Category: Randomized clinical trial

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Placebo-Controlled Effectiveness of Idiopathic Normal Pressure Hydrocephalus Shunting

Neurosurgery 92:481–489, 2023

Multiple prospective nonrandomized studies have shown 60% to 70% of patients with idiopathic normal pressure hydrocephalus (iNPH) improve with shunt surgery, but multicenter placebo-controlled trial data are necessary to determine its effectiveness.

OBJECTIVE: To evaluate the effectiveness of cerebrospinal fluid shunting in iNPH through comparison of open vs placebo shunting groups at 4 months using a pilot study.

METHODS: Patients were randomized to a Codman Certas Plus valve (Integra LifeSciences) set at 4 (open shunt group) or 8 (“virtual off”; placebo group). Patients and assessors were blinded to treatment group. The primary outcome measure was 10-m gait velocity. Secondary outcome measures included functional scales for bladder control, activities of daily living, depression, and quality of life. Immediately after 4-month evaluation, all shunts were adjusted in a blinded fashion to an active setting and followed to 12months after shunting.

RESULTS: A total of 18 patients were randomized. At the 4-month evaluation, gait velocity increased by 0.28 ± 0.28m/s in the open shunt group vs 0.04 ± 0.17m/s in the placebo group. The estimated treatment difference was 0.22 m/s ([P = .071], 95% CI 0.02 to 0.46). Overactive Bladder Short Form symptom bother questionnaire significantly improved in open shunt vs placebo (P = .007). The 4-month treatment delay did not reduce the subsequent response to active shunting, nor did it increase the adverse advents rate at 12 months.

CONCLUSION: This multicenter, randomized pilot study demonstrates the effectiveness, safety, and feasibility of a placebo-controlled trial in iNPH, and found a trend suggesting gait velocity improves more in the open shunt group than in the placebo group.

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Randomized Trial Comparing Burr Hole Craniostomy, Minicraniotomy, and Twist Drill Craniostomy for Treatment of Chronic Subdural Hematoma

Neurosurgery 91:304–311, 2022

The mainstay of treatment for symptomatic or large chronic subdural hematoma (CSDH) is surgery, but controversy still exists regarding the best surgical technique. Three different techniques are commonly used: burr hole craniostomy (BHC), minicraniotomy (MC), and twist drill craniostomy (TDC).

OBJECTIVE: To determine which surgical technique for drainage of CSDH offers best results.

METHODS: We set up a multicenter prospective randomized trial (Comparison of Chronic Subdural Hematoma Treatment [COMPACT] trial) comparing BHC, MC, and TDC for the surgical treatment of CSDH. The primary end point was reoperation rate, and secondary end points included complication rates and clinical outcome. Patients were considered to have good outcome when they did not undergo reoperation, suffered no surgical or medical complication, and had no related mortality. Clinical outcome was also evaluated by evolution of the Markwalder score and the modified Rankin score.

RESULTS: Two-hundred forty-five patients were included in the final analysis: 79 BHC, 84 MC, and 82 TDC. Mean duration of surgery was shorter for TDC than for BHC and MC (P < .001). Reoperation rate was 7.6% for BHC, 13.1% for MC, and 19.5% for TDC (P = .07). This trend toward better results for BHC was not statistically significant in logistic regression analysis. The proportion of patients with good outcome was 78.5% for BHCgroup, 76.2% for MC, and 69.5% for TDC (P = .4). Evolution of the Markwalder score and modified Rankin score were not significantly different between treatment groups.

CONCLUSION: All 3 techniques are effective at treating patients with CSDH with eventual 6-month outcome being similar. Although not reaching statistical significance in our study, BHC offers the lowest recurrence rate combined with manageable complication rate.

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Augmented reality visualization in brain lesions: a prospective randomized controlled evaluation of its potential and current limitations in navigated microneurosurgery

Acta Neurochirurgica (2022) 26:3–14

Augmented reality (AR) has the potential to support complex neurosurgical interventions by including visual information seamlessly. This study examines intraoperative visualization parameters and clinical impact of AR in brain tumor surgery.

Methods Fifty-five intracranial lesions, operated either with AR-navigated microscope (n = 39) or conventional neuronavigation (n = 16) after randomization, have been included prospectively. Surgical resection time, duration/type/mode of AR, displayed objects (n, type), pointer-based navigation checks (n), usability of control, quality indicators, and overall surgical usefulness of AR have been assessed.

Results AR display has been used in 44.4% of resection time. Predominant AR type was navigation view (75.7%), followed by target volumes (20.1%). Predominant AR mode was picture-in-picture (PiP) (72.5%), followed by 23.3% overlay display. In 43.6% of cases, vision of important anatomical structures has been partially or entirely blocked by AR information. A total of 7.7% of cases used MRI navigation only, 30.8% used one, 23.1% used two, and 38.5% used three or more object segmentations in AR navigation. A total of 66.7% of surgeons found AR visualization helpful in the individual surgical case. AR depth information and accuracy have been rated acceptable (median 3.0 vs. median 5.0 in conventional neuronavigation). The mean utilization of the navigation pointer was 2.6   /resection hour (AR) vs. 9.7   /resection hour (neuronavigation); navigation effort was significantly reduced in AR (P < 0.001).

