Comparison of posterior foraminotomy and anterior foraminotomy with fusion for treating spondylotic foraminal stenosis of the cervical spine: study protocol for a randomized controlled trial (ForaC)

Background: Cervical radiculopathy caused by spondylotic foraminal stenosis may require surgical treatment. Surgical options include anterior cervical foraminotomy and fusion or posterior cervical foraminotomy. Controversy remains regarding the preferable surgical approach. Pertinent clinical evidence is limited to low-quality observational reports. Therefore, treatment decisions are predominantly based on the individual surgeon’s preference and skill. The study objective is to evaluate the efficacy and safety of posterior foraminotomy in comparison to anterior foraminotomy with fusion for the treatment of spondylotic foraminal stenosis. Methods/design: This is a multicenter randomized, controlled, parallel group superiority trial. A total of 88 adult patients are allocated in a ratio of 1:1. Sample size and power calculations were performed to detect the minimal clinically important difference of 14 points, with an expected standard deviation of 20 in the primary outcome parameter, Neck Disability Index, with a power of 80%, based on an assumed maximal dropout rate of 20%. Secondary outcome parameters include the Core Outcome Measures Index, which investigates pain, back-specific function, work disability, social disability and patient satisfaction. Changes in physical and mental health are evaluated using the Short Form-12 (SF-12) questionnaire. Moreover, radiological and health economic outcomes are evaluated. Follow-up is performed 3, 6, 12, 24, 36, 48 and 60 months after surgery. Major inclusion criteria are cervical spondylotic foraminal stenosis causing radiculopathy of C5, C6 or C7 and requiring decompression of one or two neuroforaminae. Study data generation (study sites) and data storage, processing and statistical analysis (Department of Medical Statistics, Informatics and Health Economics) are clearly separated. Data will be analyzed according to the intention-to-treat principle. Discussion: The results of the ForaC study will provide surgical treatment recommendations for spondylotic foraminal stenosis and will contribute to the understanding of its short- and long-term clinical and radiological postoperative course. This will hopefully translate into improvements in surgical treatment and thus, clinical practice for spondylotic foraminal stenosis. Trial registration Current Controlled Trials: ISRCTN8257806

Mortality risk stratification in isolated severe traumatic brain injury using the revised cardiac risk index.

PURPOSE: Traumatic brain injury (TBI) continues to be a significant cause of mortality and morbidity worldwide. As cardiovascular events are among the most common extracranial causes of death after a severe TBI, the Revised Cardiac Risk Index (RCRI) could potentially aid in the risk stratification of this patient population. This investigation aimed to determine the association between the RCRI and in-hospital deaths among isolated severe TBI patients. METHODS: All adult patients registered in the TQIP database between 2013 and 2017 who suffered an isolated severe TBI, defined as a head AIS ≥ 3 with an AIS ≤ 1 in all other body regions, were included. Patients were excluded if they had a head AIS of 6. The association between different RCRI scores (0, 1, 2, 3, ≥ 4) and in-hospital mortality was analyzed using a Poisson regression model with robust standard errors while adjusting for potential confounders, with RCRI 0 as the reference. RESULTS: 259,399 patients met the study’s inclusion criteria. RCRI 2 was associated with a 6% increase in mortality risk [adjusted IRR (95% CI) 1.06 (1.01–1.12), p = 0.027], RCRI 3 was associated with a 17% increased risk of mortality [adjusted IRR (95% CI) 1.17 (1.05–1.31), p = 0.004], and RCRI ≥ 4 was associated with a 46% increased risk of in-hospital mortality [adjusted IRR(95% CI) 1.46 (1.11–1.90), p = 0.006], compared to RCRI 0. CONCLUSION: An elevated RCRI ≥ 2 is significantly associated with an increased risk of in-hospital mortality among patients with an isolated severe traumatic brain injury. The simplicity and bedside applicability of the index makes it an attractive choice for risk stratification in this patient population

Radiological and Clinical Outcome after Multilevel Anterior Cervical Discectomy and/or Corpectomy and Fixation

