Dilantha B. Ellegala, Christopher Kligora, Scott Vandenberg, Aaron Dumont and Mark E. Shaffrey
Rod J. Oskouian, Richard Whitehill, Amir Samii, Mark E. Shaffrey, J. Patrick Johnson and Christopher I. Shaffrey
Both total hip and knee arthroplasty have demonstrated outstanding clinical results. The functional spinal unit composed of the intervertebral disc and facet joints is at least as complex. The intricacies of the coupled motions of the functional spinal unit have made development of an artificial disc a challenge. There have been several failed attempts to create a disc replacement that recapitulates normal motion while providing significant longevity and a low incidence of complications.
Better understanding of the biomechanics of the intervertebral disc complex and improvements in implant material have made successful intervertebral disc replacement a likely reality, now that several artificial discs have completed Food and Drug Administration clinical trials. In this manuscript the authors detail the biomaterials used in disc arthroplasty and discuss joint wear and the host response to wear debris.
Richard S. Polin, Murad Bavbek, Mark E. Shaffrey, Kevin Billups, Christopher A. Bogaev, Neal F. Kassell and Kevin S. Lee
Object. The goal of this study was to explore whether the levels of soluble adhesion molecules were elevated in cerebrospinal fluid (CSF) after subarachnoid hemorrhage (SAH). This association was suggested by the known inflammatory response in vasospasm and the role of vascular adhesion molecules in regulating leukocytic adhesion to, and migration across, vascular endothelium.
Methods. A prospective analysis was performed on CSF samples obtained in 17 patients who had suffered a recent aneurysmal SAH and in 16 control patients by using quantitative enzyme-linked immunosorbent assays for E-selectin, intercellular adhesion molecule—1 (ICAM—1), vascular adhesion molecule—1 (VCAM-1), and L-selectin.
Levels of soluble forms of E-selectin (p = 0.0013), ICAM-1 (p = 0.0001), and VCAM-1 (p = 0.048) were found to be elevated in the CSF of patients after SAH compared with levels in the CSF of normal controls, patients with unruptured aneurysms, and patients tested months after SAH occurred. In addition, individual patients tested at the time of their initial ictus demonstrated a fall in adhesion molecule levels over time. Levels of E-selectin (p = 0.044) were highest in patients who later developed moderate or severe vasospasm.
Conclusions. Adhesion molecules are known to be involved in white cell adherence to the endothelium and subsequent diapedesis and migration in which a role in initiation of tissue damage is postulated. The authors have demonstrated the elevation of three adhesion molecules, with severely elevated levels of E-selectin seen in patients who later develop vasospasm. A correlation with a role of vascular adhesion molecules in the pathogenesis of cerebral vasospasm is suggested.
Gregory C. Wiggins, Michael J. Rauzzino, Christopher I. Shaffrey, Russ P. Nockels, Richard Whitehill, Mark E. Shaffrey, James Wagner and Tord D. Alden
This study was conducted to determine the safety, efficacy, and complication rate associated with the anterior approach in the use of a new titanium mesh interbody fusion cage for the treatment of unstable thoracolumbar burst fractures. The experience with this technique is compared with the senior authors' (C.S., R.W., and M.S.) previously published results in the management of patients with unstable thoracolumbar burst fractures.
Between 1996 and 1999, 21 patients with unstable thoracolumbar (T12-L3) burst fractures underwent an anterolateral decompressive procedure in which a titanium cage and Kaneda device were used. Eleven of the 21 patients had sustained a neurological deficit, and all patients improved at least one Frankel grade (average 1.2 grades). There was improvement in outcome in terms of blood loss, correction of kyphosis, and pain, as measured on the Denis Pain and Work Scale, in our current group of patients treated via an anterior approach when compared with the results in those who underwent a posterior approach.
In our current study the anterior approach was demonstrated to be a safe and effective technique for the management of unstable thoracolumbar burst fractures. It offers superior results compared with the posterior approach. The addition of the new titanium mesh interbody cage to our previous anterior technique allows the patient's own bone to be harvested from the corpectomy site and used as a substrate for fusion, thereby obviating the need for iliac crest harvest. The use of the cage in association with the Kaneda device allows for improved correction of kyphosis and restoration of normal sagittal alignment in addition to improved functional outcomes.
