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Reginald Davis, Joshua D. Auerbach, Hyun Bae, and Thomas J. Errico

Object

Posterolateral spinal fusion (PSF) has long been the standard of care for degenerative spondylolisthesis, but less invasive, motion-preserving alternatives have been proposed to reduce the complications associated with fusion while still providing neural decompression and stabilization. The object of the current study is to evaluate the safety and efficacy of coflex Interlaminar Stabilization compared with PSF to treat low-grade spondylolisthesis with spinal stenosis.

Methods

This is a prospective, randomized, multicenter FDA investigational device exemption (IDE) trial comparing coflex Interlaminar Stabilization with laminectomy and PSF. A total of 322 patients from 21 sites in the US were enrolled between 2006 and 2008 for the IDE trial. The current study evaluated only the subset of patients from this overall cohort with Grade 1 spondylolisthesis (99 in the coflex group and 51 in the fusion group). Subjects were randomized 2:1 to receive decompression and coflex interlaminar stabilization or decompression and posterolateral spinal fusion with spinal instrumentation. Data collected included perioperative outcomes, Oswestry Disability Index (ODI), back and worse leg visual analog scale (VAS) scores, 12-Item Short Form Health Survey, Zurich Claudication Questionnaire (ZCQ), and radiographic outcomes at a minimum of 2 years. The FDA criteria for overall device success required the following to be met: 15-point reduction in ODI, no reoperations, no major device-related complications, and no postoperative epidural injections.

Results

At a minimum of 2 years, patient follow-up was 94.9% and 94.1% in the coflex and fusion control groups, respectively. There were no group differences at baseline for any demographic, clinical, or radiographic parameter. The average age was 63 years in the coflex cohort and 65 years in the fusion cohort. Coflex subjects experienced significantly shorter operative times (p < 0.0001), less estimated blood loss (p < 0.0001), and shorter length of stay (p < 0.0001) than fusion controls. Both groups experienced significant improvements from baseline at 2 years in ODI, VAS back, VAS leg, and ZCQ, with no significant group differences, with the exception of significantly greater ZCQ satisfaction with coflex at 2 years. FDA overall success was achieved in 62.8% of coflex subjects (59 of 94) and 62.5% of fusion controls (30 of 48) (p = 1.000). The reoperation rate was higher in the coflex cohort (14 [14.1%] of 99) compared with fusion (3 [5.9%] of 51, p = 0.18), although this difference was not statistically significant. Fusion was associated with significantly greater angulation and translation at the superior and inferior adjacent levels compared with baseline, while coflex showed no significant radiographic changes at the operative or index levels.

Conclusions

Low-grade spondylolisthesis was effectively stabilized by coflex and led to similar clinical outcomes, with improved perioperative outcomes, compared with PSF at 2 years. Reoperation rates, however, were higher in the coflex cohort. Patients in the fusion cohort experienced significantly increased superior and inferior level angulation and translation, while those in the coflex cohort experienced no significant adjacent or index level radiographic changes from baseline. Coflex Interlaminar Stabilization is a less invasive, safe, and equally efficacious clinical solution to PSF to treat low-grade spondylolisthesis, and it appears to reduce stresses at the adjacent levels. Clinical trial registration no.: NCT00534235 (ClinicalTrials.gov).

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John K. Houten, Nicholas H. Post, Joseph W. Dryer, and Thomas J. Errico

Object

Although transforaminal lumbar interbody fusion (TLIF) is an increasingly popular surgical technique, there are a limited number of studies in which investigators have stratified outcome data with respect to surgical indications or documented radiographically proven and clinical results with respect to disc space height (DSH). The authors conducted a study to evaluate the long-term outcomes after TLIF with respect to surgical indication and radiographic/neuroimaging results.

Methods

Thirty-three consecutive TLIF-treated patients underwent follow-up investigation for a mean of 37 months. Isthmic spondylolysis was present in eight patients, recurrent disc herniation in 14, and degenerative disc disease (DDD) in 11. The operative technique involved the placement of interbody structural allograft, pedicle screw instrumentation, and morcellized autograft in the anterior interbody space and the contralateral intertransverse gutter. Surgery was performed at L4–5 in 16 patients, L5–S1 in 14, L3–4 in two, and both L4–5 and L5–S1 in one patient.

