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Effect of Ventral vs Dorsal Spinal Surgery on Patient-Reported Physical Functioning in Patients With Cervical Spondylotic Myelopathy: A Randomized Clinical Trial.
Ghogawala, Z, Terrin, N, Dunbar, MR, Breeze, JL, Freund, KM, Kanter, AS, Mummaneni, PV, Bisson, EF, Barker, FG, Schwartz, JS, et al
JAMA. 2021;(10):942-951
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Abstract
IMPORTANCE Cervical spondylotic myelopathy is the most common cause of spinal cord dysfunction worldwide. It remains unknown whether a ventral or dorsal surgical approach provides the best results. OBJECTIVE To determine whether a ventral surgical approach compared with a dorsal surgical approach for treatment of cervical spondylotic myelopathy improves patient-reported physical functioning at 1 year. DESIGN, SETTING, AND PARTICIPANTS Randomized clinical trial of patients aged 45 to 80 years with multilevel cervical spondylotic myelopathy enrolled at 15 large North American hospitals from April 1, 2014, to March 30, 2018; final follow-up was April 15, 2020. INTERVENTIONS Patients were randomized to undergo ventral surgery (n = 63) or dorsal surgery (n = 100). Ventral surgery involved anterior cervical disk removal and instrumented fusion. Dorsal surgery involved laminectomy with instrumented fusion or open-door laminoplasty. Type of dorsal surgery (fusion or laminoplasty) was at surgeon's discretion. MAIN OUTCOMES AND MEASURES The primary outcome was 1-year change in the Short Form 36 physical component summary (SF-36 PCS) score (range, 0 [worst] to 100 [best]; minimum clinically important difference = 5). Secondary outcomes included 1-year change in modified Japanese Orthopaedic Association scale score, complications, work status, sagittal vertical axis, health resource utilization, and 1- and 2-year changes in the Neck Disability Index and the EuroQol 5 Dimensions score. RESULTS Among 163 patients who were randomized (mean age, 62 years; 80 [49%] women), 155 (95%) completed the trial at 1 year (80% at 2 years). All patients had surgery, but 5 patients did not receive their allocated surgery (ventral: n = 1; dorsal: n = 4). One-year SF-36 PCS mean improvement was not significantly different between ventral surgery (5.9 points) and dorsal surgery (6.2 points) (estimated mean difference, 0.3; 95% CI, -2.6 to 3.1; P = .86). Of 7 prespecified secondary outcomes, 6 showed no significant difference. Rates of complications in the ventral and dorsal surgery groups, respectively, were 48% vs 24% (difference, 24%; 95% CI, 8.7%-38.5%; P = .002) and included dysphagia (41% vs 0%), new neurological deficit (2% vs 9%), reoperations (6% vs 4%), and readmissions within 30 days (0% vs 7%). CONCLUSIONS AND RELEVANCE Among patients with cervical spondylotic myelopathy undergoing cervical spinal surgery, a ventral surgical approach did not significantly improve patient-reported physical functioning at 1 year compared with outcomes after a dorsal surgical approach. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT02076113.
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A novel scoliosis instrumentation using special superelastic nickel-titanium shape memory rods: a biomechanical analysis using a calibrated computer model and data from a clinical trial.
Wang, X, Yeung, K, Cheung, JPY, Lau, JY, Qi, W, Cheung, KM, Aubin, CE
Spine deformity. 2020;(3):369-379
Abstract
STUDY DESIGN Biomechanical analysis of scoliosis instrumentation using superelastic Nickel-titanium shape memory (SNT) rods. OBJECTIVE To compare SNT with conventional Titanium (Ti) and Cobalt-chrome (Co-Cr) rods. A clinical trial has documented comparable efficacy between two adolescent idiopathic scoliosis (AIS) cohorts instrumented using SNT versus conventional Ti rods. The shape memory and superelasticity of the SNT rod are thought to allow easy rod insertion, progressive curve correction, and correction from spinal tissue relaxation, but study is yet to be done to assess the effects of the shape memory and superelasticity. METHODS Instrumentations of AIS patients from the clinical trial were computationally simulated using SNT, Ti and Co-Cr rods (5.5 or 6 mm; 30°, 50° or 60° sagittal contouring angles; 0°, 25° or 50° coronal over-contouring angles). Curve correction, its improvement from stress relaxation in the spine, and loads in the instrumentation constructs were computed and compared. RESULTS The simulated main thoracic Cobb angles (MT) and thoracic kyphosis with the SNT rods were 4°-7° higher and 1°-2° lower than the Ti and Co-Cr rods, respectively. Bone-implant forces with Ti and Co-Cr rods were higher than the SNT rods by 84% and 130% at 18 °C and 35% and 65% at 37 °C, respectively (p < 0.001). Further corrections of the MT from the simulated stress relaxation in the spine were 4°-8° with the SNT rods versus 2°-5° with the Ti and Co-Cr rods (p < 0.001). CONCLUSION This study concurs with clinical observation that the SNT rods are easier to insert and can result in similar correction to the conventional rods. The SNT rods allow significantly lower bone-implant forces and have the ability to take advantage of post-instrumentation correction as the tissues relax.
