 ± 5.1o pre-operatively, to 6.1 ± 3.5o at moment 1, and 7.1 ± 3.6o at moment 2 (P < 0.001). On follow-up moment 1 and 2, radiographic examination showed subsidence in 3 and 9 patients, respectively. Pseudarthrosis around the stand-alone cage was only seen at follow-up moment 2 in 3 patients. Conclusions: Instrumented fusion with bilateral pedicle screw fixation and interbody fusion may not always be necessary in patients with scoliosis-related foraminal stenosis. Unilateral stand-alone TM cages could be an alternative strategy in a subgroup of patients leading to correction of Cobb’s angle and improvement of symptoms in most cases. However, the long-term result is moderately satisfying and could be explained by the development of cage subsidence over time.

OBJECTIVE The performance of surgery for spinal metastases is rapidly increasing. Different surgical procedures, ranging from stabilization alone to stabilization combined with corpectomy, are thereby performed for various indications. Little is known about the impact of these different procedures on patient quality of life (QOL), but this factor is crucial when discussing the various therapeutic options with patients and their families. Thus, the authors of this study investigated the effect of various surgical procedures for spinal metastases on patient QOL. METHODS The authors prospectively followed a cohort of 113 patients with spinal metastases who were referred to their clinic for surgical evaluation between July 2012 and July 2014. Quality of life was assessed using the EQ-5D at intake and at 3, 6, 9, and 12 months after treatment. RESULTS Nineteen patients were treated conservatively, 41 underwent decompressive surgery with or without stabilization, 47 underwent a piecemeal corpectomy procedure with stabilization and expandable cage reconstruction, and 6 had a stabilization procedure without decompression. Among all surgical patients, the mean EQ-5D score was significantly increased from 0.44 pretreatment to 0.59 at 3 months after treatment (p < 0.001). Mean EQ-5D scores at 1 year after surgery further increased to 0.84 following decompression with stabilization, 0.74 after corpectomy with stabilization, and 0.94 after stabilization without decompression. Frankel scores also improved after surgery. There were no significant differences in improvements in EQ-5D scores and Frankel grades among the different surgical procedures. In addition, mortality and complication rates were similar. CONCLUSIONS Quality of life can improve significantly after various extensive and less extensive surgical procedures in patients with spinal metastases. The relatively invasive corpectomy procedure, as compared with alternative less invasive techniques, does not negatively affect outcome.

Expandable cages are widely used to reconstruct the spine after the removal of vertebral metastases. Long-term results, however, are lacking, and there is little information on reconstruction after multilevel corpectomies.To determine long-term outcome for reconstruction of the spine with expandable cages after single and multilevel corpectomies for spinal metastases.A prospective cohort study of 60 consecutive patients with spinal metastases treated with expandable cages.All patients were prospectively followed with regular clinical and radiographic evaluation. Outcome measures were the Frankel score, patients' self-reported recovery, radiological alignment of the spine, and neurologic plus biomechanical complications.Sixty patients were treated with expandable cages in our hospital in a 5-year period with a maximum follow-up of 6 years. Single-level reconstruction was performed in 48 cases, 2-level in 8, and 3-level in 4. Postoperatively, the Frankel score had improved significantly (p=.03), the segment height had increased (p=.02), and, in severe cases of kyphosis (20°), the regional angulation had been corrected compared with preoperatively (p.001). Complication rate, however, was high (36.7%), in particular after multilevel reconstruction, in which three cases had to be reoperated years after the initial surgery; reasons for this were hardware failure, progressive kyphosis, and bronchial perforation. Good recovery was reported in 70% of all patients.Expandable cages can be used successfully in reconstruction of the spine after single and multilevel corpectomies for spinal metastases. However, long-term complication rate is high. Promotion of bony fusion, prevention of soft-tissue damage, adequate posterior stabilization, and careful patient selection may reduce these complications.

Juvenile chronic arthritis (JCA) is a systemic disease of childhood affecting particularly joints. JCA is a heterogeneous group of inflammatory joint disorders with onset before the age of 16 years and is comprised of 7 subtype groups. The pathogenesis of JCA seen in the cervical spine is synovial inflammation, hyperaemia, and pannus formation at the occipitoatlantoaxial joints resulting in characteristic craniovertebral junction findings. Treatment of craniovertebral junction instability as a result of JCA is a challenge. The best treatment strategy may be difficult because of various radiological and clinical severities. A review of the literature and management considerations is presented.No randomised controlled trial or systematic review on this subject has been published. Only experts' opinions, case reports, and case series have been described. Thirty-four studies have been reviewed in this study. Involvement of the cervical spine in patients with JCA can lead to pain and functional disability. The subtypes that usually affect the cervical spine are the polyarticular type and systemic onset type and rarely the pauciarticular type. The most common cervical spine changes related to JCA are as follows: (1) apophyseal joint ankylosis at C2-C3, (2) atlantoaxial subluxation, (3) atlantoaxial impaction, (4) atlantoaxial rotatory fixation, and (5) growth disturbances of the cervical spine. The incidence of severe subluxations has decreased in the last decade as result of antirheumatoid drugs and biologicals. However, neurological compromise still occurs in JCA patients necessitating surgical treatment.Whenever the cervical spine is involved in rheumatoid arthritis patients without neurological deficits, conservative treatment is legitimate. Once patients develop neurological signs and symptoms, surgical treatment should be considered with particular focus to age, severity of the disease, and general health condition. Skilled anaesthesia is crucial and the surgical procedure should only be carried out in centres with experience in craniovertebral junction abnormalities.