Conclusions The main benefit of HUD-based AR visualization in brain tumor surgery is the integrated continuous display allowing for pointer-less navigation. Navigation view (PiP) provides the highest usability while blocking the operative field less frequently. Visualization quality will benefit from improvements in registration accuracy and depth impression.

German clinical trials registration number. DRKS00016955.

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Decompression alone versus decompression and instrumented fusion for the treatment of isthmic spondylolisthesis: a randomized controlled trial

J Neurosurg Spine 35:687–697, 2021

The most advocated surgical technique to treat symptoms of isthmic spondylolisthesis is decompression with instrumented fusion. A less-invasive classical approach has also been reported, which consists of decompression only. In this study the authors compared the clinical outcomes of decompression only with those of decompression with instrumented fusion in patients with isthmic spondylolisthesis.

METHODS Eighty-four patients with lumbar radiculopathy or neurogenic claudication secondary to low-grade isthmic spondylolisthesis were randomly assigned to decompression only (n = 43) or decompression with instrumented fusion (n = 41). Primary outcome parameters were scores on the Roland Disability Questionnaire (RDQ), separate visual analog scales (VASs) for back pain and leg pain, and patient report of perceived recovery at 12-week and 2-year follow-ups. The proportion of reoperations was scored as a secondary outcome measure. Repeated measures ANOVA according to the intention-to-treat principle was performed.

RESULTS Decompression alone did not show superiority in terms of disability scores at 12-week follow-up (p = 0.32, 95% CI −4.02 to 1.34), nor in any other outcome measure. At 2-year follow-up, RDQ disability scores improved more in the fusion group (10.3, 95% CI 3.9–8.2, vs 6.0, 95% CI 8.2–12.4; p = 0.006, 95% CI −7.3 to −1.3). Likewise, back pain decreased more in the fusion group (difference: −18.3 mm, CI −32.1 to −4.4, p = 0.01) on a 100-mm VAS scale, and a higher proportion of patients perceived recovery as showing “good results” (44% vs 74%, p = 0.01). Cumulative probabilities for reoperation were 47% in the decompression and 13% in the fusion group (p < 0.001) at the 2-year follow-up.

CONCLUSIONS In patients with isthmic spondylolisthesis, decompression with instrumented fusion resulted in comparable short-term results, significantly better long-term outcomes, and fewer reoperations than decompression alone. Decompression with instrumented fusion is a superior surgical technique that should in general be offered as a first treatment option for isthmic spondylolisthesis, but not for degenerative spondylolisthesis, which has a different etiology. Clinical trial registration number: NTR1300 (Netherlands Trial Register)

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A critical comparison between the semisitting and the supine positioning in vestibular schwannoma surgery: subgroup analysis of a randomized, multicenter trial

J Neurosurg 133:249–256, 2020

Patient positioning in vestibular schwannoma (VS) surgery is a matter of ongoing discussion. Factors to consider include preservation of cranial nerve functions, extent of tumor resection, and complications. The objective of this study was to determine the optimal patient positioning in VS surgery.

METHODS A subgroup analysis of a randomized, multicenter trial that investigated the efficacy of prophylactic nimodipine in VS surgery was performed to investigate the impact of positioning (semisitting or supine) on extent of resection, functional outcomes, and complications. The data of 97 patients were collected prospectively. All procedures were performed via a retrosigmoid approach. The semisitting position was chosen in 56 patients, whereas 41 patients were treated while supine.

RESULTS Complete resection was obtained at a higher percentage in the semisitting as compared to the supine position (93% vs 73%, p = 0.002). Logistic regression analysis revealed significantly better facial nerve function in the early postoperative course in the semisitting group (p = 0.004), particularly concerning severe facial nerve paresis (House- Brackmann grade IV or worse; p = 0.002). One year after surgery, facial nerve function recovered. However, there was still a tendency for better facial nerve function in the semisitting group (p = 0.091). There were no significant differences between groups regarding hearing preservation rates. Venous air embolism with the necessity to terminate surgery occurred in 2 patients in the semisitting position (3.6%). Supplementary analysis with a 2-tailed permutation randomization with 10,000 permutations of treatment choice and a propensity score matching showed either a tendency or significant results for better facial nerve outcomes in the early postoperative course and extent of resection in the semisitting group.

CONCLUSIONS Although the results of the various statistical analyses are not uniform, the data indicate better results concerning both a higher rate of complete removal (according to the intraoperative impression of the surgeon) and facial nerve function after a semisitting as compared to the supine position. These advantages may justify the potential higher risk for severe complications of the semisitting position in VS surgery. The choice of positioning has to consider all individual patient parameters and risks carefully.