Thomas J. Buell, James H. Nguyen, Marcus D. Mazur, Jeffrey P. Mullin, Juanita Garces, Davis G. Taylor, Chun-Po Yen, Mark E. Shaffrey, Christopher I. Shaffrey and Justin S. Smith
Fixed sagittal spinal malalignment is a common problem in adult spinal deformity (ASD). Various three-column osteotomy techniques, including the extended pedicle subtraction osteotomy (ePSO), may correct global and regional malalignment in this patient population. In contrast to the number of reports on traditional PSO (Schwab grade 3 osteotomy), there is limited literature on the outcomes of ePSO (Schwab grade 4 osteotomy) in ASD surgery. The objective of this retrospective study was to provide focused investigation of radiographic outcomes and complications of single-level lumbar ePSO for ASD patients with fixed sagittal malalignment.
Consecutive ASD patients in whom sagittal malalignment had been treated with single-level lumbar ePSO at the authors’ institution between 2010 and 2015 were analyzed, and those with a minimum 2-year follow-up were included in the study. Radiographic analyses included assessments of segmental lordosis through the ePSO site (sagittal Cobb angle measured from the superior endplate of the vertebra above and inferior endplate of the vertebra below the ePSO), lumbar lordosis (LL), pelvic tilt (PT), pelvic incidence and LL mismatch, thoracic kyphosis (TK), and sagittal vertical axis (SVA) on standing long-cassette radiographs. Complications were analyzed for the entire group.
Among 71 potentially eligible patients, 55 (77%) had a minimum 2-year follow-up and were included in the study. Overall, the average postoperative increases in ePSO segmental lordosis and overall LL were 41° ± 14° (range 7°–69°, p < 0.001) and 38° ± 11° (range 9°–58°, p < 0.001), respectively. The average SVA improvement was 13 ± 7 cm (range of correction: −33.6 to 3.4 cm, p < 0.001). These measurements were maintained when comparing early postoperative to last follow-up values, respectively (mean follow-up 52 months, range 26–97 months): ePSO segmental lordosis, 34° vs 33°, p = 0.270; LL, 47.3° vs 46.7°, p = 0.339; and SVA, 4 vs 5 cm, p = 0.330. Rod fracture (RF) at the ePSO site occurred in 18.2% (10/55) of patients, and pseudarthrosis (PA) at the ePSO site was confirmed by CT imaging or during rod revision surgery in 14.5% (8/55) of patients. Accessory supplemental rods across the ePSO site, a more recently employed technique, significantly reduced the occurrence of RF or PA on univariate (p = 0.004) and multivariable (OR 0.062, 95% CI 0.007–0.553, p = 0.013) analyses; this effect approached statistical significance on Kaplan-Meier analysis (p = 0.053, log-rank test). Interbody cage placement at the ePSO site resulted in greater ePSO segmental lordosis correction (45° vs 35°, p = 0.007) without significant change in RF or PA (p = 0.304). Transient and persistent motor deficits occurred in 14.5% (8/55) and 1.8% (1/55) of patients, respectively.
Extended PSO is an effective technique to correct fixed sagittal malalignment for ASD. In comparison to traditional PSO techniques, ePSO may allow greater focal correction with comparable complication rates, especially with interbody cage placement at the ePSO site and the use of accessory supplemental rods.
Olumide A. Danisa, Christopher I. Shaffrey, John A. Jane, Richard Whitehill, Gwo-Jaw Wang, Thomas A. Szabo, Carolyn A. Hansen, Mark E. Shaffrey and Donald P. K. Chan
✓ The authors retrospectively studied 49 nonparaplegic patients who sustained acute unstable thoracolumbar burst fractures. All patients underwent surgical treatment and were followed for an average of 27 months. All but one patient achieved solid radiographic fusion. Three treatment groups were studied: the first group of 16 patients underwent anterior decompression and fusion with instrumentation; the second group of 27 patients underwent posterior decompression and fusion; and the third group of six patients had combined anterior—posterior surgery. Prior to surgical intervention, these groups were compared and found to be similar in age, gender, level of injury, percentage of canal compromise, neurological function, and kyphosis. Patients treated with posterior surgery had a statistically significant diminution in operative time and blood loss and number of units transfused. There were no significant intergroup differences when considering postoperative kyphotic correction, neurological function, pain assessment, or the ability to return to work. Posterior surgery was found to be as effective as anterior or anterior—posterior surgery when treating unstable thoracolumbar burst fractures. Posterior surgery, however, takes the least time, causes the least blood loss, and is the least expensive of the three procedures.