Introduction Juvenile chronic arthritis (JCA) is a systemic disease of childhood affecting particularly joints. JCA is a heterogeneous group of inflammatory joint disorders with onset before the age of 16 years and is comprised of 7 subtype groups. The pathogenesis of JCA seen in the cervical spine is synovial inflammation, hyperaemia, and pannus formation at the occipitoatlantoaxial joints resulting in characteristic craniovertebral junction findings. Treatment of craniovertebral junction instability as a result of JCA is a challenge. The best treatment strategy may be difficult because of various radiological and clinical severities. A review of the literature and management considerations is presented.

In anterior cervical spine surgery a retractor is obligatory to approach the spine. Previous studies showed an increase of endotracheal tube cuff pressure after placement of a retractor. It is known that high endotracheal tube cuff pressure increases the incidence of postoperative dysphagia, hoarseness, and sore throat. However, until now no evidence supports the fact whether adjusting the endotracheal tube cuff pressure during anterior cervical spine surgery will prevent this comorbidity. We present the design of a randomized controlled trial to determine whether adjusting endotracheal tube cuff pressure after placement of a retractor during anterior cervical spine surgery will prevent postoperative dysphagia. 177 patients (aged 18–90 years) scheduled for anterior cervical spine surgery on 1 or more levels will be included. After intubation, endotracheal tube cuff pressure is manually inflated to 20 mm Hg in all patients. Patients will be randomized into two groups. In the control group endotracheal tube cuff pressure is not adjusted after retractor placement. In the intervention group endotracheal tube cuff pressure after retractor placement is maintained at 20 mm Hg and air is withdrawn when cuff pressure exceeds 20 mm Hg. Endotracheal tube cuff pressure is measured after intubation, before and after placement and removal of the retractor. Again air is inflated if cuff pressure sets below 20 mmHg after removal of the retractor. The primary outcome measure is postoperative dysphagia. Other outcome measures are postoperative hoarseness, postoperative sore throat, degree of dysphagia, length of hospital stay, and pneumonia. The study is a single centre double blind randomized trial in which patients and research nurses will be kept blinded for the allocated treatment during the follow-up period of 2 months. Postoperative dysphagia occurs frequently after anterior cervical spine surgery. This may be related to high endotracheal tube cuff pressure. Whether adaptation and maintaining the pressure after placement of the retractor will decrease the incidence of dysphagia, has to be determined by this trial. Netherlands Trial Register (NTR) 3542: http://www.trialregister.nl .

Background: Same-level reherniation and progressive degeneration with disc height loss are main causes of poor outcome after discectomy and may necessitate reoperation. A novel prosthesis for anular closure was developed to address these causes.Methods: The design of a multicenter, prospective, randomized, post-market superiority trial comparing limited lumbar discectomy augmented with this device (intervention group) with limited lumbar discectomy alone (control group) is presented.Results: Patients with single-level (L1-S1) posterior or posterolateral disc herniation and radiologic confirmation of neural compression for whom at least six weeks of conservative treatment has failed are eligible. Patients must have posterior disc height ≥5 mm at index level and baseline Oswestry and VAS leg pain scores of ≥40/100. Intraoperatively, subjects meeting anular defect size criteria post-discectomy (4-6 mm tall and 6-10 mm wide) will be randomized to study groups in a 1:1 ratio using centralized, web-based software. A Bayesian statistical approach will be used to enroll 400 to 800 subjects who will be followed for at least 24 months. Two co-primary endpoints will be assessed at 24 months: 1) a composite of leg pain, clinical function, disc height maintenance, and absence of reherniation, reoperation, and device failure; and 2) absence of reherniation based upon independent radiologic analysis. Conclusions: This type of analysis is becoming increasingly important as governments and health insurers continue to be pressured to spend limited healthcare funding wisely.