Preoperative symptoms were back pain (in 91% of cases), leg pain (in 94%), sensory loss (in 67%), and motor deficits (in 30%). Postoperatively, back pain was improved in 67% of the patients, unchanged in 27%, and worsened in 7%. Leg pain improved in 80% of patients, was unchanged in 10%, and worsened in 10%. Outcome, as measured using the Prolo Functional and Economic Scales, improved from a score of 4.9 to 7. In patients with spondylolysis and recurrent disc herniation outcomes were better than in those with DDD only. There was no correlation of outcome with symptom duration, patient age, or level of surgery. In an independent review of pre- and late postoperative radiographs no significant differences in lordosis angles, Cobb angles, or DSHs were found. Fusion occurred in all cases.

Conclusions

The TLIF procedure was associated with good clinical outcomes and a high fusion rate but no change in the DSH. Patients who present with spondylolysis and recurrent herniations experience better outcome than those with degenerative disease alone.

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Jerry Cheriyan, Thomas Cheriyan, Anterpreet Dua, Jeffrey A. Goldstein, Thomas J. Errico, and Vikas Kumar

OBJECTIVE

Intraoperative cell salvage systems, or cell savers, are widely used for the management of blood loss in patients undergoing spine surgery. However, recent studies report conflicting evidence of their efficacy. The purpose of the meta-analysis was to investigate the efficacy of cell savers in reducing blood transfusion requirements in patients undergoing spine surgery.

METHODS

Both retrospective and prospective studies that investigated the efficacy of cell savers in reducing transfusion requirements in spine surgery patients when compared with control patients were identified from MEDLINE, Embase, Cochrane Collaboration Library, Google Scholar, and Scopus databases. Outcome data extracted included number of patients receiving allogenic transfusions (transfusion rate); units of allogenic transfusions; postoperative hemoglobin; costs; operative time; and complications. RevMan 5 software was used to perform statistical analyses. A random-effects model was used to calculate pooled odds ratios (with 95% CIs) and weighted mean differences (WMDs [95% CI]) for dichotomous and continuous variables, respectively.

RESULTS

Eighteen studies with 2815 patients in total were included in the meta-analysis. During spine surgery, the use of intraoperative cell salvage did not reduce the intraoperative (OR 0.66 [95% CI 0.30, 1.41]), postoperative (OR −0.57 [95% CI 0.20, 1.59]), or total transfusion (OR 0.92 [95% CI 0.43, 1.98]) rate. There was a reduction in the number of allogenic units transfused intraoperatively by a mean of 0.81 (95% CI −1.15, −0.48). However, there were no differences in the number of units transfused postoperatively (WMD −0.02 [95% CI −0.41, 0.38]) or the total units transfused (WMD 0.08 [95% CI −1.06, 1.22]). There were also no differences in operative time (WMD 19.36 [95% CI −2.43, 42.15]) or complications reported (OR 0.79 [95% CI 0.46, 1.37]) between groups. A difference in postoperative hemoglobin (WMD 0.54 [95% CI 0.11, 0.98]) between both groups was observed.

CONCLUSIONS

Cell saver is efficacious at reducing intraoperative allogenic units transfused. There is no difference in transfusion rates, postoperative units transfused, and the total number of units transfused. Further cost analysis studies are necessary to evaluate the cost-effectiveness of this method of blood conservation.

■ CLASSIFICATION OF EVIDENCE Type of question: therapeutic; study design: meta-analysis; strength of recommendation: low.

