Load Sharing and Endplate Pressure Distribution in Anterior Interbody Fusion Influenced by Graft Choice.

BACKGROUND: Cage subsidence is a known complication of spinal fusion. Various aspects of cage design have been investigated for their influence on cage subsidence, whereas the potential contribution of graft material to load sharing is often overlooked. We aimed to determine whether graft in the aperture affects endplate pressure distribution. METHODS: The pressure distributions of a polyetheretherketone interbody cage with 3 different aperture graft conditions were evaluated: empty, demineralized bone matrix, and supercritical CO2-treated allograft bone crunch (SCCO2). RESULTS: Graft materials contributed as much as half the load transmission for SCCO2, whereas demineralized bone matrix contributed one third. Endplate areas in contact with the cage demonstrated decreased areas within the highest-pressure spectrum with SCCO2 graft materials compared with empty cages. CONCLUSIONS: Graft choice plays a role in reducing peak endplate pressures. This finding is relevant to implant subsidence, as well as graft loading and remodeling.

A comparison of contiguous two-level anterior cervical discectomy and fusion using a structural allograft versus a Polyetheretherketone (PEEK) cage: the results of a three-year follow-up.

BACKGROUND: Allografts and polyetheretherketone (PEEK) cages are the two most commonly used materials in anterior cervical discectomy and fusion (ACDF). However, their effectiveness in two-level ACDF remains controversial. The primary aim of this retrospective study was to compare the clinical and radiological outcomes of two-level ACDF with plate fixation using either a structural allograft or a PEEK cage. METHODS: From 2010 to 2015, 88 consecutive patients underwent two-level ACDF, of whom 53 received an allograft and 35 patients received a PEEK cage. All PEEK cages were filled with local autografts. All clinical outcomes were prospectively collected before and six months and two years after surgery. Clinical efficacy was evaluated using a visual analogue scale for neck pain and limb pain, the Neck Pain and Disability Score, the Neck Disability Index, the Neurogenic Symptom Score, and the Japanese Orthopedic Association score. Radiological outcomes were assessed preoperatively, immediately after surgery, and at the final follow-up. RESULTS: A preoperative comparison revealed no difference between the two patient groups in terms of age, sex, body mass index, smoking status, preoperative symptoms, operation level, or follow-up (mean = 42.8 months). No differences in the improvements in clinical outcomes were observed between the two groups. Both groups showed significant improvement in mean disc height, segmental height, and segmental lordosis postoperatively. The fusion rate for the PEEK cage was 100% at both levels, while the fusion rate for the allograft group was 98.1% at the cephalad level and 94.2% at the caudad level (p > 0.05). Subsidence at the cephalad level occurred in 22.9% (8/35) of segments in the PEEK group and 7.7% (4/52) of segments in the allograft group (p = 0.057). At the caudal level, a higher incidence of cage subsidence was noted in the PEEK group than in the allograft group [37.1% (13/35) versus 15.4% (8/52)] (p = 0.02). Overall, subsidence was noted in 30% (21/70) of the PEEK group and in 11% (12/104) of the allograft group (p <  0.05). CONCLUSION: The use of PEEK cages resulted in a higher rate of subsidence in two-level ACDF than the use of allografts. Two-level ACDF using either allografts or PEEK cages resulted in similar clinical outcomes, radiological improvements in alignment and fusion rates.

Surgical preference regarding different materials for custom-made allograft cranioplasty in patients with calvarial defects: Results from an internal audit covering the last 20 years.