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Radiological diagnostic accuracy study comparing Lenke, Bridwell, BSF, and CT-HU fusion grading scales for minimally invasive lumbar interbody fusion spine surgery and its correlation to clinical outcome.
Soriano Sánchez, JA, Soriano Solís, S, Soto García, ME, Soriano Solís, HA, Torres, BYA, Romero Rangel, JAI
Medicine. 2020;(21):e19979
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Abstract
Prospective randomized double-blinded diagnostic accuracy study about radiological grading of fusion after minimally invasive lumbar interbody fusion procedures (MI-LIFP).To determinate the intra and the inter-observer correlation between different radiological lumbar interbody fusion grading scales (RLIFGS) in patients undergoing MI-LIFP and their correlation to clinical outcome.Besides technological improvements in medical diagnosis and the many existing RLIFGS, surgical exploration continues to be the gold-standard to assess fusion in patients with radiological pseudarthrosis, with little if any research on the relationship between RLIFGS and clinical outcome.We collected data from patients undergoing MI-LIFP procedures operated by a single surgeon from 2009 to 2017, which had follow-up and CT-scan control greater than 12 months, whose clinical registers specified lumbar and radicular visual analogue scale (L and R-VAS) and Oswestry Disability Index (ODI) score preoperatively and at the end of follow-up. Interbody fusion levels were coded for blinded evaluation by three different minimally invasive spine (MIS) surgeons, using Lenke, Bridwell, BSF (Brantigan, Steffe, Fraser), and CT-HU RLIFGS. We established fusion criteria, as described in their original papers. Another independent spine surgeon blindly evaluated successful clinical outcome (SCO), defined as a significant improvement in 2 of 3 of the following issues: L-VAS, R-VAS, or ODI score at follow-up; otherwise, rated as clinical pseudarthrosis. Radiological and clinical data was coded and statistically analyzed using Student T-Test, Pearson P-Test, and ANOVA with statistical package for the social sciences 21 by another blinded researcher, positive and negative predictive values were also calculated for each RLFGS.We found a significant clinical improvement with a moderate intra-observer correlation between scales and no inter-observer or clinical correlation, with no sub-group statistically significant differences.This paper represents the first study about the diagnostic accuracy of RLFGS, we concluded that their diagnostic accuracy is pretty low to determine fusion or pseudoarthrosis based on its low correlation to clinical outcome, we recommend surgeons rely on clinical findings to decide whether a patient has clinical fusion or pseudoarthrosis based on successful clinical outcome.
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Multimodal Nutritional Management in Primary Lumbar Spine Surgery: A Randomized Controlled Trial.
Xu, B, Xu, WX, Lao, YJ, Ding, WG, Lu, D, Sheng, HF
Spine. 2019;(14):967-974
Abstract
STUDY DESIGN A prospective randomized controlled trial. OBJECTIVE The purpose of this study was to evaluate the clinical effect and safety of a new multimodal nutritional management (MNM) protocol for patients receiving primary lumbar spine surgery. SUMMARY OF BACKGROUND DATA Poor nutritional status is common in the perioperative period in primary lumbar spine surgery, and may impede recovery after surgery. METHODS A total of 187 patients were included in this prospective randomized controlled trial. They were randomly assigned to the MNM group or the control group. Albumin (ALB) infusion, postoperative ALB level, electrolyte disorders, postoperative electrolyte levels, transfusion rate, postoperative hemoglobin level, length of stay (LOS), and complications were compared between the groups. RESULTS Compared with the control group, the rate and the total amount of ALB infusion were lower in the MNM group, and the postoperative level of ALB in the MNM group was higher on the first postoperative day, and the third postoperative day. The incidence of hypokalemia, hyponatremia, and hypocalcemia were lower in the MNM group. In the MNM group, the postoperative levels of sodium, potassium, and calcium were higher than the control group. The transfusion rate was similar between the two groups. The hemoglobin level was similar between the two groups on first postoperative day, but was higher in the MNM group on third postoperative day. LOS in the MNM group was shorter than in the control group. The incidence of wound drainage was lower in the MNM group. No statistical differences were observed regarding surgical complications between the two groups. CONCLUSION The MNM protocol effectively reduced ALB infusion, the incidence of electrolyte disorders, and wound drainage, increased the postoperative levels of ALB, sodium, potassium, and calcium, and reduced the LOS without increasing the rate of postoperative complications. LEVEL OF EVIDENCE 2.
