Introduction. Periprosthetic infections are leading causes of revision surgery resulting in significant increased patient comorbidities and costs. Considerable research has targeted development of biomaterials that may eliminate implant-related infections. 1. This in vitro study was developed to compare biofilm formation on three materials used in spinal fusion surgery – silicon nitride, PEEK, and titanium – using one gram-positive and one gram-negative bacterial species. Materials and Methods. Several surface treated silicon nitride (Si. 3. N. 4. , MC2. ®. , Amedica Corporation, Salt Lake City, UT), poly-ether-ether-ketone (PEEK, ASTM D6262), and medical grade titanium (Ti6Al4V, ASTM F136) discs Ø12.7 × 1mm were prepared or acquired for use in this well-plate study. Each group of discs (n=3) were ultrasonically cleaned, UV-sterilized, inoculated with 10. 5. Staphylococcus epidermidis (ATCC. ®. 25922™) or Escherichia coli (ATCC. ®. 14990™) and placed in a culture medium of phosphate buffered saline (PBS) containing 7% glucose and 10% human plasma on a shaking incubator at 37°C and 120 rpm for 24 or 48 hrs. Coupons were retrieved, rinsed in PBS to remove planktonic bacteria, placed in a centrifuge with fresh PBS, and vortexed. The bacterial solutions were serially diluted, plated, and incubated at 37°C for 24 to 48 hrs. Colony forming units (CFU/mm. 2. ) were counted using applicable dilution factors and surface areas. A two-tailed, heteroscedastic Student's t-test (95% confidence) was used to determine statistical significance. Results. Biofilm adhesion results are provided in Figures 1 and 2 for S. epi. and E. coli, respectively. For S. epi. at 24 hrs, biofilm growth on PEEK was about three orders of magnitude greater than on Ti6Al4V or any Si. 3. N. 4. material (all p<0.005). Ti6Al4V also had more bacteria than the Si. 3. N. 4. samples, but was only significant for as-fired and nitrogen-annealed treatments. Similar trends and significance for S. epi. were observed at 48 hrs. For E. coli, biofilm formation on PEEK was significantly greater than all other materials at both 24 and 48 hrs. Bacterial growth on Ti6Al4V was also statistically greater than all Si. 3. N. 4. conditions, with the possible exception of nitrogen-annealed Si. 3. N. 4. By 48 hrs, PEEK remained 2 orders of magnitude above Ti6Al4V, and 2.5–3 orders of magnitude greater than the Si. 3. N. 4. conditions. Ti6Al4V was also significantly greater than all of the Si. 3. N. 4. treatments at 48 hrs. Discussion. Si. 3. N. 4. , PEEK, and Ti6Al4V surfaces demonstrated significant differences in bacterial adhesion and proliferation for both gram-positive S. epi. and gram-negative E. coli, particularly at 48 hrs post-inoculation. The various Si. 3. N. 4. samples showed the most favorable bacterial resistance for both species tested. The exact mechanism of the bacteriostatic behavior of Si. 3. N. 4. is still under investigation; but it may result from chemical interaction with the material's surface to form peroxynitrite (a powerful oxidative agent). 2. Conclusion. Identifying biomaterial surfaces that resist biofilm adhesion is an important emerging strategy in addressing implant-related infections. Si. 3. N. 4. is a new biomaterial with the apparent potential to suppress biofilm formation

Surgical site infections (SSIs) after spinal fusion surgery increase healthcare costs, morbidity and mortality. Routine measures of obesity fail to consider site specific fat distribution. We aimed to assess the association between the spine adipose index and deep surgical site infection and determine a threshold value for spine adipose index that can assist in preoperative risk stratification in patients undergoing posterior instrumented lumbar fusion (PILF). A multicentre retrospective case-control study was completed. We reviewed patients who underwent PILF from January 1, 2010 to December 31, 2018. All patients developing a deep primary incisional or organ-space SSI within 90 days of surgery as per US Centre for Disease Control and Prevention criteria were identified. We gathered potential pre-operative and intra-operative deep infection risk factors for each patient. Spine adipose index was measured on pre-operative mid-sagittal cuts of T2 weighted MRI scans. Each measurement was repeated twice by three authors in a blinded fashion, with each series of measurement separated by a period of at least six weeks. Forty-two patients were included in final analysis, with twenty-one cases and twenty-one matched controls. The spine adipose index was significantly greater in patients developing deep SSI (p =0.029), and this relationship was maintained after adjusting for confounders (p=0.046). Risk of developing deep SSI following PILF surgery was increased 2.0-fold when the spine adipose index was ≥0.51. The spine adipose index had excellent (ICC >0.9; p <0.001) inter- and intra-observer reliabilities. The spine adipose index is a novel radiographic measure and an independent risk factor for developing deep SSI, with 0.51 being the ideal threshold value for pre-operative risk stratification in patients undergoing PILF surgery