BACKGROUND: Secondary cranioplasty (CP) plays a key role in restoring cranial vault anatomy and normal brain function following decompressive craniectomy (DC). The scientific literature provides only fragmentary information regarding the best timing and material for CP, making a direct comparison of different materials difficult. OBJECT: To identify and report according to STROBE guidelines local trends in choice of materials for CP, complications rate and surgical outcomes. METHODS: We conducted an audit on secondary CP covering the last 20 years of surgical practice at our Institution. Custom-made CP used over the years were made of: porous hydroxyapatite (PHA), polymetylmethacrylate (PMMA), polyetheretherketone (PEEK), acrylic and titanium. The primary endpoint of this study was the incidence of postoperative complications, such as: implant infection, fracture and dislocation. Secondary endpoints were the followings: patients satisfaction with cosmetic result, rate of implant integration, and long-term neurological outcome. RESULTS: A total of 218 patients were included, given the predominance of PHA (Group A) or PMMA (Group B) CP, a direct comparison was made only between those two groups. Overall reoperation rate was 6.5% versus 28%; implants' osseointegration rate was of 69% versus 24%; satisfaction rate was 66% versus 44%, in Group A and B respectively. CONCLUSIONS: This single-centre study provides Level 3 evidence that PHA yields better outcomes than PMMA CP. Designing a management algorithm for planning and executing CP is difficult for clinical and organizational reasons; till a widespread consensus is reached, neurosurgeons with subspecialty interest in neurotrauma should favor pragmatism and patient safety over costs.

[Observation of stand-alone MC+polyether-ether-ketone (PEEK) Cage in anterior cervical double-level fusion for more than 2 years follow-up].

OBJECTIVE: To investigate the effectiveness of stand-alone MC+polyether-ether-ketone (PEEK) Cage (single blade type) in anterior cervical double-level fusion for more than 2 years follow-up. METHODS: A clinical data of 30 patients who were treated with anterior cervical fusion surgery with stand-alone MC+PEEK Cage (single blade type) between January 2013 and December 2016 and followed up for more than 2 years, was retrospectively analyzed. There were 16 males and 14 females, aged from 34 to 72 years with an average of 52.2 years. There were 16 cases of cervical spondylotic myelopathy, 8 cases of cervical spondylotic myelopathy, and 6 cases of traumatic cervical disc herniation. The continuous double segments were C 4, 5, C 5, 6 in 12 cases and C 5, 6, C 6, 7 in 18 cases; and the disease duration ranged from3 days to 24 months (mean, 12 months). Postoperative neck hematoma and wound healing were observed; dysphagia was assessed by Bazaz system; and bone fusion was assessed by Suk method. Before operation, at 1 week after operation, and at last follow-up, the Japanese Orthopaedic Association (JOA) score was used to evaluate the neurological recovery; the cervical X-ray film was performed to record the cervical curvature (C 2-C 7 Cobb angle), the height of the intervertebral space of the fusion segment, and to judge the occurrence of the fusion Cage subsidence. RESULTS: No complication such as neck hematoma, incision infection, or esophageal fistula was found, primary healing of incisions was obtained in all cases. All patients were followed up 24-72 months (mean, 46 months). Neurological symptoms such as limb numbness and pain gradually disappeared after operation; during the follow-up period, the cervical curvature could be effectively maintained; dysphagia and internal fixation related complications such as displacement of Cages were not found. All patients obtained bony fusion from 3 to 8 months with an average time of 4.3 months. Compared with preoperative ones, the JOA score, intervertebral space height, and Cobb angle of cervical spine were significantly improved at 1 week after operation and at last follow-up ( P<0.05), but there was no significant difference between 1 week after operation and last follow-up ( P>0.05). CONCLUSION: The application of stand-alone MC+PEEK Cage (single card type) in anterior cervical fusion can provide early cervical stability, effectively maintain the physiological curvature of cervical spine and the height of fusion intervertebral space.

Comparison of allograft and polyetheretherketone (PEEK) cage subsidence rates in anterior cervical discectomy and fusion (ACDF).

Structural allografts and PEEK cages are commonly used interbody fusion devices in ACDF. The subsidence rates of these two spacers have not yet been directly compared. The primary aim of this study was to compare the subsidence rate of allograft and PEEK cage in ACDF. The secondary aim was to determine if the presence of subsidence affects the clinical outcome. We reviewed 67 cases (117 levels) of ACDF with either structural allograft or PEEK cages. There were 85 levels (48 cases) with PEEK and 32 levels (19 cases) with allograft spacers. Anterior and posterior disc heights at each operative level were measured at immediate and 6months post-op. Subsidence was defined as a decrease in anterior or posterior disc heights >2mm. NDI of the subsidence (SG) and non-subsidence group (NSG) were recorded. Chi-square test was used to analyze subsidence rates. T-test was used to analyze clinical outcomes (α=0.05). There was no statistically significant difference between subsidence rates of the PEEK (29%; 25/85) and allograft group (28%; 9/32) (p=0.69). Overall mean subsidence was 2.3±1.7mm anteriorly and 2.6±1.2mm posteriorly. Mean NDI improvement was 11.7 (from 47.1 to 35.4; average follow-up: 12mos) for the SG and 14.0 (from 45.8 to 31.8; average follow-up: 13mos) for the NSG (p=0.74). Subsidence rate does not seem to be affected by the use of either PEEK or allograft as spacers in ACDF. Furthermore, subsidence alone does not seem to be predictive of clinical outcomes of ACDF.

