Clinical outcomes for lumbar fusion using silicon nitride versus other biomaterials.

BACKGROUND: In lumbar fusion surgery, intervertebral spacer cages made of silicon nitride (Si3N4) ceramic are an available option among other biomaterials. While the surface chemistry of Si3N4 is known to favor bone fusion, large-scale clinical studies attesting to its efficacy are lacking. This multicenter retrospective study compared lumbar fusion outcomes for Si3N4 cages to previously reported data for other cage materials. METHODS: Pre-operative patient demographics, comorbidities, changes in visual analog scale (ΔVAS) pain scores, complications, adverse events, and secondary surgical interventions (SSI) were compiled from the records of 450 patients who underwent Si3N4 lumbar spinal fusion at four separate U.S. surgical centers. For comparison, MEDLINE/PubMed and Google Scholar searches identified studies reporting similar outcomes for other biomaterials. A total of 1,025 patients from 26 cohorts reported in 14 publications met inclusion criteria for this control group. RESULTS: Overall, the mean last-follow-up for all patients was 341±293 days (11.4±9.8 months), with the longest follow-up being 6.4 years. Patients with Si3N4 implants were similar in gender and age distribution to the control group but had higher BMI values (30.9±6.1 vs. 25.8±4.1, P<0.01) and lower tobacco use (15.8% vs. 30.0%, P<0.01). Both the Si3N4 and control groups showed significant improvements in VAS pain scores from preoperative to last follow-up. For the Si3N4 group, ΔVAS was 36.8±35.4 points compared to 37.6±22.5 points (P=0.63) for the metadata group. Complications and reoperations for the Si3N4 and the control groups were similar (i.e., 9.8% and 3.1% versus 12.4% and 2.9%, P=0.16 and P=0.84, respectively). CONCLUSIONS: Lumbar fusion with Si3N4 spacers compared favorably with the improvements reported with other commonly used biomaterial cages.

Clinical outcomes for anterior cervical discectomy and fusion with silicon nitride spine cages: a multicenter study.

BACKGROUND: Intervertebral spacers made of silicon nitride (Si3N4) are currently used in cervical and thoracolumbar fusion. While basic science data demonstrate several advantages of Si3N4 over other biomaterials, large-scale clinical results on its safety and efficacy are lacking. This multicenter retrospective study examined outcomes for anterior cervical discectomy and fusion (ACDF) using Si3N4 cages. Results were compared to compiled metadata for other ACDF materials. METHODS: Pre-operative patient demographics, comorbidities, changes in visual analog scale (VAS) pain scores, complications, adverse events, and secondary surgical interventions were collected from the medical records of 860 patients who underwent Si3N4 ACDF at four surgical centers. For comparison, MEDLINE/PubMed and Google Scholar searches were performed for ACDF using other cage or spacer materials. Nine studies with 13 cohorts and 736 patients met the inclusion criteria for this control group. RESULTS: Overall, the mean last-follow-up for all patients was 319±325 days (10.6±10.8 months), with the longest follow-up being 6.5 years. In comparison to the metadata, patients from the Si3N4 groups were older (57.9±12.2 vs. 56.8±11.1 y, P=0.06) and had higher BMI values (30.0±6.3 vs. 28.1±6.5, P<0.01), but gender and smoking were not different. The Si3N4 patients reported significant improvements in VAS pain scores at last follow-up (i.e., pre-op of 71.0±22.1 vs. follow-up of 36.4±31.5, P<0.01). Although both preoperative and last-follow-up pain scores were higher for Si3N4 patients than the control, the overall change in scores (ΔVAS) was similar. From pre-op to last-follow up, ΔVAS values were 35.4±34.3 for patients receiving the Si3N4 implants versus 34.4±27.3 for patients from the meta-analysis (P=0.56). The complication and reoperation rate for the Si3N4 and the metadata were also comparable (i.e., 7.39% and 0.31% versus 9.79% and 0%, P=0.17 and 0.25, respectively). CONCLUSIONS: ACDF outcomes using Si3N4 implants matched the clinical efficacy of other cage biomaterials.

Comparison of two different fixation techniques for a segmental defect in a rat femur model.