Hip instability is one of the most common causes for total hip arthroplasty (THA) revision surgery. Studies have indicated that lumbar fusion (LF) surgery is a risk factor for hip dislocation. Instrumented spine fusion surgery decreases pelvic tilt, which might lead to an increase in hip motion to accommodate this postural change. To the best of our knowledge, spine-pelvis-hip kinematics during a dynamic activity in patients that previously had both a THA and LF have not been investigated. Furthermore, patients with a combined THA and LF tend to have greater disability. The purpose was to examine spine-pelvis-hip kinematics during a sit to stand task in patients that have had both THA and LF surgeries and compare it to a group of patients that had a THA with no history of spine surgery. The secondary purpose was to compare pain, physical function, and disability between these patients. This cross-sectional study recruited participants that had a combined THA and LF (n=10; 6 females, mean age 73 y) or had a THA only (n=11; 6 females, mean age 72 y). Spine, pelvis, and hip angles were measured using a TrakSTAR motion capture system sampled at 200 Hz. Sensors were mounted over the lateral thighs, base of the sacrum, and the spinous process of the third lumbar,12th thoracic, and ninth thoracic vertebrae. Participants completed 10 trials of a standardized sit-to-stand-to-sit task. Hip, pelvis, lower lumbar, upper lumbar, and lower thoracic sagittal joint angle range of motion (ROM) were calculated over the entire task. In addition, pain, physical function, and disability were measured with clinical outcomes: Hip Disability Osteoarthritis Outcome Score (pain and physical function), Oswestry Low Back Disability Questionnaire (disability), and Harris Hip Score (pain, physical function, motion). Physical function performance was measured using 6-Minute Walk Test, Stair Climb Test, and 30s Chair Test. Angle ROMs during the sit-to-stand-to-sit task and clinical outcomes were compared between THA+LF and THA groups using independent t-tests and effect sizes (d). The difference in hip ROM was approaching statistical significance (p=0.07). Specifically, the THA+LF group had less hip ROM during the sit-to-stand-to-sit task than the THA only group (mean difference=11.17, 95% confidence interval=-1.13 to 23.47), which represented a large effect size (d=0.83). There were no differences in ROM for pelvis (p=0.54, d=0.28) or spinal (p=0.14 to 0.97; d=0.02 to 0.65) angles between groups. The THA+LF group had worse clinical outcomes for all measures of pain, physical function, and disability (p=0.01 to 0.06), representing large effect sizes (d=0.89 to 2.70). Hip ROM was not greater in the THA+LF group, and thus this is unlikely a risk factor for hip dislocation during this specific sit-to-stand-to-sit task. Other functional tasks that demand greater excursions in the joints should be investigated. Furthermore, the lack of differences in spinal and pelvis ROM were likely due to the task and the THA+LF group had spinal fusions at different levels. Combined THA+LF results in worse clinical outcomes and additional rehabilitation is required for these patients

Proximal junctional kyphosis (PJK) is defined as adjacent segment kyphosis >10° between the upper instrumented vertebrae and the vertebrae 2 levels above following scoliosis surgery. There are few studies investigating the predictors and clinical sequelae involved with this relatively common complication. Our purpose was to determine the radiographic predictors of post-op PJK and to examine the association between PJK and pain/HRQOL following surgery for AIS. The Post-Operative Recovery after Scoliosis Correction: Home Experience (PORSCHE) study was a prospective multicenter cohort of AIS patients undergoing spinal fusion surgery. Pre-op and minimum 2 year f/u scoliosis and sagittal spinopelvic parameters (thoracic kyphosis–TK, lordosis–LL, pelvic tilt-PT, sacral slope-SS, pelvic incidence-PI) were measured and compared to numeric rating scale for pain (NRS) score, SRS-30 HRQOL and to the presence or absence of PJK (proximal junctional angle >100). Continuous and categorical variables were assessed using logistic regression and binomial variables were compared to binomial outcomes using chi-square. 