Polyetheretherketone interbody cages versus autogenous iliac crest bone grafts with anterior fixation for cervical disc disease.

OBJECTIVE: The aim of this study was to compare the fusion rate, operation time, recovery of disc space height, clinical duration and improvement, return to activities of daily living, and complication rate associated with anterior cervical discectomy with interbody fusion by using polyetheretherketone cages or autogenous iliac crest bone grafts as disc replacement in a series of 60 patients. MATERIALS AND METHODS: Between November 2006 and February 2010 a retrospective analytical observational cohort study was carried out in 60 consecutive patients surgically treated with anterior cervical discectomy with interbody fusion for degenerative disc desease at the Neurosurgical Department of the Hospital Italiano de Buenos Aires. The patients were divided into 2 groups for the assessment of clinical characteristics, demographics, fusion rates, duration of surgical procedure, neurological and functional outcomes, imaging results, and complications. Group A included patients treated with autogenous iliac crest bone grafts, and group B included patients treated with polyetheretherketone cages. RESULTS: The mean age of the patients was 50.8 years. Female patients comprised the majority in both groups (63.3%). Cervicobrachialgia was the most common presentation. Clinical improvement, fusion rates, and recovery of disc space height were similar in both groups. The operation time was significantly shorter in the polyetheretherketone group (P<0.001). Twenty percent (n=6) of the patients in group A suffered complications, >80% of which were associated with iliac crest bone graft harvesting. Patients in group B had no complications (P<0.05). CONCLUSIONS: Although outcomes were very successful in both groups in terms of fixation stability, recovery of disc space, return to activities of daily living and work, and remission of symptoms, operation time was considerably shorter for patients in the polyetheretherketone group, who had none of the complications associated with iliac crest bone graft harvesting, both differences being statistically significant.

Outcomes of interbody fusion cages used in 1 and 2-levels anterior cervical discectomy and fusion: titanium cages versus polyetheretherketone (PEEK) cages.

STUDY DESIGN: A prospective study was performed in case with cervical spondylosis who underwent anterior cervical discectomy and fusion (ACDF) with titanium or polyetheretherketone (PEEK) cages. OBJECTIVE: To find out which fusion cage yielded better clinical and radiographic results. SUMMARY OF BACKGROUND DATA: Although use of autogenous iliac-bone grafts in ACDF for cervical disc diseases remain standard surgical procedure, donor site morbidity and graft collapse or breakage are concerns. Cage technology was developed to prevent these complications. However, there is no comparison regarding the efficacy between titanium and PEEK cage. METHODS: January 2005 to January 2006, 53 patients who had 1 and 2-levels ACDF with titanium or PEEK cages were evaluated. We measured the rate and amount of interspace collapse, segmental sagittal angulations, and the radiographic fusion success rate. Odom criteria were used to assess the clinical results. RESULTS: The fusion rate was higher in the PEEK group (100% vs. 86.5%, P=0.0335). There was no significant difference between both groups in loss of cervical lordosis (3.2 + or - 2.4 vs. 2.8 + or - 3.4, P=0.166). The mean anterior interspace collapse (1.6 + or - 1.0 mm) in the titanium group was significantly higher than the collapse of the PEEK group (0.5 + or - 0.6 mm) (P<0.0001). The mean posterior interspace collapse was also higher in the titanium group (1.6 + or - 0.9 mm vs. 0.5 + or - 0.5 mm, P<0.0001). An interspace collapse of 3 mm or greater was observed in 16.2% of the patients in the titanium group, compared with zero patients in the PEEK group (P<0.0001). The PEEK group achieved an 80% rate of successful clinical outcomes, compared with 75% in the titanium group (P=0.6642). CONCLUSIONS: The PEEK cage is superior to the titanium cage in maintaining cervical interspace height and radiographic fusion after 1 and 2-levels anterior cervical decompression procedures.