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The Efficacy of Ultrasonic Bone Scalpel for Unilateral Cervical Open-Door Laminoplasty: A Randomized Controlled Trial

Neurosurgery 86:825–834, 2020

In cervical open-door laminoplasty for cervical myelopathy, a high-speed rotatory drill and rongeurs are used to make unicortical troughs and bicortical openings in the laminae. The lamina is reflected at the trough to enlarge the spinal canal, followed by bone healing on the hinge side to stabilize laminoplasty. The ultrasonic bone scalpel (UBS) has been used due to theoretical advantages including a better hinge union rate, less soft tissue trauma, less neurological injury, and shorter operative time.

OBJECTIVE: To assess the superiority of UBS for hinge union compared to the drill through randomized controlled trial.

METHODS: In 190 randomly allocated cervical myelopathy patients, the trough and opening at the lamina were made using either the drill (n = 95) or UBS (n = 95) during 2015 to 2018. The primary outcome was the hinge union rate on 6-mo postoperative computed tomography. Secondary outcomes included the hinge union rate at 12 mo, the operative time, intraoperative/postoperative bleeding, neurological injury, complications, and clinical outcomes over a 24-mo follow-up.

RESULTS: Hinge union in all laminae was achieved in 60.0% (drill) and 43.9% (UBS) of patients at 6mo (intention-to-treat analysis; P = .02; odds ratio, 2.1) and in 91.9% (drill) and 86.5% (UBS) at 12mo. Dural injury only occurred in the drill group (2.1%), and the UBS group showed significantly less intraoperative bleeding (P < .01). The other secondary outcomes did not differ between groups.

CONCLUSION: The hinge union rate was inferior in the UBS group at 6mo postoperatively, but UBS was efficacious in reducing dural injuries and bleeding.

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Surgical management of spontaneous intracerebral hemorrhage: insights from randomized controlled trials

Neurosurgical Review (2020) 43:999–1006

Spontaneous intracerebral hemorrhages (ICH) are a major cause of neurologic morbidity and mortality. The optimal management strategy of ICH remains controversial.

We examine the available randomized controlled trial (RCT) data regarding neurosurgical evacuation of ICHs. A systematic literature review on surgical evacuation of spontaneous ICHs was performed to identify pertinent RCT data published between 1980 and 2019.

We identified five RCTs that assessed the clinical impact of evacuation of spontaneous ICHs. Data from two high-quality RCTs randomizing 1033 and 601 patients with spontaneous ICHs (Surgical Trial in Intracerebral Hemorrhage (STICH) I and II) (1) failed to demonstrate a significant clinical benefit of routine open surgical evacuation of spontaneous cortical ICHs and (2) reinforced the high morbidity and mortality associated with ICH. These trials were nonetheless limited by high (> 20%) crossover from the medical to surgical arms. Data from three smaller RCTs on minimally invasive (stereotactic and endoscopic) surgical approaches randomizing 377, 242, and 100 patients with spontaneous ICHs suggest potential benefits relating to mortality and functional outcomes in patients with subcortical ICHs.

While these RCTs do not clearly define the role of surgical resection for ICHs, they provide insights into opportunities for patient advocacy, clinical trial design, and future research studies. Ongoing studies building upon the potential for minimally invasive approaches for ICH evacuation may expand the surgical indications for ICH.

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The Hydrogel Endovascular Aneurysm Treatment Trial (HEAT): A Randomized Controlled Trial of the Second-Generation Hydrogel Coil

Neurosurgery 86:615–624, 2020

Aneurysm recurrence after coiling has been associated with aneurysm growth, (re)hemorrhage, and a greater need for follow-up. The second-generation HydroCoil Embolic System (HES; MicroVention, Inc) consists of a platinum core with integrated hydrogel and was developed to reduce recurrence through enhancing packing density and healing within the aneurysm.

OBJECTIVE: To compare recurrence between the second-generation HES and bare platinum coil (BPC) in the new-generation Hydrogel Endovascular Aneurysm Treatment Trial (HEAT).

METHODS: HEAT is a randomized, controlled trial that enrolled subjects with ruptured or unruptured 3- to 14-mm intracranial aneurysms amenable to coiling. The primary endpoint was aneurysm recurrence using the Raymond-Roy scale. Secondary endpoints included minor and major recurrence, packing density, adverse events related to the procedure and/or device, mortality, initial complete occlusion, aneurysm retreatment, hemorrhage fromtarget aneurysm during follow-up, aneurysmocclusion stability, and clinical outcome at final follow-up.

RESULTS: A total of 600 patients were randomized (HES, n = 297 and BPC, n = 303), including 28% with ruptured aneurysms. Recurrence occurred in 11 (4.4%) subjects in the HES arm and 44 (15.4%) subjects in the BPC arm (P = .002). While the initial occlusion rate was higher with BPC, the packing density and both major and minor recurrence rates were in favor of HES. Secondary endpoints including adverse events, retreatment, hemorrhage, mortality, and clinical outcome did not differ between arms.