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Max Vaynrub, Brandon P. Hirsch, Jared Tishelman, Dennis Vasquez-Montes, Aaron J. Buckland, Thomas J. Errico, and Themistocles S. Protopsaltis

OBJECTIVE

Verifying the adequacy of surgical correction of adult spinal sagittal deformity (SSD) leads to improved postoperative alignment and clinical outcomes. Traditionally, surgeons relied on intraoperative measurements of lumbar lordosis (LL) correction. However, T-1 pelvic angle (TPA) and its component angles more reliably predict postoperative alignment. While TPA is readily measured on standing radiographs, intraoperative radiographs offer poor resolution of the bicoxofemoral axis. A method to recreate this radiographic landmark by extrapolating preoperative measurements has been described. The authors aimed to assess the reliability of measurements of global spinal alignment obtained via geometrical reconstitution of the bicoxofemoral axis on prone intraoperative radiographs.

METHODS

A retrospective review was performed. Twenty sets of preoperative standing full-length and intraoperative prone 36-inch lateral radiographs were analyzed. Pelvic incidence (PI) and sacral to bicoxofemoral axis distance (SBFD) were recorded on preoperative films. A perpendicular line was drawn on the intraoperative radiograph from the midpoint of the sacral endplate. This was used as one limb of the PI, and the second limb was digitally drawn at an angle that reproduced the preoperatively obtained PI, extending for a distance that matched the preoperative SBFD. This final point marked the obscured bicoxofemoral axis. These landmarks were used to measure the L-1, T-9, T-4, and T-1 pelvic angles (LPA, T9PA, T4PA, and TPA, respectively) and LL. Two spine fellows and 2 attending spine surgeons made independent measurements and repeated the process in 1 month. Mixed-model 2-way intraclass correlation coefficient (ICC) and Cronbach’s α values were calculated to assess interobserver, intraobserver, and scale reliability.

RESULTS

Interobserver reliability was excellent for preoperative PI and intraoperative LPA, T9PA, and T4PA (ICC = 0.88, 0.84, 0.84, and 0.93, respectively), good for intraoperative TPA (ICC = 0.68), and fair for preoperative SBFD (ICC = 0.60) and intraoperative LL (ICC = 0.50). Cronbach’s α was ≥ 0.80 for all measurements. Measuring PI on preoperative standing images had excellent intraobserver reliability for all raters (ICC = 0.89, range 0.80–0.93). All raters but one showed excellent reliability for measuring the SBFD. Reliability for measuring prone LL was good for all raters (ICC = 0.71, range 0.64–0.76). The LPA demonstrated good to excellent reliability for each rater (ICC = 0.76, range 0.65–0.81). The thoracic pelvic angles tended to be more reliable at more distal vertebrae (T9PA ICC = 0.71, range 0.49–0.81; T4PA ICC = 0.62, range 0.43–0.83; TPA ICC = 0.56, range 0.31–0.86).

CONCLUSIONS

Intraoperative assessment of global spinal alignment with TPA and component angles is more reliable than intraoperative measurements of LL. Reconstruction of preoperatively measured PI and SBFD on intraoperative radiographs effectively overcomes poor visualization of the bicoxofemoral axis. This method is easily adopted and produces accurate and reliable prone intraoperative measures of global spinal alignment.

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M. Burhan Janjua, Jared C. Tishelman, Dennis Vasquez-Montes, Max Vaynrub, Thomas J. Errico, Aaron J. Buckland, and Themistocles Protopsaltis

Sitting radiographs are a valuable tool to consider the thoracic compensatory mechanism in patients who are candidates for thoracolumbar correction surgery.

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Devon J. Ryan, Nicholas D. Stekas, Ethan W. Ayres, Mohamed A. Moawad, Eaman Balouch, Dennis Vasquez-Montes, Charla R. Fischer, Aaron J. Buckland, Thomas J. Errico, and Themistocles S. Protopsaltis

OBJECTIVE

The goal of this study was to reliably predict sagittal and coronal spinal alignment with clinical photographs by using markers placed at easily localized anatomical landmarks.

METHODS

A consecutive series of patients with adult spinal deformity were enrolled from a single center. Full-length standing radiographs were obtained at the baseline visit. Clinical photographs were taken with reflective markers placed overlying C2, S1, the greater trochanter, and each posterior-superior iliac spine. Sagittal radiographic parameters were C2 pelvic angle (CPA), T1 pelvic angle (TPA), and pelvic tilt. Coronal radiographic parameters were pelvic obliquity and T1 coronal tilt. Linear regressions were performed to evaluate the relationship between radiographic parameters and their photographic “equivalents.” The data were reanalyzed after stratifying the cohort into low–body mass index (BMI) (< 30) and high-BMI (≥ 30) groups. Interobserver and intraobserver reliability was assessed for clinical measures via intraclass correlation coefficients (ICCs).