Objective. Rheumatoid arthritis commonly involves the upper cervical spine and can cause significant neurologic morbidity and mortality. However, there is no consensus on the optimal timing for surgical intervention: whether surgery should be performed prophylactically or once neurologic deficits have become apparent. Methods. A systematic review of the literature was performed to analyze neurologic outcome (Ranawat) and survival time (Kaplan-Meier) after surgical or conservative treatment using the MOOSE (Meta-analysis Of Observational Studies in Epidemiology) and GRADE (Grading of Recommendations, Assessment, Development and Evaluation system) criteria. Results. Twenty-five observational studies were selected. No randomized controlled trials (RCTs) could be found. All of the studies had a high risk of bias. Twenty-three studies reported the neurologic outcome after surgery for 752 patients. Neurologic deterioration rarely occurred in Ranawat I and II patients. Ranawat III patients did not fully recover. The 10-year survival rates were 77%, 63%, 47%, and 30% for Ranawat I, II, IIIA, and IIIB, respectively. The Ranawat IIIB patients had a significantly worse outcome. Another 185 patients treated conservatively were described in 7 studies. Neurologic deterioration rarely occurred in Ranawat I patients, but was almost inevitable in Ranawat II, IIIA, and IIIB patients. The Kaplan-Meier analysis showed a 10-year overall survival rate of 40%. Conclusion. There are no RCTs that compared surgery with conservative treatment. In observational studies, surgical neurologic outcomes were better than conservative treatment in all patients with cervical spine involvement, and in asymptomatic patients with no neurologic impairment (Ranawat I) the outcomes were similar; however, the evidence is weak. Survival time of surgical and conservative treatment could not be compared. © 2009, American College of Rheumatology.

Background Rheumatoid arthritis is a chronic inflammatory disease, which affects 1% of the population. Hands and feet are most commonly involved followed by the cervical spine. The spinal column consists of vertebrae stabilized by an intricate network of ligaments. Especially in the upper cervical spine, rheumatoid arthritis can cause degeneration of these ligaments, causing laxity, instability and subluxation of the vertebral bodies. Subsequent compression of the spinal cord and medulla oblongata can cause severe neurological deficits and even sudden death. Once neurological deficits occur, progression is inevitable although the rapidity of progression is highly variable. The first signs and symptoms are pain at the back of the head caused by compression of the major occipital nerve, followed by loss of strength of arms and legs. The severity of the subluxation can be observed with radiological investigations (MRI, CT) with a high sensitivity. The authors have sent a Delphi Questionnaire about the current treatment strategies of craniocervical involvement by rheumatoid arthritis to an international forum of expert rheumatologists and surgeons. The timing of surgery in patients with radiographic instability without evidence of neurological deficit is an area of considerable controversy. If signs and symptoms of myelopathy are present there is little chance of recovery to normal levels after surgery. Design In this international multicenter randomized clinical trial, early surgical atlantoaxial fixation in patients with rheumatoid arthritis and radiological abnormalities without neurological deficits will be compared with prolonged conservative treatment. The main research question is whether early surgery can prevent radiological and neurological progression. A cost-effectivity analysis will be performed. 250 patients are needed to answer the research question. Discussion Early surgery could prevent serious neurological deficits, but may have peri-operative morbidity and loss of rotation of the head and neck. The objective of this study is to identify the best timing of surgery for patients at risk for the development of neurological signs and symptoms.

Background Anterior cervical discectomy with interbody fusion cages is considered the standard surgical procedure in patients with cervical disc herniation. However, PEEK or metal cages have some undesirable imaging characteristics, leading to a search for alternative materials not creating artifacts on images; silicon nitride ceramic. Whether patients treated with silicon nitride ceramic cages have similar functional outcome as patients treated with PEEK cages is not known. We present the design of the CASCADE trial on effectiveness of ceramic cages versus PEEK cages in patients with cervical disc herniation and/or osteophytes. Methods/Design Patients (age 18–75 years) with monoradicular symptoms in one or both arms lasting more than 8 weeks, due to disc herniation and/or osteophytes, are eligible for the trial. The study is designed as a randomized controlled equivalence trial in which patients are blinded to the type of cage for 1 year. The total follow-up period is 2 years. The primary outcome measure is improvement in the Neck and Disability Index (NDI). Secondary outcomes measures include improvement in arm pain and neck pain (VAS), SF-36 and patients' perceived recovery. The final elements of comparison are perioperative statistics including operating time, blood loss, length of hospital stay, and adverse events. Lateral plane films at each follow-up visit and CT scan (at 6 months) will be used to judge fusion and the incidence of subsidence. Based on a power of 90% and assuming 8% loss to follow-up, 100 patients will be randomized into the 2 groups. The first analysis will be conducted when all patients have 1 year of follow-up, and the groups will be followed for 1 additional year to judge stability of outcomes. Discussion While the new ceramic cage has received the CE Mark based on standard compliance and animal studies, a randomized comparative study with the golden standard product will provide more conclusive information for clinicians. Implementation of any new device should only be done after completion of randomized controlled effectiveness trials.