CONCLUSION: Coiling of small-to-medium aneurysms with second-generation HES resulted in less recurrence when compared to BPC, without increased harm. These data further support the use of the second-generation HES for the embolization of intracranial aneurysms.

 

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Percutaneous Transforaminal Endoscopic Discectomy Versus Microendoscopic Discectomy for Lumbar Disc Herniation

SPINE Volume 45, Number 8, pp 493–503

Study Design. A prospective randomized controlled study.

Objective. To clarify whether percutaneous transforaminal endoscopic discectomy (PTED) has better clinical outcomes and less surgical trauma compared with microendoscopic discectomy (MED).

Summary of Background Data. Two kinds of minimally invasive spine surgeries, PTED and MED, are now widely used for the treatment of lumbar disc herniation (LDH). It is still a controversial issue to choose the proper surgical approach.

Methods. In this single-center, open-label, randomized controlled trial, patients were included if they had persistent signs and symptoms of radiculopathy with corresponding imagingconfirmed LDH, and were randomly allocated to PTED or MED group. The primary outcome was the score of Oswestry Disability Index (ODI) and the secondary outcomes included the score of Medical Outcomes Study 36-Item Short-Form Health Survey bodily pain and physical function scales, European Quality of Life-5 Dimensions, and Visual Analogue Scales for back pain and leg pain.

Results. A total of 250 participants were randomly assigned to two treatment groups, 241 of that received the specific surgical procedure. Two hundred twenty-two patients (92.1%) have completed the 2-year follow-up. Both the primary and secondary outcomes did not differ significantly between the two treatment groups at each prespecified follow-up time (P>0.05). For PTED, the postoperative improvement of ODI score in the median herniation subgroup was less compared with paramedian subgroup. For MED, less improvement of ODI score was found in far-lateral herniation subgroup compared with paramedian subgroup. Total complication rate over the course of 2 year was 13.44% in PTED group and 15.57% in MED group (P¼0.639). Ten cases (8.40%) in PTED group and five cases (4.10%) in MED group suffered from residue/recurrence of herniation, for which reoperation was required.

Conclusion. Over the 2-year follow-up period, PTED did not show superior clinical outcomes and did not appear to be safer procedure for patients with LDH compared with MED. PTED had inferior results for median disc herniation, whereas MED did not appear to be the best option for far-lateral disc herniation.

Level of Evidence: 2

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Does lumbar drainage reduce postoperative cerebrospinal fluid leak after endoscopic endonasal skull base surgery? A prospective, randomized controlled trial

J Neurosurg 131:1172–1178, 2019

Based on a null hypothesis that the use of short-term lumbar drainage (LD) after endoscopic endonasal surgery (EES) for intradural pathology does not prevent postoperative CSF leaks, a trial was conducted to assess the effect of postoperative LD on postoperative CSF leak following standard reconstruction.

METHODS A prospective, randomized controlled trial of lumbar drain placement after endoscopic endonasal skull base surgery was performed from February 2011 to March 2015. All patients had 3-month follow-up data. Surgeons were blinded to which patients would or would not receive the drain until after closure was completed. An a priori power analysis calculation assuming 80% of power, 5% postoperative CSF leak rate in the no-LD group, and 16% in the LD group determined a planned sample size of 186 patients. A routine data and safety check was performed with every 50 patients being recruited to ensure the efficacy of randomization and safety. These interim tests were run by a statistician who was not blinded to the arms they were evaluating. This study accrued 230 consecutive adult patients with skull base pathology who were eligible for endoscopic endonasal resection. Inclusion criteria (high-flow leak) were dural defect greater than 1 cm2 (mandatory), extensive arachnoid dissection, and/or dissection into a ventricle or cistern. Sixty patients were excluded because they did not meet the inclusion criteria. One hundred seventy patients were randomized to either receive or not receive a lumbar drain.

RESULTS One hundred seventy patients were randomized, with a mean age of 51.6 years (range 19–86 years) and 38% were male. The mean BMI for the entire cohort was 28.1 kg/m 2 . The experimental cohort with postoperative LD had an 8.2% rate of CSF leak compared to a 21.2% rate in the control group (odds ratio 3.0, 95% confidence interval 1.2–7.6, p = 0.017). In 106 patients in whom defect size was measured intraoperatively, a larger defect was associated with postoperative CSF leak (6.2 vs 2.9 cm 2 , p = 0.03). No significant difference was identified in BMI between those with (mean28.4 ± 4.3 kg/m 2 ) and without (mean 28.1 ± 5.6 kg/m 2 ) postoperative CSF leak (p = 0.79). Furthermore, when patients were grouped based on BMI < 25, 25–29.9, and > 30 kg/m 2 , no difference was noted in the rates of CSF fistula (p =0.97).