RESULTS

A total of 38 patients were enrolled (mean age 61 years, mean BMI 27.4 kg/m2, 63% female). All regression models were significant, but sagittal parameters were more closely correlated to photographic parameters than coronal measurements. TPA and CPA had the strongest associations with their photographic equivalents (both r2 = 0.59, p < 0.001). Radiographic and clinical parameters tended to be more strongly correlated in the low-BMI group. Clinical measures of TPA and CPA had high intraobserver reliability (all ICC > 0.99, p < 0.001) and interobserver reliability (both ICC > 0.99, p < 0.001).

CONCLUSIONS

The photographic measures of spinal deformity developed in this study were highly correlated with their radiographic counterparts and had high inter- and intraobserver reliability. Clinical photography can not only reduce radiation exposure in patients with adult spinal deformity, but also be used to assess deformity when full-spine radiographs are unavailable.

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Emmanuelle Ferrero, Barthelemy Liabaud, Vincent Challier, Renaud Lafage, Bassel G. Diebo, Shaleen Vira, Shian Liu, Jean Marc Vital, Brice Ilharreborde, Themistocles S. Protopsaltis, Thomas J. Errico, Frank J. Schwab, and Virginie Lafage

OBJECT

Previous forceplate studies analyzing the impact of sagittal-plane spinal deformity on pelvic parameters have demonstrated the compensatory mechanisms of pelvis translation in addition to rotation. However, the mechanisms recruited for this pelvic rotation were not assessed. This study aims to analyze the relationship between spinopelvic and lower-extremity parameters and clarify the role of pelvic translation.

METHODS

This is a retrospective study of patients with spinal deformity and full-body EOS images. Patients with only stenosis or low-back pain were excluded. Patients were grouped according to T-1 spinopelvic inclination (T1SPi): sagittal forward (forward, > 0.5°), neutral (−6.3° to 0.5°), or backward (< −6.3°). Pelvic translation was quantified by pelvic shift (sagittal offset between the posterosuperior corner of the sacrum and anterior cortex of the distal tibia), hip extension was measured using the sacrofemoral angle (SFA; the angle formed by the middle of the sacral endplate and the bicoxofemoral axis and the line between the bicoxofemoral axis and the femoral axis), and chin-brow vertical angle (CBVA). Univariate and multivariate analyses were used to compare the parameters and correlation with the Oswestry Disability Index (ODI).

RESULTS

In total, 336 patients (71% female; mean age 57 years; mean body mass index 27 kg/m2) had mean T1SPi values of −8.8°, −3.5°, and 5.9° in the backward, neutral, and forward groups, respectively. There were significant differences in the lower-extremity and spinopelvic parameters between T1SPi groups. The backward group had a normal lumbar lordosis (LL), negative SVA and pelvic shift, and the largest hip extension. Forward patients had a small LL and an increased SVA, with a large pelvic shift creating compensatory knee flexion. Significant correlations existed between lower-limb parameter and pelvic shift, pelvic tilt, T-1 pelvic angle, T1SPi, and sagittal vertical axis (0.3 < r < 0.8; p < 0.001). ODI was significantly correlated with knee flexion and pelvic shift.

CONCLUSIONS

This is the first study to describe full-body alignment in a large population of patients with spinal pathologies. Furthermore, patients categorized based on T1SPi were found to have significant differences in the pelvic shift and lower-limb compensatory mechanisms. Correlations between lower-limb angles, pelvic shift, and ODI were identified. These differences in compensatory mechanisms should be considered when evaluating and planning surgical intervention for adult patients with spinal deformity.

