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Oren N. Gottfried and Darrel S. Brodke

Lumbar disc arthroplasty is now a common treatment for lumbar degenerative disc disease. Whereas the immediate and delayed complications in patients with artificial lumbar discs are well reported, the durability of artificial disc hardware after severe spine trauma is unknown. The authors describe the management of a rare case of a traumatic lumbar burst fracture in a patient who had undergone disc arthroplasty. This 31-year-old male contractor had undergone placement of an L4–5 Charité artificial disc (DePuy Spine) and L5–S1 anterior lumbar fusion 10 months before he fell from a roof and sustained a traumatic L-3 burst fracture with significant canal compromise and cauda equina injury. Despite the considerable compressive load on his spine, the artificial disc (L4–5) remained intact without any radiological signs of hardware failure, and the vertebrae above (L-4) and below (L-5) the artificial disc had no signs of injury. For the L-3 burst fracture the patient underwent an open decompressive laminectomy at L2–3 and posterior fusion with instrumentation from L-2 to L-4. At 24 months postinjury, he had returned to full work activities as a contractor with minimal back pain and mild right lower-extremity sensory changes and weakness left over from the trauma. The total disc arthroplasty at L4–5 is functional and has preserved motion, and there is a solid fusion at L2–4 and L5–S1. This case demonstrates that a lumbar artificial disc can tolerate a significant load from trauma and remain functional without hardware failure even after a traumatic burst fracture at the adjacent lumbar vertebral body and shows the successful treatment of this fracture, with posterior fusion preserving the motion of an artificial disc.

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Ganesh Rao, Darrel S. Brodke, Matthew Rondina and Andrew T. Dailey

Object. To validate computerized tomography (CT) scanning as a tool to assess the accuracy of thoracic pedicle screw placement, the authors compared its accuracy with that of direct visualization in instrumented cadaveric spine specimens.

Methods. A grading scale was devised to score the placement of the pedicle screw. The grades ranged from 0 to 3 depending on the extent to which the pedicle had been violated. One hundred fifty-five pedicles were fitted with instrumentation in eight cadaveric spines. A single observer graded the appearance of the screw based on CT scans (3-mm axial sections with 1-mm overlap) and direct visualization of the specimen. The authors arrived at a Kappa value of 0.51, which suggested only moderate agreement between the two measurement techniques. Whereas CT had a positive predictive value of 95%, it had a negative predictive value of 62%.

Conclusions. The authors thus conclude that although CT scanning is the most valid tool to assess the accuracy of thoracic pedicle screw placement, it tends to overestimate the number of misplaced screws.

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Graham C. Calvert, Brandon D. Lawrence, Amir M. Abtahi, Kent N. Bachus and Darrel S. Brodke

OBJECT

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.

METHODS

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.

RESULTS

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.

CONCLUSIONS

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.

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Matthew L. Goodwin, William Ryan Spiker, Darrel S. Brodke and Brandon D. Lawrence

The aim of this study was to report on 2 patients in whom metal-on-metal (MOM) facet replacements failed, with subsequent positive findings on allergy testing. Motion-preserving devices have been used with limited success when instrumentation is indicated in the mobile spine. MOM-bearing surfaces in orthopedics were developed to increase implant longevity, yet have been associated with numerous adverse outcomes, including local tissue reactions, pseudotumors, metallosis, and the need for revision surgery. Five patients with spinal stenosis and low-grade spondylolisthesis were randomized to undergo facet replacement surgery with the ACADIA facet replacement system at the authors’ institution. Two patients experienced a return of neurological symptoms after a pain-free interval (< 2 years) with development of local tissue reaction and positive findings on allergy testing to cobalt, the metal in the MOM-bearing surface. Both patients underwent successful removal of the implant and revision to titanium posterior spinal fusion and interbody fusion without further complication.

Motion-preserving devices have been designed and trialed for specific indications in the mobile spine. Given the adverse results from MOM devices in hip arthroplasty and now the early reports with MOM facet replacements, caution is warranted when moving forward with any MOM joint–bearing surface. Both patients presented here had an unusual tissue reaction locally and subsequent positive allergy testing results to cobalt. These 2 patients appear to have developed a delayed hypersensitivity reaction to the metal, likely from fine debris at the MOM interface.

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Kee D. Kim, Jeffrey C. Wang, Daniel P. Robertson, Darrel S. Brodke, Mohammed BenDebba, Kathleen M. Block and Gere S. diZerega

Object

Although good surgical technique is effective in reducing postoperative epidural fibrosis, compression or tethering of the nerve root may cause recurrent radicular pain and physical impairment. The implantation of a bioresorbable gel on the dura may further decrease the amount of scar formation after surgery and thus improve the patient's ability to perform activities of daily living (ADL). This study is a 12-month evaluation of the safety and effectiveness of Oxiplex/SP Gel (FzioMed, Inc., San Luis Obispo, CA) in the reduction of pain and radiculopathy after lumbar discectomy.

Methods

A pilot randomized single-blind multicenter clinical trial was conducted to evaluate the performance of Oxiplex/SP Gel in patients who underwent surgery for unilateral herniation of the lumbar disc at L4–5 or L5–S1. Eighteen patients with severe leg pain and lower-extremity weakness (11 women and seven men) were randomly assigned intraoperatively to receive the gel at the conclusion of surgery (treatment group) or to undergo surgery alone (control group). Self-assessment questionnaires (Lumbar Spine Outcomes Questionnaire) to assess pain, symptoms, and ADL were completed preoperatively and at scheduled postoperative intervals (30 days, 90 days, 6 months, and 12 months).