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Early Rehabilitation Program and Vitamin D Supplementation Improves Sensitivity of Balance and the Postural Control in Patients after Posterior Lumbar Interbody Fusion: A Randomized Trial.
Skrobot, W, Liedtke, E, Krasowska, K, Dzik, KP, Flis, DJ, Samoraj-Dereszkiewicz, A, Libionka, W, Kortas, J, Kloc, W, Antosiewicz, J, et al
Nutrients. 2019;(9)
Abstract
BACKGROUND The introduction of early rehabilitation exercise is the foundation of treatment post-Posterior lumbar interbody fusion (PLIF) surgery, and the search for additional sources of reinforcement physiotherapy seems to be very important. METHODS The patients were randomly divided into the vitamin D3 (n = 15; D3) supplemented group and received 3200 IU per day for five weeks before surgery and the placebo group (n = 18; Pl) received vegetable oil during the same time. The patients began the supervisor rehabilitation program four weeks after surgery. RESULTS The limits of stability (LOS) were significantly improved in the D3 group after 5 and 14 weeks (p < 0.05), while in the Pl group, progress was only observed after 14 weeks (p < 0.05). The LOS were also higher in the D3 group than in the Pl group after five weeks of supervised rehabilitation (p < 0.05). In the postural stability (PST) test, significant progress was observed in the D3 group after 14 weeks (p < 0.02). In addition, neither rehabilitation nor supplementation had significant effects on the risk of falls (RFT). CONCLUSIONS Vitamin D supplementation seems to ameliorate the effects of an early postoperative rehabilitation program implemented four weeks after posterior lumbar interbody fusion. Early physiotherapy treatment after PLIF surgery combined with vitamin D supplementation appears to be a very important combination with regard to the patients' recovery process.
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A prospective randomized study to analyze the efficacy of balanced pre-emptive analgesia in spine surgery.
Raja S, DC, Shetty, AP, Subramanian, B, Kanna, RM, Rajasekaran, S
The spine journal : official journal of the North American Spine Society. 2019;(4):569-577
Abstract
BACKGROUND CONTEXT Surgical procedures involving the spine are known to cause moderate to severe postoperative pain. Inadequate management of acute pain in the postoperative period results in higher morbidity, and consequently may lead to chronic pain caused by central sensitization. The role of pre-emptive analgesia (PA) and intraoperative analgesia in management of postoperative pain has gained precedence over recent years. Pathophysiology of postoperative pain in spine surgery is unique, as it is a combination of nociceptive, inflammatory, and neuronal stimuli. Blockage of all three stimuli in the perioperative period by pre-emptively administrating a combination of paracetamol (P), ketorolac (K), and pregabalin (PR) might help in adequate management and alleviation of acute postoperative pain. PURPOSE To evaluate the analgesic effect of a combination of P, K, and PR as pre-emptive multimodal analgesia, aimed to block or reduce acute postoperative pain after spine surgery. STUDY DESIGN A prospective, randomized, controlled, and double-blinded clinical trial. PATIENT SAMPLE After Institutional Review Board approval, 100 consecutive patients requiring single- or double level spinal fusion procedures were randomized into two groups-PA and control (C). METHODS The PA group received P, K, and PR 4 hours before surgery, as PA. Both groups underwent identical anesthetic and postoperative pain management protocol. OUTCOME MEASURES Demographic and surgical data, 4 hourly postoperative pain levels-Numeric Pain Rating scale (NRS), Ambulatory NRS scores; level of consciousness-Ramsay sedation scale, total amount of opioids consumed (TOC) through patient-controlled analgesia; functional levels-Oswestry Disability Index (ODI), surgical satisfaction index-North American Spine Society (NASS) satisfaction scale, duration of hospital stay, and all complications were recorded and analyzed. A research grant of 6,032 USD was obtained from AO Spine toward this work. There is no conflict to disclose. RESULTS Both the groups had identical demographic backgrounds and surgical profiles. The average NRS score within the first 48-hour period in the PA group (2.7±0.79) was significantly less than the C group (3.4±0.98) and the differences were more in the first 12 hours following surgery. Similarly, Ambulatory NRS scores were significantly low in the PA group during the first and second postoperative days. The PA group individuals were found to be more physically motivated, as 95.7% were able to ambulate 50 m on the first postoperative day compared with 30% in the C group. The PA group had significantly low TOC (3.02±2.29 mg) in comparison to the C group (4.94±3.08 mg). The duration of hospital stay was 4.17±1.02 and 4.84±1.62 days in the PA and C groups (p=.017), respectively. No major complications occurred in either groups and were found to be similar in percentage between both the groups, except for nausea and vomiting which were more in C group. Dry mouth was the most common side effect noted irrespective of the groups. All patients had significant improvement in ODI with better results in PA group at first month follow up. The PA group (97.90%) was extremely satisfied compared with C group (72%, p=.002) according to NASS scale. CONCLUSIONS Postoperative pain management in spine surgery is maximized if perioperative painful stimuli can be inhibited, which requires adequate blood levels of analgesic, anti-inflammatory, and neuropathic drugs intraoperatively. The employed strategy of preoperative administration of balanced analgesia with a combination of P, K, and PR, each having different mechanisms of action, resulted in lesser pain intensity, allowed better ambulation tolerance, improved functional outcomes and has also reduced the requirement of opioids and duration of hospital stay with no additional complications. Thus, this balanced analgesia administered preoperatively would address the complicated postsurgical pain.