CONCLUSIONS Among patients undergoing intradural EES judged to be at high risk for CSF leak as defined by the study’s inclusion criteria, perioperative LD used in the context of vascularized nasoseptal flap closure significantly reduced the rate of postoperative CSF leaks.

Clinical trial registration no.: NCT03163134 (clinicaltrials.gov). https://thejns.org/doi/abs/10.3171/2018.4.JNS172447

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Two-level cervical disc arthroplasty versus anterior cervical discectomy and fusion: 10-year outcomes of a prospective, randomized investigational device exemption clinical trial

J Neurosurg Spine 31:508–518, 2019

The authors assessed the 10-year clinical safety and effectiveness of cervical disc arthroplasty (CDA) to treat degenerative cervical spine disease at 2 adjacent levels compared to anterior cervical discectomy and fusion (ACDF).

METHODS A prospective, randomized, controlled, multicenter FDA-approved clinical trial was conducted comparing the low-profile titanium ceramic composite–based Prestige LP Cervical Disc (n = 209) at two levels with ACDF (n = 188). Ten-year follow-up data from a postapproval study were available on 148 CDA and 118 ACDF patients and are reported here. Clinical and radiographic evaluations were completed preoperatively, intraoperatively, and at regular postoperative follow-up intervals for up to 10 years. The primary endpoint was overall success, a composite variable that included key safety and efficacy considerations. Ten-year follow-up rates were 86.0% for CDA and 84.9% for ACDF.

RESULTS From 2 to 10 years, CDA demonstrated statistical superiority over ACDF for overall success, with rates at 10 years of 80.4% versus 62.2%, respectively (posterior probability of superiority [PPS] = 99.9%). Neck Disability Index (NDI) success was also superior, with rates at 10 years of 88.4% versus 76.5% (PPS = 99.5%), as was neurological success (92.6% vs 86.1%; PPS = 95.6%). Improvements from preoperative results in NDI and neck pain scores were consistently statistically superior for CDA compared to ACDF. All other study effectiveness measures were at least noninferior for CDA compared to ACDF through the 10-year follow-up period, including disc height. Mean angular ranges of motion at treated levels were maintained in the CDA group for up to 10 years. The rates of grade IV heterotopic ossification (HO) at the superior and inferior levels were 8.2% and 10.3%, respectively. The rate of severe HO (grade III or IV) did not increase significantly from 7 years (42.4%) to 10 years (39.0%). The CDA group had fewer serious (grade 3–4) implantrelated or implant/surgical procedure–related adverse events (3.8% vs 8.1%; posterior mean 95% Bayesian credible interval [BCI] of the log hazard ratio [LHR] -0.92 [-1.88, -0.01]). The CDA group also had statistically fewer secondary surgical procedures at the index levels (4.7%) than the ACDF group (17.6%) (LHR [95% BCI] -1.39 [-2.15, -0.61]) as well as at adjacent levels (9.0% vs 17.9%).

CONCLUSIONS The Prestige LP Cervical Disc, implanted at two adjacent levels, maintains improved clinical outcomes and segmental motion 10 years after surgery and is a safe and effective alternative to fusion.

Clinical trial registration no.: NCT00637156 (clinicaltrials.gov)

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Postoperative Rigid Cervical Collar Leads to Less Axial Neck Pain in the Early Stage After Open-Door Laminoplasty—A Single-Blinded Randomized Controlled Trial

Neurosurgery, Volume 85, Issue 3, September 2019, Pages 325–334

Cervical collars are used after laminoplasty to protect the hinge opening, reduce risks of hinge fractures, and avoid spring-back phenomena. However, their usemay lead to reduced range of motion and worse neck pain.

OBJECTIVE: To investigate the clinical, radiological, and functional outcomes of patients undergoing single-door laminoplasty with or without collar immobilization.

METHODS: This was a prospective, parallel, single-blinded randomized controlled trial. Patients underwent standardized single-door laminoplasty with mini-plates for cervical myelopathy and were randomly allocated into 2 groups based on the use of collar postoperatively. Clinical assessments included cervical range of motion, axial neck pain (VAS [visual analogue scale]), and objective scores (short-form 36-item, neck disability index, andmodified Japanese Orthopaedic Association). All assessmentswere performed preoperativelyandatpostoperative 1, 2, 3, and 6 wk, and 3, 6, and 12 mo. Comparative analysis was performed via analysis of variance adjusted by baseline scores, sex, and age as covariates.

RESULTS: A total of 35 patients were recruited and randomized to collar use (n = 16) and without (n = 19). There were no dropouts or complications. There were no differences between groups at baseline. Subjects had comparable objective scores and range of motion at postoperative time-points. Patientswithout collar use had higher VAS at postoperative 1 wk (5.4 vs 3.5; P = .038) and 2 wk (3.5 vs 1.5; P = .028) but subsequently follow-up revealed no differences between the 2 groups.

CONCLUSION: The use of a rigid collar after laminoplasty leads to less axial neck pain in the first 2 wk after surgery. However, there is no additional benefit with regards to range of motion, quality of life, and complication risk.