Thomas J. Buell, Davis G. Taylor, Ching-Jen Chen, Lauren K. Dunn, Jeffrey P. Mullin, Marcus D. Mazur, Chun-Po Yen, Mark E. Shaffrey, Christopher I. Shaffrey, Justin S. Smith and Bhiken I. Naik
Significant blood loss and coagulopathy are often encountered during adult spinal deformity (ASD) surgery, and the optimal intraoperative transfusion algorithm is debatable. Rotational thromboelastometry (ROTEM), a functional viscoelastometric method for real-time hemostasis testing, may allow early identification of coagulopathy and improve transfusion practices. The objective of this study was to investigate the effect of ROTEM-guided blood product management on perioperative blood loss and transfusion requirements in ASD patients undergoing correction with pedicle subtraction osteotomy (PSO).
The authors retrospectively reviewed patients with ASD who underwent single-level lumbar PSO at the University of Virginia Health System. All patients who received ROTEM-guided blood product transfusion between 2015 and 2017 were matched in a 1:1 ratio to a historical cohort treated using conventional laboratory testing (control group). Co-primary outcomes were intraoperative estimated blood loss (EBL) and total blood product transfusion volume. Secondary outcomes were perioperative transfusion requirements and postoperative subfascial drain output.
The matched groups (ROTEM and control) comprised 17 patients each. Comparison of matched group baseline characteristics demonstrated differences in female sex and total intraoperative dose of intravenous tranexamic acid (TXA). Although EBL was comparable between ROTEM versus control (3200.00 ± 2106.24 ml vs 3874.12 ± 2224.22 ml, p = 0.36), there was a small to medium effect size (Cohen’s d = 0.31) on EBL reduction with ROTEM. The ROTEM group had less total blood product transfusion volume (1624.18 ± 1774.79 ml vs 2810.88 ± 1847.46 ml, p = 0.02), and the effect size was medium to large (Cohen’s d = 0.66). This difference was no longer significant after adjusting for TXA (β = −0.18, 95% confidence interval [CI] −1995.78 to 671.64, p = 0.32). More cryoprecipitate and less fresh frozen plasma (FFP) were transfused in the ROTEM group patients (cryoprecipitate units: 1.24 ± 1.20 vs 0.53 ± 1.01, p = 0.03; FFP volume: 119.76 ± 230.82 ml vs 673.06 ± 627.08 ml, p < 0.01), and this remained significant after adjusting for TXA (cryoprecipitate units: β = 0.39, 95% CI 0.05 to 1.73, p = 0.04; FFP volume: β = −0.41, 95% CI −772.55 to −76.30, p = 0.02). Drain output was lower in the ROTEM group and remained significant after adjusting for TXA.
For ASD patients treated using lumbar PSO, more cryoprecipitate and less FFP were transfused in the ROTEM group compared to the control group. These preliminary findings suggest ROTEM-guided therapy may allow early identification of hypofibrinogenemia, and aggressive management of this may reduce blood loss and total blood product transfusion volume. Additional prospective studies of larger cohorts are warranted to identify the appropriate subset of ASD patients who may benefit from intraoperative ROTEM analysis.
Jay Jagannathan, Ekawut Chankaew, Peter Urban, Aaron S. Dumont, Charles A. Sansur, John Kern, Benjamin Peeler, W. Jeffrey Elias, Francis Shen, Mark E. Shaffrey, Richard Whitehill, Vincent Arlet and Christopher I. Shaffrey
In this paper, the authors review the functional and cosmetic outcomes and complications in 300 patients who underwent treatment for lumbar spine disease via either an anterior paramedian or conventional anterolateral retroperitoneal approach.
Seven surgeons performed anterior lumbar surgeries in 300 patients between August 2004 and December 2006. One hundred and eighty patients were treated with an anterior paramedian approach, and 120 patients with an anterolateral retroperitoneal approach. An access surgeon was used in 220 cases (74%). Postoperative evaluation in all patients consisted of clinic visits, assessment with the modified Scoliosis Research Society–30 instrument, as well as a specific questionnaire relating to wound appearance and patient satisfaction with the wound.
At a mean follow-up of 31 months (range 12–47 months), the mean Scoliosis Research Society–30 score (out of 25) was 21.2 in the patients who had undergone the anterior paramedian approach and 19.4 in those who had undergone the anterolateral retroperitoneal approach (p = 0.005). The largest differences in quality of life measures were observed in the areas of pain control (p = 0.001), self-image (p = 0.004), and functional activity (p = 0.003), with the anterior paramedian group having higher scores in all 3 categories. Abdominal bulging in the vicinity of the surgical site was the most common wound complication observed and was reported by 22 patients in the anterolateral retroperitoneal group (18%), and 2 patients (1.1%) in the anterior paramedian group. Exposures of ≥ 3 levels with the anterolateral approach were associated with abdominal bulging (p = 0.04), while 1- or 2-level exposures were not (p > 0.05). Overall satisfaction with incisional appearance was higher in patients with an anterior paramedian incision (p = 0.001) and with approaches performed by an access surgeon (p = 0.004).