Studies have attempted to identify the osteogenic effects of bone morphogenetic proteins using a rat femur model, which commonly involves the creation of a critical size defect followed by internal fixation of the femur. Among the most familiar fixation methods are either plating or intramedullary placement of a Kirschner wire (K-wire). There are advantages and disadvantages to each method; however, this study attempts to identify the best method by exploring the histological effects of each technique. The experiment involved two groups with no added treatment: Group P (plate fixation method) and Group K (K-wire fixation method). The animals were allowed a 4-week interval for the femurs to heal, and proximal, distal, and two midshaft cuts were examined under high-power microscopy after the fixation apparatus was removed. Group K exhibited a peculiar fibrotic healing pattern that followed the shaft of the then vacated K-wire and there was minimal new viable bone formation. Group P, however, exhibited a more natural ingrowth of newly formed bone that began at the proximal and distal cuts and proceeded centrally into the core of the defect. Due to the fibrotic tissue in Group K, this study shows that the model is insufficient due to the micromotion created and thus supports plating of critical defects as the fixation method of choice due to the creation of a stable healing environment.

Remote Cerebellar Hemorrhage after Revision Lumbar Spine Surgery.

Study Design Case report. Objective To report a case of remote cerebellar hemorrhage (RCH) without intraoperative dural tear after revision lumbar spine surgery. RCH is a rare postoperative complication following spine surgery. RCH has previously been reported only in cases with intraoperative dural tear or durotomy. Methods Case report and literature review. Results A 58-year-old woman underwent removal of L4-S1 posterior spinal instrumented fusion (PSIF) implants and L3-L4 decompressive laminectomy with PSIF. There was no intraoperative dural tear. After doing well initially, the patient developed new neurologic symptoms and was found to have RCH. Lumbar spine magnetic resonance imaging (MRI) demonstrated a large dural defect. After repair of the dura, the patient had dramatic improvement of her neurologic symptoms. At 1-year follow-up, the patient continued to have no neurologic sequelae. Conclusion This report demonstrates that RCH can occur without intraoperative dural tear. Although rare, any patient with new onset of declining neurologic symptoms following spine surgery should have a brain MRI and should have RCH on the differential diagnosis.

Cortical screws used to rescue failed lumbar pedicle screw construct: a biomechanical analysis.

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.

Use of permanently placed metal expandable cages for vertebral body reconstruction in the surgical treatment of spondylodiscitis.

This is a retrospective study of 15 patients treated for spondylodiscitis with implanted metal cages. The purpose of this study is to investigate the outcomes of patients treated with permanently placed metal hardware in vertebral body reconstruction for spondylodiscitis. The use of metal implants in the face of infection has classically been discouraged in orthopedic literature because of the ability of bacteria to form biofilms on metal surfaces. Traditional treatment of spondylodiscitis has been aggressive debridement followed by reconstruction with bone grafts. Expandable metallic cages made reconstruction of these defects significantly easier. However, concern exists that metallic implants affect the resolution of infection. A search of the authors' patient database from 2005 to 2009 revealed 21 patients with spondylodiscitis treated with anterior debridement and reconstruction with an expandable metallic cage. Fourteen patients (15 cases) had sufficient documented clinical follow-up and were available for review. Resolution of infection was determined by evaluating symptoms, laboratory data, and final radiographic result. Of the 15 cases, all had clinical resolution of infection with an average follow-up time of 25 months. An average loss of 1.9° of correction was observed when comparing final follow-up radiographs with initial postoperative radiographs. Radiograph review revealed no extensive osteolysis around the hardware or progressive collapse. These results suggest that the use of expandable metal cages maintains alignment while not perpetuating infection. The spine appears to provide a unique environment that permits the use of metal implants in the setting of infection.

Mechanical strength repercussions of various fixative storage methods on bone.

This study compensates for the lack of literature on the actual effects that various fixative storage methods have on the mechanical strength characteristics of bone and attempts to identify the ideal fixative method for preservation of all tissues while maintaining in vivo bone strength. Researchers currently use a wide variety of storage methods that lessen the mechanical strength to varying degrees. Differences could introduce error into a great number of bone fracture studies if an inexact discrepancy in the mechanical properties of fixed bone does actually exist. Furthermore, such disparities could go on to pose clinical risks for patients. This study focuses on the mechanical strength testing of four different groups of rat femora that were retrieved at various times and subjected to differing storage procedures. The first, Group N, were fresh, new femora retrieved just days before testing. The second, Group F, were femora that have been fixed in a 10% formalin bath for just over a year prior to testing. The third, Group W, are femora that have also been fixed in 10% formalin for just over a year but were washed out just prior to testing. The fourth, Group P, were femora that were retrieved from rats that were perfused with formalin immediately following euthanasia. Mechanical strength tests on the four groups revealed that fixing bone in a 10% formalin bath significantly reduces the mechanical fracture strength properties of the bone regardless of whether the formalin is washed out prior to testing. Testing also revealed that bone from perfused animals behaves more similarly to fresh bones from non-perfused animals suggesting that the formalin did not entirely infiltrate the bone and permanently fix the material. These results could have profound implications on how studies equate the behavior of in vitro bone to in vivo bone which could manifest as clinical complications for patients.