163 (137 females) patients from 8 Canadian centers met inclusion criteria. At final f/u, PJK was present in 27 patients (17%). Pre-op means for PJK vs No PJK: Age 14.1 vs 14.7yr; females 85 vs 86%; scoliosis 57±22 vs 62±15deg; TK 28±18 vs 19±16deg ∗, LL 62±11 vs 60±12deg, PT 8±12 vs 10±10deg, SS 39±8 vs 41±9deg, PI 47±14 vs 52±13deg, SVA −9±30 vs −7±31mm. Final f/u for PJK vs No PJK: Scoliosis 20±11 vs 18±8deg, final TK 26±12 vs 19±10deg∗, LL 60±11 vs 57±12deg, PT 9±12 vs 12±13deg, SS 39±9 vs 41±9deg, PI 48±17 vs 52±14deg, SVA −23±26 vs −9±32mm∗. Significant findings: Pre-op kyphosis >40deg has an odds ratio (OR) of 4.41 (1.50–12.92) for developing PJK∗. The presence of PJK was not associated with any significant differences in NRS or SRS-30. ∗denotes p<0.05. This prospective multicenter cohort of AIS patients demonstrated a 17% risk of developing PJK. Pre-op thoracic kyphosis >40deg was associated with the development of PJK; however, the presence of PJK was not associated with increased pain or decreased HRQOL

Low back pain is more common in women than men, yet most studies of intervertebral disc (IVD) degeneration do not address sex differences. In humans, there are sex differences in spinal anatomy and degenerative changes in biomechanics, and animal models of chronic pain have demonstrated sex differences in pain transduction. However, there are few studies investigating sex differences in annular puncture IVD degeneration models. IVD puncture is known to result in progressive biomechanical alterations, but whether these IVD changes correlate with pain is unknown. This study used a rat IVD injury model to determine if sex differences exist in mechanical allodynia, biomechanics, and the relationship between them, six weeks after IVD injury. Procedures were IACUC approved. 24 male & 24 female four-month-old Sprague-Dawley rats underwent a sham or annular puncture injury surgery (n=12 male, 12 female). In injury groups, three lumbar IVDs were each punctured three times with a needle, and injected with tumor necrosis factor-alpha. Mechanical allodynia was tested biweekly using von Frey filaments. Six weeks after IVD injury, rats were euthanized and motion segments were dissected for non-destructive axial tension-compression and torsional rotation biomechanical testing. Two-way ANOVA with Bonferroni corrections identified statistically significant differences (p < 0 .05) and correlations used Pearson's coefficient. Annular puncture injury induced a significant increase in mechanical allodynia compared to sham in male but not female rats up to six weeks after injury. There was a significant sex effect on both torque range and torsional stiffness, with males exhibiting greater stiffness and torque range than females. Tensile stiffness, compressive stiffness, and axial range of motion showed no sex difference. Males and females showed similar patterns of correlation between variables when sham and injury groups were analyzed together, but correlations were stronger in males. Most correlations were clustered within testing approach: axial biomechanics negatively correlated, torsional biomechanics positively correlated, and von Frey thresholds positively correlated. Surprisingly, mechanical allodynia did not correlate with any biomechanics after injury, and the axial and torsional biomechanics showed little correlation. This study demonstrates that males and females respond to IVD injury differently. Given the absence of correlation between pain and biomechanics, pain cannot be attributed completely to biomechanical changes. This may explain why spinal fusion surgery, an intervention limited to the spine, has produced inconsistent results and is controversial for patients with low back pain. Thus, in addressing low back pain, we must consider both spinal tissues and the nervous system. Further, the limited correlation between axial and torsional biomechanics indicates that IVD injury may have distinct effects on nucleus pulposus and annulus fibrosus. Biomechanics did not differ between sham and injury at week six, suggesting healing after injury. It remains possible that acute biomechanical changes may initiate chronic pain pathogenesis. We conclude that the observed sex differences demonstrate the need for inclusion of both males and females in IVD injury and pain studies, and suggest that males and females may require different treatments for conditions that appear similar