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Bassel G. Diebo, Jonathan H. Oren, Vincent Challier, Renaud Lafage, Emmanuelle Ferrero, Shian Liu, Shaleen Vira, Matthew Adam Spiegel, Bradley Yates Harris, Barthelemy Liabaud, Jensen K. Henry, Thomas J. Errico, Frank J. Schwab, and Virginie Lafage

OBJECTIVE

Sagittal malalignment requires higher energy expenditure to maintain an erect posture. Because the clinical impact of sagittal alignment is affected by both the severity of the deformity and recruitment of compensatory mechanisms, it is important to investigate new parameters that reflect both disability level and compensatory mechanisms for all patients. This study investigated the clinical relevance of the global sagittal axis (GSA), a novel measure to evaluate the standing axis of the human body.

METHODS

This is a retrospective review of patients who underwent full-body radiographs and completed health-related quality of life (HRQOL) questionnaires: Oswestry Disability Index (ODI), Scoliosis Research Society–22, EuroQol-5D (EQ-5D), and the visual analog scale for back and leg pain. The GSA was defined as the angle formed by a line from the midpoint of the femoral condyles to the center of C-7, and a line from the midpoint between the femoral condyles to the posterior superior corner of the S-1 sacral endplate. After evaluating the correlation of GSA/HRQOL with sagittal parameters, linear regression models were generated to investigate how ODI and GSA related to radiographic parameters (T-1 pelvic angle, pelvic retroversion, knee flexion, and pelvic posterior translation).

RESULTS

One hundred forty-three patients (mean age 44 years) were included. The GSA correlated significantly with all HRQOL (up to r = 0.6 with EQ-5D) and radiographic parameters (up to r = 0.962 with sagittal vertical axis). Regression between ODI and sagittal radiographic parameters identified the GSA as an independent predictor (r = 0.517, r2 = 0.267; p < 0.001). Analysis of standardized coefficients revealed that when controlling for deformity, the GSA increased with a concurrent decrease in pelvic retroversion (−0.837) and increases in knee flexion (+0.287) and pelvic posterior translation (+0.193).

CONCLUSIONS

The GSA is a simple, novel measure to assess the standing axis of the human body in the sagittal plane. The GSA correlated highly with spinopelvic and lower-extremities sagittal parameters and exhibited remarkable correlations with HRQOL, which exceeded other commonly used parameters.

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Alex Soroceanu, Douglas C. Burton, Bassel Georges Diebo, Justin S. Smith, Richard Hostin, Christopher I. Shaffrey, Oheneba Boachie-Adjei, Gregory M. Mundis Jr., Christopher Ames, Thomas J. Errico, Shay Bess, Munish C. Gupta, Robert A. Hart, Frank J. Schwab, Virginie Lafage, and International Spine Study Group

OBJECT

Adult spinal deformity (ASD) surgery is known for its high complication rate. This study examined the impact of obesity on complication rates, infection, and patient-reported outcomes in patients undergoing surgery for ASD.

METHODS

This study was a retrospective review of a multicenter prospective database of patients with ASD who were treated surgically. Patients with available 2-year follow-up data were included. Obesity was defined as having a body mass index (BMI) ≥ 30 kg/m2. Data collected included complications (total, minor, major, implant-related, radiographic, infection, revision surgery, and neurological injury), estimated blood loss (EBL), operating room (OR) time, length of stay (LOS), and patient-reported questionnaires (Oswestry Disability Index [ODI], Short Form-36 [SF-36], and Scoliosis Research Society [SRS]) at baseline and at 6 weeks, 1 year, and 2 years postoperatively. The impact of obesity was studied using multivariate modeling, accounting for confounders.

RESULTS

Of 241 patients who satisfied inclusion criteria, 175 patients were nonobese and 66 were obese. Regression models showed that obese patients had a higher overall incidence of major complications (IRR 1.54, p = 0.02) and wound infections (odds ratio 4.88, p = 0.02). Obesity did not increase the number of minor complications (p = 0.62), radiographic complications (p = 0.62), neurological complications (p = 0.861), or need for revision surgery (p = 0.846). Obesity was not significantly correlated with OR time (p = 0.23), LOS (p = 0.9), or EBL (p = 0.98). Both groups experienced significant improvement overtime, as measured on the ODI (p = 0.0001), SF-36 (p = 0.0001), and SRS (p = 0.0001) questionnaires. However, the overall magnitude of improvement was less for obese patients (ODI, p = 0.0035; SF-36, p = 0.0012; SRS, p = 0.022). Obese patients also had a lower rate of improvement over time (SRS, p = 0.0085; ODI, p = 0.0001; SF-36, p = 0.0001).