Patients who undergo an anterior paramedian approach to the lumbar spine have a higher quality of life and better cosmetic outcomes than patients undergoing an anterolateral retroperitoneal approach.
Rod J. Oskouian Jr., Christopher I. Shaffrey, Richard Whitehill, Charles A. Sansur, Nader Pouratian, Adam S. Kanter, Ashok R. Asthagiri, Aaron S. Dumont, Jason P. Sheehan, W. Jeffrey Elias and Mark E. Shaffrey
The purpose of this study was to evaluate the results obtained in patients who underwent anterior stabilization for three-column thoracolumbar fractures.
The authors retrospectively reviewed available clinical and radiographic data (1997–2006) to classify three-column thoracolumbar fractures according to the Association for the Study of Internal Fixation (AO) system, neurological status, spinal canal compromise, pre- and postoperative segmental angulation, and arthrodesis rate.
The mean computed tomography–measured preoperative spinal canal compromise was 48.3% (range 8–92%), and the mean vertebral body height loss was 39.4%. The mean preoperative kyphotic deformity of 14.9° improved to 4.6° at the final follow-up examination. Although this angulation had increased a mean of 1.8° during the follow-up period, the extent of correction was still significant compared with the preoperative angulation (p < 0.01). There were no cases of vascular complication or neurological deterioration.
Contemporary anterior spinal reconstruction techniques can allow certain types of unstable three-column thoracolumbar fractures to be treated via an anterior approach alone. Compared with traditional posterior approaches, the anterior route spares lumbar motion segments and obviates the need for harvesting of the iliac crest.
Anthony L. Asher, Panagiotis Kerezoudis, Praveen V. Mummaneni, Erica F. Bisson, Steven D. Glassman, Kevin T. Foley, Jonathan R. Slotkin, Eric A. Potts, Mark E. Shaffrey, Christopher I. Shaffrey, Domagoj Coric, John J. Knightly, Paul Park, Kai-Ming Fu, Clinton J. Devin, Kristin R. Archer, Silky Chotai, Andrew K. Chan, Michael S. Virk and Mohamad Bydon
Patient-reported outcomes (PROs) play a pivotal role in defining the value of surgical interventions for spinal disease. The concept of minimum clinically important difference (MCID) is considered the new standard for determining the effectiveness of a given treatment and describing patient satisfaction in response to that treatment. The purpose of this study was to determine the MCID associated with surgical treatment for degenerative lumbar spondylolisthesis.
The authors queried the Quality Outcomes Database registry from July 2014 through December 2015 for patients who underwent posterior lumbar surgery for grade I degenerative spondylolisthesis. Recorded PROs included scores on the Oswestry Disability Index (ODI), EQ-5D, and numeric rating scale (NRS) for leg pain (NRS-LP) and back pain (NRS-BP). Anchor-based (using the North American Spine Society satisfaction scale) and distribution-based (half a standard deviation, small Cohen’s effect size, standard error of measurement, and minimum detectable change [MDC]) methods were used to calculate the MCID for each PRO.
A total of 441 patients (80 who underwent laminectomies alone and 361 who underwent fusion procedures) from 11 participating sites were included in the analysis. The changes in functional outcome scores between baseline and the 1-year postoperative evaluation were as follows: 23.5 ± 17.4 points for ODI, 0.24 ± 0.23 for EQ-5D, 4.1 ± 3.5 for NRS-LP, and 3.7 ± 3.2 for NRS-BP. The different calculation methods generated a range of MCID values for each PRO: 3.3–26.5 points for ODI, 0.04–0.3 points for EQ-5D, 0.6–4.5 points for NRS-LP, and 0.5–4.2 points for NRS-BP. The MDC approach appeared to be the most appropriate for calculating MCID because it provided a threshold greater than the measurement error and was closest to the average change difference between the satisfied and not-satisfied patients. On subgroup analysis, the MCID thresholds for laminectomy-alone patients were comparable to those for the patients who underwent arthrodesis as well as for the entire cohort.
The MCID for PROs was highly variable depending on the calculation technique. The MDC seems to be a statistically and clinically sound method for defining the appropriate MCID value for patients with grade I degenerative lumbar spondylolisthesis. Based on this method, the MCID values are 14.3 points for ODI, 0.2 points for EQ-5D, 1.7 points for NRS-LP, and 1.6 points for NRS-BP.