Background: Multilevel anterior cervical decompression and fixation of four and more levels is a common surgical procedure used for several diseases. Methods: We reviewed the radiological and clinical outcomes after anterior cervical discectomy or corpectomy and fixation of four and more levels in 85 patients (55 men and 30 women) with an average age of 59.6 years. Surgical indication was multilevel cervical degenerative myelopathy and radiculopathy in 72 (85%) patients, multilevel cervical spondylodiscitis in four (5%), complex traumatic cervical fractures in four (5%), metastatic cervical spine tumor in two (2%), and ossification of the posterior longitudinal ligament in three (3%) patients. Results: There were no severe intraoperative complications such as spinal cord or vertebral artery injury or dissection. Seventy-three patients had four, 10 patients had five, and two patients had six anterior cervical level fixations. The visual analog scale (VAS) and Japanese Orthopedic Association (mJOA) scale scores improved (6.9 to 1.3 (p < 0.001) and 13.9 to 16.5 (p < 0.001), respectively). The Cobb angle increased from 5.7° to 17.6° postoperatively (p < 0.001). Secondary posterior fixation was necessary in three cases due to pseudarthrosis. Conclusion: The anterior approach appears to be optimal for ventral compressive pathology and lordosis restoration to the cervical spine. Limitations of multiple level decompression and fixation included increasing pseudoarthrosis rates, especially after corpectomy, and increasing fused level numbers

Surgical data and early postoperative outcomes after minimally invasive lumbar interbody fusion: results of a prospective, multicenter, observational data-monitored study.

Minimally invasive lumbar interbody fusion (MILIF) offers potential for reduced operative morbidity and earlier recovery compared with open procedures for patients with degenerative lumbar disorders (DLD). Firm conclusions about advantages of MILIF over open procedures cannot be made because of limited number of large studies of MILIF in a real-world setting. Clinical effectiveness of MILIF in a large, unselected real-world patient population was assessed in this Prospective, monitored, international, multicenter, observational study.To observe and document short-term recovery after minimally invasive interbody fusion for DLD.In a predefined 4-week analysis from this study, experienced surgeons (≥ 30 MILIF surgeries pre-study) treated patients with DLD by one- or two-level MILIF. The primary study objective was to document patients' short-term post-interventional recovery (primary objective) including back/leg pain (visual analog scale [VAS]), disability (Oswestry Disability Index [ODI]), health status (EQ-5D) and Patient satisfaction.At 4 weeks, 249 of 252 patients were remaining in the study; the majority received one-level MILIF (83%) and TLIF was the preferred approach (94.8%). For one-level (and two-level) procedures, surgery duration was 128 (182) min, fluoroscopy time 115 (154) sec, and blood-loss 164 (233) mL. Time to first ambulation was 1.3 days and time to study-defined surgery recovery was 3.2 days. Patients reported significantly (P < 0.0001) reduced back pain (VAS: 2.9 vs 6.2), leg pain (VAS: 2.5 vs 5.9), and disability (ODI: 34.5% vs 45.5%), and a significantly (P < 0.0001) improved health status (EQ-5D index: 0.61 vs 0.34; EQ VAS: 65.4 vs 52.9) 4 weeks postoperatively. One adverse event was classified as related to the minimally invasive surgical approach. No deep site infections or deaths were reported.For experienced surgeons, MILIF for DLD demonstrated early benefits (short time to first ambulation, early recovery, high patient satisfaction and improved patient-reported outcomes) and low major perioperative morbidity at 4 weeks postoperatively

Back pain intensity (a) and leg pain intensity scores (b) reported preoperatively and postoperatively on a 10-cm visual analog scale (VAS), where 0 = minimal pain intensity or pain frequency and 10 = maximal pain intensity or pain frequency (total population; N = 252).

<p><i>P</i> < 0.0001 for difference between preoperative (B: 6.2 ± 2.3; L: 5.9 ± 2.8), and 4-week postoperative scores (B: 2.9 ± 2.2; L: 2.5 ± 2.6).</p

EQ VAS scores reported preoperatively and 4-week postoperatively on a 0 to 100 scale, where 0 = maximal health-related problems and 100 = minimal health-related problems (total population; N = 252).

<p><i>P</i> < 0.0001 for difference between preoperative (52.9 ± 19.5) and 4-week postoperative scores (65.4 ± 18.6).</p

Five individual EQ-5D domains were reported preoperatively and 4-week postoperatively.

<p>At 4 weeks, the percentages of patients who reported no health-related problems increased from preoperative values in each domain: mobility (40.3% vs 11.1%), self-care (63.3% vs 54.3%), usual activities (23.4% vs 9.6%), pain/discomfort (14.9% vs 1.4%), and anxiety/depression (63.5% vs 49.5%).</p

Patient Demographics.

<p><i>MIS</i>, <i>minimally invasive surgery</i>.</p><p>Patient Demographics.</p

Intraoperative Surgery Results.

<p>Intraoperative Surgery Results.</p