Introduction. Support of appositional bone ingrowth and resistance to bacterial adhesion and biofilm formation are preferred properties for biomaterials used in spinal fusion surgery. Although polyetheretherketone (PEEK) is a widely used interbody spacer material, it exhibits poor osteoconductive and bacteriostatic properties. In contrast, monolithic silicon nitride (Si. 3. N. 4. ) has shown enhanced osteogenic and antimicrobial behavior. Therefore, it was hypothesized that incorporation of Si. 3. N. 4. into a PEEK matrix might improve upon PEEK's inherently poor ability to bond with bone and also impart resistance to biofilm formation. Methods. A PEEK polymer was melted and compounded with three different silicon nitride powders at 15% (by volume, vol.%), including: (i) α-Si. 3. N. 4. ; (ii) a liquid phase sintered (LPS) ß-Si. 3. N. 4. ; and (iii) a melt-derived SiYAlON mixture. These three ceramic powders exhibited different solubilities, polymorphic structures, and/or chemical compositions. Osteoconductivity was assessed by seeding specimens with 5 × 10. 5. /ml of SaOS-2 osteosarcoma cells within an osteogenic media for 7 days. Antibacterial behavior was determined by inoculating samples with 1 × 10. 7. CFU/ml of Staphylococcus epidermidis (S. epi.) in a 1 × 10. 8. /ml brain heart infusion (BHI) agar culture for 24 h. After staining with PureBlu™ Hoechst 33342 or with DAPI and CFDA for SaOS-2 cell adhesion or bacterial presence, respectively, samples were examined with a confocal fluorescence microscope using a 488 nm Krypton/Argon laser source. Images were also acquired using a FEG-SEM in secondary and backscattered modes on gold sputter-coated specimens (∼20–30Å). Hydroxyapatite (HAp) deposition was measured using a laser microscope. Raman spectra were collected for samples in backscattering mode using a triple monochromator using a 532 nm excitation source (Nd:YVO. 4. diode-pumped solid-state laser). Results. PEEK composites with 15 vol.% α-Si. 3. N. 4. , LPS ß-Si. 3. N. 4. , or the SiYAlON mixture showed significantly greater SaOS-2 cell proliferation (>600%, p<0.003, cf., Fig. 1(a)) and HAp deposition (>100%, p<0.003, cf., Fig. 1(b)) relative to monolithic PEEK. The largest increase in cell proliferation was observed with the SiYAlON composite, while the greatest amount of HAp was found on the LPS ß-Si. 3. N. 4. composite. Following exposure to S. epidermidis, the composite containing the LPS β-Si. 3. N. 4. powder showed one order of magnitude reduction in adherent live bacteria (p<0.003, cf., Fig. 1(c)) as compared to the PEEK monolith. It is interesting to note that the composite containing α-Si. 3. N. 4. exhibited the worst bacterial resistance (i.e., ∼100% higher than monolithic PEEK), suggesting that the bacteriostatic effectiveness of Si. 3. N. 4. bioceramics is apparently dependent upon the presence of selective sintering additives, viz. yttria and alumina. Conclusions. The addition of 15 wt.% of specific Si. 3. N. 4. powders to PEEK showed enhanced SaOS-2 cell adhesion, proliferation, and HAp deposition when compared to monolithic PEEK. These same composites also showed resistance to S. epi. adhesion and biofilm formation.. Although improvements in osteoconductivity have been previously observed by compounding or coating PEEK with HAp, titanium, or tantalum, these approaches did not provide anti-microbial properties. Compounding PEEK with Si. 3. N. 4. represents a significant advancement due to its ability to provide both improved bone apposition and resistance to biofilm formation. For any figures or tables, please contact the authors directly

Purpose of study. This RCT is to determine whether or not there is a clinical benefit from inserting a dynamic stabilising implant such as the Wallis ligament on the functional recovery of patients who have undergone lumbar decompression surgery. This Interspinous implant was developed as an anatomically conserving procedure without recourse to lumbar spinal fusion surgery. The biomechanical studies have shown that unloading the disc and facet joints reduces intradiscal pressures at same and adjacent levels. The aim of this study was to identify a patential Wallis affect. Methods. Ethicallly approved. Patients were randomized into 2 groups, decompression alone or decompression with wallis interspinous ligament stabilisation. Patients were assessed pre operatively and post operatively every 6 months by VAS pain score and Oswestry Disability Index. Summary of findings. A total of 60 patients were recriuted the study from October 2005. Equal number had been randomized into two groups. The mean age of 54 (24–85) and the average follow is 36 months (6–48). The results were significantly better in decompression plus Wallis group compared to decompression alone, showing a minimal clinical difference compared to the control group. Relationship between findings and existing knowledge: Our results deomonstrate that clincial outcomes are significantly better when a Wallis implant was used in lumbar deompression. Patients experienced less back pain. Overall significance of findings: The Wallis implant represents a successful non fusion stabilisation device in the treatment of degenerative lumbar spine disease with canal stenosis. Minimal soft tissue dissection, quick rehabilitation, low morbidity. The Wallis ligament sucessfully treats spinal stenosis by reducing pain score, preserving mobility, and function