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Intrathecal Morphine Following Lumbar Fusion: A Randomized, Placebo-Controlled Trial

Neurosurgery, Volume 85, Issue 2, August 2019, Pages 189–198

Despite the potential for faster postoperative recovery and the ease of direct intraoperative injection, intrathecal morphine is rarely provided in lumbar spine surgery.

OBJECTIVE: To evaluate the safety and efficacy of intrathecal morphine following lumbar fusion.

METHODS: We randomly assigned 150 patients undergoing elective instrumented lumbar fusion to receive a single intrathecal injection of morphine (0.2 mg) or placebo (normal saline) immediately prior to wound closure. The primary outcome was pain on the visual- analogue scale during the first 24 h after surgery. Secondary outcomes included respiratory depression, treatment-related side effects, postoperative opioid requirements, and length of hospital stay. An intention-to-treat, repeated-measures analysis was used to estimate outcomes according to treatment in the primary analysis.

RESULTS: The baseline characteristics of the 2 groups were similar. Intrathecal morphine reduced pain both at rest (32% area under the curves [AUCs] difference, P < .01) and with movement (22% AUCs difference, P < .02) during the initial 24 h after surgery. The risk of respiratory depression was not increased by intrathecal morphine (hazard ratio, 0.86; 95% confidence interval, 0.44 to 1.68; P = .66). Although postoperative opioid requirements were reduced with intrathecal morphine (P < .03), lengths of hospital stay were similar (P = .32). Other than a trend towards increased intermittent catheterization among patients assigned to intrathecal morphine (P = .09), treatment-related side effects did not significantly differ. The early benefits of intrathecal morphine on postoperative pain were no longer apparent after 48 h.

CONCLUSION: A single intrathecal injection of 0.2 mg of morphine safely reduces postoperative pain following lumbar fusion.

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Effectiveness of anterior cervical discectomy with or without interbody fusion and arthroplasty in the treatment of cervical disc herniation; a double-blinded randomised controlled trial

The Spine J Volume 19, Issue 6, Pages 965–975. 2019

Motion preserving anterior cervical disc arthroplasty (ACDA) in patients with cervical radiculopathy was introduced to prevent symptomatic adjacent disc degeneration as compared to anterior cervical discectomy and fusion (ACDF). Prior reports suggest that ACDF is not more effective than anterior cervical discectomy (ACD) alone for the treatment of cervical radiculopathy.

Purpose: To evaluate whether patients with cervical radiculopathy due to a herniated disc benefit more from undergoing ACDA, ACDF, or ACD in terms of clinical outcome measured by the Neck Disability Index (NDI).

Study design: Double-blinded randomized controlled trial

Methods: One hundred-nine patients with one level herniated disc were randomized to one of the following treatments: ACDA, ACDF with intervertebral cage, ACD without fusion. Clinical and radiological outcome was measured by NDI, Visual Analogue Scale (VAS) neck pain, VAS arm pain, SF36, EQ-5D, patients’ self-reported perceived recovery, radiographic cervical curvature, and adjacent segment degeneration (ASD) parameters at baseline and until two years after surgery. BBraun Medical paid €298.837 to cover the costs for research nurses.

Results: The NDI declined from 41 to 47 points at baseline to 19±15 in the ACD group, 19± 18 in the ACDF group, and 20±22 in the ACDA group after surgery (p=0.929). VAS arm and neck pain declined to half its baseline value and decreased below the critical value of 40 mm. Quality of life, measured by the EQ-5D, increased in all three groups. ASD parameters were comparable in all three groups as well. No statistical differences were demonstrated between the treatment groups.

Conclusions: The hypothesis that ACDA would lead to superior clinical outcome in comparison to ACDF or ACD could not be confirmed during a two-year follow-up time period. Single level ACD without implanting an intervertebral device may be a reasonable alternative to ACDF or ACDA.

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Randomized controlled trials comparing surgery to non-operative management in neurosurgery: a systematic review

Acta Neurochirurgica (2019) 161:627–634

A randomized controlled trial (RCT) remains the pinnacle of clinical research design. However, RCTs in neurosurgery, especially those comparing surgery to non-operative treatment, are rare and their relevance and applicability have been questioned. This study set out to assess trial design and quality and identify their influence on outcomes in recent neurosurgical trials that compare surgery to non-operative treatment.

Methods From 2000 to 2017, PubMed and Embase databases and four trial registries were searched. RCTs were evaluated for study design, funding, adjustments to reported outcome measures, accrual of patients, and academic impact.