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A Prospective, Randomized, Multicenter Study Comparing Silicated Calcium Phosphate versus BMP-2 Synthetic Bone Graft in Posterolateral Instrumented Lumbar Fusion for Degenerative Spinal Disorders.
Coughlan, M, Davies, M, Mostert, AK, Nanda, D, Willems, PC, Rosenberg, G, Ferch, R
Spine. 2018;(15):E860-E868
Abstract
STUDY DESIGN A prospective, Phase IV, multicenter, randomized study. OBJECTIVE The aim of this study was to compare vertebral fusion success rates following posterolateral fusion [(PLF)/posterolateral intertransverse fusion (PITF)] surgery. The surgical procedure combined posterior lumbar interbody fusion (PLIF) and PLF with internal fixation over one or two levels using silicated calcium phosphate (SiCaP) or bone morphogenetic protein (BMP)-2 as graft material in patients with a degenerative disorder of the lumbar spine. SUMMARY OF BACKGROUND DATA Few controlled trials have evaluated the bone graft materials available to surgeons treating patients with spinal disorders, including degenerative disc disease, spondylolisthesis, and disc herniation. METHODS Following randomization, the surgical procedure consisting of PLIF and PLF with internal fixation over one or two levels was performed using SiCaP or BMP-2. No other osteoconductive/osteoinductive graft materials were permitted. Spinal fusion was assessed radiographically at ≤24 months. Clinical outcomes (pain on visual analog scale, Oswestry Disability Index, SF-36) and adverse events (AEs) were monitored. RESULTS One hundred three patients were enrolled. At 12 months, fusion was achieved in 25 of 35 (71.4%) of the SiCaP and 20 of 27 (74.1%) of the BMP-2 group, respectively (P = 1.000). At 24 months, the fusion rate was 78.6% and 84.8% for SiCaP and BMP-2, respectively (P = 0.5613). Clinical outcomes improved similarly in both groups over time. AEs were consistent with this surgical population. CONCLUSION SiCaP was safe and well tolerated in patients with degenerative spinal disorders requiring PLF and provided fusion rates similar to BMP-2. LEVEL OF EVIDENCE 2.
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Cobalt chromium-Titanium rods versus Titanium-Titanium rods for treatment of adolescent idiopathic scoliosis; which type of rod has better postoperative outcomes?
Etemadifar, MR, Andalib, A, Rahimian, A, Nodushan, SMHT
Revista da Associacao Medica Brasileira (1992). 2018;(12):1085-1090
Abstract
OBJECTIVE Compare the outcome of spinal deformity correction between Ti-Ti and CrCo-Ti rods for the treatment of spinal Adolescent Idiopathic Scoliosis (AIS) using rods mentioned with all pedicle screws and translation technique. METHOD 59 patients operated for spinal deformity (Lenke 1 or 2) AIS. The patients were divided into two groups by random allocation using Ti-Ti rods (n = 29) and CrCo-Ti rods (n = 30) and the alone difference among them in the surgical procedure was rod material (Ti-Ti or CrCo-Ti rods) and finally, radiological outcomes were compared preoperatively, postoperatively and at last follow-up for 12 months. RESULTS Patients' main curve correction after surgical procedure regardless type of rod was 48.95±11.04 (13-75) degree. Success rate of spinal deformity correction following surgical procedure regardless of type of administered rod was 86.76 ± 11.30 percent (62.5-100%). Mean of deformity correction rate was 91.49±10.67% using CrCo-Ti rods versus 81.86±9.88% using Ti-Ti rods (P-value=0.01). Angle change was 3.29±6.60 for kyphosis angle and 0.59±7.76 for lordosis angle. Rate of main curve correction was not significantly different considering patients' gender (P-value0.657). Main curve correction success rate was in association with patients' age and type of rod (P-value=0.054, r=-1.863 and P-value=0.001, r=8.865 respectively). CONCLUSION CrCo-Ti rods have the ability to produce higher correction rates in AIS compared to Ti-Ti rod of the same diameter. CrCo-Ti rods provide significant and stable spinal correction, especially in correction of main curve. This rate was associated with patients' age and type of rod administered but not gender.