Oxide ceramics, such as alumina and zirconia have been used extensively in arthroplasty bearings to address bearing wear and mitigate its delayed, undesirable consequences. In contrast to oxide ceramics that are well-known to orthopaedic surgeons, silicon nitride (Si. 3. N. 4. ) is a non-oxide ceramic that has been investigated extensively in very demanding industrial applications, such as precision bearings, cutting tools, turbo-machinery, and electronics. For the past four years, Si. 3. N. 4. has also been used as a biomaterial in the human body; specifically in spinal fusion surgery. As a implantable biomaterial, Si. 3. N. 4. has unique properties, such as high strength and fracture toughness, inherent chemical and phase stability, low wear, proven biocompatibility, excellent radiographic imaging, antibacterial advantages, and superior osteointegration. This property combination has proven beneficial and desirable in orthopaedic implants made for spinal fusion, spinal disc reconstruction, hip and knee arthroplasty, and other total joints (Fig. 1). The physical properties, shapes, sizes and surface features of Si. 3. N. 4. can be engineered for each application – ranging from dense, finely polished articulation components, to highly porous scaffolds that promote osteointegration. Both porous and polished surfaces can be incorporated in the same implant, opening a number of opportunities for arthroplasty implant design. Crack propagation modes for in situ toughened Si. 3. N. 4. differ favorably from those of conventional ceramics, rendering Si. 3. N. 4. extremely resistant to catastrophic failure in vivo (Fig. 2). Most significantly, our recent work has shown that Si. 3. N. 4. is resistant to bacterial biofilm formation, colonization and growth, when compared to medical-grade PEEK and titanium. These anti-infective characteristics are particularly valuable for in vivo implantation. We will present the unique properties and characteristics of Si. 3. N. 4. , and compare these to other ceramic and non-ceramic biomaterials. Si. 3. N. 4. was once used only in industrial applications, but early data show that this novel biomaterial is positively impacting orthopaedic care and will continue to do so into the future

Introduction. Problematic bone defects are encountered regularly in orthopaedic practice particularly in fracture non-union, revision hip and knee arthroplasty, following bone tumour excision and in spinal fusion surgery. At present the optimal source of graft to ‘fill’ these defects is autologous bone but this has significant drawbacks including harvest site morbidity and limited quantities. Bone marrow has been proposed as the main source of osteogenic stem cells for the tissue-engineered cell therapy approach to bone defect management. Such cells constitute a minute proportion of the total marrow cell population and their isolation and expansion is a time consuming and expensive strategy. In this study we investigated human bone marrow stem cells as a potential treatment of bone defect by looking at variability in patient osteogenic cell populations as a function of patient differences. We produced a model to predict which patients would be more suited to cell based therapies and propose possible methods for improving the quality of grafts. Methods. Bone marrow was harvested from 30 patients undergoing elective total hip replacement surgery in Musgrave Park Hospital, Belfast (12 males, 18 females, age range 52-82 years). The osteogenic stem cell fraction was cultured and subsequently analysed using colony forming efficiency assays, flow cytometry, fluorescence activated cell sorting and proteomics. Results. The number and proliferative capacity of osteogenic stem cells varied markedly between patients. Statistical analysis revealed significantly better osteogenic capacity in:. male patients. samples in which the growth hormone Fibroblastic Growth Factor-2 was added to culture medium. patients who used the cholesterol lowering agent simvastatin. Patient use of inhaled steroids and NSAIDs were found to have detrimental effects. A statistical model to predict marrow profiles based on these variables was produced. Conclusions. Stem cell based tissue engineering represents the future of the treatment of bone defect. This study provides evidence that inter-patient variability in marrow cell colony forming and proliferation ability can in some way be explained by patient associated factors. Using this knowledge, we can identify which patients would be best suited to this method of treatment and propose techniques for enhancement of their graft profiles