Results Eighty-two neurosurgical RCTs were identified, 40 in spine disorders, 19 neurovascular and neurotrauma, 11 functional neurosurgery, ten peripheral nerve, and two pituitary surgery. Eighty-four RCTs were registered, of which some are ongoing. Trial registration rate differed per subspecialty. Funding was mostly from non-industry institutions (58.5%), but 25.6% of RCTs did not report funding sources. 36.4% of RCTs did not report a difference between surgical and non-operative treatment, 3.7% favored non-operative management. Primary and secondary outcome measures were changed in 13.2% and 34.2% of RCTs respectively and varied by subspecialty. 41.9% of RCTs subtracted ≥ 10% of the anticipated accrual and 12.9% of RCTs added ≥ 10%. 7.3% of registered RCTs were terminated, mostly due to too slow recruitment. Subspecialty, registration, funding, masking, population size, and changing outcome measures were not significantly associated with a reported benefit of surgery. High Jadad scores (≥ 4) were negatively associated with a demonstration of surgical benefit (P < 0.05).

Conclusions Neurosurgical RCTs comparing surgical to non-operative treatment often find a benefit for surgical treatment. Changes to outcome measurements and anticipated accrual are common and funding sources are not always reported.

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Artificial disc replacement versus fusion in patients with cervical degenerative disc disease and radiculopathy: a randomized controlled trial with 5-year outcomes

J Neurosurg Spine 30:323–331, 2019

The method of artificial disc replacement (ADR) has been developed as an alternative treatment to fusion surgery after decompression for cervical degenerative disc disease (DDD) with radiculopathy. Preserving the motion of ADR devices aims to prevent immobilization side effects such as adjacent-segment pathology (ASP). However, longterm follow-up evaluations using MRI are needed to investigate if this intent is achieved.

METHODS The authors performed a randomized controlled trial with 153 patients (mean age 47 years) undergoing surgery for cervical radiculopathy. Eighty-three patients received an ADR and 70 patients underwent fusion surgery. Outcomes after 5 years were assessed using patient-reported outcome measures using the Neck Disability Index (NDI) score as the primary outcome; motion preservation and heterotopic ossification by radiography; ASP by MRI; and secondary surgical procedures.

RESULTS Scores on the NDI were approximately halved in both groups: the mean score after 5 years was 36 (95% confidence interval [CI] 31–41) in the ADR group and 32 (95% CI 27–38) in the fusion group (p = 0.48). There were no other significant differences between the groups in six other patient-related outcome measures. Fifty-four percent of the patients in the ADR group preserved motion at the operated cervical level and 25% of the ADRs were spontaneously fused. Seventeen ADR patients (21%) and 7 fusion patients (10%) underwent secondary surgery (p = 0.11), with 5 patients in each group due to clinical ASP.

CONCLUSIONS In patients with cervical DDD and radiculopathy decompression as well as ADR, surgery did not result in better clinical or radiological outcomes after 5 years compared with decompression and fusion surgery.

Clinical trial registration no.: 44347115 (ISRCTN).

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Symptomatic Adjacent Level Disease Requiring Surgery: Analysis of 10-Year Results From a Prospective, Randomized, Clinical Trial Comparing Cervical Disc Arthroplasty to Anterior Cervical Fusion

Neurosurgery 84:347–354, 2019

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 BRYANR  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.

 

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Randomized controlled study comparing 2 surgical techniques for decompressive craniectomy: with watertight duraplasty and without watertight duraplasty

J Neurosurg 129:1017–1023, 2018

Decompressive craniectomy (DC) is a widely used procedure in neurosurgery; however, few studies focus on the best surgical technique for the procedure. The authors’ objective was to conduct a prospective randomized controlled trial comparing 2 techniques for performing DC: with watertight duraplasty and without watertight duraplasty (rapid-closure DC).

METHODS The study population comprised patients ranging in age from 18 to 60 years who were admitted to the Neurotrauma Service of the Hospital da Restauração with a clinical indication for unilateral decompressive craniectomy. Patients were randomized by numbered envelopes into 2 groups: with watertight duraplasty (control group) and without watertight duraplasty (test group). After unilateral DC was completed, watertight duraplasty was performed in the control group, while in the test group, no watertight duraplasty was performed and the exposed parenchyma was covered with Surgicel and the remaining dura mater. Patients were then monitored daily from the date of surgery until hospital discharge or death. The primary end point was the incidence of surgical complications (CSF leak, wound infection, brain abscess, or subgaleal fluid collections). The following were analyzed as secondary end points: clinical outcome (analyzed using the Glasgow Outcome Scale [GOS]), surgical time, and hospital costs.

RESULTS Fifty-eight patients were enrolled, 29 in each group. Three patients were excluded, leaving 27 in the test group and 28 in the control group. There were no significant differences between groups regarding age, Glasgow Coma Scale score at the time of surgery, GOS score, and number of postoperative follow-up days. There were 9 surgical complications (5 in the control group and 4 in the test group), with no significant differences between the groups. The mean surgical time in the control group was 132 minutes, while in the test group the average surgical time was 101 minutes, a difference of 31 minutes (p = 0.001). The mean reduction in total cost was $420.00 USD (a 23.4% reduction) per procedure in the test group.