CONCLUSIONS

This study revealed that obese patients have an increased risk of complications following ASD correction. Despite these increased complications, obese patients do benefit from surgical intervention; however, their improvement in health-related quality of life (HRQL) is less than that of nonobese patients.

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Justin S. Smith, Michael P. Kelly, Elizabeth L. Yanik, Christine R. Baldus, Thomas J. Buell, Jon D. Lurie, Charles Edwards, Steven D. Glassman, Lawrence G. Lenke, Oheneba Boachie-Adjei, Jacob M. Buchowski, Leah Y. Carreon, Charles H. Crawford III, Thomas J. Errico, Stephen J. Lewis, Tyler Koski, Stefan Parent, Virginie Lafage, Han Jo Kim, Christopher P. Ames, Shay Bess, Frank J. Schwab, Christopher I Shaffrey, and Keith H Bridwell

OBJECTIVE

Although short-term adult symptomatic lumbar scoliosis (ASLS) studies favor operative over nonoperative treatment, longer outcomes are critical for assessment of treatment durability, especially for operative treatment, because the majority of implant failures and nonunions present between 2 and 5 years after surgery. The objectives of this study were to assess the durability of treatment outcomes for operative versus nonoperative treatment of ASLS, to report the rates and types of associated serious adverse events (SAEs), and to determine the potential impact of treatment-related SAEs on outcomes.

METHODS

The ASLS-1 (Adult Symptomatic Lumbar Scoliosis–1) trial is an NIH-sponsored multicenter prospective study to assess operative versus nonoperative ASLS treatment. Patients were 40–80 years of age and had ASLS (Cobb angle ≥ 30° and Oswestry Disability Index [ODI] ≥ 20 or Scoliosis Research Society [SRS]–22 subscore ≤ 4.0 in the Pain, Function, and/or Self-Image domains). Patients receiving operative and nonoperative treatment were compared using as-treated analysis, and the impact of related SAEs was assessed. Primary outcome measures were ODI and SRS-22.

RESULTS

The 286 patients with ASLS (107 with nonoperative treatment, 179 with operative treatment) had 2-year and 5-year follow-up rates of 90% (n = 256) and 74% (n = 211), respectively. At 5 years, compared with patients treated nonoperatively, those who underwent surgery had greater improvement in ODI (mean difference −15.2 [95% CI −18.7 to −11.7]) and SRS-22 subscore (mean difference 0.63 [95% CI 0.48–0.78]) (p < 0.001), with treatment effects (TEs) exceeding the minimum detectable measurement difference (MDMD) for ODI (7) and SRS-22 subscore (0.4). TEs at 5 years remained as favorable as 2-year TEs (ODI −13.9, SRS-22 0.52). For patients in the operative group, the incidence rates of treatment-related SAEs during the first 2 years and 2–5 years after surgery were 22.38 and 8.17 per 100 person-years, respectively. At 5 years, patients in the operative group who had 1 treatment-related SAE still had significantly greater improvement, with TEs (ODI −12.2, SRS-22 0.53; p < 0.001) exceeding the MDMD. Twelve patients who received surgery and who had 2 or more treatment-related SAEs had greater improvement than nonsurgically treated patients based on ODI (TE −8.34, p = 0.017) and SRS-22 (TE 0.32, p = 0.029), but the SRS-22 TE did not exceed the MDMD.

CONCLUSIONS

The significantly greater improvement of operative versus nonoperative treatment for ASLS at 2 years was durably maintained at the 5-year follow-up. Patients in the operative cohort with a treatment-related SAE still had greater improvement than patients in the nonoperative cohort. These findings have important implications for patient counseling and future cost-effectiveness assessments.