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Transforaminal lumbar interbody fusion using polyetheretherketone oblique cages with and without a titanium coating: a randomised clinical pilot study.
Rickert, M, Fleege, C, Tarhan, T, Schreiner, S, Makowski, MR, Rauschmann, M, Arabmotlagh, M
The bone & joint journal. 2017;(10):1366-1372
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AIMS: We compared the clinical and radiological outcomes of using a polyetheretherketone cage with (TiPEEK) and without a titanium coating (PEEK) for instrumented transforaminal lumbar interbody fusion (TLIF). MATERIALS AND METHODS We conducted a randomised clinical pilot trial of 40 patients who were scheduled to undergo a TLIF procedure at one or two levels between L2 and L5. The Oswestry disability index (ODI), EuroQoL-5D, and back and leg pain were determined pre-operatively, and at three, six, and 12 months post-operatively. Fusion rates were assessed by thin slice CT at three months and by functional radiography at 12 months. RESULTS At final follow-up, one patient in each group had been lost to follow-up. Two patients in each of the PEEK and TiPEEK groups were revised for pseudarthrosis (p = 1.00). The rate of complete or partial fusion at three months was 91.7% in both groups. Overall, there were no significant differences in ODI or in radiological outcomes between the groups. CONCLUSION Favourable results with identical clinical outcomes and a high rate of fusion was seen in both groups. The titanium coating appears to have no negative effects on outcome or safety in the short term. A future study to determine the effect of titanium coating is warranted. Cite this article: Bone Joint J 2017;99-B:1366-72.
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Comparison Between Acrylic Cage and Polyetheretherketone (PEEK) Cage in Single-level Anterior Cervical Discectomy and Fusion: A Randomized Clinical Trial.
Farrokhi, MR, Nikoo, Z, Gholami, M, Hosseini, K
Clinical spine surgery. 2017;(1):38-46
Abstract
STUDY DESIGN Prospective, single-blind randomized-controlled clinical study. OBJECTIVE To compare polyetheretherketone (PEEK) cage with a novel Acrylic cage to find out which fusion cage yielded better clinical outcomes following single-level anterior cervical discectomy and fusion (ACDF). SUMMARY OF BACKGROUND DATA ACDF is considered a standard neurosurgical treatment for degenerative diseases of cervical intervertebral disks. There are many options, including bone grafts, bone cement, and spacers made of titanium, carbon fiber, and synthetic materials, used to restore physiological disk height and enhance spinal fusion, but the ideal device, which would provide immediate structural support and subsequent osteointegration and stability, has not been identified yet. To overcome this, we designed a new, inexpensive Acrylic cage. MATERIALS AND METHODS A total of 64 patients were eligible to participate and were randomly allocated to undergo ACDF either with Acrylic interbody fusion cage filled with bone substitute (n=32) or PEEK cage (n=32). Nurick's grading was used for quantifying the neurological deficit. Clinical and radiologic outcome was assessed preoperatively, immediately after surgery, and subsequently at 2, 6, and 12 months of follow-up using Odom's criteria and dynamic radiographs (flexion-extension) and computed tomography scans, respectively. RESULTS There was a statistically significant improvement in the clinical outcomes of the Acrylic cage group compared with the PEEK cage group (mean difference: -0.438; 95% confidence interval, -0.807 to -0.068; P=0.016). There was a statistically significant difference in disk space height increase between the 2 groups at the 6- and 12-month follow-up. The Acrylic cage achieved higher fusion rate (good fusion) than the PEEK cage (96.9% vs. 93.8%). Intervertebral angle demonstrated a significant difference among the 2 treated groups throughout the follow-up period. CONCLUSION This study suggests that the use of Acrylic cage is associated with good clinical and radiologic outcomes and it can be therefore a good substitute for bone graft and other cages in ACDF.