CONCLUSIONS Rapid-closure DC without watertight duraplasty is a safe procedure. It is not associated with a higher incidence of surgical complications (CSF leak, wound infection, brain abscess, or subgaleal fluid collections), and it decreased surgical time by 31 minutes on average. There was also a hospital cost reduction of $420.00 USD (23.4% reduction) per procedure. Clinical trial registration no.: NCT02594137 (clinicaltrials.gov)

 

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Impact of local steroid application on dysphagia following an anterior cervical discectomy and fusion: results of a prospective, randomized single-blind trial

J Neurosurg Spine 29:10–17, 2018

Intraoperative local steroid application has been theorized to reduce swelling and improve swallowing in the immediate period following anterior cervical discectomy and fusion (ACDF). Therefore, the purpose of this study was to quantify the impact of intraoperative local steroid application on patient-reported swallow function and swelling after ACDF.

METHODS A prospective, randomized single-blind controlled trial was conducted. A priori power analysis determined that 104 subjects were needed to detect an 8-point difference in the Quality of Life in Swallowing Disorders (SWAL-QOL) questionnaire score. One hundred four patients undergoing 1- to 3-level ACDF procedures for degenerative spinal pathology were randomized to Depo-Medrol (DEPO) or no Depo-Medrol (NODEPO) cohorts. Prior to surgical closure, patients received 1 ml of either Depo-Medrol (DEPO) or saline (NODEPO) applied to a Gelfoam carrier at the surgical site. Patients were blinded to the application of steroid or saline following surgery. The SWAL-QOL questionnaire was administered both pre- and postoperatively. A ratio of the prevertebral swelling distance to the anteroposterior diameter of each vertebral body level was calculated at the involved levels ± 1 level by using pre- and postoperative lateral radiographs. The ratios of all levels were averaged and multiplied by 100 to obtain a swelling index. An air index was calculated in the same manner but using the tracheal air window diameter in place of the prevertebral swelling distance. Statistical analysis was performed using the Student t-test and chi-square analysis. Statistical significance was set at p < 0.05.

RESULTS Of the 104 patients, 55 (52.9%) were randomized to the DEPO cohort and 49 (47.1%) to the NODEPO group. No differences in baseline patient demographics or preoperative characteristics were demonstrated between the two cohorts. Similarly, estimated blood loss and length of hospitalization did not differ between the cohorts. Neither was there a difference in the mean change in the scaled total SWAL-QOL score, swelling index, and air index between the groups at any time point. Furthermore, no complications were observed in either group (retropharyngeal abscess or esophageal perforation).

CONCLUSIONS The results of this prospective, randomized single-blind study did not demonstrate an impact of local intraoperative steroid application on patient-reported swallowing function or swelling following ACDF. Neither did the administration of Depo-Medrol lead to an earlier hospital discharge than that in the NODEPO cohort. These results suggest that intraoperative local steroid administration may not provide an additional benefit to patients undergoing ACDF procedures.

 

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A randomised controlled trial comparing autologous cranioplasty with custom-made titanium cranioplasty

Acta Neurochirurgica (2018) 160:885–891

Objective To compare the long-term outcomes of patients who had been randomly allocated to receive primary titanium cranioplasty or autologous bone graft following decompressive craniectomy.

Methods Sixty-four patients had been previously enrolled and randomised to receive either their own bone graft or a primary titanium cranioplasty. Functional and cosmetic outcomes had previously been assessed at 1-year following the cranioplasty procedure. Hospital records and the Picture Archiving communication system were reviewed to determine how many patients had cranioplasty failure or associated complications such as seizures beyond 1 year—with a minimum of 24-month follow-up.

Results Amongst the 31 patients in the titanium group (one patient had died), no patients had a partial or complete cranioplasty failure at 12 months follow-up and there had been no failures beyond 12 months. Amongst the 31 patients who had an autologous cranioplasty (one patient had died), 7 patients had complete resorption of the autologous bone such that it was adjudged a complete failure at 12-month follow-up. Five of these patients had had titanium augmentation and two patients declined further surgery. Both of these patients requested cranial augmentation for functional and cosmetic reasons subsequent to the 12-month follow-up. Another patient who had previously been noted to have moderate resorption at 12 months presented 1 year later with progressive bone flap resorption and also required subsequent augmentation for functional and cosmetic reasons. When follow-up was extended to a minimum of 24 months, use of titanium instead of autologous bone for primary cranioplasty resulted in a significant reduction in the number of patients who required rescue cranioplasty (0 vs 25%, 95% confidence interval [CI] 9.1–42.1%; p = 0.001). In addition, there were significantly less total hospital healthcare costs in those patients randomised to the titanium arm of the trial (difference = A$9999, 95%CI 2231–17,768; p = 0.015).

Conclusions Bone resorption continued to occur beyond 12 months after autologous cranioplasty; use of primary titanium cranioplasty after decompressive craniectomy reduced the number of reoperations needed and the associated long-term total hospital costs.

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