Determination of carbonyl compounds in smoke samples: strategies for sampling and standardization.

There are significant drawbacks to the calibration procedure recommended in the normalized Spanish or American methods used to determine carbonyl compounds in ambient air by quantifying hydrazones that form with 2,4-dinitrophenylhydrazine. The impurities present in 2,4-dinitrophenylhydrazine, as well as the lack of quantitativity and the slow kinetics of some derivatization reactions can lead to considerable errors in quantification. This work proposes two alternative systems for sampling biomass smoke in order to analyze aldehydes and ketones. The standardization process used by both systems requires standard solutions to be reacted with 2,4-dinitrophenylhydrazine under experimental conditions similar to those used to collect the sample. The resulting calibration curve slopes differ between 8% and 74% from the curves used in methods that employ commercial standard hydrazone solutions. The detection limits reached by using the proposed methods are between 0.07 and 0.47 mg L(-1). Both methods are complementary for smoke samples that have significant differences in the concentrations of aldehydes or ketones.

The FEMA GRAS assessment of aromatic substituted secondary alcohols, ketones, and related esters used as flavor ingredients.

This publication is the 11th in a series of safety evaluations performed by the Expert Panel of the Flavor and Extract Manufacturers Association (FEMA). In 1993, the Panel initiated a comprehensive program to re-evaluate the safety of more than 1700 GRAS flavoring substances under conditions of intended use. The list of GRAS substances has now grown to more than 2100 substances. Elements that are fundamental to the safety evaluation of flavor ingredients include exposure, structural analogy, metabolism, pharmacokinetics and toxicology. Flavor ingredients are evaluated individually and in the context of the available scientific information on the group of structurally related substances. In this monograph, a detailed interpretation is presented on the renal carcinogenic potential of the aromatic secondary alcohol alpha-methylbenzyl alcohol, aromatic ketone benzophenone, and corresponding alcohol benzhydrol. The relevance of these effects to the flavor use of these substances is also discussed. The group of aromatic substituted secondary alcohols, ketones, and related esters was reaffirmed as GRAS (GRASr) based, in part, on their rapid absorption, metabolic detoxication, and excretion in humans and other animals; their low level of flavor use; the wide margins of safety between the conservative estimates of intake and the no-observed-adverse effect levels determined from subchronic and chronic studies and the lack of significant genotoxic and mutagenic potential.

Anterior cervical fusion with polyetheretherketone (PEEK) cages in the treatment of degenerative disc disease. Preliminary observations in 36 consecutive cases with a minimum 12-month follow-up.

STUDY DESIGN: Retrospective analysis of 36 cases of degenerative disc disease treated by interbody fusion with polyetheretherketone (PEEK) cages. OBJECTIVE: To determine the safety and efficiency of PEEK cages for anterior cervical fusion (ACF). SUMMARY OF BACKGROUND DATA: ACF with autologous bone has been reported since over 50 years ago. The recent development of cages housing materials inducing osteogenesis simplifies the technique of interbody fusion. The main purposes of bone substitutes for ACF are immediate biomechanical support, osteo-integration of the graft, and elimination of local side effects at the donor site. This report shows our results using PEEK cages. MATERIALS AND METHODS: During an 18-month period, 36 consecutive patients had cervical fusions at 43 levels between C3 and C7. All operations involved one or two disc spaces for degenerative disc disease. We implanted all disc spaces with PEEK cages (Stryker Corporation, Kalamazoo, MI) containing granulated coralline hydroxylapatite (Pro-Osteon 200, Interpore Cross International, Irvine, CA) or deantigenated pig bone in a gel solution (Gen-Os, Tecnoss, Torino, Italy). RESULTS: About 97% of patients had a good to excellent outcome; the result in one myelopathic patient was fair. The cervical fusion rate was 16.7% at 3 months, 61.1% at 6 months, and 100% at one year. CONCLUSIONS: PEEK cages appear to be safe and efficient for ACF. In order to confirm our preliminary impressions studies on larger series with long term follow-up are warranted.