Zorica Buser, Darrel S. Brodke, Jim A. Youssef, Hans-Joerg Meisel, Sue Lynn Myhre, Robin Hashimoto, Jong-Beom Park, S. Tim Yoon and Jeffrey C. Wang
The purpose of this review was to compare the efficacy and safety of synthetic bone graft substitutes versus autograft or allograft for the treatment of lumbar and cervical spinal degenerative diseases. Multiple major medical reference databases were searched for studies that evaluated spinal fusion using synthetic bone graft substitutes (either alone or with an autograft or allograft) compared with autograft and allograft. Randomized controlled trials (RCT) and cohort studies with more than 10 patients were included. Radiographic fusion, patient-reported outcomes, and functional outcomes were the primary outcomes of interest.
The search yielded 214 citations with 27 studies that met the inclusion criteria. For the patients with lumbar spinal degenerative disease, data from 19 comparative studies were included: 3 RCTs, 12 prospective, and 4 retrospective studies. Hydroxyapatite (HA), HA+collagen, β-tricalcium phosphate (β-TCP), calcium sulfate, or polymethylmethacrylate (PMMA) were used. Overall, there were no differences between the treatment groups in terms of fusion, functional outcomes, or complications, except in 1 study that found higher rates of HA graft absorption.
For the patients with cervical degenerative conditions, data from 8 comparative studies were included: 4 RCTs and 4 cohort studies (1 prospective and 3 retrospective studies). Synthetic grafts included HA, β-TCP/HA, PMMA, and biocompatible osteoconductive polymer (BOP). The PMMA and BOP grafts led to lower fusion rates, and PMMA, HA, and BOP had greater risks of graft fragmentation, settling, and instrumentation problems compared with iliac crest bone graft.
The overall quality of evidence evaluating the potential use and superiority of the synthetic biological materials for lumbar and cervical fusion in this systematic review was low or insufficient, largely due to the high potential for bias and small sample sizes. Thus, definitive conclusions or recommendations regarding the use of these synthetic materials should be made cautiously and within the context of the limitations of the evidence.
Marcus D. Mazur, Vijay M. Ravindra, Meic H. Schmidt, Darrel S. Brodke, Brandon D. Lawrence, Jay Riva-Cambrin and Andrew T. Dailey
S-2 alar-iliac (S2AI) screws are an attractive alternative to conventional fixation with iliac bolts because they are lower profile, require less muscle dissection, and have greater pullout strength. Few studies, however, compare outcomes between these techniques.
The authors conducted a retrospective cohort study of consecutive adult patients at a single institution from December 2009 to March 2012 who underwent lumbopelvic fixation using S2AI screws or iliac bolts. Medical records were reviewed for patients with clinical failure, defined as an unplanned reoperation because of instrumentation failure and/or wound-related complications. Univariate, multivariate, and survival analyses were used to compare patients who required reoperation with those who did not. Method of pelvic fixation was the main predictor variable of interest, and the authors adjusted for potential confounding risk factors.
Of the 60 patients included, 23 received S2AI screws. Seventeen patients (28%) underwent an osteotomy. The mean follow-up was 22 months. A Kaplan-Meier survival model was used to evaluate the time to reoperation from the initial placement of lumbopelvic instrumentation. The failure-free rate was 96.6% at 6 months, 87.0% at 1 year, and 73.5% at 2 years. Reoperation was more common in patients with iliac bolts than in those with S2AI screws (13 vs 2; p = 0.031). Univariate analysis identified potential risk factors for unplanned reoperation, including use of iliac bolts (p = 0.031), absence of L5–S1 interbody graft (p = 0.048), previous lumbar fusion (p = 0.034), and pathology other than degenerative disease or scoliosis (p = 0.034). After adjusting for other risk factors, multivariate analysis revealed that the use of S2AI screws (OR 8.1 [1.5–73.5]; p = 0.030) was the only independent predictor for preventing unplanned reoperation.
Both S2AI screws and iliac bolts were effective at improving fusion rates at the lumbosacral junction. The use of S2AI screws, however, was independently associated with fewer unplanned reoperations for wound-related complications and instrumentation failures than the use of iliac bolts.
Graham C. Calvert, Brandon D. Lawrence, Amir M. Abtahi, Kent N. Bachus and Darrel S. Brodke
Cortical trajectory screw constructs, developed as an alternative to pedicle screw fixation for the lumbar spine, have similar in vitro biomechanics. The possibility of one screw path having the ability to rescue the other in a revision scenario holds promise but has not been evaluated. The objective in this study was to investigate the biomechanical properties of traditional pedicle screws and cortical trajectory screws when each was used to rescue the other in the setting of revision.