The authors examined the spine and lower extremities of patients scheduled for discectomy to assess neurological function and pain. Treated patients received sufficient Oxiplex/SP Gel (1–3 ml) to coat the nerve root and fill the epidural space. Postoperative clinical evaluations were performed at 30 and 90 days. Patients completed the self-assessment questionnaires at baseline and were contacted by telephone or mail for the completion of the postoperative self-assessment questionnaires.

Surgical procedures were well tolerated; no device-related adverse events and no clinically significant laboratory results were reported. The 11 patients with severe leg pain and lower-extremity weakness who were treated with Oxiplex/SP Gel had a reduction in those symptoms at 30 days, 90 days, 6 months, and 12 months after discectomy, compared with the seven control patients who underwent surgery only.

Conclusions

Oxiplex/SP Gel was easy to use and safe in patients who underwent unilateral discectomy. A greater benefit in clinical outcome measures was seen over the 12-month follow-up period in gel-treated patients.

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Michael A. Finn, Daniel R. Fassett, Todd D. Mccall, Randy Clark, Andrew T. Dailey and Darrel S. Brodke

Object

Stabilization with rigid screw/rod fixation is the treatment of choice for craniocervical disorders requiring operative stabilization. The authors compare the relative immediate stiffness for occipital plate fixation in concordance with transarticular screw fixation (TASF), C-1 lateral mass and C-2 pars screw (C1L-C2P), and C-1 lateral mass and C-2 laminar screw (C1L-C2L) constructs, with and without a cross-link.

Methods

Ten intact human cadaveric spines (Oc–C4) were prepared and mounted in a 7-axis spine simulator. Each specimen was precycled and then tested in the intact state for flexion/extension, lateral bending, and axial rotation. Motion was tracked using the OptoTRAK 3D tracking system. The specimens were then destabilized and instrumented with an occipital plate and TASF. The spine was tested with and without the addition of a cross-link. The C1L-C2P and C1L-C2L constructs were similarly tested.

Results

All constructs demonstrated a significant increase in stiffness after instrumentation. The C1L-C2P construct was equivalent to the TASF in all moments. The C1L-C2L was significantly weaker than the C1L-C2P construct in all moments and significantly weaker than the TASF in lateral bending. The addition of a cross-link made no difference in the stiffness of any construct.

Conclusions

All constructs provide significant immediate stability in the destabilized occipitocervical junction. Although the C1L-C2P construct performed best overall, the TASF was similar, and either one can be recommended. Decreased stiffness of the C1L-C2L construct might affect the success of clinical fusion. This construct should be reserved for cases in which anatomy precludes the use of the other two.

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Alpesh A. Patel, Andrew Dailey, Darrel S. Brodke, Michael Daubs, Paul A. Anderson, R. John Hurlbert, Alexander R. Vacccaro and the Spine Trauma Study Group

Object

The authors review a novel subaxial cervical trauma classification system and demonstrate its application through a series of cervical trauma cases.

Methods

The Spine Trauma Study Group collaborated to create the Subaxial Injury Classification (SLIC) and Severity score. The SLIC system is reviewed and is applied to 3 cases of subaxial cervical trauma.

Results

The SLIC system identifies 3 major injury characteristics to describe subaxial cervical injuries: injury morphology, discoligamentous complex integrity, and neurological status. Minor injury characteristics include injury level and osseous fractures. Each major characteristic is assigned a numerical score based upon injury severity. The sum of these scores constitutes the injury severity score.

Conclusions

By addressing both discoligamentous integrity and neurological status, the SLIC system may overcome major limitations of earlier classification systems. The system incorporates a number of critical clinical variables—including neurological status, absent in earlier systems—and is simple to apply and may provide both diagnostic and prognostic information.

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Alpesh A. Patel, Andrew Dailey, Darrel S. Brodke, Michael Daubs, James Harrop, Peter G. Whang, Alexander R. Vaccaro and the Spine Trauma Study Group

Object

The aim of this study was to review the Thoracolumbar Injury Classification and Severity Score (TLICS) and to demonstrate its application through a series of spine trauma cases.

Methods

The Spine Trauma Study Group collaborated to create and report the TLICS system. The TLICS system is reviewed and applied to 3 cases of thoracolumbar spine trauma.

Results

The TLICS system identifies 3 major injury characteristics to describe thoracolumbar spine injuries: injury morphology, posterior ligamentous complex integrity, and neurological status. In addition, minor injury characteristics such as injury level, confounding variables (such as ankylosing spondylitis), multiple injuries, and chest wall injuries are also identified. Each major characteristic is assigned a numerical score, weighted by severity of injury, which is then summated to yield the injury severity score. The TLICS system has demonstrated initial success and its use is increasing. Limitations of the TLICS system exist and, in some instances, have yet to be addressed. Despite these limitations, the severity score may provide a basis to judge spinal stability and the need for surgical intervention.

Conclusions

By addressing both the posterior ligamentous integrity and the patient's neurological status, the TLICS system attempts to overcome the limitations of prior thoracolumbar classification systems. The TLICS system has demonstrated both validity and reliability and has also been shown to be readily learned and incorporated into clinical practice.

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Marcus D. Mazur, Vijay M. Ravindra, Meic H. Schmidt, Darrel S. Brodke, Brandon D. Lawrence, Jay Riva-Cambrin and Andrew T. Dailey

OBJECT

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.

METHODS

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.

RESULTS

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.

CONCLUSIONS

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.

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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.