Ten fresh-frozen human lumbar spines were instrumented at L3–4, 5 with cortical trajectory screws and 5 with pedicle screws. Construct stiffness was recorded in flexion/extension, lateral bending, and axial rotation. The L-3 screw pullout strength was tested to failure for each specimen and salvaged with screws of the opposite trajectory. Mechanical stiffness was again recorded. The hybrid rescue trajectory screws at L-3 were then tested to failure.
Cortical screws, when used in a rescue construct, provided stiffness in flexion/extension and axial rotation similar to that provided by the initial pedicle screw construct prior to failure. The rescue pedicle screws provided stiffness similar to that provided by the primary cortical screw construct in flexion/extension, lateral bending, and axial rotation. In pullout testing, cortical rescue screws retained 60% of the original pedicle screw pullout strength, whereas pedicle rescue screws retained 65% of the original cortical screw pullout strength.
Cortical trajectory screws, previously studied as a primary mode of fixation, may also be used as a rescue option in the setting of a failed or compromised pedicle screw construct in the lumbar spine. Likewise, a standard pedicle screw construct may rescue a compromised cortical screw track. Cortical and pedicle screws each retain adequate construct stiffness and pullout strength when used for revision at the same level.
Michael G. Fehlings, Justin S. Smith, Branko Kopjar, Paul M. Arnold, S. Tim Yoon, Alexander R. Vaccaro, Darrel S. Brodke, Michael E. Janssen, Jens R. Chapman, Rick C. Sasso, Eric J. Woodard, Robert J. Banco, Eric M. Massicotte, Mark B. Dekutoski, Ziya L. Gokaslan, Christopher M. Bono and Christopher I. Shaffrey
Rates of complications associated with the surgical treatment of cervical spondylotic myelopathy (CSM) are not clear. Appreciating these risks is important for patient counseling and quality improvement. The authors sought to assess the rates of and risk factors associated with perioperative and delayed complications associated with the surgical treatment of CSM.
Data from the AOSpine North America Cervical Spondylotic Myelopathy Study, a prospective, multicenter study, were analyzed. Outcomes data, including adverse events, were collected in a standardized manner and externally monitored. Rates of perioperative complications (within 30 days of surgery) and delayed complications (31 days to 2 years following surgery) were tabulated and stratified based on clinical factors.
The study enrolled 302 patients (mean age 57 years, range 29–86) years. Of 332 reported adverse events, 73 were classified as perioperative complications (25 major and 48 minor) in 47 patients (overall perioperative complication rate of 15.6%). The most common perioperative complications included minor cardiopulmonary events (3.0%), dysphagia (3.0%), and superficial wound infection (2.3%). Perioperative worsening of myelopathy was reported in 4 patients (1.3%). Based on 275 patients who completed 2 years of follow-up, there were 14 delayed complications (8 minor, 6 major) in 12 patients, for an overall delayed complication rate of 4.4%. Of patients treated with anterior-only (n = 176), posterior-only (n = 107), and combined anterior-posterior (n = 19) procedures, 11%, 19%, and 37%, respectively, had 1 or more perioperative complications. Compared with anterior-only approaches, posterior-only approaches had a higher rate of wound infection (0.6% vs 4.7%, p = 0.030). Dysphagia was more common with combined anterior-posterior procedures (21.1%) compared with anterior-only procedures (2.3%) or posterior-only procedures (0.9%) (p < 0.001). The incidence of C-5 radiculopathy was not associated with the surgical approach (p = 0.8). The occurrence of perioperative complications was associated with increased age (p = 0.006), combined anterior-posterior procedures (p = 0.016), increased operative time (p = 0.009), and increased operative blood loss (p = 0.005), but it was not associated with comorbidity score, body mass index, modified Japanese Orthopaedic Association score, smoking status, anterior-only versus posterior-only approach, or specific procedures. Multivariate analysis of factors associated with minor or major complications identified age (OR 1.029, 95% CI 1.002–1.057, p = 0.035) and operative time (OR 1.005, 95% CI 1.002–1.008, p = 0.001). Multivariate analysis of factors associated with major complications identified age (OR 1.054, 95% CI 1.015–1.094, p = 0.006) and combined anterior-posterior procedures (OR 5.297, 95% CI 1.626–17.256, p = 0.006).
For the surgical treatment of CSM, the vast majority of complications were treatable and without long-term impact. Multivariate factors associated with an increased risk of complications include greater age, increased operative time, and use of combined anterior-posterior procedures.